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The MediSISS™ Reprocessed Phacoemulsification Tips/Needles are intended to emulsify and excise cataract tissue in ophthalmic microsurgical procedures.

Reprocessed Phacoemulsification Tips/Needles are specifically designed to be used to emulcataractous lens material and remove it from the eye (phacoemulsification). Electric energy is generated in the Phacoemulsification System, delivered in a headpiece, and is finally converted to ultrasonic energy delivered through a hollow titanium needle or tip. Irrigation fluid is delivered to the eye via a combination of an irrigation sleeve over the handpiece tip. The emulsified lens material is aspirated out of the eye through the center of the headpiece /tip assembly. The headpieces are routinely used repeatedly in multiple surgical procedures, while the tips are marketed as single use only.

The provided text is a 510(k) clearance letter from the FDA regarding a reprocessed medical device, specifically MediSISS™ Reprocessed Phacoemulsification Tips/Needles. It does not describe an AI medical device or its performance criteria. Therefore, most of the requested information regarding AI device acceptance criteria, studies, sample sizes, expert involvement, and ground truth establishment is not applicable to this document.

However, based on the provided text, I can extract the following relevant details about the reprocessed medical device itself:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of numerical acceptance criteria for a new AI device or its performance. Instead, it focuses on demonstrating that the reprocessed devices are substantially equivalent to legally marketed predicate devices and meet certain established standards for reprocessing.

Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the document is a validation submission for reprocessed single-use devices. It demonstrates substantial equivalence.

• Cleaning, sterilization, packaging validations, and visual/mechanical testing were performed to show that the reprocessed devices are equivalent to new devices and are safe and effective for their intended use.
• Process validation testing was specifically done to validate the cleaning and sterilization procedures, as well as the device's packaging.
• The conclusion states that the device meets the requirements of the stated standards and embodies technological characteristics identical to the predicate device, implying it is safe, effective, and performs as well as or better than the predicate device.

Information Not Applicable or Available from the Provided Text (for an AI device):

The following points are not directly addressed as the document concerns a reprocessed physical medical device, not an AI medical device:

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 for a reprocessed physical device. Validation involves testing of the reprocessed devices themselves, not a data set.
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. Ground truth for a reprocessed device would involve analytical and performance testing against established standards, not expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this reprocessed device centers on compliance with established reprocessing standards (cleaning, sterilization, material integrity, functional performance) and substantial equivalence to the original predicate devices. This is verified through laboratory testing and engineering analysis rather than clinical outcomes data or expert consensus on diagnostic interpretations.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

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