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Forceps for single use designed for the manipulation of tissue or muscles in various ophthalmic procedures.

A single use ophthalmic device designed to manipulate eye tissues or muscles.

The provided text describes a 510(k) premarket notification for the Stephens Disposable Forceps, a Class I ophthalmic device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a complex AI-driven system. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated as a separate "test set" in the context of clinical trials or data analysis. The performance tests ("Dimensional Equivalency Test" and "Manipulation Tests") likely involved a sample of the manufactured forceps.
• Data Provenance: Not applicable in the traditional sense of patient data. The tests were likely conducted in a laboratory setting on prototypes or production samples of the device and predicate devices. No country of origin for specific "data" is mentioned other than the company's location (Lexington, KY, USA). The studies are not considered "retrospective" or "prospective" as they are performance tests, not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The performance tests described (dimensional and manipulation) would be assessed against engineering specifications or by direct comparison to the physical characteristics and function of the predicate devices, not by expert clinical consensus for "ground truth."

4. Adjudication method for the test set

Not applicable. There's no mention of a formal adjudication process for interpreting test results, as these are objective engineering and performance comparisons.

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 device is a physical ophthalmic forceps, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI performance metrics are irrelevant.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

For dimensional equivalency, the ground truth would be the measurements of the predicate devices' teeth. For manipulation tests, the ground truth would be the observed performance (mechanism and holding ability) of the predicate devices. Neither is "expert consensus," "pathology," or "outcomes data."

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.

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