(86 days)
CollaWound wound dressing is intended for the management of wounds including:
- partial and full-thickness wounds
- diabetic ulcers
- venous ulcers
- pressure ulcers
- chronic vascular ulcers
- tunneled/undermined wounds
- surgical wounds (donor site/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- trauma wounds (abrasions, lacerations, secondary-degree burns, and skin tears)
- draining wounds
CollaWound wound dressing is a sterile, single use, disposable wound dressing comprised of cross-linked porous collagen matrix with yellow to off-yellow appearance and is supplied in sponge configuration. It forms a layer of thin film at the wound site and provides a biodegradable scaffold for the cell invasion and capillary growth.
The provided document describes a 510(k) premarket notification for the "CollaWound wound dressing." This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting a de novo study to establish specific performance acceptance criteria and then proving the device meets them.
Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not applicable to this submission. The 510(k) process for this device focuses on demonstrating that it is as safe and effective as existing products.
Here's an analysis of the provided information based on your request, identifying what is present and what is not applicable:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The 510(k) submission for the CollaWound wound dressing does not include a table of specific numerical acceptance criteria (e.g., minimum tensile strength, maximum absorption rate, specific clinical outcome percentages) and corresponding reported device performance values from a study designed to meet those criteria.
- Instead, the submission states that "Biocompatibility tests have confirmed that CollaWound wound dressing meets the requirements stated in the FDA Blue book memorandum G95-1 and ISO 10993." This is a general statement of compliance with recognized standards, not a table of performance against predefined acceptance criteria for the device's function as a wound dressing.
- The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and material.
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. The document does not describe a clinical performance study with a test set of patients or data to evaluate the device's efficacy against specific performance criteria. The biocompatibility tests would have involved specific sample sizes, but these are not for clinical performance.
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. As there is no described clinical test set for performance, there is no mention of experts used to establish ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no described clinical test set, so no adjudication method is mentioned.
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 physical wound dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study involving human readers and AI assistance is entirely irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No clinical study for performance is described that would require a ground truth. For the biocompatibility tests, the ground truth would be established by the specific chemical and biological assays and their validated controls as per ISO 10993 and FDA guidelines.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of this 510(k) submission for a wound dressing, as it does not involve machine learning or an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. No training set is mentioned or relevant.
Summary of Device Acceptance (based on the provided document):
The CollaWound wound dressing was accepted by the FDA based on the demonstration of substantial equivalence to four legally marketed predicate devices. The key elements for this acceptance were:
- Intended Use: The CollaWound wound dressing has the same intended use as the predicate devices (management of partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds, first and second degree burns, surgical wounds, draining wounds).
- Technological Characteristics: The device is a collagen wound dressing, similar in technological characteristics to the predicates. It is a sterile, single-use, disposable, cross-linked porous collagen matrix.
- Material: The device is made of collagen, which is the same material as the predicate devices.
- Safety: Biocompatibility tests confirmed compliance with FDA Blue Book Memorandum G95-1 and ISO 10993. This demonstrated the safety profile of the material.
The FDA's decision, as stated in the letter, is that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the device was found to be as safe and effective as the existing products on the market without requiring new clinical trials to prove its efficacy against new performance criteria.
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