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The Radial Artery Compression Tourniquet is designed for temporary hemostasis of radial artery post percutaneous puncture.

Radial Artery Compression Tourniquets

The provided document is a 510(k) clearance letter for the "Radial Artery Compression Tourniquets" and does not contain the specific information about acceptance criteria, device performance, study details, or AI-related data as requested. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but does not include the detailed technical study information you're looking for.

Therefore, I cannot provide the requested information based on the input text.

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The Radial Artery Compression Tourniquet Device is a compression device to assist haemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, haemodialysis, and in patients on anticoagulation therapy.

The Radial Artery Compression Tourniquet devices consist of a plastic belt with an adjustable fastener on each end, two compression balloons, tubing and a unilateral valve. The plastic belt has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist and are made of clear plastic which allows the physician to view the access site during the haemostasis process. The inflation device introduces air through the unilateral valve filling two compression balloons (large and small) at the same time. The top small balloon is layered and internally connected to the bottom large balloon. The result of the balloon inflation is the haemostasis of the puncture site within the patient's wrist.

The provided text describes the Radial Artery Compression Tourniquet and its substantial equivalence to predicate devices, but it does not contain the specific information requested in points 1 through 9 regarding acceptance criteria and a study proving device performance in the context of an AI/algorithm-based device.

The document details the device's description, intended use, contraindications, warnings, and cautions. It also mentions "Tests Conducted," which include:

• Biocompatibility: Assessed against ISO 10993 Biological Evaluation of Medical Devices - Part 10 for Irritation and Sensitization and Part 5 Tests for Cytotoxicity. It states that the device "has been shown to meet the acceptance criteria, and did not raises additional safety and effectiveness concerns."
• Performance: A "side-by-side comparison of the predicate TR Band®, Terumo Corporation, K070423 performance of the balloon’s maintenance of internal pressure was performed with the Lepu’s device." The conclusion is that "The balloon profile performance characteristics of both devices are very similar when factoring the balloon size and volume inflation difference and do not impose any additional safety or performance issues."

However, this information is for a physical medical device (a tourniquet) and not for an AI/algorithm-based device. Therefore, the requested details like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth for training was established are not present in the provided text.

Based on the provided text, the answer to the specific questions regarding acceptance criteria and a study proving the device meets those criteria for an AI/algorithm would be:

1. Table of acceptance criteria and reported device performance: Not applicable for an AI/algorithm performance study. The document mentions biocompatibility acceptance criteria (meeting ISO 10993 standards) and performance comparison of balloon pressure maintenance to a predicate device, concluding similarity.
2. Sample size for the test set and data provenance: No test set information for an AI/algorithm is provided.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable for an AI/algorithm.
4. Adjudication method: Not applicable for an AI/algorithm.
5. Multi reader multi case (MRMC) comparative effectiveness study: No MRMC study is mentioned.
6. Standalone performance: No standalone (algorithm only) performance is mentioned.
7. Type of ground truth used: Not applicable for an AI/algorithm. For the physical device, the "ground truth" for biocompatibility was meeting ISO standards, and for performance, it was comparable balloon pressure maintenance to a marketed predicate.
8. Sample size for the training set: No training set information for an AI/algorithm is provided.
9. How the ground truth for the training set was established: Not applicable for an AI/algorithm.

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