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The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.

The phaco tip is a component of the phacoemulsification system. The tip is attached to an ultrasonic transducer. When properly stimulated, the transducer lengthens and shortens, causing the tip to oscillate at a specific frequency usually between 27 to 64 kHz. Phacofragmentation of the cataractous lens is accomplished by the action of the phaco tip, a hollow needle located centrally in the device handpiece. When the device is used in the phacofragmentation mode both irrigation and aspiration occur simultaneously. The irrigating solution enters the eye via a collinear axial lumen, which encircles the phaco tip. The fragmentation process is the result of combined mechanical and ultrasonic action induced by the oscillating phaco tip. The cataractous lens and its fragments are disrupted by the phaco tip during the procedure and removed due to the pump suction at the phaco tip orifice. This submission is for the phaco tip only.

The provided document describes the FDA clearance for SterilMed, Inc.'s reprocessed phaco tips (K012579). The key information regarding acceptance criteria and the supporting study is found in the "Functional and Safety Testing" section and the comparison table.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with specific numerical thresholds. Instead, it broadly states that "Representative samples of phaco tips underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced."

However, we can infer some performance characteristics from the comparison table (Table 1: Comparison of Subject Devices' and Predicate Devices' Characteristics) which implicitly serve as acceptance criteria for reprocessing, aiming for substantial equivalence to predicate devices.

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

• Sample Size: The document mentions "Representative samples of phaco tips underwent bench testing." However, it does not specify the exact sample size used for the functional and safety testing.
• Data Provenance: The nature of reprocessing (SterilMed, Inc. reprocessing devices from OEMs like Alcon, Allergan, AMO, and OPTIKON) implies that the devices themselves are from various manufacturers. The testing was conducted by SterilMed, Inc., which is located in Minneapolis, MN, USA. The data would therefore be retrospective in the sense that the devices were initially manufactured and used, then reprocessed and tested. The testing itself is prospective in relation to the reprocessing process.

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

This document describes a 510(k) submission for a reprocessed medical device, focusing on functional and safety equivalence rather than diagnostic performance or interpretation. Therefore:

• No "ground truth" established by experts in the context of disease diagnosis or image interpretation.
• The "truth" is established by comparing the physical and functional characteristics of the reprocessed devices to those of new, legally marketed predicate devices, and demonstrating that reprocessing maintains safety and effectiveness. This is typically done through engineering and microbiology testing, not expert clinical review of test data.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of clinical outcomes or interpretations. The "adjudication" in this context would be the internal review and approval by SterilMed's R&D team and the FDA's regulatory review of the submitted data.

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

No. This is a 510(k) submission for a reprocessed medical device, not a diagnostic AI device requiring an MRMC study. There is no human reader component that would be "assisted by AI" in this context.

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

Yes, in a sense. The bench testing and process validation for the reprocessed phaco tips are standalone performance evaluations of the device itself and the reprocessing procedures. The performance is assessed based on predefined engineering and sterility parameters, without a human "in-the-loop" for interpretation or decision-making beyond operating the test equipment.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is the established performance and safety characteristics of the original, new predicate devices (Alcon Limited Reuse Ultrasonic Tip, Tri-Star Ophthalmic Phaco Tip, Surgin High Efficiency Phaco Tip). SterilMed's reprocessed devices are deemed substantially equivalent if they meet these established benchmarks through functional, material, and sterility testing.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm development study, so there is no concept of a "training set" in the traditional sense. The "training" for the reprocessing procedures would have been done during the initial process development and validation, but this refers to process optimization, not a data-driven training set for an algorithm.

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

Not applicable, as there is no training set mentioned or implied for an AI algorithm. If "training set" were interpreted as the data used to validate the reprocessing process, then the ground truth for that validation would be the specifications and requirements for a safe and effective reprocessed device, derived from regulatory standards, material science, and the characteristics of the predicate devices.

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