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The scleral plugs are intended to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures.

Scleral plugs, 19 and 20 gauge, for use in ophthalmic surgical procedures. Both 19 and 20 gauge plugs are stainless steel. The 19 gauge plugs are gold plated.

This is a 510(k) premarket notification for a medical device (Scleral Plugs) and not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, is not applicable to this document.

The document primarily focuses on establishing substantial equivalence to a predicate device based on material, construction, function, and biocompatibility testing. It states:

• Basis for Substantial Equivalence (Section 6):
  • No change in materials, basic components, or manufacturing methods compared to the predicate device.
  • No change in basic configuration or construction.
  • Biocompatibility testing by an independent lab was performed.
  • The function and use are no different from the predicate device.

The document asserts that the Micro Vision Scleral Plugs are substantially equivalent to the predicate device (Storz MVS 19 & 20 Gauge Scleral Plug, K854507) and that "any differences are minor and do not raise new issues of safety and effectiveness."

Without further documentation detailing specific performance studies and acceptance criteria for this non-AI device, it is not possible to provide the requested table or additional information.

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The scleral plugs are provided as part of single- and multiple-use surgical component kits/packs, or as kit replacements, in order to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures, performed by a certified clinician in a clinical setting.

Scleral plugs, 19 and 20 ga., for use in ophthalmic surgical procedures. Both as stainless steel, with the 19 ga. plugs gold plated, and the 20 ga. plugs silver plated.

This 510(k) submission for the Scleral Plug does not include a study demonstrating how the device meets acceptance criteria. Instead, it relies on demonstrating substantial equivalence to pre-existing predicate devices. Therefore, much of the requested information regarding a specific study and its methodology is not available in this document.

Here's a breakdown of the available information and a notation where information is not provided:

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

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

• Not applicable / Not provided. This submission relies on substantial equivalence to predicate devices, not a clinical study with a test set of data. The biocompatibility testing likely used laboratory samples, but details are not included.

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 / Not provided. No test set or ground truth in the context of clinical performance evaluation is described.

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

• Not applicable / Not provided. No test set requiring adjudication is described.

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. This is a medical device (scleral plug), not an AI-powered diagnostic tool. MRMC studies are not relevant to this type of device.

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

• No. This is a medical device (scleral plug), not an algorithm. Standalone performance as typically understood for AI algorithms is not relevant.

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

• Not applicable / Not provided. No ground truth in the context of clinical performance evaluation is described. The "ground truth" for this device's approval is its substantial equivalence to other legally marketed predicate devices, meaning it is considered safe and effective because similar products have been proven so.

8. The sample size for the training set

• Not applicable / Not provided. This is a medical device, not an AI model requiring a training set.

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

• Not applicable / Not provided. As above, no training set for an AI model is involved.

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