(28 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 .
- Acute wounds, for example trauma and surgical wounds .
- Partial-thickness burns .
Collagen Topical Wound Dressing is a white to off-white, absorbent, porous, sponge-like collagen matrix intended for topical use. The product is supplied sterile and for single use only.
The provided document (K040211) is a 510(k) premarket notification for a medical device called "Collagen Topical Wound Dressing". The document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and detailed performance metrics of the device itself.
Therefore, many of the requested categories like sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or not provided in this type of regulatory submission.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Safety/Biocompatibility | Pass all applicable ISO 10993-1 testing for the biological evaluation of medical devices. | "The device passed all applicable ISO 10993-1 testing for the biological evaluation of medical devices." |
| Technical Characteristics | Have the same fundamental scientific technology, intended use, material, source, and sterilization methods as the predicate device (Collagen Topical Wound Dressing, K030921). | "Collagen Topical Wound Dressing has the same fundamental scientific technology and intended use as the predicate device. In particular, the Collagen Topical Wound Dressing and its predicate are the same with respect to intended use, material, source, sterilization, etc." |
| Substantial Equivalence | Be demonstrated to be substantially equivalent to a legally marketed predicate device (K030921) regarding safety and effectiveness for its intended use. | "The results of the in vitro product characterization studies and biocompatibility studies show that the Collagen Topical Wound Dressing is safe and substantially equivalent to its predicate device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This document describes a 510(k) submission primarily based on demonstrating substantial equivalence through in vitro and biocompatibility testing, not clinical trial data with a "test set" in the context of AI/diagnostic device validation.
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 / Not Provided. Ground truth establishment by experts for a test set is not relevant to this type of device and submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. Adjudication methods are not described as this is not a study involving human interpretation of data for ground truth.
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
- No. This is not an AI/diagnostic imaging device, an MRMC study was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical wound dressing, not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided in the AI/diagnostic context. The "ground truth" here would relate to the successful completion of ISO 10993-1 biocompatibility tests and comparison of material properties, manufacturing methods, and intended use to the predicate device. These are objective scientific measurements and manufacturing specifications, not subjective expert consensus or pathology.
8. The sample size for the training set
- Not Applicable / Not Provided. There is no "training set" in the context of this device.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. This concept does not apply to this device and its regulatory submission.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document describes a series of in vitro product characterization studies and biocompatibility studies as the "study" proving the device meets its (largely implicit) acceptance criteria for safety and effectiveness.
- Safety: The device was subjected to ISO 10993-1 testing for biological evaluation of medical devices. The reported performance is that the device "passed all applicable ISO 10993-1 testing." This indicates that the device met the established international standards for biocompatibility, addressing potential risks such as cytotoxicity, sensitization, and irritation.
- Effectiveness/Substantial Equivalence: The primary "proof" of effectiveness and that it meets performance criteria (as per 510(k) pathway) is the demonstration of substantial equivalence to a previously cleared predicate device (K030921, also a Collagen Topical Wound Dressing). The study involved comparing the new device and the predicate on their "fundamental scientific technology and intended use," specifically noting they are the same with respect to "intended use, material, source, sterilization, etc." This comparison, supported by the in vitro and biocompatibility test results, established that the new device is as safe and effective as the predicate.
In essence, the "study" for this 510(k) submission consisted of:
- Biocompatibility testing: Adherence to ISO 10993-1 standards.
- Product characterization: In vitro studies to confirm material properties and other technical characteristics.
- Comparative analysis: Direct comparison of the new device's characteristics (material, source, sterilization, intended use, and fundamental scientific technology) with those of the predicate device to demonstrate sameness.
The conclusion drawn from these activities was that the Collagen Topical Wound Dressing is safe and substantially equivalent to its predicate device, thereby fulfilling the regulatory requirements for market clearance without requiring extensive clinical trials.
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