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The Granton Medical Sterilization Pouches are to be used to enclose another medical device that is to be 121°C gravity steam or ethylene oxide sterilized by a health care provider, following the ANSI/AAMI ST-46 OR ST-41 sterilization recommendations.

Self Seal Sterilization Pouch

This is a 510(k) clearance letter for a medical device called "Self Seal Sterilization Pouch". This document is an administrative letter from the FDA and unfortunately, it does not contain the specific information you are requesting about acceptance criteria and device performance studies.

The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed. However, it does not provide details about the performance criteria, study design, or results typically found in full submissions or scientific publications.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set or its data provenance.
3. Number of experts used or their qualifications for ground truth.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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