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BloodSTOP iX Battle Matrix is indicated for external temporary control of minor to moderate bleeding of traumatic wounds.

BloodSTOP iX Battle Matrix is a biocompatible, non-irritating, woven matrix of fibers made from cellulose. Using a proprietary process, regenerated cellulose is etherified and oxidized to make a watersoluble, hemostatic matrix. When applied to a wound, BloodSTOP® iX Battle Matrix absorbs blood and other body fluids, transforms into a gel, actively aids in blood coagulation, and adheres to the wound with a protective translucent layer. BloodSTOP iX exerts its pro-coagulant activity by activating the intrinsic coagulation pathway, accelerating clot formation. Its water solubility allows for easy removal through rinsing without disruption of the clotted wound surface. BloodSTOP iX Battle Matrix is provided sterile in a simple to use format that readily conforms to a wound: 3"x24" strip, z-folded to an 8-layer 3"x3" pad.

The provided text describes the BloodSTOP iX Battle Matrix device and its substantial equivalence to predicate devices, particularly focusing on biocompatibility and hemostatic efficacy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the input text:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Biocompatibility Testing: The text does not specify the sample size for individual biocompatibility tests. It states that tests were performed "for evaluation of devices in contact with breached or compromised surfaces for a limited duration." These are generally standardized in vitro and in vivo tests, but specific animal or cell line numbers are not provided.
  • Data Provenance: Not explicitly stated, but typically these tests are conducted in certified laboratories according to ISO standards.
• Hemostatic Efficacy (In vivo testing):
  • Test Set: "a widely recognized 6mm femoral artery injury model in swine." The exact number of swine used is not specified.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but it's an in vivo animal model, implying prospective (experimental) data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The text does not provide information about the number of experts or their qualifications for establishing ground truth for either biocompatibility or hemostatic efficacy testing. These types of studies typically follow established scientific protocols and endpoint measurements rather than relying on expert consensus for ground truth on the test itself.

4. Adjudication method for the test set:

The text does not mention an adjudication method (like 2+1, 3+1) for the test set. For the types of studies described (biocompatibility and animal hemostasis model), results are usually objectively measured and interpreted by laboratory personnel and veterinary scientists, rather than clinical experts adjudicating outcomes from images or patient data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The studies described are laboratory and animal model-based, not human reader-based evaluations. Therefore, there is no effect size of human readers improving with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable. The device, BloodSTOP iX Battle Matrix, is a physical hemostatic dressing, not an algorithm or an AI-powered device. Therefore, the concept of "standalone performance" for an algorithm without human intervention does not apply here.

7. The type of ground truth used:

• Biocompatibility Testing: The ground truth for these tests is established by standardized laboratory assays and observations as defined by ISO 10993-1 and FDA Blue Book Memo, G95-1 (e.g., cell viability for cytotoxicity, skin reaction scores for irritation/sensitization).
• Hemostatic Efficacy (In vivo testing): The ground truth for hemostatic efficacy in the swine model is based on direct physiological measurements and observations of objective endpoints, such as:
  • Measured time to hemostasis (actual time until bleeding stops).
  • Quantified blood loss.
  • Measured Mean Arterial Pressure (MAP).
  • Survival rate (3-hour survival).
  • Hematological analysis of clot stability.
  • Pathological examination for adverse effects (absence of conclusive distant adverse effects).

8. The sample size for the training set:

This question is not applicable. The BloodSTOP iX Battle Matrix is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

9. How the ground truth for the training set was established:

This question is not applicable for the same reason as #8.

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