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InnovaMatrix™ FS is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wounds (donor sites/grafts, post Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns and skin tears) and draining wounds.

The device is intended for one-time use.

InnovaMatrix™ FS is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound covering. InnovaMatrix™ FS is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans. The wound dressing is provided in fenestrated sheets that are approximately 40-100 microns thick in sizes ranging from 2 x 2cm to 5 x 5cm. They are provided as single-use, sterile wound coverings.

This is a 510(k) premarket notification for a medical device called InnovaMatrix™ FS. The document describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria, a scientific study detailing device performance against those criteria, or information on specific statistical metrics (e.g., sensitivity, specificity, AUC) normally associated with AI/algorithm performance studies.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared device (InnovaMatrix™ K193552) and mentions verification testing to ensure certain characteristics. The primary change in the InnovaMatrix™ FS is the addition of fenestrations.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth for AI performance are not available in this regulatory submission.

Here's what can be extracted based on the provided text, while explicitly noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific numerical values or ranges for "specified values" (e.g., for bioburden, endotoxin, water absorption capacity) are not provided in this document. The "acceptance criterion for the verification activity" for fenestrations is also not detailed.

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

This document describes verification testing and design controls for the modified device (InnovaMatrix™ FS), not a clinical or AI performance study with a "test set" in the typical sense.

• Sample Size for Test Set: Not applicable in the context of an AI/algorithm performance study. The document mentions "verification testing" for characteristics like bioburden, endotoxin, and water absorption, but does not provide sample sizes for these tests.
• Data Provenance: Not applicable for an AI/algorithm performance study. The data for verification testing would likely be from laboratory tests performed by the manufacturer.

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

Not applicable. This is not an AI/algorithm performance study that relies on expert interpretation to establish ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as this is not an AI/algorithm performance study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This submission is for a collagen wound dressing, not an AI software device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone (algorithm only) performance study was not done. InnovaMatrix™ FS is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established laboratory standards and specifications for material characteristics (bioburden, endotoxin, water absorption capacity) and manufacturing/design output (fenestrations). It is not pathology, outcomes data, or expert consensus in an observational or diagnostic sense. The ground truth for proving substantial equivalence relies on comparison to the predicate device and established safety/performance parameters for similar products.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm, so there is no "training set."

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

Not applicable. There is no "training set" or corresponding ground truth establishment methodology.

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