(131 days)
Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) is indicated for external temporary use as a topical dressing on minor bleeding wounds such as minor cuts, minor lacerations and minor abrasions.
The Polysaccharide Hemostatic Powder (HP-2, HP-5) are sterile, topical wound dressings comprised of plant base polysaccharides. The hemostatic particles contained in powder absorb the water in the blood through physical adsorption, so that the blood components are concentrated to form a stable clot and achieve the purpose of hemostasis.
The information provided pertains to the regulatory submission for a medical device (Polysaccharide Hemostatic Powder) and does not describe acceptance criteria for a study showing device performance in the way typically associated with AI/ML-based diagnostic devices. The document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, primarily through non-clinical testing.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set information) are not applicable or not explicitly detailed in this type of submission.
However, I can extract the non-clinical testing performed and the conclusions drawn to fulfill the spirit of the request regarding "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of this regulatory document.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrated through Non-Clinical Testing) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Sterilization: Sterilization procedure validated per ISO 11135:2014. | Sterilization procedure validated in accordance with ISO 11135:2014, for ETO sterilization. |
| Shelf-Life: Demonstrate essential performance is achieved before and after shelf-life test at 2 years, validated per ASTM F1980-21 and packaging requirements per ISO 11607-1:2006. | Shelf-life for two years validated via accelerated testing (ASTM F1980-21) and packaging requirements (ISO 11607-1:2006) met. Essential performance achieved before and after shelf-life test. |
| Biocompatibility: Meet biocompatibility requirements per 2020 FDA Guidance (Use of International Standard ISO-10993-1) for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and pyrogenicity. | Biocompatibility evaluations conducted per FDA Guidance document 'Use of International Standard ISO-10993-1'. Tests performed for cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, and material-mediated pyrogenicity. |
| Physical & Functional Requirements: Design verification testing demonstrates physical and functional requirements are met. | Design verification testing performed to demonstrate physical and functional requirements were met. |
| Safety and Effectiveness (Substantial Equivalence): Performed substantially equivalent to the predicate device in an animal model. | Safety and effectiveness study performed on a porcine animal model demonstrated substantial equivalence to the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of numerical size for the animal model or other non-clinical tests. The document only mentions "a porcine animal model."
- Data Provenance: The animal study was performed (implied as part of the manufacturer's testing). No country of origin for the data is specified, nor is it classified as retrospective or prospective (animal studies are typically prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This information is typically required for studies involving human clinicians interpreting data or images. The current submission describes non-clinical and animal testing.
4. Adjudication method for the test set
- Not Applicable. Again, this is relevant for studies involving human interpretation and disagreement resolution, which is not described here.
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. No MRMC study was conducted, as this device is a physical hemostatic powder, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or software device.
7. The type of ground truth used
- For the animal study ("safety and effectiveness study on a porcine animal model"), the "ground truth" would likely be derived from direct observation of hemostasis and potentially histological examination of the wound site, compared to the performance of the predicate device. For other non-clinical tests (sterilization, shelf-life, biocompatibility, design verification), the ground truth is established by meeting predefined scientific and regulatory standards (e.g., bioassay results meeting specified limits, physical tests meeting design specifications).
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device requiring a training set.
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