(176 days)
INTEGRA™ Meshed Bilayer Wound Matrix is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. The device may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.
INTEGRA™ Meshed Bilayer Wound Matrix is an advanced wound care device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminonlycan with a polysiloxane (silicone) layer. The meshed bilayer matrix allows drainage of wound exudate and provides a flexible adherent covering for the wound surface. The collagen- glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
The provided text describes a 510(k) premarket notification for the Integra™ Meshed Bilayer Wound Matrix. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish de novo safety and efficacy. Therefore, the information typically requested in your prompt regarding acceptance criteria, specific study designs (like MRMC or standalone algorithm studies), sample sizes for test and training sets, and ground truth establishment, is generally not present in a 510(k) summary focused on material and processing equivalence.
However, I can extract the relevant information from the provided document regarding substantial equivalence and performance testing for this type of device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Equivalence/Performance Characteristic) | Reported Device Performance (Integra™ Meshed Bilayer Wound Matrix) |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Acceptable (based on predicate testing) |
| Dermal Sensitization | Acceptable (based on predicate testing) |
| Irritation | Acceptable (based on predicate testing) |
| Acute Systemic Toxicity | Acceptable (based on predicate testing) |
| Pyrogenicity | Acceptable (based on predicate testing) |
| Hemolysis | Acceptable (based on predicate testing) |
| Product Characterization/Performance: | |
| Pore size (pre-determined functional pore size) | Determined using SEM and Image Analysis |
| Helical content of collagen | Evaluated using Fourier Transform Infrared (FTIR) Spectrophotometry |
| Chondroitin-6-sulfate (C-6-S) quantification | Quantified using visible spectroscopy |
| Degree of cross-linking | Determined using a colorimetric assay |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a "test set" in the context of clinical performance data for the Integra™ Meshed Bilayer Wound Matrix. The primary demonstration is that it is comprised of identical materials and processed and sterilized by identical methods as its predicate device (Integra™ Bilayer Matrix Wound Dressing, K021792).
The biocompatibility testing was performed on the predicate device (Integra™ Bilayer Matrix Wound Dressing) in accordance with International Standard ISO 10993-1:1992 and Good Laboratory Practices. The document implies the "data provenance" for these biocompatibility tests would be the lab that conducted them, likely in the country where Integra LifeSciences Corp. operates (USA, given the FDA submission). This was a retrospective application of predicate data to the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This type of 510(k) submission does not typically involve expert review of a "test set" in the sense of clinical images or patient outcomes for ground truth establishment. The ground truth for biocompatibility is established by standardized, objective laboratory tests.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical "test set" requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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-powered diagnostic or assistive tool. MRMC studies are not relevant to this type of medical device submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical wound matrix, not an algorithm.
7. The Type of Ground Truth Used
- For Biocompatibility: The "ground truth" was established by standardized laboratory test results against established biological safety guidelines (ISO 10993-1:1992) for cytotoxicity, dermal sensitization, irritation, acute systemic toxicity, pyrogenicity, and hemolysis.
- For Product Characterization: The "ground truth" for characteristics like pore size, helical content of collagen, C-6-S quantification, and degree of cross-linking was based on objective measurement techniques (SEM, Image Analysis, FTIR, visible spectroscopy, colorimetric assay) against internal specifications or established material properties.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth for a training set to establish.
Summary of the Study:
The "study" described for the Integra™ Meshed Bilayer Wound Matrix is primarily a comparative study for substantial equivalence to a predicate device (INTEGRA™ Bilayer Matrix Wound Dressing, K021792). The key findings are:
- The new meshed device uses identical materials and undergoes identical processing and sterilization methods as the cleared predicate device.
- Biocompatibility data for the predicate device, performed according to ISO 10993-1:1992 and Good Laboratory Practices, were found to be acceptable and are considered applicable to the new meshed product due to material and process identity.
- In vitro product characterization studies were performed on the new device (e.g., pore size, collagen helical content, C-6-S quantification, cross-linking degree) to confirm its physical and chemical properties.
The conclusion is that based on the in vitro product characterization studies, performance testing, and biocompatibility data (from the predicate), the Integra™ Meshed Bilayer Wound Matrix is safe and substantially equivalent to its predicate device. This demonstrates that the new device meets the regulatory acceptance criteria for substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission.
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