(42 days)
Non-absorbable hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required.
BloodSTOP and BloodSTOP iX Hemostatic Gauze are made from regenerated cotton cellulose, chemically treated to become water-soluble. When contacting blood and exudates, they expand into clear gel, thereby adhering and creating pressure to seal the wound.
The provided text describes a 510(k) premarket notification for the "BloodSTOP and BloodSTOP iX Hemostatic Gauze" and its substantial equivalence determination. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the specific study that proves the device meets those criteria.
The document is a US FDA 510(k) clearance letter (K072681) from 2007, and an administrative update letter from 2023. It states that the device is substantially equivalent to a predicate device, "Seal-On Hemostatic Powder Spray" (K010933). It mentions that "Animal studies included in this submission show that BloodSTOP and BloodSTOP iX are equivalent or faster than the predicate Seal-On Powder Spray in time to hemostasis."
Based on the provided information, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner for performance. It broadly states: "Animal studies included in this submission show that BloodSTOP and BloodSTOP iX are equivalent or faster than the predicate Seal-On Powder Spray in time to hemostasis."
- Acceptance Criteria (Implicit): Time to hemostasis for BloodSTOP/BloodSTOP iX should be equivalent to or faster than the predicate device (Seal-On Hemostatic Powder Spray).
- Reported Device Performance: BloodSTOP/BloodSTOP iX demonstrated performance that was "equivalent or faster" than the predicate device in terms of time to hemostasis in animal studies.
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The document only mentions "Animal studies."
- Data Provenance: "Animal studies" were used. The country of origin and whether it was retrospective or prospective is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For animal studies evaluating hemostasis, "ground truth" would typically be objective measurements of bleeding cessation, rather than expert consensus on an image or clinical observation.
4. Adjudication method for the test set
This information is not provided in the document.
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
This is not applicable. The device is a hemostatic gauze, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used
For hemostasis studies, the ground truth would be objective measurements of bleeding cessation, typically observed directly during the animal procedure. The document doesn't specify the exact metrics but implies direct observation of "time to hemostasis."
8. The sample size for the training set
This information is not provided. As this is not an AI/ML device, a "training set" in the computational sense is not directly relevant. The "training" or development of the device would involve research and development, but not an algorithmic training set.
9. How the ground truth for the training set was established
This information is not provided and is not directly applicable in the context of a physical medical device. The "ground truth" for developing such a device would relate to the chemical properties and physical performance observed during its formulation and testing, aiming to achieve the desired hemostatic effect.
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