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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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Topical control of bleeding from minor cuts and abrasions of the skin surface

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 document is a 510(k) premarket notification for the BloodSTOP and BloodSTOP iX Hemostatic Gauze. It is not a study that describes acceptance criteria and proves the device meets them in the context of an AI/ML medical device.

The 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Seal-On Hemostatic Powder Spray, K010933) for its intended use, which is "Topical control of bleeding from minor cuts and abrasions of the skin surface."

Therefore, based on the provided document, I cannot fulfill your request for the following reasons:

• No Acceptance Criteria for AI/ML performance: The document does not define performance acceptance criteria for an AI/ML device, as it is not an AI/ML device. It's a wound dressing.
• No Reported Device Performance relevant to AI/ML: The performance reported is related to hemostasis time in animal studies, comparing it to the predicate device. This is not performance data for an AI/ML system (e.g., sensitivity, specificity, accuracy).
• No Test Set/Data Provenance for AI/ML: There is no mention of test sets, data provenance, or ground truth for an AI/ML model.
• No Expert Ground Truth establishment: The document does not discuss experts establishing ground truth for a test set.
• No Adjudication Method: Adjudication methods are not applicable here.
• No MRMC Comparative Effectiveness Study: There is no mention of a multi-reader multi-case study, as this device does not involve human readers interpreting outputs.
• No Standalone Algorithm Performance: The concept of standalone algorithm performance is irrelevant for a hemostatic gauze.
• No Ground Truth Type relevant to AI/ML: The "ground truth" for this device would be direct observation of hemostasis, not expert consensus, pathology, or outcomes data in the context of an AI/ML model.
• No Training Set Size/Ground Truth for Training Set: Since it's not an AI/ML device, there are no training sets or ground truth established for training.

What the document does describe (and how it relates to your request's concepts, even if not directly fulfilling it):

• Device Performance (not for AI/ML): "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." This is the primary "performance" discussed.
• Ground Truth (implicitly for animal studies): The concept of "time to hemostasis" in animal studies implies direct observation or measurement of when bleeding stops, which would serve as the "ground truth" for that specific performance metric.
• Comparison to Predicate Device: The study's "acceptance criteria" can be implicitly understood as demonstrating substantial equivalence to the predicate device, particularly regarding safety and effectiveness (hemostasis time and biocompatibility).

In summary, the provided FDA 510(k) notification for BloodSTOP and BloodSTOP iX Hemostatic Gauze is for a physical medical device and therefore does not contain information about acceptance criteria, study design, or performance metrics relevant to an AI/ML-driven device.

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