(29 days)
RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.
RESPONDER® Polysaccharide Hemostat (RESPONDER®) is a medical device composed of absorbable modified polymer (AMP®) particles. AMP® particles are biocompatible, non-pyroqenic and derived from plant starch. The device contains no human or animal components.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called RESPONDER® Polysaccharide Hemostat. This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding specific acceptance criteria, device performance metrics, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC) typically found in clinical study reports.
The document primarily states that the new models (RP0002/RP0003/RP0005) of the RESPONDER® Polysaccharide Hemostat are substantially equivalent to a previously cleared device (K220525) for over-the-counter (OTC) indications. This substantial equivalence is based on the new models having the same raw material, production technique, packaging, sterilization, indications for use, composition, form of device, method of application, mechanism of action, biocompatibility, and resorption performance as the previously cleared predicate device.
Key takeaway for your request: The entire document points to "substantial equivalence" as the primary "acceptance criterion" rather than a specific numerical performance metric. The study proving this is essentially the demonstration that the new device models are identical in all relevant aspects to a previously cleared device.
Given the information available, I can provide what is implied by the document regarding your questions:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Implied) |
|---|---|
| Raw Material: Identical to predicate device | Identical to predicate device |
| Production Technique: Identical to predicate device | Identical to predicate device |
| Packaging: Identical to predicate device | Identical to predicate device |
| Sterilization: Identical to predicate device | Identical to predicate device |
| Indications for Use (OTC): Identical to predicate device | Identical to predicate device |
| Composition: Identical to predicate device | Identical to predicate device |
| Form of Device (Granules): Identical to predicate device | Identical to predicate device |
| Method of Application: Identical to predicate device | Identical to predicate device |
| Mechanism of Action: Identical to predicate device | Identical to predicate device (forms gel barrier to achieve hemostasis) |
| Biocompatibility: Identical to predicate device | Verified in predicate device's submission (K220525) |
| Resorption Performance: Identical to predicate device | Verified in predicate device's submission (K220525) |
| Safety: As safe as the predicate device | Concluded to be as safe as the predicate device |
| Effectiveness/Performance: Functionally equivalent to predicate device for local management of bleeding. | Can achieve hemostasis by forming a gel barrier, verified in predicate device's submission (K220525). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document does not specify a distinct "test set" or its sample size for evaluating the new device models. The "study" here is largely a comparison to a previously cleared device. The equivalence is stated based on common characteristics. There is no information about data provenance.
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. The ground truth for this submission is based on the established safety and performance of the predicate device, not a new "test set" requiring expert ground truthing in the typical sense of a clinical or diagnostic study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a regulatory clearance based on substantial equivalence, not a clinical trial with adjudicated outcomes from a test set.
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. The device is a hemostat (a physical product to stop bleeding), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" in this context is the regulatory clearance and established safety/performance profile of the predicate device (RESPONDER® Polysaccharide Hemostat, K220525) based on previous submissions and evaluations.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
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