(19 days)
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:
| Acceptance Criterion (Implicit) | Reported Device Performance (as stated for "substantial equivalence") |
|---|---|
| Intended Use | Identical to predicate device (Unite® Biomatrix, K071425), Equivalent to predicate device (Oasis® Wound Matrix, K061711) |
| Technology | Identical to predicate device (Unite® Biomatrix, K071425), Equivalent to predicate device (Oasis® Wound Matrix, K061711) |
| Design | Identical to predicate device (Unite® Biomatrix, K071425), Equivalent to predicate device (Oasis® Wound Matrix, K061711) |
| Materials | Identical to predicate device (Unite® Biomatrix, K071425) |
| Performance | Identical to predicate device (Unite® Biomatrix, K071425) |
| Safety (Sterility & Endotoxin) | Passed USP sterility test; Satisfies FDA requirements for LAL endotoxin limit for a medical device. |
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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