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Intended Use: Medium for In Vitro Fertilization Procedures
Indications for Use: For the immobilization and isolation of sperm prior to intracytoplasmic sperm injection, ICSI.

Viscous sperm handling solution. Ready-to-use after equilibration at 15-25°C.

The provided text is related to a 510(k) premarket notification for a medical device called ICSI™, an Assisted Reproduction Media. However, it does not contain any information regarding specific acceptance criteria, performance data, or a study demonstrating that the device meets such criteria.

The document is a clearance letter from the FDA, stating that the device is substantially equivalent to a legally marketed predicate device (PVP-Polyvinylpyrrolidone device, K991343). This substantial equivalence determination is based on the technological characteristics being "essentially similar to those of the predicate device" and that "none of these changes raise new questions of safety or effectiveness."

Therefore, I cannot provide the requested information as it is not present in the given text. The prompt asks for:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample size used for the test set and the data provenance: Not available, as no performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: The document does not mention any comparative effectiveness study, with or without AI assistance. The device is a "viscous sperm handling solution," not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's not an algorithm.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not applicable, as it's not an AI/algorithm-based device.
9. How the ground truth for the training set was established: Not applicable.

The document signifies regulatory clearance based on substantial equivalence to a predicate device, rather than a detailed performance study against explicit acceptance criteria.

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