(153 days)
The Mirragen™ Advanced Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, first and second degree burns, skin tears) and draining wounds.
The Mirragen™ Advanced Wound Matrix is composed solely of biocompatible and resorbable borate glass fibers and particulate. The borate glass constituent is medical-grade. The device is a resorbable fiber dressing that covers the wound. It may be used for a period of 3 to 7 days. The porosity of the device allows for absorption of fluid.
This document describes the Mirragen™ Advanced Wound Matrix and its substantial equivalence to predicate devices, but it does not provide specific acceptance criteria or a study designed to prove the device meets such criteria in the format requested.
The document is a 510(k) summary for the device, which aims to demonstrate that a new medical device is at least as safe and effective as a legally marketed predicate device. This is different from a performance study demonstrating a device meets predefined numerical acceptance criteria for, for example, diagnostic accuracy.
Therefore, most of the requested information cannot be directly extracted from the provided text.
Here's an attempt to answer based on the information available, highlighting what is not provided:
1. A table of acceptance criteria and the reported device performance
This information is not provided in a quantified, tabular format within the document. The document states that the device "meets its specifications" and "functioned as intended," and showed "similar wound healing response" to predicate devices, but no specific numerical acceptance criteria or performance metrics are given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a numerical sample size for a test set. The document refers to "samples of the Mirragen™ dressing" for characterization and states, "The dressing was also tested against the predicate devices in full and partial thickness wounds in a clinically relevant porcine model." The number of porcine subjects or wounds is not specified.
- Data Provenance: The document does not specify the country of origin for the data. The porcine model study would be considered prospective for that specific animal study.
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 applicable/provided. The studies described are preclinical (bench testing and animal studies), not clinical studies involving human expert assessment for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. The studies described are preclinical.
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
This information is not applicable/provided. The device is a wound matrix, not an AI-powered diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a wound matrix, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the preclinical characterization tests, the "ground truth" would be the direct measurements and observations of the physical and chemical properties of the device (e.g., mass, density, composition, dissolution time, fluid absorption capacity).
- For the porcine wound healing study, the "ground truth" was established through:
- Macroscopic assessment of wound healing
- Planimetric measurement of wound closure
- Histopathology
- Histomorphometry
These are objective measurements and histological examinations rather than expert consensus on subjective findings.
8. The sample size for the training set
This information is not applicable/provided. The device is a physical wound matrix, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. The device is a physical wound matrix, not a machine learning model.
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