(14 days)
Collagen Topical Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.
Collagen Topical Wound Dressing may be used for the management of exudating wounds such as:
- . Pressure ulcers
- Venous stasis ulcers .
- Diabetic ulcers .
- Acutc wounds, for example trauma and surgical wounds .
- . Partial-thickness burns
Collagen Topical Wound Drcssing is an opaque, absorbent, collagen membrane matrix intended for topical use. The product is supplied sterile and for single use only.
This document describes the Collagen Topical Wound Dressing and its regulatory submission. It is a 510(k) premarket notification, which means the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials as would be required for a PMA.
Therefore, the submission does not contain the typical information about acceptance criteria, efficacy studies with human subjects, or AI performance metrics that your questions are asking for. Instead, the focus is on demonstrating that the new device is fundamentally similar to existing, cleared devices.
Here's an analysis of the provided text in the context of your questions:
1. A table of acceptance criteria and the reported device performance
- Not applicable for this type of submission. This submission does not provide acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) for addressing specific clinical outcomes. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
- The "performance" reported is primarily in relation to safety and material characteristics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety/Biocompatibility (ISO 10993-1) | Passed all applicable ISO 10993-1 testing for biological evaluation of medical devices. |
| Substantial Equivalence to Predicate Device | Same fundamental scientific technology, intended use, material, source, sterilization as the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission does not involve a clinical "test set" in the sense of patient data for efficacy evaluation. The "tests" mentioned are biocompatibility and in vitro product characterization. No information on sample size or data provenance for these types of tests is provided in this summary.
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. There is no "ground truth" establishment by medical experts for a clinical test set in this 510(k) summary. The evaluation focuses on manufacturing, material, and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication by experts 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 topical wound dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with human readers and AI assistance is entirely irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As stated above, this is a physical medical device, not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the clinical sense. The "ground truth" for this submission revolves around established biocompatibility standards (ISO 10993-1) and the technical characteristics of the predicate device. The "truth" is that the device meets these standards and is sufficiently similar to an already cleared product.
8. The sample size for the training set
- Not applicable. This submission does not involve a "training set" of data for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. This submission does not involve a "training set" of data for an algorithm.
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