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510(k) Data Aggregation
(151 days)
WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
Core Scientific Creations WoundClot device is water soluble, based on cellulosic structure. In contact with liquids it forms an adhesive gel which expands and adheres to the wound for bleeding control.
The provided text is a 510(k) summary for the medical device WoundClot. It describes the device, its intended use, and comparison to predicate devices, but it does not contain acceptance criteria or study results in the format requested. The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is a different regulatory hurdle than proving the device meets specific performance acceptance criteria through a dedicated study.
Here's a breakdown of why I cannot fulfill your request for a table of acceptance criteria and reported device performance based on the provided text, and what information is available:
Missing Information and Why:
- Acceptance Criteria Table: The document does not specify quantitative acceptance criteria (e.g., "device must stop bleeding within X seconds" or "achieve Y% reduction in blood loss").
- Reported Device Performance against Acceptance Criteria: Since no specific acceptance criteria are stated, there are no reported performance values to compare against them.
- Study That Proves Device Meets Acceptance Criteria: The document mentions "Performance Data" but this refers to biocompatibility testing and non-clinical (bench) testing, not a clinical study designed to prove efficacy against specific performance criteria.
Information Derived from the Text (where applicable):
Since the document does not present efficacy data in the way you've requested, I will address points 2-9 by detailing what information is provided regarding testing and ground truth, and explicitly state where the requested information is absent.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria | Reported Device Performance |
---|---|
Not specified | Not specified |
Not specified | Not specified |
Not specified | Not specified |
Not specified | Not specified |
Explanation: The 510(k) summary does not include specific quantitative acceptance criteria for the device's hemostatic performance (e.g., time to hemostasis, blood loss reduction). It focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety (biocompatibility). Therefore, there are no reported device performance figures that directly correspond to such criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for efficacy studies. The document refers to "Biocompatibility Testing" and "Non-Clinical (Bench) Testing" which would involve various samples (e.g., rabbits, guinea pigs, mice for in vivo biocompatibility, and physical samples for bench tests).
- Data Provenance (country of origin, retrospective/prospective): Not specified.
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)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not specified. The document does not describe a clinical study involving human readers or assessment of outcomes that would require an adjudication method.
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
- MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. This device (WoundClot, a hemostatic dressing) is not an AI-assisted diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not applicable. The WoundClot is a physical medical device (hemostatic dressing), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the "Biocompatibility Testing," the "ground truth" would be established by observation of biological responses (e.g., cytotoxicity, irritation, sensitization, systemic toxicity) against predefined toxicological endpoints and thresholds as per ISO 10993 standards.
- For "Non-Clinical (Bench) Testing," the "ground truth" for physical properties (color, odor, uniformity, softness, weight, pH, solubility, dissolution) would be established by objective measurements and comparisons.
- There is no indication of clinical outcomes data in this summary.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document describes a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. This document describes a physical medical device, not an AI algorithm that requires a training set.
Summary of available "Performance Data" from the document:
The "Performance Data" referenced in Section VII of the 510(k) summary includes:
- Biocompatibility Testing: Conducted in compliance with ISO 10993 standards (1, 5, 10, 11). This included tests for cytotoxicity, skin irritation (in rabbits), guinea pig maximization sensitization, and systemic toxicity (in mice). The implication is that the device passed these tests given the substantial equivalence determination.
- Non-Clinical (Bench) Testing: Comparison of physical characteristics (color, odor, uniformity, softness, weight, pH, solubility, dissolution behavior) between WoundClot and its predicate, BloodSTOP and BloodSTOP iX Hemostatic Gauze. The document states "found to have substantial equivalent physical properties." It also notes that solubility results demonstrated WoundClot is "completely soluble in water and can be easily rinsed and removed from the wound."
This information supports the safety profile and physical equivalence, but not a specific set of efficacy-related acceptance criteria being met.
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