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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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Restrata™ Wound Matrix is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores/ ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wound (e.g., donor site/ grafts, post-Mohs surgery, podiatric wounds, wound dehiscence), trauma wounds (e.g., abrasions, partial thickness burns, skin tears), and draining wounds.

The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body's natural healing process to occur. Restrata™ is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix. Restrata™ is a porous matrix with a defined rate of resorption that provides a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis. The device permits the ingress of cells and soft tissue formation in the defect space / wound bed. The device does not contain any human or animal materials or tissues. Restrata™ Wound Matrix is supplied terminally sterile, in a single use double peel package in a variety of sizes. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.

The provided text is a 510(k) Summary for the Acera Surgical Restrata™ Wound Matrix. This document describes the device, its intended use, and its technological characteristics as part of a premarket notification to the FDA to demonstrate substantial equivalence to an already legally marketed predicate device.

Key takeaway: This document is not a study proving a device meets acceptance criteria, but rather a submission to the FDA demonstrating substantial equivalence. Therefore, much of the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment will not be found in this type of regulatory submission. The 510(k) process focuses on demonstrating similarity to an existing device, rather than proving a device meets specific, predefined performance metrics through a clinical study with acceptance criteria.

However, I can extract the information that is present and explain why other information is not available:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of specific, numeric acceptance criteria with corresponding device performance metrics. Instead, it demonstrates equivalence through comparative tables of characteristics and references to performance data.

From the "Technological Characteristics" section, a comparative table is provided:

Performance Data Summary:

• "The subject device has mechanical properties (tensile strength and suture pull-out strength) equivalent or superior to the reference device." (No specific numerical values or acceptance criteria are stated).
• "The subject device was also tested against a commercially available wound dressing with the same intended use in a clinically relevant full thickness porcine wound model. Analysis included an assessment of biocompatibility, along with macroscopic assessment of wound healing, planimetric measurement of wound closure, and histopathology. Test results showed that the subject device had an equivalent wound healing response compared to the control article, and exhibited no adverse tissue responses." (Again, no specific numerical outcomes or acceptance criteria are provided; the finding is "equivalent").

2. Sample size used for the test set and the data provenance

• Sample size: Not explicitly stated. The "Performance Data" section mentions a "clinically relevant full thickness porcine wound model," implying animal testing, but the number of animals or wounds tested is not specified.
• Data provenance: The performance data comes from non-clinical testing (mechanical properties and a porcine wound model). The country of origin for the data is not specified, nor is whether the study was retrospective or prospective (though animal model studies are inherently prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided. Since the described tests are primarily non-clinical (mechanical and animal model), the concept of "experts establishing ground truth for a test set" in the context of human data (e.g., radiologists for imaging) does not directly apply. For the animal study, the assessment of "equivalent wound healing response" and "no adverse tissue responses" would have been made by researchers/veterinarians/pathologists, but their number and specific qualifications are not detailed in this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not provided and is generally not applicable to the non-clinical tests described in this 510(k) summary. Adjudication methods are typically used in clinical studies involving interpretation of human data.

5. 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

• No MRMC study was performed or described. This document is for a physical medical device (wound matrix), not an AI/software device that assists human readers.

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

• Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the mechanical properties, the "ground truth" would be established by standardized mechanical testing methods.
• For the porcine wound model, the "ground truth" was established through "macroscopic assessment of wound healing, planimetric measurement of wound closure, and histopathology." This is effectively a combination of direct observation, quantitative measurement, and microscopic pathology, as assessed by the researchers of that study.

8. The sample size for the training set

• Not applicable. This is a physical device being submitted via 510(k), not an AI/machine learning algorithm that requires a training set. The "testing" referred to is for device performance, not algorithm training.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for a physical device.

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The Keratec Keragel, Kerafoam and Keraderm Wound Dressings are intended for the management of partial and full thickness wounds such as:

• first and second degree burns
• severe sunburns
• superficial injuries, cuts, abrasions and surgical wounds

The Keratec Wound Dressings may also be used under guidance of a health care professional in the management of the following types of dry, light and moderately exudating partial and full thickness wounds:

• Pressure (stage I-IV) and venous stasis ulcers
• Ulcers caused by mixed vascular etiologies
• Diabetic ulcers
• Donor sites and grafts

Keragel is intended for dry to moderately exuding wounds, Keraderm for low to highly exuding wounds and Kerafoam for moderately exuding wounds to highly exuding wounds.

The Keratec Wound Dressings are not intended to be used on third degree burns.

The Keratec Keragel, Kerafoam and Keraderm Wound Dressings (Keratec Wound Dressings) are designed as chronic wound treatment devices for dry to heavily exuding wounds. The Keratec Wound Dressings are sterile, single-use wound care dressings that include keratin proteins derived from sheep wool for use in moist wound management.

The primary mode of action of keratin containing dressings Keragel, Keraderm and Kerafoam is to absorb and interact with wound fluids to form a soft, hydrophilic keratin gel that facilitates a moist wound healing environment. The secondary mode of action is to provide the cells in the wound with a friendly structural framework that allows cellular migration where no framework exists.

Keragel is a gel dressing that provides moisture to dry wound beds by using water. emollients, and biocompatible thickeners in a similar manner to other hydrogels.

Kerafoam is a keratin film coated on a polyurethane foam substrate for use in multilayered advanced wound dressings. The keratin film is in matrix form with soluble keratin proteins. The Kerafoam product forms a gel when in contact with wound exudates. The Kerafoam provides the exudate management features of other advanced moist wound dressings.

Keraderm is open-celled foam derived from freeze-dried keratin protein. Keraderm is re-absorbed into the developing tissue without traumatic dressing changes. Keraderm provides a bio-absorbable "scaffold" for the rapid growth of new tissue in three dimensions. Keraderm is provided in an acellular form of keratin protein.

The Keratec Wound Dressings (Keratec Keragel, Kerafoam, and Keraderm) are wound care dressings containing keratin proteins from sheep wool, intended for moist wound management.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not include specific quantifiable acceptance criteria in a tabular format with corresponding reported device performance metrics. Instead, it relies on a comparison to predicate devices and a general statement of positive performance testing.

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

The summary states that "Extensive bench, biocompatibility, animal and clinical testing have been performed." However, it does not specify the sample size for any of these test sets. The provenance of the data (country of origin, retrospective or prospective) is not explicitly mentioned for these tests.

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

This information is not provided in the 510(k) summary. The document does not detail how specific ground truths for "safety" or "efficacy" were established by experts for the performance testing.

4. Adjudication Method for the Test Set

The adjudication method (e.g., 2+1, 3+1) for establishing ground truth in performance testing is not specified in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a wound dressing, not an AI diagnostic tool.

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

This question is not applicable. The Keratec Wound Dressings are physical medical devices (dressings) and do not involve an algorithm or AI. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The document broadly refers to "safety and efficacy" demonstrated through "bench, biocompatibility, animal and clinical testing." This implies that the ground truth for these tests would have been established through:

• Bench Testing: Engineering specifications, material properties, absorption rates (measurable parameters).
• Biocompatibility Testing: Standards-based biological response (e.g., cytotoxicity, sensitization, irritation).
• Animal Testing: Physiological responses, wound healing rates, tissue integration in animal models.
• Clinical Testing: Clinical outcomes related to wound healing, adverse event rates, patient comfort (likely adjudicated by healthcare professionals, though not explicitly stated).

8. The Sample Size for the Training Set

This question is not applicable as the Keratec Wound Dressings are not AI/ML devices that require a "training set."

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

This question is not applicable as the Keratec Wound Dressings are not AI/ML devices.

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