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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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