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For use following surgery in sutured or stapled wounds, to be used incisional wound dressing with attached packing gauze strips.

PROTOCOL™ Incision Dressing is a sterile, single use device. It is manufactured by using the already cleared Calgitrol AG Silver Alginate Foam and Gel Foam Dressings with or without Maltodextrin (K011618) and sewing the Kendall Kerlix Antimicrobial Gauze (K990530) to the middle of the silver dressing as an additional absorption feature. The antimicrobial gauze packing strips will be inserted in to the wound, while the silver dressing will be the primary dressing on top of the wound. Adhesive tape will be applied to hold PROTOCOL™ Incision Dressing in place.

The provided FDA 510(k) premarket notification for the PROTOCOL™ Incision Dressing does not contain information typically associated with studies proving device performance against acceptance criteria in the context of an AI/algorithm-based medical device.

This document describes a traditional medical device (an incision dressing) and its substantial equivalence to predicate devices, rather than an AI or algorithm-driven device. Therefore, much of the requested information (like AI performance metrics, sample sizes for test and training sets, expert consensus for ground truth, MRMC studies, etc.) is not applicable or cannot be extracted from this document.

However, I can extract the relevant information regarding the device itself and the type of testing performed.

Device Description and Purpose:

The PROTOCOL™ Incision Dressing is a sterile, single-use incision dressing for use following surgery in sutured or stapled wounds. It combines features of existing cleared devices: a silver alginate foam primary dressing and antimicrobial gauze packing strips. The packing strips are inserted into the wound, and the silver dressing covers the wound, held in place by adhesive tape.

Acceptance Criteria and Reported Device Performance (as inferred from the document):

Given this is a physical medical device and not an AI, the "acceptance criteria" here refers to demonstrating safety and effectiveness by being substantially equivalent to existing predicate devices.

Study That Proves the Device Meets Acceptance Criteria:

The document refers to a "Summary of Testing Performed" which included:

1. Bench Testing - Pull Testing: "Pull testing was performed on the PROTOCOL™ Incision Dressing and can be found in section 018 Performance Validation - Bench." This test likely evaluated the securement of the antimicrobial gauze to the silver dressing.

Information Not Applicable or Not Provided for this Device (due to it not being an AI/algorithm device):

1. Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated via substantial equivalence and physical bench testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the AI sense was established.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Clinical Studies:

The document explicitly states: "Clinical Testing was not performed for this device as it is not a high risk, class III device for which clinical evaluations are needed." This further confirms that the assessment relies on substantial equivalence to predicate devices and bench testing, rather than clinical trials for novel performance claims.

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