(73 days)
The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds.
Prescription: TraumArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, · dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at perculaneous needle access, vascular access and percutaneous catheter access sites.
OTC: BleedArrest™ particles and foam are indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.
As described above, the Hemostasis, LLC hemostats are comprised of plant based starch particles. The particles consist in two forms; one is starch particles and one is starch particles processed into a foam using a lyophylization process and include a polysaccharide binder hydroxypropylmethylcellulose (HPMC). Starch is a polysaccharide that is a well known hemostatic agent due to its ability to hold moisture. The Hemostasis hemostatic particles and foam quickly dehydrate blood cells, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding in moderate to severe lacerations,
The provided text is a 510(k) summary for the TraumArrest™ and BleedArrest™ devices. It describes the devices, their intended use, and establishes substantial equivalence to predicate devices. However, this document does not report on a study that proves the device meets specific acceptance criteria with quantifiable performance metrics.
Instead, it states that:
- "Comparative testing was performed using a Porcine Model and the devices met the performance criteria." This indicates a study was done, and it was successful, but the specific acceptance criteria and the results are not detailed.
- "Hemostasis, LLC believes we have demonstrated that our hemostat devices have performed as well as the above predicate devices." This is a statement of belief based on the comparative testing, but again, without specific data.
- "Performance Standards: N/A" This means there are no formal, recognized performance standards for this type of device that the manufacturer had to meet.
Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth are not present in the provided document.
Here's an attempt to answer the questions based on the limited information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Performance in a porcine model equivalent to predicate devices. | "the devices met the performance criteria" in a Porcine Model. |
| Biocompatibility according to ISO 10993 and FDA guidance. | "The criteria have been satisfied for biocompatibility." |
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: Not specified.
- Data Provenance: The study was a "Porcine Model," indicating an animal study rather than human clinical data. The location of the study (country) is not specified. It would be prospective since it's an experimental study.
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 specified. The nature of a porcine model study typically involves veterinary experts or researchers, but this is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- No. This device is a topical hemostat, not an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding human reader improvement with AI is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable as the device is a physical hemostat, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "Porcine Model," the ground truth would likely be direct observation of hemostasis, measurement of blood loss, or time to hemostasis, as assessed by the researchers or veterinary staff involved in the study. This constitutes "outcomes data" in an animal model context.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable as there is no training set for this type of physical medical device.
N/A