(269 days)
PerClot Topical is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of mildly bleeding wounds such as surgical wounds (postoperative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access, and percutaneous catheter access sites.
PerClot® Topical is a medical device composed of absorbable polysaccharide granules and delivery applicators. The granules are biocompatible, non-pyrogenic and derived from purified potato starch. The granules do not contain any human or animal components. PerClot granules have a molecular structure that rapidly absorbs water, forming a gelled adhesive matrix that provides a mechanical barrier to further bleeding and results in the concentration of platelets, red blood cells, and coagulation proteins (thrombin, fibrinogen, etc.) at the site of application. The gelled adhesive matrix thus promotes the normal physiological clotting cascade. PerClot granules are enzymatically degraded by alpha-amylase and glucoamylase and by macrophages.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PerClot Topical device:
This 510(k) summary for PerClot Topical does not describe a study involving an AI/Machine Learning device or a direct comparison to human performance. Instead, it outlines the regulatory pathway for a conventional medical device (a topical hemostatic agent).
Therefore, many of your requested sections regarding AI-specific criteria, such as multi-reader multi-case studies, ground truth establishment for training sets, or expert qualifications for interpreting AI outputs, are not applicable to this document. I will focus on the information that is present and indicate where the requested information is not relevant to this type of submission.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Substantial equivalence to predicate device | PerClot is substantially equivalent compared to the predicate device (NexStat® Topical Hemostat Powder). |
| Performance Specifications | Total water absorption | Meets specifications. |
| Rate of water absorption | Meets specifications. | |
| Adhesion/Cohesion | Meets specifications. | |
| Particle/granule size distribution specifications | Meets specifications. | |
| Safety and Effectiveness | Pre-clinical GLP evaluation | Conducted according to applicable standards, supports safety and effectiveness. |
| Biocompatibility | Biocompatibility studies (ISO 10993) | Performed in accordance with ISO 10993. |
"Study That Proves the Device Meets the Acceptance Criteria":
The document describes several types of testing that collectively demonstrate the device meets acceptance criteria:
- Bench Testing: Functional testing demonstrated "substantial equivalence" to the predicate device (NexStat® Topical Hemostat Powder).
- Performance Testing: Studies demonstrated that PerClot meets specific performance specifications related to water absorption (total and rate), adhesion/cohesion, and particle/granule size distribution. The document states, "The function of the product is directly related to these performance specifications."
- Pre-clinical GLP Evaluation: This study was conducted according to applicable standards and is reported to support PerClot's safety and effectiveness.
- Biocompatibility Studies: Performed in accordance with ISO 10993.
These tests, rather than a single overarching study, are presented as the evidence for meeting acceptance criteria.
Regarding AI/Machine Learning Specific Information (Not Applicable to this Document):
The following points are not applicable as this 510(k) pertains to a physical medical device (hemostatic particles) and not an AI/Machine Learning diagnostic or assistive device.
2. Sample size used for the test set and the data provenance: Not applicable. No test set of data (e.g., medical images, patient records) is mentioned for an AI device. The testing involved functional, performance, pre-clinical, and biocompatibility assessments of the material itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment for an AI test set is relevant here. The ground truth refers to the physical properties and biological effects of the hemostatic particles.
4. Adjudication method for the test set: Not applicable. There is no test set in the context of AI evaluation.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI device. For this physical device, the "ground truth" would be the established scientific and engineering principles for hemostasis, material science, and biocompatibility, as evaluated through the described bench, performance, pre-clinical, and biocompatibility testing. No "expert consensus" on interpreting data for an algorithm is mentioned.
8. The sample size for the training set: Not applicable. No AI training set is mentioned.
9. How the ground truth for the training set was established: Not applicable. No AI training set is mentioned.
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