Search Results

An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.

All Kirchner & Wilhelm ophthalmoscopes are battery powered. The Piccolight E50 and Eurolight E10 and E30 are single aperture ophthalmoscopes while the Piccolight E56 and Eurolight E36 have six apertures each. The Piccolight and Eurolight series are different in the handles, with Piccolight handles made of PA 6 GF 30% while Eurolight handles are made of metal. The Piccolight E50 and Eurolight E10 heads are same as the Eurolight E30 head except for the locking system. Similarly, but for the locking system, the Piccolight E56 and Eurolight E36 heads are the same.

This document is a 510(k) summary for ophthalmoscopes. It's a regulatory submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study reporting on the device's performance against specific acceptance criteria in a clinical trial or stand-alone testing. Therefore, many of the requested details, such as sample sizes, expert qualifications, and specific effectiveness metrics, are not applicable or available within this type of document.

However, I can extract information related to product specifications and how the device aims to meet the regulatory requirements for safety and effectiveness through comparison to predicate devices.

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission and not a clinical study report, formal "acceptance criteria" for performance metrics in the typical sense of a clinical trial are not presented. Instead, the document demonstrates substantial equivalence to predicate devices based on functional characteristics and intended use. The "reported device performance" is essentially its similarity to the predicate devices in the listed attributes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe "test sets" in the sense of patient data for evaluating a diagnostic or therapeutic algorithm. The assessment is qualitative by comparing device specifications and intended use to predicate devices and adherence to recognized standards. Therefore, there is no sample size or data provenance in this context.

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 applicable. This is not a study assessing diagnostic performance against a ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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

Not applicable. This is a submission for a medical device (ophthalmoscope) and not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This involves a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this submission are the established safety and effectiveness profiles of the predicate devices and conformity to recognized international standards.

8. The sample size for the training set

Not applicable. There is no machine learning or AI algorithm described in this submission.

9. How the ground truth for the training set was established

Not applicable.

Ask a specific question about this device