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The IM Band ™ is a compression device to assist hemostasis of the radial artery after a transradial procedure.

The IM Band TM Adjustable Arterial Compression Band is intended to be used to oppress the vascular puncture in order to stop the bleeding by the inflation of a balloon. Transparent balloon material allows clear monitoring of the hemostasis time. Oppressing inside the balloon can be adapt to the skin surface for better contact. Bleeding can be stopped by simply adjusting the band or turncap according to doctor's instruction. Soft and adjustable wrist band enhances patient comfort.

The provided text {0}-{4} does not contain sufficiently detailed information regarding the acceptance criteria, study design, or performance data of the IM Band Adjustable Arterial Compression Band to fully complete the requested table and study description.

The document is a 510(k) summary and FDA clearance letter, which primarily focuses on establishing substantial equivalence to a predicate device rather than presenting extensive performance study results.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not specified. The document does not mention a "test set" in the context of expert-adjudicated ground truth.

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

• Not specified. This is typically relevant for studies involving subjective assessments or image interpretation, which does not appear to be the focus here.

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 comparative effectiveness study is mentioned. This device is an arterial compression band, not an AI-powered diagnostic or assistive tool.

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

• Not applicable/Not mentioned. This device is not an algorithm.

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

• Not explicitly defined. For a physical device like this, "ground truth" would likely refer to objective clinical outcomes such as successful hemostasis, time to hemostasis, incidence of complications (e.g., hematoma, bleeding), and patient comfort. The document only generically states "performance testing demonstrated safety and effectiveness."

8. The sample size for the training set:

• Not applicable/Not specified. This device is not an AI model requiring a "training set."

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

• Not applicable.

Summary of available information:

The provided K113600 submission summary indicates that Synexmed (Shenzhen) Company Limited submitted the IM Band Adjustable Arterial Compression Band for 510(k) clearance. The device is intended to assist hemostasis of the radial artery after a transradial procedure.

The core of the submission relies on demonstrating substantial equivalence to the TR Band by Terumo Medical Corporation (#K070423). The document explicitly states: "Comparisons of the proposed and predicate devices show that the technological characteristics such as materials, performance characteristics, and sterilization are identical or substantially equivalent to the currently marketed predicate devices."

Section 5.7, "Performance Data," concludes with a general statement: "The results of the performance testing demonstrated the safety and effectiveness of the IM Band Adjustable Arterial Compression Band." However, it does not provide any specific details about the nature of this performance testing, the acceptance criteria, the sample sizes, the methodology, or the actual numerical results obtained. This level of detail is typically not required in the publicly available 510(k) summary, which often provides a high-level overview. The detailed study reports would be reviewed by the FDA during their assessment but are not included in this extract.

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