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As an accessory device of a compatible phacoemulsification system, the phaco needle is intended for the breaking up of a cataractous lens nucleus with simultaneous irrigation and aspiration of the emulsified fragments.

A phacoemulsification needle is a component of a phacoemulsification system that utilizes ultrasound to disrupt and extract a cataract through a small incision. Ultrasonic energy combined with the mechanical action of the vibrating tip applicator (phaco tip) is applied to the cataractous lens of the eye. The lens undergoes fragmentation and emusification and is rapidly removed from the eye by aspiration.

The phaco tip is a hollow titanium needle located centrally in a handpiece with is connected via an irrigation and/or aspiration line(s) to a console for powering and controlling the functions of the phaco system. The tip is piezoelectronically oscillated longitudinally at an ultrasonic frequency of about 40,000 hertz.

Vanguard receives previously used phaco needles (only) from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.

The provided document is a 510(k) summary for reprocessed phacoemulsification needles/tips by Vanguard Medical Concepts. It details their substantial equivalence to legally marketed predicate devices.

However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics presented in a quantitative manner (e.g., sensitivity, specificity, accuracy, precision, recall) that are typically associated with AI/ML device validation. It focuses on demonstrating that the reprocessed devices are functionally equivalent to new devices.

Therefore, I cannot extract the requested information (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC study results, or standalone algorithm performance) because these details are not present in the provided text.

The document states:

• "Performance/functional testing demonstrate that the devices are equivalent and continue to be safe and effective for their intended use."
• "Cleaning, sterilization and packaging validations; and functional/performance demonstrates that the reprocessed devices perform as intended and are safe and effective."

This indicates that functional testing was performed for the reprocessed devices, but the specific acceptance criteria (e.g., maximum allowable deviation in ultrasonic frequency, aspiration rate, tip integrity) and the results against these criteria are not detailed in this summary. The information provided is high-level and focused on regulatory clearance for reprocessed medical devices, not the in-depth performance validation of an AI/ML algorithm.

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