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Restrata® MiniMatrix is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores / ulcers, venous ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wounds (e.g., donor site / grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced wounds), trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), and draining wounds.

Restrata MiniMatrix is a sterile, single use device intended for the local management of wounds. Restrata MiniMatrix is a form of Restrata Matrix that can be dispersed at the wound site during application. The device is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity similar to native extracellular matrix. Restrata MiniMatrix completely degrades via hydrolysis. The device does not contain any human or animal materials or tissues.

Restrata MiniMatrix is supplied in a nested pouch configuration, placed within a shelf-box. The product is terminally sterilized. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.

The provided text describes data regarding the Restrata® MiniMatrix wound dressing, which is a medical device. However, it does not contain any information about an AI/ML-driven medical device, nor does it present acceptance criteria or a study proving performance for such a device.

The document is an FDA 510(k) clearance letter and its summary for a medical device (wound dressing). The studies mentioned (biocompatibility, sterilization, wound healing animal model) are typical for assessing the safety and efficacy of a medical device, especially when seeking substantial equivalence to a predicate device, but they are not related to AI/ML performance.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it describes a non-AI medical device:

1. A table of acceptance criteria and the reported device performance: Not applicable for an AI device. The document discusses performance in terms of biocompatibility, sterilization, and wound healing in an animal model, not AI metrics.
2. Sample sizes used for the test set and the data provenance: Not applicable in the AI context. The document mentions a "full thickness porcine wound model" but not a test set for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the AI context. The ground truth for this device's evaluation would be biological outcomes (e.g., wound healing progression in the animal model) and material properties.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the FDA regulatory clearance for a wound dressing, not an AI/ML medical device. Therefore, the requested information pertaining to AI acceptance criteria and performance studies is not present.

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