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For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.

Kerecis SurgiBind (50241) is a part of a family of devices manufactured by Kerecis® Limited. The device is lyophilized, terminally sterilized, fish skin medical device comprised of biocompatible, resorbable fish skin (Wild North Atlantic Cod). The device is intended for single use only.

Analysis of Kerecis SurgiBind (K251844) Acceptance Criteria and Study

This FDA 510(k) clearance letter details the Kerecis SurgiBind device, which is essentially a re-submission of the Kerecis Reconstruct (K202430) with an updated label to include additional rehydration fluid options. Due to this, the performance testing for this submission primarily focuses on demonstrating that the change (new rehydration fluids) does not negatively impact the device's performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense for this 510(k) submission, as it largely leverages prior testing of the predicate device. Instead, the focus is on demonstrating that the new rehydration fluids do not compromise the device's existing performance characteristics. The implicit acceptance criterion is that performance using the expanded rehydration fluids (including autologous body fluids) is comparable to performance using the previously cleared rehydration fluids (saline and Ringer's solution).

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

The document states: "Performance testing... was largely leveraged from the Kerecis predicate device... As a result, performance testing is not required, except for rehydration and suture retention tests using autologous body fluid."

• Sample Size for this submission's additional tests: Not explicitly stated. The nature of these tests (bench testing) suggests a relatively small, controlled sample size, but the exact number is not provided.
• Data Provenance: The new tests (rehydration and suture retention with autologous body fluids) are presumed to be prospective bench testing conducted specifically for this submission. The origin of the "autologous body fluids (such as blood)" used for testing is not detailed (e.g., human, animal, synthetic proxy).

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

• Experts: Not applicable for this type of bench testing. The "ground truth" for these tests would be the established scientific and engineering principles for material properties and device function.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Performance testing for this submission involves objective physical measurements (e.g., rehydration rate, suture pull-out force) rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No. This device is a biological surgical mesh (fish skin), not an AI/software device. Therefore, MRMC studies are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the specific tests conducted for this submission (rehydration and suture retention with autologous body fluids), the ground truth is based on bench testing measurements against established parameters or comparison to the predicate device's performance. For the broader substantial equivalence claim, the ground truth is the performance and safety profile of the legally marketed predicate device (K202430).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a medical device, not an AI/machine learning model that requires a "training set." The manufacturing process for the fish skin material itself has an inherent "training" through its development and validation, but this is not typically referred to as a "training set" in this context.

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

• Ground Truth for Training Set: Not applicable. See point 8.

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