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Cataractscreener CT-S is designed to observe lens opacity of human eye by retroillumination method.

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This is a 510(k) premarket notification for the Neitz Cataract Screener CT-S, a device intended to observe lens opacity of the human eye using a retroillumination method. This document is a clearance letter from the FDA, and as such, it does not contain the detailed study information typically found in a clinical trial report or a comprehensive device submission.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies is not available within the provided text. The document is primarily a regulatory approval acknowledging substantial equivalence.

However, based on the limited information, here's what can be extracted:

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

   • Not available. The document does not specify performance metrics or acceptance criteria as it is an FDA clearance letter, not a study report. It simply states the device is "substantially equivalent" to predicate devices.

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

   • Not available. The document does not describe any specific test set or clinical study details.

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 available. The document does not describe the establishment of ground truth or the involvement of experts in a test set.

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

   • Not available. This information is not present in the regulatory clearance letter.

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 available. This device, the Neitz Cataract Screener CT-S, appears to be an observation device for lens opacity using retroillumination, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is unlikely and not mentioned.

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

   • Not available. The device is described as a "Cataractscreener" to "observe lens opacity," implying human observation is an integral part of its use, rather than a standalone algorithm.

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

   • Not available. No details on ground truth are provided.

8. The sample size for the training set

   • Not available. The document does not mention any training set as it's not a description of a machine learning or AI algorithm development.

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

   • Not available. No training set is mentioned in the context of this device.

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