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The Synovis Orthopedic and Woundcare Unite® Biomatrix is an animal-derived extracellular matrix (xenograft) intended for the management of moderately to severely exudating 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 [seconddegree] burns, skin tears)
• . Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced surgical incisions)

The Unite® Biomatrix is a decellularized equine pericardial extracellular matrix (xenograft) which has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use. The device is for single use, single patient application only.

This is a 510(k) premarket notification for the Unite® Biomatrix from Synovis Orthopedic and Woundcare, Inc. The document states that the device is substantially equivalent to a previously cleared device. Therefore, a de-novo study is not required.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and reported device performance:

The document does not specify explicit "acceptance criteria" in terms of statistical thresholds (e.g., sensitivity, specificity, accuracy percentages) for clinical performance. Instead, the substantial equivalence decision is based on:

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

• Sample size: Not applicable. This document is a 510(k) submission based on substantial equivalence to existing devices, not a new clinical study with a "test set" and outcome data for the device itself.
• Data provenance: Not applicable for a new clinical study. The "provenance" here relates to the predicate devices which are already cleared for commercial distribution in the United States.

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

• Not applicable. No new test set for clinical performance was generated for this 510(k) submission.

4. Adjudication method for the test set:

• Not applicable. No new test set for clinical performance was generated.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers with vs. without AI assistance:

• Not applicable. This device is a biomatrix, not an AI or imaging diagnostic tool. No MRMC study was performed.

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

• Not applicable. This device is a biomatrix, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this 510(k) submission is the established safety and efficacy of the predicate devices (Unite® Biomatrix, K071425, and Oasis® Wound Matrix, K061711) which have already been cleared by the FDA. The new device is deemed substantially equivalent based on its identical characteristics to the primary predicate.

8. The sample size for the training set:

• Not applicable. This is not a study involving a training set for machine learning.

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

• Not applicable. This is not a study involving a training set for machine learning.

In summary:

The provided document is a 510(k) premarket notification for a medical device (Unite® Biomatrix) seeking clearance based on substantial equivalence to already legally marketed predicate devices. It does not describe a new clinical study or a study to demonstrate performance against specific numerical acceptance criteria. The "study" mentioned is the comparison to predicate devices, focusing on fundamental characteristics like intended use, technology, design, materials, and performance, along with basic safety tests (sterility and endotoxin). The acceptance criteria are therefore implicitly based on demonstrating that the new device shares these essential characteristics with the cleared predicates, and meets basic safety standards.

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The Pegasus Biologics Unite™ Biomatrix is a collagen-based wound dressing 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 Pegasus Biologics Unite™ Biomatrix is decellularized, equine pericardium. The Unite™ Biomatrix has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.

Please note that the provided text describes a medical device called "Unite™ Biomatrix," which is a collagen-based wound dressing. It is not an AI/ML device, and therefore, many of the typical acceptance criteria and study details relevant to AI/ML device performance (like sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training set details, etc.) are not applicable or present in this type of submission.

The document primarily focuses on establishing substantial equivalence to a predicate device for a wound dressing,
not on evaluating the performance of an algorithm.

Here's an analysis of the provided text based on your request, highlighting what is (and isn't) present:

Device Name: Unite™ Biomatrix

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a wound dressing that establishes substantial equivalence to a predicate device, the "acceptance criteria" are not reported in terms of specific performance metrics (like accuracy, sensitivity, specificity) for an AI/ML algorithm. Instead, the acceptance criteria are implicitly met by demonstrating equivalence in design, materials, manufacturing controls, and intended use. The "device performance" in this context refers to its
similarity to the predicate device.

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

This information is not applicable/not provided in the context of this 510(k) submission for a wound dressing. There is no "test set" in the sense of a dataset for an AI/ML algorithm. The equivalence is based on physical and chemical characterization, and comparison of design, materials, and intended use to the predicate device.

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

This information is not applicable/not provided as there is no "test set" or "ground truth" establishment in the context of an AI/ML algorithm. The evaluation is chemical and physical testing, and comparison to regulatory standards and a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable/not provided for the same reasons as above.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance for diagnostic tasks, which is not the nature of this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study was not done. This concept is only applicable to AI/ML algorithms, which the Unite™ Biomatrix is not.

7. The Type of Ground Truth Used

Not applicable in the AI/ML sense. The "ground truth" for this device's acceptance would be defined by:

• Standardized chemical and physical testing results (e.g., USP sterility test, LAL endotoxin limit).
• Demonstration of material properties and design characteristics matching the predicate device.
• Compliance with general controls for medical devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided as the device is not an AI/ML algorithm and therefore does not have a "training set."

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

This information is not applicable/not provided for the same reasons as above.

Summary of the Study:

The "study" described in the 510(k) submission for the Unite™ Biomatrix is not a clinical trial or an AI/ML performance study. Instead, it is a design verification and substantial equivalence demonstration study.

• Objective: To demonstrate that the Unite™ Biomatrix is substantially equivalent to the predicate device, DermADAPT™ Wound Dressing (K061494).
• Methodology: The submission focuses on comparing the new device to the predicate in terms of:
  • Device Description: Both are decellularized equatorial pericardium, crosslinked, and liquid chemical sterilized.
  • Material Composition: Equine pericardium.
  • Performance Characteristics: Meeting USP sterility, satisfying FDA LAL endotoxin limits. The document states, "Supplier qualification activities, receiving controls, and design verification testing demonstrate that the Unite™ Biomatrix device is equivalent to the predicate device in terms of design, performance and intended use."
  • Intended Use/Indications for Use: The indications for use listed are identical to those of the predicate device.
• Conclusion: The FDA reviewed the submission and determined the device to be substantially equivalent to the legally marketed predicate device for the stated indications for use. This determination allows the device to be marketed.

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