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Hyaluronidase is used prior to intracytoplasmic sperm injections (ICSI) procedures to digest the hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.

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This is a 510(k) premarket notification decision letter from the FDA regarding a medical device called "Hyaluronidase." This type of document does not typically contain the detailed information required to answer your specific questions about acceptance criteria and device study data.

The letter primarily:

• Confirms that the FDA has reviewed the 510(k) notification.
• Determines that the device is "substantially equivalent" to legally marketed predicate devices.
• States the regulatory class of the device and its procode.
• Outlines general regulatory requirements the manufacturer must adhere to.
• Provides contact information for further regulatory questions.

The attached "Indications For Use" form simply states the intended purpose of the device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This level of detail is found in the actual 510(k) submission, not the FDA's decision letter.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present.
6. If a standalone performance (algorithm only) was done: Not applicable for a drug/biological product like Hyaluronidase.
7. The type of ground truth used: Not applicable in the context of this device's function.
8. The sample size for the training set: Not applicable for a drug/biological product.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory approval letter and does not include the detailed technical and clinical study information you are seeking. To find that information, you would need to access the full 510(k) submission document (K991393) itself, which is often available through the FDA's public access policies or databases.

Ask a specific question about this device