Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display. Final order.

The Food and Drug Administration (FDA) is classifying the continuous glucose monitor secondary display into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the continuous glucose monitor secondary display's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Using visual displays as a tool to demonstrate disease management program effectiveness.

With the rapid introduction of new medical and information technologies, there are much more data available today than ever before. Translating data into useful information for a wide variety of audiences is a challenge for health care in general and disease management programs in particular. This paper addresses these issues by introducing several visual displays that illustrate important data elements in an unencumbered fashion. Examples are provided using the various stages of a hypothetical congestive heart failure (CHF) disease management program (ie, patient identification, program enrollment, intervention process, and outcomes evaluation).

Influence of displayed image size on radiographic detection of approximal caries.

OBJECTIVES: To evaluate the validity of approximal caries detection on digital bitewing radiographs displayed at different image sizes on either a cathode ray tube (CRT) monitor or a thin film transistor (TFT) monitor. METHODS: Five observers assessed digital radiographs of a charge-coupled device (CCD)-based sensor system (Sidexis) of 160 unrestored premolars and molars for approximal caries using a six category caries rating scale. Images were displayed at ratios of 1:1, 1:2 and 1:7 on a CRT monitor (Nokia 446 XS) and a TFT display (Panasonic LC 50S). Histological assessments of serial sections were used as the validation standard. Diagnostic accuracy was expressed as area under the receiver operating characteristic (ROC) curve (AUC) and was calculated at two levels of caries penetration: presence of caries (I) and presence of a lesion in the dentine (II). The influence of the factors "monitor type", "image size" and "validation threshold" were analysed with repeated measures analysis of variance. RESULTS: The ROC curve areas for approximal caries detection at both histological penetration levels were not influenced by the type of monitor display, whereas image size had a significant impact (P<0.01). AUCs for image size 1:7 (I, 0.62; II, 0.65) were smaller compared with ratios of 1:1 and 1:2 (P<0.01). No differences were observed between image size ratios 1:1 (I, 0.69; II, 0.74) and 1:2 (I, 0.68; II, 0.73). CONCLUSIONS: In this study, the type of monitor did not influence approximal caries detection on digital radiographs. Image sizes with a display ratio of 1:1 and 1:2 resulted in better diagnostic validity than those with a ratio of 1:7.

Comparison of digital dental X-ray systems with self-developing film and manual processing for endodontic file length determination.

Human skulls were sectioned into 15 sextants. Teeth were then removed and 45 canals were instrumented to their apical foramina. Endodontic files were glued in place at random distances from the apical foramina. Image geometry was maintained by a custom mounting jig. Images were captured with self-developing film, manually processed D-speed film, and a digital radiographic system (Dexis). Digital images were read on a conventional color monitor (cathode ray tube) and a laptop screen (active-matrix liquid crystal display). Fifteen dentists measured the distance from the file tip to the apical foramen of the tooth. Results showed that the measurement error was significantly less for the digital images than for the film-based images. It is likely that these statistical differences may not be of great clinical significance because the digital images could be measured in increments < 0.25 mm.

High-fidelity electronic display of digital radiographs.

A fully digital radiography system requires high-fidelity electronic display devices that preserve diagnostic quality. Current cathode-ray tube monitors do not meet desired performance criteria for displaying radiographs and have excessive size, weight, and power consumption. Recent developments in flat-panel display technology (in particular active-matrix liquid crystal displays, field-emission displays, and organic light-emitting displays) suggest that high-fidelity, lightweight displays will be available in the near future. Large-size active-matrix liquid crystal display devices have been demonstrated. High brightness can be easily achieved with bright back illumination. Further developments in optical design for monochrome displays should provide high fidelity and improve the angular dependence of the emitted light. Field-emission display devices have attractive emission distribution and potential for low veiling glare. This technology needs to be extended to a large area, and problems with cathode aging and nonuniformity have to be contemplated. Organic light-emitting displays represent a simple and potentially inexpensive display technology with the ability to achieve high image quality. However, extensive research and development is required to achieve large-area manufacturing methods.