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The Harbor MedTech Architect™ Px Extracellular Collagen Matrix is indicated for the local management of moderately to heavy exuding wounds, including:

· Partial and full thickness wounds,

• · Draining wounds,
  · Pressure sores/ulcers,

· Venous ulcers,

· Chronic vascular ulcers,

· Diabetic ulcers,

· Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears),

· Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced surgical incisions)

The Harbor MedTech Architect™ Px Extracellular Collagen Matrix (ECM) is a decellularized equine pericardial device The Architect™ Px ECM is provided sterile for single use only. The device must be rehydrated and rinsed prior to use following the procedure described in the Instructions for Use.

The Architect™ Px ECM is available in multiple sizes. The Architect™ Px ECM is available as a standard dressing and in a fenestrated model with pre-cut slits in the collagen matrix.

This document is a 510(k) summary for the Harbor MedTech Architect™ Px Extracellular Collagen Matrix. It does not describe an AI/ML device or a study involving human readers or ground truth established by experts.

Therefore, many of the requested categories are not applicable to the provided text.

Here's a breakdown of the relevant information from the document:

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

The document does not provide a formal table of acceptance criteria with specific numerical targets. Instead, it describes performance testing results in a narrative way, stating that the device "conforms to the performance specifications established" for its predicate and that "the Architect™ Px ECM tissue has the mechanical strength and integrity to perform as intended."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes "verification and validation studies" and "performance bench testing." It does not specify sample sizes for these tests, nor does it provide information on data provenance (country of origin, retrospective/prospective). These appear to be laboratory bench tests on material samples, not clinical data sets from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a medical device (collagen matrix), and the testing described is bench testing, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. This pertains to expert review for diagnostic algorithms, which is not relevant here.

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

Not applicable. This document is for a medical device (collagen matrix) and does not involve AI or human readers.

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

Not applicable. This document is for a medical device (collagen matrix), not an algorithm.

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

Not applicable in the context of diagnostic AI. For this device, the "ground truth" or reference for performance is the established specifications and performance of the predicate device, as confirmed through physical and mechanical testing.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

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

Not applicable. This is a medical device, not an AI model.

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The Harbor MedTech BriDGE Extracellular Collagen Matrix Wound Dressing is indicated for the local management of moderately to heavy exuding wounds, including:

• Partial and full thickness wounds, .
• Draining wounds, .
• Pressure sores/ulcers. .
• Venous ulcers, ●
• Chronic vascular ulcers, .
• Diabetic ulcers, .
• Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears),
• Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric . wounds, dehisced surgical incisions)

The Harbor MedTech BriDGE Extracellular Collagen Matrix (ECM) Wound Dressing is a decellularized equine pericardial device that has been stabilized and radiation sterilized. The BriDGE ECM is non-pyrogenic and is provided sterile for single use only. The device must be rehydrated and rinsed prior to use following the procedure described in the Instructions for Use.

The BriDGE ECM is available in four sizes. The BriDGE ECM is available as a standard dressing and in a fenestrated model with pre-cut slits in the collagen matrix.

The provided text describes the acceptance criteria and study for the Harbor MedTech BriDGE Extracellular Collagen Matrix Wound Dressing.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BriDGE Extracellular Collagen Matrix Wound Dressing were primarily established through biocompatibility testing and material testing (tensile strength and suture pull-out testing) to demonstrate substantial equivalence to predicate devices. The reported device performance is indicated by the "Pass" status for biocompatibility tests and comparative results for material testing.

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

• Sample Size for Test Set: The document does not explicitly state the exact sample sizes for each of the performance and biocompatibility studies. The studies are described as "A study" or "Complete biocompatibility studies," indicating that samples were used, but the specific number of units, animals, or specimens is not detailed.
• Data Provenance: The biocompatibility studies were conducted by NAmSA under Good Laboratory Practices (GLP) in accordance with ISO 10993 standards. The material testing (tensile strength and suture pull-out) was conducted presumably by or for Harbor MedTech, Inc. The document does not specify the country of origin of the data beyond mentioning NAmSA as the testing facility. All studies described are preclinical studies, implying they were conducted in a controlled lab environment rather than on human subjects. They are prospective in nature, designed specifically to evaluate the device.

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

This information is not applicable as the studies described are preclinical performance and biocompatibility tests, not studies that require expert-established ground truth in the context of medical imaging or clinical diagnostics. The "ground truth" here is defined by objective laboratory measurements and standardized biological responses, as determined by the GLP-adhering personnel at NAmSA and in material testing labs.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews to resolve disagreements, which is not relevant to laboratory-based material or biocompatibility testing.

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

This information is not applicable. The device described is a wound dressing, not an AI-powered diagnostic or imaging tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this device.

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

This information is not applicable. The device is a physical wound dressing, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the performance testing includes:

• Standardized biological responses: For biocompatibility tests (e.g., cell viability for cytotoxicity, mutation rates for genotoxicity, inflammatory responses for irritation/sensitization). These are established by international standards (ISO 10993, OECD Test No. 474) and assessed under GLP conditions.
• Objective physical measurements: For material testing (e.g., peak load in Newtons for tensile strength and suture pull-out). These are quantitative measurements against established material properties.
• Predicate device comparison: The performance of the BriDGE ECM was directly compared to the performance of legally marketed predicate devices (Unite™ Biomatrix and Oasis Wound Dressing) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical wound dressing and does not involve AI or machine learning, thus no "training set" in the computational sense is used. The manufacturing process and formulation could be considered "trained" through iterative development, but this is not quantifiable as a typical training set.

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

This information is not applicable for the same reasons as #8.

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