(31 days)
Prescription, Rx UltraClot™ is intended as a hemostatic dressing for emergency external use and temporary wound treatment to achieve hemostasis of moderate to severe bleeding.
Over the Counter, OTC
UltraClot™ OTC is intended as a topical hemostatic dressing for the local management of bleeding from minor cuts, lacerations, and abrasions.
UltraClot™ is a hemostatic agent comprising a clay-based powder contained in a dissolving pouch with a non-stick gauze pad backing that is placed on a moderate to severe wound and held in place until hemostasis is achieved. The device is packaged in a vacuum sealed foil bag and is provided sterile.
The provided text is a 510(k) summary for the UltraClot™ and UltraClot™ OTC devices. These documents are typically for medical devices seeking FDA clearance based on substantial equivalence to a predicate device, rather than requiring extensive clinical trials to prove efficacy against defined acceptance criteria in the same way a new drug or high-risk medical device might.
The key information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) is related to demonstrating substantial equivalence to a predicate device through non-clinical testing, particularly animal models and biocompatibility.
Here's an analysis of the provided text in relation to your questions, noting that many of the requested details for AI/software studies are not applicable to this type of device submission:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, tabular format as one might find for a software-based diagnostic AI. Instead, the "acceptance criteria" for this 510(k) are implicitly met by demonstrating substantial equivalence to the predicate device, Quikclot®, in terms of mechanism, safety, and efficacy.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (UltraClot™) |
|---|---|
| Similar adsorptive mechanism | Has a similar adsorptive mechanism to Quikclot®. |
| Equivalent speed of hemostasis | Found to be at least substantially equivalent to Quikclot® in terms of speed of hemostasis. |
| Equivalent efficacy of hemostasis | Found to be at least substantially equivalent to Quikclot® in terms of efficacy. |
| Absence of exothermia | Demonstrates absence of exothermia. |
| Reduced blood loss | Demonstrates reduced blood loss. |
| Biocompatibility (safety for intended use) | Biocompatibility testing demonstrated UltraClot™ to be safe for its intended use (mutagenicity, cytotoxicity, intracutaneous studies). |
| Similar indications for use | Intended as a hemostatic dressing for emergency external use and temporary wound treatment to achieve hemostasis of moderate to severe bleeding (similar to predicate). |
| OTC version labeling conformance | Labeling modified in conformance with 21CFR 801 Subpart C, consistent with other legally marketed OTC wound management devices. |
2. Sample sized 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: The document mentions "animal models" for testing speed and efficacy. However, it does not specify the number of animals (sample size) used in these models.
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective. Animal studies are experimental. The document does not specify the country of origin. This is a non-clinical 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)
This is not applicable to the type of device and study described. The evaluation in animal models would typically be based on physiological measurements (e.g., clotting time, blood loss) rather than expert interpretation of images or clinical assessments requiring a panel of human experts to establish "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or adjudicators of a test set in the context of diagnostic AI.
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 a physical hemostatic device, not an AI or software-based diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical hemostatic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in the animal model studies would be objective physiological measures of hemostasis, such as:
- Time to hemostasis
- Volume of blood loss
- Presence/absence of exothermic reaction
These are direct measurements of the device's physical and physiological effect in a controlled animal setting, rather than subjective expert consensus or pathology in the context of diagnostic performance.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device 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 device.
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