(262 days)
INTEGRA® Wound Matrix (Macro-Channels) is indicated for the management of wounds including: partial and full-thickness wounds, pressure 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, partial thickness burns, skin tears) and draining wounds. The device is intended for one-time use.
INTEGRA® Wound Matrix (Macro-Channels) is a collagen-glycosaminoglycan wound dressing that maintains and supports a healing environment for wound management. INTEGRA® Wound Matrix (Macro-Channels) has macro-channels to facilitate drainage of wound exudate. INTEGRA® Wound Matrix (Macro-Channels) is supplied sterile and is intended for one-time use.
The provided text is a 510(k) Pre-market Notification document for a medical device called INTEGRA® Wound Matrix (Macro-Channels). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting in the way an AI/ML device study might.
Since this document is not for an AI/ML device, the typical metrics and study designs (like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample size of a test set, etc.) are not applicable here. The device is a collagen wound dressing, meaning its evaluation relies on material properties, biocompatibility, and animal models, rather than diagnostic accuracy or human interpretation of outputs.
However, I can extract the information relevant to its acceptance criteria and the studies performed to demonstrate equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of specific acceptance criteria in the sense of predefined thresholds for clinical outcomes (e.g., wound closure rate) for the subject device. Instead, it focuses on demonstrating that the technological characteristics of the subject device are substantially equivalent to the predicate device, and that its performance meets general scientific and safety standards.
Here's a breakdown of the key characteristics and findings:
| Characteristic/Test | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Subject Device) |
|---|---|---|
| Composition | Type I Bovine Collagen - glycosaminoglycan matrix | Type I Bovine Collagen - glycosaminoglycan matrix (Identical to predicate) |
| Form | Sheet | Sheet (Identical to predicate) |
| Perforations | No (Predicate) | Yes (Subject device modification: Macro-channels to facilitate drainage) |
| Dimensions | 2"x2", 4"x5", 4"x10", 8"x10" | 2"x2", 4"x5", 4"x10", 8"x10" (Identical to predicate) |
| Resistance to collagenase Digestion | Optical Density Less than 0.800 absorbance unit | Optical Density Less than 0.800 absorbance unit (Matches predicate) |
| Endotoxin | Must be Less than 20 EU/device | Must be Less than 20 EU/device (Matches predicate) |
| Biocompatibility | Passes ISO 10993 tests (Cytotoxicity, Dermal Irritation, Dermal Sensitization, Acute Systemic Toxicity, Hemolysis, Sub-chronic (sub-acute) Toxicity, Genotoxicity) | Biocompatibility testing on predicate leveraged; additional chemical analysis for new manufacturing step. Passes ISO 10993 tests for cytotoxicity. (Deemed acceptable based on predicate data and additional assessment). |
| Anatomical Location | Wounds | Wounds (Identical to predicate) |
| Thickness | Approximately 0.8mm | Approximately 0.8mm (Identical to predicate) |
| Sterility | e-beam irradiation, 10-6 SAL, single-use only | e-beam irradiation, 10-6 SAL, single-use only (Identical to predicate) |
| Pore size | Not explicitly stated for predicate in table, but listed as a tested parameter for subject device | Tested to ensure specifications are met (Specific values not provided in this summary). |
| Collagen nativity-FTIR test of denaturing | Not explicitly stated for predicate in table, but listed as a tested parameter for subject device | Tested to ensure specifications are met (Specific values not provided in this summary). |
| Chondroitin-6-sulfate content | Not explicitly stated for predicate in table, but listed as a tested parameter for subject device | Tested to ensure specifications are met (Specific values not provided in this summary). |
| Permeability | Not explicitly stated for predicate in table, but listed as a tested parameter for subject device | Tested to ensure specifications are met (Specific values not provided in this summary). |
| Drapeability | Not explicitly stated for predicate in table, but listed as a tested parameter for subject device | Tested to ensure specifications are met (Specific values not provided in this summary). |
| Degree of cross-linking | Not explicitly stated for predicate in table, but listed as a tested parameter for subject device | Tested to ensure specifications are met (Specific values not provided in this summary). |
| In Vivo Safety & Effectiveness | Equivalent healing to predicate device | No significant differences in healing between the predicate and modified devices in a porcine wound healing model. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the individual tests. For the in vivo study, a "porcine wound healing model" was used, but the number of animals or wounds is not mentioned.
- Data Provenance: The biocompatibility data was leveraged from the predicate device (K022127). The in vivo study was conducted, likely by the manufacturer, but country of origin is not specified. The studies are retrospective in the sense that existing data from the predicate device was largely used, and any new tests (like the in vivo porcine study) would be considered prospective for the subject device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a diagnostic device that requires expert interpretation for ground truth. The evaluation is based on material science, chemical analysis, and animal model outcomes.
4. Adjudication method for the test set:
- Not Applicable. No human adjudication of results in the context of interpretation of diagnostic outputs. Results are from laboratory tests and an animal study.
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 is not an AI/ML device, nor does it involve human readers or comparative effectiveness in that sense.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML algorithm.
7. The type of ground truth used:
- Laboratory Measurements & Animal Study Outcomes:
- Compositional analysis: Used to confirm material identity.
- Physical property measurements: (e.g., pore size, thickness, resistance to collagenase, endotoxin levels).
- Biocompatibility test results: Against ISO 10993 standards.
- Histopathological & clinical observations from porcine wound healing model: To assess safety and effectiveness in wound healing.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set.
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