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Reprocessed Phacoemulsification Tips are intended to emulsify and excise cataract tissues in ophthalmic microsurgical procedures.
Reprocessed Phacoemulsification Tips are indicated for use to emulsify and excise cataract tissues in patients requiring eye surgery.

Phacoemulsification Tips are used to emulsify and excise cataract tissue in ophthalmic microsurgical procedures. When connected to the ultrasonic handpiece of a phacoemulsification system and activated, the Phacoemulsification Tip vibrates at an ultrasonic frequency that emulsifies cataract tissue. The extracted tissue is then aspirated away through the hollow tip. Irrigation of the eye with a saline solution compensates for the loss of volume in the eye when the cataract tissue is removed.

Here's a breakdown of the acceptance criteria and study information for the Alliance Medical Corporation Reprocessed Phacoemulsification Tips, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Performance testing demonstrates that Reprocessed Phacoemulsification Tips perform as originally intended." This indicates that the device met the acceptance criteria for each of these categories.

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the bench and laboratory testing.

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

The provided text does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on technical performance testing rather than expert-reviewed data.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The evaluation focuses on the reprocessed device's physical and functional equivalence to the predicate device, not on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device described is a physical medical device (Phacoemulsification Tips), not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The "standalone" performance here refers to the device's own functional performance, which was demonstrated through the listed performance tests.

7. Type of Ground Truth Used

The ground truth for the performance evaluation was based on technical specifications and functional output in comparison to the original, non-reprocessed predicate devices. This includes demonstrating:

• Biocompatibility
• Successful reprocessing
• Sterility
• Appropriate function
• Packaging integrity

8. Sample Size for the Training Set

The device is a reprocessed physical medical device, not an AI or machine learning model that would require a "training set." Therefore, the concept of a training set sample size is not applicable.

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

As explained above, there is no "training set" for this type of device. The performance evaluation relies on comparing the reprocessed devices to the established performance and specifications of the original predicate devices.

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