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For use to perform endo-ocular laser photocoaguation treatments, with illumination, aspiration and back-wash during surgical interventions. The operating wavelength is 500 nm to 1,100 nm.

This device consists of the following parts already connected to each other: Handpiece with a 20G extension that holds the tip of the fibers and tubes, and guides it inside the eye. 8 ft fiber. A special connector that attaches the laser fiberoptic end to the laser source. A special connector that attaches the illumination fiberoptic end to the illumination source Luer lock that attaches the aspiration/ back-wash tube to the vitrectomy machine A flexible plastic jacket covers the length of the fiberoptics and tubes. Laser fiberoptic provides the function of laser photocoagulation treatment. Illumination fiberoptic (by providing illumination) provides the physician with the view at the surgical site, while aspiration/backwash tube allows suction of intraocular fluids at the surgical site to facilitate the laser photocoagulation.

The provided document is a 510(k) summary for a medical device (OphthalMed 20g SMA Laser/Illumination/Aspiration/Back-wash probes, Model LF100). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies with acceptance criteria and precise performance metrics in the way one might expect for a novel device requiring a full premarket approval (PMA) or de novo classification.

Therefore, the study described does not include typical acceptance criteria, a test set with ground truth, or an MRMC study. Instead, it relies on a comparative analysis against existing predicate devices to assert safety and effectiveness.

Here’s a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" defined in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy thresholds) of the new device itself. Instead, the "acceptance criteria" are implicitly that the new device's technological characteristics and performance are "similar" or "identical" to those of the predicate devices.

The "reported device performance" is not quantified with specific numerical values for the new device. Instead, its performance is deemed similar to that of the predicate devices. The safety and effectiveness are "better expressed in the tabulated comparison" by showing these similarities.

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

Not applicable. This type of 510(k) submission does not typically involve a "test set" in the sense of a dataset used to evaluate a diagnostic algorithm. It relies on a comparison of design, materials, and intended use to existing devices. There is no mention of clinical data or studies involving human subjects in this summary for the purpose of demonstrating device performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No test set or ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. No test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe an MRMC study. The comparison is against predicate devices' characteristics, not a study involving human readers with and without AI assistance. The device itself is a surgical tool, not an AI diagnostic algorithm.

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

Not applicable. The device is a surgical probe, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. There is no mention of a ground truth in the context of device performance data. The "truth" in this submission is the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set for an algorithm.

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

Not applicable. There is no mention of a training set or its ground truth.

Summary of the Study and Acceptance Criteria:

The "study" presented is a comparative analysis demonstrating substantial equivalence to legally marketed predicate devices. The acceptance criteria are that the new device's technological characteristics (indications, target population, design, materials, performance, safety features, etc.) are similar or identical to those of the predicate devices. The document tables these characteristics and directly states "Identical" or "Similar" for each, effectively demonstrating that these criteria are met. This approach avoids the need for new, extensive clinical trials to prove safety and effectiveness, as it leverages the established safety and effectiveness of the predicate devices.

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