Search Results

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.

Ask a specific question about this device

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

Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix. Restrata® is a porous matrix with a defined rate of resorption that provides a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis. The device permits the ingress of cells and soft tissue formation in the defect space / wound bed. The device does not contain any human or animal materials or tissues. Restrata® is terminally sterilized, in a single use double peel package in a variety of sizes in non-meshed and meshed configurations. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged. The subject device is a modification of the predicate device to include updated product labeling, a change in product size offerings, and a change in product design offerings.

The provided text is a 510(k) Summary for the Acera Surgical Restrata® wound matrix, seeking substantial equivalence to a predicate device. This type of document focuses on demonstrating that a new medical device is as safe and effective as a legally marketed device and does not typically include detailed studies with acceptance criteria, sample sizes, expert qualifications, or MRMC studies, as would be expected for an AI/ML powered device.

The "study" in this context is the submission and review process for substantial equivalence (510(k)), which primarily relies on demonstrating that the technological characteristics and performance of the new device are equivalent to a predicate device.

Here's an attempt to answer your questions based on the provided text, while acknowledging that many of your points are not directly addressed because this is not an AI/ML device submission:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in the way one might for a diagnostic performance study. Instead, the "acceptance criteria" can be inferred as demonstrating substantial equivalence to the predicate device (Restrata® Wound Matrix K170300) and the reference device (PriMatrix® Dermal Repair Scaffold K153690) across various technological characteristics. The reported device performance is presented as direct equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a "test set" in the context of a statistical study for device performance. It refers to the predicate device (Restrata® Wound Matrix K170300) and a reference device (PriMatrix® Dermal Repair Scaffold K153690). The "data" provenance for asserting equivalence comes from prior approvals and testing related to these predicate and reference devices, not new patient data or a specific test set for the subject device. The submission focuses on changes to the predicate device (updated labeling, new smaller size, and meshed design options) and argues these changes do not alter fundamental safety and effectiveness.

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)

Not applicable. The ground truth here is the established safety and effectiveness of the predicate device, as determined by its original 510(k) clearance process. No new expert adjudication for a test set is reported for this specific submission, as it relies on equivalence to existing devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new test set requiring expert adjudication is described.

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 device is a wound matrix, not an AI/ML-powered diagnostic or assistive tool.

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

Not applicable. This device is a wound matrix, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this 510(k) submission, the "ground truth" is that the predicate device is safe and effective. The subject device demonstrates substantial equivalence by showing that its technological characteristics are the same or adequately similar to the predicate, and any differences (like new sizes or meshed configuration) do not raise new questions of safety or effectiveness. This is supported by relying on previously submitted and reviewed non-clinical testing (mechanical, biocompatibility) for the predicate device.

8. The sample size for the training set

Not applicable. No training set is involved as this is not an AI/ML device.

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

Not applicable. No training set is involved.

Ask a specific question about this device