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Ophthalmic sponge drains are used during surgery to protect delica tissue from trauma, absorb fluids, and to act as a filter to aspirate.

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I'm sorry, but this document does not contain the information requested. The document is an FDA 510(k) clearance letter for the Ultracell Suction Sponge, which is a medical device used in ophthalmic surgery. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the letter does not include any details about:

• Acceptance criteria or reported device performance for a study.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Types of ground truth used.
• How ground truth for a training set was established.

This document is a regulatory approval, not a technical report on a device's performance study.

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Removal of suture from the epidermis.

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The provided documents are 510(k) clearance letters from the FDA regarding "CPR Lap Sponges", "Basic Set-Up Tray", and "CPR Suture Removal Kit". These documents establish that the devices are substantially equivalent to devices marketed prior to May 28, 1976. This correspondence is primarily administrative and regulatory in nature.

There is no information in these documents about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details related to the technical performance of an AI/ML powered medical device.

The document dated April 9, 2024, is an administrative update to a previous 510(k) letter from March 28, 1996, indicating a re-categorization of the device technology under a new product code (GDY for Nonabsorbable gauze for internal use). It explicitly states, "Please note that the 510(k) submission was not re-reviewed."

The original 510(k) letter from March 28, 1996, makes a determination of substantial equivalence based on the devices being "marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)." This indicates that the clearance was based on equivalence to predicate devices already on the market, not on a detailed performance study as would be required for a novel device, especially an AI/ML one.

Therefore, I cannot provide the requested information from these documents as they do not contain details about:

1. A table of acceptance criteria and reported device performance
2. Sample sizes or data provenance for test sets
3. Number or qualifications of experts
4. Adjudication method
5. Multi-reader multi-case comparative effectiveness study or effect size
6. Standalone algorithm performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

Ask a specific question about this device

Ask a specific question about this device