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The E-Pass is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French.

The guide wire insertion tool helps the guide wire go through the hemostasis valve to reach the guiding catheter.

The torquer provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.

The E-Pass is a unique one-hand operated, "push-pull" hemostatic valve system. It consists of two pieces of silicone hemostasis valve. The quick open-close valve reduces the patient blood loss significantly during endovascular procedures. In the push forward position the valves is 100% open for safe insertion and removal of devices. In the pulled back position the valve is 100% closed and seals smoothly around the inserted devices. Once the valve is closed, devices can still be manipulated freely. E-Pass eliminates the need for rotating hemostatic valve adjustments during the procedure. The E-Pass hemostatic valve system is compatible with most interventional devices based on rapid exchanged and over-the-wire technology. There are three models of the E-Pass: the standard E-Pass and the E-Pass20/E-Pass50. The configuration of the sideport is the only difference among the three models. The sideport of the standard E-Pass ends in a female luer, while the sidearm of the E-Pass 20/ 50ends with a 20/50 cm extension tubing and 3-way stopcock.

The provided text describes a 510(k) summary for the E-Pass™ Hemostasis Valve. However, it does not include detailed acceptance criteria or a comprehensive study report with specific performance metrics to fill a table and address all the requested points.

The document states:

• "The results of the performance testing demonstrated the safety and effectiveness of the E-Pass TM Hemostatic Valve."
• "Performance testing mainly includes the following tests: Visual Inspection for Pouch Integrity, Pouch Peel Test, E-Pass Visual Inspection, Leak Test without products inserted, E-Pass Alarm pressure leak rate, Tensile test on assembly of Extention tube/Y-hub."

This lists the types of tests performed but does not provide the acceptance criteria or reported results for these tests. Therefore, I cannot construct the requested table or answer many of the specific questions.

Here's what can be inferred or stated based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

The provided 510(k) summary is very high-level and does not contain the detailed study information regarding acceptance criteria, sample sizes, expert qualifications, adjudication methods, or specific quantitative results typically found in full test reports. This type of detail is usually in the appendices or a more comprehensive submission, not in the summary document provided.

Therefore, for the remaining points, most answers are "Not specified" or "Not applicable" based solely on the provided text.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., retrospective or prospective, country of origin). This involves physical testing of the device, not clinical data that would typically have country of origin.

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

• Not applicable. This device is a hemostatic valve, and the testing described consists of engineering/physical performance tests (e.g., leak tests, tensile tests, visual inspections), not clinical studies requiring expert image interpretation or ground truth establishment in a diagnostic sense.

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

• Not applicable. As above, this is physical performance testing, not a diagnostic study requiring adjudication of expert interpretations.

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:

• Not applicable. This device is a hemostatic valve, not an AI-powered diagnostic tool.

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

• Not applicable. This device is a hemostatic valve, not an algorithm or AI system.

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

• Not applicable. The "ground truth" for this device's performance would be the specifications and requirements for mechanical and sealing integrity, based on engineering standards and design validation.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that would have a "training set."

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

• Not applicable. As above.

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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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