(274 days)
Collagen Powder may be used for the management of wounds such as:
- Diabetic ulcers
- Venous ulcers
- Pressure ulcers
- Ulcers caused by mixed vascular etiologies
- Full-thickness & partial thickness wounds
- Abrasions
- Traumatic wounds
- 1st and 2nd degree burns
- Dehisced surgical wounds
- Exuding wounds
Collagen Powder is a collagen matrix in powder form intended for application as a wound management device. The product is supplied sterile for single use only.
The provided text is a 510(k) summary for Collagen Powder. It asserts substantial equivalence to predicate devices based on materials, intended use, and biocompatibility. However, it does not include acceptance criteria or the details of a study proving the device meets specific performance criteria in the way typically expected for a medical device efficacy study (e.g., clinical trial data, performance metrics).
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
Reasoning: The document primarily focuses on demonstrating "substantial equivalence" based on materials, intended use, and biocompatibility testing against a predicate device. It does not define specific performance metrics (e.g., wound healing rates, infection reduction) for the Collagen Powder or report results against such criteria. The "testing" mentioned is for biocompatibility, viral inactivation, and particle size, which are typically safety and characterization tests rather than performance efficacy tests against clinical acceptance criteria.
Study Information
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "Biocompatibility and Testing" and "Biochemical characterization," and "Viral inactivation validation assessment," and "Particle size analysis." These are laboratory tests, not clinical studies with human participants. No sample sizes or data provenance for a clinical test set are provided.
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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. No clinical test set with ground truth established by experts is described.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
-
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, not performed. This device is a topical wound dressing, not an AI-assisted diagnostic tool, so an MRMC study is not relevant here.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, not applicable. This is a physical wound dressing, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical performance. For the characterization tests (biocompatibility, viral inactivation, particle size), the "ground truth" would be established by validated laboratory assays and standards (e.g., ISO 10993).
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The sample size for the training set:
- Not applicable. No training set for an algorithm is discussed.
-
How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm is discussed.
Summary of Device Rationale from the Document:
The 510(k) submission for Collagen Powder relies on demonstrating substantial equivalence to existing, legally marketed predicate devices (Collagen Sponge K092805 and Collatek Powder K012990). This is achieved by:
- Stating that Collagen Powder has the same intended use (management of various types of wounds) as the predicates.
- Confirming that its materials of construction match Collagen Sponge (K092805).
- Providing biocompatibility evaluation (ISO 10993-1:2009) to show it meets requirements and introduces no new biocompatibility issues.
- Conducting biochemical characterization to confirm the collagen is predominantly Type I and not denatured.
- Performing viral inactivation validation to assure safety.
- Conducting particle size analysis for product characterization.
Crucially, this type of 510(k) submission for an Unclassified device like a topical wound dressing does not typically require extensive clinical efficacy studies with predefined "acceptance criteria" and "performance metrics" in the same way a novel diagnostic or therapeutic device might. Substantial equivalence is often established through comparison to predicates and demonstrating equivalent safety and performance characteristics via bench testing and material characterization, rather than comparative clinical outcomes data for specific performance metrics like wound healing rates.
N/A