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JMS Bypass Tube is intended to be used to internally shunt blood vessel during anastomosis constructions. The shunt allows blood to be delivered distally past the anastomosis site preventing ischemia while the target coronary artery is opened and surgical grafted to a donor vessel. The bypass shunt is to be removed prior to the final sutures being performed. Select the blood vessel bypass tube which is appropriate for the internal diameter of the blood vessel.

The JMS Bypass Tube is a sterile, single use, consists of a tube shaft made by nylon with bulging bulbs at the distal ends. A guide-wire is inserted within the tube shaft to guide the easy insertion of tube shunt into target vessel. A tab on a thread is attached near to the mid-point of the flexible shaft. Each JMS Bypass Tube is individually packaged sterile and non-pyrogenic in a sealed, peel type pouch.

The provided text describes the 510(k) summary for the JMS Bypass Tube, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies with specific acceptance criteria as you might find for novel or AI-powered devices.

Therefore, many of the requested elements regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth are not applicable or not provided within this type of regulatory submission for this particular device.

Here's a breakdown of the information that is available and what is not:

Acceptance Criteria and Study Details for JMS Bypass Tube

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. The document refers to "non-clinical performance testing" but does not detail the number of units tested.
• Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer, JMS North America Corporation.

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 physical medical instrument (a bypass tube), not a diagnostic AI or imaging device that requires expert ground truth for interpretation. The "ground truth" for this device would relate to its physical and material properties, and its ability to function as intended during a surgical procedure, which is evaluated through non-clinical testing and material compliance.

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

• Not Applicable. See point 3.

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 is not an AI or imaging device that would involve human readers or AI assistance.

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

• Not Applicable. This is not an algorithm or AI device.

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

• Not Applicable / Indirectly Implied: The "ground truth" for this device would be its adherence to established engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and functional performance in non-clinical models (e.g., fluid flow, mechanical integrity). This is established through standard engineering and laboratory tests, not clinical outcomes data in the usual sense for diagnostic devices.

8. The sample size for the training set:

• Not Applicable. This device does not use machine learning or AI, so there is no "training set."

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

• Not Applicable. See point 8.

Summary of the Study Discussed:

The "study" described in the provided text is a collection of non-clinical performance tests focused on demonstrating the safety and effectiveness of the JMS Bypass Tube and its substantial equivalence to an existing predicate device (T-AnastaFLO, K990396).

• Test Type: Non-clinical (likely bench testing, material compatibility testing).
• Purpose: To confirm the device can perform its intended function (temporary bypass shunt to prevent ischemia during anastomosis) and meets material safety standards (ISO 10993).
• Conclusion: The tests demonstrated the device is "safe and effective for use as intended and the device is substantially equivalent to existing predicate devices."

The 510(k) submission process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical trial data with specific performance metrics and acceptance criteria for novel claims.

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