(112 days)
INTEGRA™ Wound Matrix (Thin) is indicated 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds. The device is intended for one-time use.
INTEGRA® Wound Matrix (Thin) is a collagen-glycosaminoglycan wound dressing that maintains and supports a healing environment for wound management. INTEGRA® Wound Matrix (Thin) is supplied sterile and is intended for one-time use. The device is provided in a thinner form than the predicate, K022127.
The INTEGRA® Wound Matrix (Thin) is a collagen-glycosaminoglycan wound dressing. The substantial equivalence was established by comparing it to a predicate device, INTEGRA® Matrix Wound Dressing (K022127). The primary difference is the thickness of the device.
Here's a breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance/Comparison to Predicate |
|---|---|
| Pore Size | Same as predicate device (INTEGRA® Matrix Wound Dressing K022127) |
| Collagen Nativity (FTIR test of denaturing) | Same as predicate device (INTEGRA® Matrix Wound Dressing K022127) |
| Chondroitin-6-sulfate content | Same as predicate device (INTEGRA® Matrix Wound Dressing K022127) |
| Degree of cross-linking | Same as predicate device (INTEGRA® Matrix Wound Dressing K022127) |
| Biocompatibility | All test results were acceptable. |
| Sterilization Method | Identical to predicate device (INTEGRA® Matrix Wound Dressing K022127) |
| Materials/Chemical Composition | Identical to predicate device (INTEGRA® Matrix Wound Dressing K022127) |
| Intended Use | Same as predicate device, managing partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds, and draining wounds. |
2. Sample size used for the test set and the data provenance:
The provided text does not specify a separate "test set" in the context of a clinical study with patients. The evaluation was primarily based on bench testing of the device's physical and chemical properties and comparison to a predicate device, along with the "history of clinical use of similar collagen products, including the predicate device."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The evaluation relies on laboratory testing and comparison to an established predicate device, not on expert ground truth determination of specific cases.
4. Adjudication method for the test set:
This information is not applicable as there was no test set requiring human adjudication in the traditional sense of a clinical study measuring diagnostic accuracy or clinical outcomes of individual cases.
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 device is a wound matrix, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is a wound matrix, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable.
7. The type of ground truth used:
The ground truth for this device's acceptance was established through:
- Physical and Chemical Testing: Measuring pore size, collagen nativity, chondroitin-6-sulfate content, and degree of cross-linking against defined specifications.
- Biocompatibility Testing: Evaluating the device's interaction with biological systems.
- Comparison to Predicate Device: Demonstrating identical materials, sterilization methods, and technological characteristics to a legally marketed device with a known history of safe and effective use.
- History of Clinical Use: Citing the clinical history of the predicate device and similar collagen products.
8. The sample size for the training set:
This information is not applicable as this is not an AI/machine learning device that requires a training set. The evaluation is based on product characteristics and previous clinical experience with the predicate device.
9. How the ground truth for the training set was established:
This information is not applicable as this is not an AI/machine learning device.
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