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To provide single-use components to be used in conjunction with a facility's existing compatable equipment, in one convenient kit/pack, for ophthalmic surgical procedures, used in accordance with the equipment manufacturer's instructions, performed by a certified clinician in a clinical setting, as follows:

• (1) Phaco Emulsifier Pack: Provides the irrigation and aspiration tubing/ administration sets and equipment covers/drapes used in anterior, e.g., cataract, surgical procedures;
• (2) Anterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs for incision patency, and 10 cc syringe and fluid irrigation and aspiration tubing/administration sets, and equipment covers/drapes, used in anterior surgical procedures;
• (3) Anterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic anterior surgical procedures:
• (4) Posterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs for incision patency, and 10 cc syringe and fluid irrigation and aspiration tubing/administration sets, and equipment covers/drapes, used in posterior segment, e.g., retinal, surgical procedures;
• (5) Posterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic posterior surgical procedures.
• (6) Filtered Irrigation Administration Set: Provides commonly used tubing sets for the filtering and administration of fluids for flushing/irrigating a surgical site during either posterior or anterior ophthalmic procedures.

Ophthalmic surgical kits/packs containing components used for irrigation/aspiration, anterior and posterior vitrectomies, phacoemulsification, and or administration of fluids.

The provided document describes a 510(k) premarket notification for ophthalmic surgical kits/packs, not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies or human-in-the-loop performance) is not applicable or cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving a device meets specific performance acceptance criteria through a clinical study in the way an AI/ML device would.

Here's what can be extracted, adapting to the context of a traditional medical device submission for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the typical sense for this submission. The "acceptance criteria" here is implicitly demonstrating substantial equivalence to predicate devices. The "performance" is primarily described by the device's technological characteristics and intended use being similar to existing (predicate) devices.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of evaluating an AI/ML algorithm's performance on cases. The "testing" mentioned is for biocompatibility of components.

• Sample size for biocompatibility testing: Not specified, but stated to be done by an independent lab.
• Data provenance: Not applicable for performance evaluation of an AI/ML device. Biocompatibility testing results come from laboratory tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts

Not applicable. This submission doesn't involve establishing "ground truth" through expert review of medical images or data for an AI algorithm.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" or diagnostic performance evaluation described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a traditional medical device submission for ophthalmic surgical kits/packs, not an AI/ML device. MRMC studies are used to evaluate human reader performance with and without AI assistance.

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

No. This is a traditional medical device.

7. The Type of Ground Truth Used

Not applicable. There's no diagnostic or prognostic output from these surgical kits that would require "ground truth" for performance evaluation in the AI/ML context. The closest concept might be conformance to manufacturing specifications or sterility, but that's not what "ground truth" typically refers to in AI/ML performance evaluation.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no AI/ML algorithm or training set.

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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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