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The VISUCAM™ Fundus Camera is intended to capture, display and store images of eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.

The VISUCAMite model is designed for a more general ophthalmology practice than the VISUPAC Fundus Camera. Therefore the VISUCAM™ is a more compact model of the VISUPAC Fundus Camera and designed for less specialized ophthalmic practices. Certain technical specifications for the VISUCAMite have been modified because the VISUCAM™ model is not designed for indocyanine angiography and imaging that requires very high image resolution, different field angles, and corresponding viewing fields. Specifically, Zeiss has modified the cleared device to: {1} reduce the light intensity; (2) eliminate specific device equipment like an external power supply unit, an external computer with storage and archiving module, and different external dedicated electronic cameras as well as dedicated photographic equipment; (3) reduce the available viewing angles and image resolution; and (4) revise the device software to accommodate less demanding image processing requirements.

The provided text describes a 510(k) premarket notification for a device modification, not a study designed to meet specific acceptance criteria with performance metrics. The document asserts "substantial equivalence" to a predicate device rather than demonstrating performance against a predefined set of criteria through a dedicated study.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory submission. The submission focuses on explaining the modifications and arguing that these modifications do not affect safety or efficacy when compared to the previously cleared predicate device.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

Acceptance Criteria and Device Performance

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics against such criteria. The core assertion is that the modified device is "virtually identical" to the predicate with "minor variations that are detailed introduced," meaning it is expected to perform equivalently.

The modifications are:

• Reduced light intensity.
• Elimination of specific device equipment (external power supply, external computer with storage/archiving, external dedicated electronic cameras, dedicated photographic equipment).
• Reduced available viewing angles and image resolution.
• Revised device software for less demanding image processing.

The conclusion drawn is that these modifications "do not affect any question for safety and efficacy," implying the device's performance, post-modification, is still considered safe and effective at a level comparable to the predicate for its intended use, despite the reduced capabilities.

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

Not applicable. This is a 510(k) submission for a device modification asserting substantial equivalence. There is no mention of a formal "test set" or a study involving patient data to evaluate performance for these specific modifications. The comparison appears to be on the technical specifications and components of the modified device versus the predicate device.

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. No "experts" are described as being used to establish ground truth for a test set in this regulatory submission. The comparison is feature-based against the predicate device.

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

Not applicable. No test set requiring adjudication is mentioned.

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 document pertains to a fundus camera modification, not an AI-based diagnostic tool. No MRMC study is mentioned.

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

Not applicable. This document pertains to a fundus camera, not an algorithm, and no standalone performance study is mentioned.

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

Not applicable. No ground truth is established or discussed in the context of a performance study for these modifications. The "ground truth" for the submission is the performance and safety profile of the legally marketed predicate device (FF450plus Fundus Camera and VISUPAC Digital Image Archiving System).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; thus, no training set size is relevant or mentioned.

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

Not applicable. See point 8.

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