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The KSS-400 Image Storage System is a software product intended to be used for automatic image analysis and data storage for corneal images taken with Specular Microscopes The program analyzes cell density, coefficient of variation, and hexagonality using images taken by the specular microscopes

The KSS 400 Image Storage System is a software product that permits users to analyze corneal images made by Konan specular microscopes in a separate computer and to store them in the computer's memory

This document is a 510(k) summary for the Konan KSS-400 Image Storage System, submitted to the FDA in 2009. It describes a software product designed for automatic image analysis and data storage of corneal images captured by Konan specular microscopes. The software analyzes cell density, coefficient of variation, and hexagonality.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state specific acceptance criteria or provide a table outlining them. It generally states that "The software has been extensively validated and tested." and "Extensive clinical tests were performed for this system as part of the clearance of one of the predicate devices."

The conclusion drawn is that the "Konan KSS 400 is equivalent in safety and efficacy to the legally marketed predicate devices." This implies that the performance of the KSS-400, in terms of safety and efficacy for analyzing corneal images (cell density, coefficient of variation, and hexagonality), meets the established standards set by its predicate devices. However, the specific quantitative metrics are not provided.

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

This information is not provided in the document. The text only states that "Extensive clinical tests were performed for this system as part of the clearance of one of the predicate devices," but no details about the sample size, type of study (retrospective/prospective), or data provenance are given for either the KSS-400 or the predicate device's tests.

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)

This information is not provided in the document. The details about ground truth establishment are absent.

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

This information is not provided in the document.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor is there any mention of comparing human readers with and without AI assistance. The device is a "software product intended to be used for automatic image analysis," suggesting a standalone analysis rather than an AI-assisted human reading workflow.

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

Yes, the description strongly implies a standalone performance evaluation. The device is described as "automatic image analysis," and its intended use is to "analyze cell density, coefficient of variation, and hexagonality using images taken by the specular microscopes." This suggests the algorithm performs these analyses without direct human intervention in the analysis process itself (though a human would interpret the output). The performance data section refers to "Non-clinical tests" and "Clinical tests" for "this system," implying evaluation of the software's inherent analytical capabilities.

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

This information is not explicitly stated in the document. Given that the software analyzes "cell density, coefficient of variation, and hexagonality," the ground truth for these features would likely involve manual expert measurements or validated reference methods for these specific corneal endothelial cell characteristics, but the document does not specify.

8. The sample size for the training set

This information is not provided in the document. The 510(k) summary focuses on the device's performance validation rather than its development or training details.

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

This information is not provided in the document, as details about the training set itself are absent.

In summary:

The document primarily focuses on establishing substantial equivalence to predicate devices based on the device's intended use and general performance claims. It lacks the specific, quantitative details regarding acceptance criteria, study design (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies that would typically be found in a more detailed technical report or clinical study summary. The claim of "extensive validation and testing" and "extensive clinical tests" is made, but without the supporting data.

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