Search Results

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.

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.

Ask a specific question about this device

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

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:

1. Biocompatibility testing: Adherence to ISO 10993-1 standards.
2. Product characterization: In vitro studies to confirm material properties and other technical characteristics.
3. 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.

Ask a specific question about this device