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Nevoscope is a hand-held, skin examination microscope that is similar in concept to the Episcope (K920103) and the Dermatoscope devices approved by the FDA. It is a non invasive device that is designed to view skin lesions by either surface illumination or transillumination. Light is directed onto the skin by a special light ring that is coupled to an AC powered halogen lamp by an optical fiber bundle. Built-in mirrors permit viewing a skin lesion from different elevations and angles simultaneously. A variable focus zoom lens controls the magnification of the lesion and a CCD TV camera is attached for image viewing and digitization. Skin lesion images can be stored in the computer for analysis and archiving.
The provided text describes a medical device called "Nevoscope" and compares it to existing devices (Episcope and Dermatoscope). However, it does not contain information about acceptance criteria, specific device performance metrics, detailed study designs, sample sizes for test or training sets, ground truth establishment, or expert qualifications in the manner typically required to fill the requested table and answer the study-related questions.
The document is a 510(k) summary from 1995, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with quantitative performance metrics against pre-defined acceptance criteria.
Therefore, most of the information requested cannot be extracted from this text.
Here's what can be inferred or directly stated based on the provided text, and where information is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| The Nevoscope is described as functioning similarly to the Episcope and Dermatoscope for surface illumination. It also offers additional features: transillumination and mirror views. | |
| "Research papers and scientific presentations have been made that demonstrate the surface illumination imaging with the Nevoscope and the additional information obtained by transillumination." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: The device "has been tested in skin lesion patients" and "has been in clinical research setting for the last three years." This suggests prospective data collection in a clinical research setting, but country of origin is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study is described. The device is a diagnostic imaging tool, not specifically an AI-assisted reader workflow. The text describes the device's imaging capabilities, not its impact on human reader performance in a controlled study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The Nevoscope is a viewing and imaging device for human interpretation, not an algorithm that performs standalone diagnosis. Therefore, no standalone algorithmic performance study would be applicable or described here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. Given the context of skin lesion assessment, pathology would be a common ground truth, but it is not mentioned.
8. The sample size for the training set
- Not specified. The document does not describe a machine learning algorithm that would require a "training set" in the modern sense. It describes a medical device used for physicians to view lesions.
9. How the ground truth for the training set was established
- Not applicable, as no training set for a machine learning algorithm is mentioned.
§ 880.6320 AC-powered medical examination light.
(a)
Identification. An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.