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ChitoPulse™ Radial Hemostatic Device is intended to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's radial artery, including arterial or venous line or sheath removal, hemodialysis and in patients on anticoagulation therapy.

ChitoPulse™ Hemostatic Device is intended to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's leg, including dorsalis pedis or tibial blood vessels, arterial or venous line or sheath removal and in patients on anticoagulation therapy.

ChitoPulse™ is a mechanical compression band incorporating a hemostatic chitosan patch. The compression band and chitosan patch are positioned over the radial access site and secured in place by a strap fastener. Addition of air to the compression band balloon provides rapid bleeding control by localized compression.

The chitosan patch provides adjunct bleeding control to the balloon compression and provides a barrier against bacterial penetration by a wide range of gram positive and gram negative organisms.

Compression is applied or reduced using a syringe and luer lock valve to add or remove air volume to or from the balloon. Once hemostasis has been achieved, compression may be reduced by gradual removal of air from the balloon.

ChitoPulse™ is a single use device. Once hemostasis is achieved, the compression band is intended to be removed leaving the hemostatic chitosan patch in place. The hemostatic chitosan patch can be secured in place with a securement dressing for up to 24 hrs.

The provided document is a 510(k) Premarket Notification for the ChitoPulse device. It does not describe a study involving an AI/ML device that requires acceptance criteria related to its performance in interpreting medical data or assisting human readers. Instead, it focuses on demonstrating the substantial equivalence of ChitoPulse (a vascular compression device incorporating a hemostatic chitosan patch) to predicate devices through non-clinical testing.

Therefore, many of the requested fields related to AI/ML device performance metrics, human reader studies, and ground truth establishment for AI/ML models are not applicable to this document.

Here's the information that can be extracted or deduced from the document based on the provided request:

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

Since this is a physical medical device (vascular clamp) and not an AI/ML diagnostic tool, the "acceptance criteria" are related to safety and performance specifications for the device itself, rather than diagnostic accuracy metrics. The document focuses on demonstrating substantial equivalence to predicate devices through various tests.

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

The document does not specify sample sizes in terms of "test sets" of patients or images for AI/ML evaluation. The tests described are laboratory/benchtop tests:

• Biocompatibility: Tests were performed in accordance with ISO 10993 standards. The specific number of test articles or biological samples is not provided, but these are typically standardized protocols.
• Bacterial Barrier Testing: Performed using AATCC Test Method 100-2004. The number of samples tested is not specified.
• Performance Testing (Pressure Equivalence, Tensile Strength): Number of units tested is not specified.

Data Provenance: Not applicable in the context of AI/ML data provenance, as these are material and mechanical property tests.

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

Not applicable. Ground truth in the context of this device relates to established scientific and engineering principles for material testing and biological safety, not a diagnostic interpretation by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no human interpretation or adjudication involved in the reported performance tests.

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 MRMC study was done, as this is not an AI-assisted diagnostic device.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For biocompatibility, the ground truth is established by standardized biological assays and regulatory guidelines (ISO 10993). For sterility, it's a validated sterilization process to achieve a specific SAL. For bacterial barrier and mechanical performance, it's based on quantitative laboratory measurements against established test methods and comparison to predicate device performance.

8. The sample size for the training set

Not applicable. No training set for an AI/ML model was used.

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

Not applicable. No training set for an AI/ML model was used.

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