(76 days)
MicroMatrix® is intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds (donor sites/ grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.
MicroMatrix® is composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied as a dry, absorbant, white to off-white particulate with two particle distributions, specifically
This document is a 510(k) Pre-Market Notification from the FDA regarding the device MicroMatrix®. It outlines the device's indications for use and states its substantial equivalence to a predicate device.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a table format with specific performance metrics such as sensitivity, specificity, accuracy, or other quantifiable measures typically associated with device performance in diagnostic or screening contexts. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
The "performance data" section primarily discusses biocompatibility testing and the support for labeling changes.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (as per ISO-10993-1) with 10X safety factor | Conducted for cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, pyrogenicity, acute and subchronic toxicity, implantation, genotoxicity, and LAL endotoxin. |
| Hydration uptake for pre-hydration labeling | Supported by hydration uptake testing. |
| Support for use with other sheet-based ECM scaffolds | Supported by a retrospective review of published literature describing the clinical use of urinary bladder matrix devices in wound management. |
| No alteration to intended therapeutic effect or technological characteristics due to minor changes | Performance testing demonstrates comparable performance to predicates. |
| Does not raise different questions of safety or efficacy | No different questions of safety or efficacy raised by minor differences. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific sample sizes for a "test set" in the context of clinical performance data for the MicroMatrix® itself. The "performance data" section mentions biocompatibility testing and a retrospective review of published literature.
- Test set sample size: Not specified as a distinct clinical test set for performance metrics. Biocompatibility testing involved various in-vitro and in-vivo tests, but the specific number of samples or subjects is not provided.
- Data provenance:
- Biocompatibility testing: Conducted according to ISO-10993-1. The location of these tests or the source of any in-vivo subjects is not specified.
- Literature review: Retrospective, for "published literature describing the clinical use of urinary bladder matrix devices in wound management." No country of origin is specified for this literature.
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)
This information is not provided. The document focuses on demonstrating substantial equivalence through biocompatibility testing and a literature review, not on a study involving expert-adjudicated ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a clinical test set requiring adjudication in the context of expert consensus or interpretation.
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 pertains to a medical device (wound dressing) and its regulatory clearance based on substantial equivalence, not an AI/CADe or CADx system that would typically involve human readers and MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "performance data" mentioned:
- Biocompatibility: Ground truth is established by standardized testing protocols (ISO-10993-1) against defined endpoints (e.g., absence of cytotoxicity, sensitization, etc.).
- Hydration uptake: Ground truth is established by physical measurements of hydration.
- Clinical use with other scaffolds: Ground truth is derived from the "published literature describing the clinical use of urinary bladder matrix devices in wound management," which would encompass various types of clinical evidence including outcomes data, expert observations, etc., as documented in scientific publications.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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