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The Nam illumination probe with chopper is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and manipulation during cataract surgery.

This product transmits light through the optical fiber to the inside of the eye to illuminate the intraoperative field of the eyeball. It consists of tube, handle, optical fiber, fiber cloth, and connector.

Please note that the provided document is a 510(k) summary for the "Nam illumination probe with chopper," a non-powered device used for illumination during cataract surgery. These types of devices typically do not involve the same kind of performance studies (e.g., diagnostic accuracy, reader studies) as AI/ML-driven or image-analyzing software as a medical device (SaMD).

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for a diagnostic/AI performance study with corresponding performance metrics like sensitivity, specificity, or AUC. Instead, the performance data focuses on demonstrating the device's physical and biological safety, and benchtop performance against relevant standards.

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 applicable or not provided in the document. The studies conducted are primarily benchtop or laboratory-based (sterilization, biocompatibility, mechanical performance) on the device itself, rather than studies involving patient data or a "test set" in the context of diagnostic accuracy.

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 applicable as the studies are not diagnostic performance studies requiring expert ground truth for patient data.

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

This information is not applicable as the studies are not diagnostic performance studies requiring adjudication of ground truth.

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

No MRMC study was conducted. This device is an illumination probe, not an AI-driven diagnostic tool.

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

No standalone algorithm performance study was done as this is a physical medical device, not a software algorithm.

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

The concept of "ground truth" as typically defined for diagnostic or AI performance studies is not applicable here. The "truth" for the performance data presented (e.g., sterility, biocompatibility, mechanical properties) is established by adherence to recognized international standards (ISO, ASTM, USP) and validated laboratory testing methodologies.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device that requires a training set.

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

This information is not applicable as this is not an AI/ML device.

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