(111 days)
The Miromatrix Wound Matrix is intended 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, lacerations, second-degree bums, and skin tears);
- Draining wounds.
The Miromatrix Wound Matrix is an animal-sourced, acellular wound dressing that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting wound dressing is comprised primarily of collagen type I. The device is intended for use in the management of wounds. The Miromatrix Wound Matrix is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The dressing is available in sizes ranging from 1 cm x 2 cm to 10 cm x 25 cm, and may be trimmed or cut as required.
Here's an analysis of the provided text regarding the Miromatrix Wound Matrix, focusing on acceptance criteria and the supporting study information:
This document describes a 510(k) premarket notification for the Miromatrix Wound Matrix, which is a medical device. For devices seeking 510(k) clearance, the primary acceptance criteria revolve around demonstrating substantial equivalence to an already legally marketed predicate device. This is typically shown through comparison of indications for use, technological characteristics, and performance data.
1. A table of acceptance criteria and the reported device performance
For a 510(k) device, the "acceptance criteria" are not explicit numerical targets for diagnostic performance like sensitivity/specificity, but rather a demonstration of sufficient similarity and safety to a predicate device. The "reported device performance" is the outcome of the studies aiming to demonstrate this similarity.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Identical Indications for Use | The Miromatrix Wound Matrix has identical indications for use as the predicate device (K061711, Oasis Wound Matrix). |
| Similar Technological Characteristics | Both devices are porcine-derived, acellular dressings primarily comprised of collagen type I. Both are intended for wound management. |
| Comparable Safety Profile (Biocompatibility) | GLP compliant biocompatibility studies were conducted (In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, In Vitro Bacterial Reverse Mutation (AMES), In Vitro Chromosome Aberration, In Vitro Mammalian Cell Gene Mutation, Pyrogenicity, Sub-Chronic Systemic Toxicity). The testing showed a comparable safety profile to the predicate. |
| Other Laboratory Studies (Shelf-life, Sterilization, Animal-derived material) | DNA Residuals, Collagen Analysis, Viral Inactivation, Endotoxin, and Expiration Dating studies were conducted. No direct performance metrics are provided, but their completion supports substantial equivalence. |
2. Sample size used for the test set and the data provenance
The provided text does not specify sample sizes for human clinical test sets or the data provenance (country of origin, retrospective/prospective) for any clinical studies. The studies mentioned are primarily laboratory and biocompatibility tests, which typically don't involve human test subjects in the same way a diagnostic AI study would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided as this submission focuses on a wound matrix (a physical device) and its equivalence to a predicate, not a diagnostic AI or image analysis device that would require expert ground truth labeling.
4. Adjudication method for the test set
This information is not applicable and not provided for the same reasons as above.
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 comparative effectiveness study was done or reported. This type of study is relevant for AI-assisted diagnostic devices, which the Miromatrix Wound Matrix is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the Miromatrix Wound Matrix is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biocompatibility studies, the "ground truth" would be established by standardized laboratory testing methods and controls, with results interpreted against established safety benchmarks for medical devices. For the other laboratory tests (DNA residuals, collagen analysis, etc.), the ground truth is the measured biochemical or physical property of the device against predefined specifications or comparison to the predicate. There is no "expert consensus" or "pathology" in the human clinical sense mentioned here.
8. The sample size for the training set
This information is not applicable and not provided as this is not an AI/machine learning device. The "training set" concept does not apply.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
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