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The JMS Blood Tubing Sets with transducer protector and priming sets are disposable bloodlines intended to provide extracorporeal access to the patient's blood during hemodialysis.

The tubing sets that JMS intended to market include arterial and venous dialysis blood tubing as described in 21 CFR 876.5820. Various models of blood tubing sets are being manufactured for application with different dialysis machines, such as Baxter, Fresenius, Althin, etc. All components of blood tubing set, including drip chambers, infusion tubing, monitoring lines, ports, and segments which are use to pump blood, retain and capture air and blood debris, infuse medications or fluid, sampling blood, pressure monitoring and making connections to other devices, are all included. The materials used are mainly, polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), acrylonitrite butadiene styrene (ABS), and polycarbonate (PC).

The provided text is a 510(k) summary for a medical device called "JMS Blood Tubing Sets." This document focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. As such, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance.

The document highlights the following:

• Device Type: Hemodialysis system and accessories (blood tubing sets).
• Intended Use: To transfer blood from patients' vascular access system to the hemodialyzer through an arterial tubing, and from the hemodialyzer to the patient vascular system via a venous tubing.
• Substantial Equivalence: The manufacturer asserts that the JMS Blood Tubing Sets are substantially equivalent to several legally marketed predicate devices in terms of intended use, design, safety, and effectiveness.
• Testing: The document mentions compliance with the AAMI/ANSI RD 17:1994 standard for "Hemodialyzer Tubing set" and biocompatibility testing according to ISO 10993. These are engineering and biocompatibility standards, not clinical performance acceptance criteria or studies involving AI/algorithms.

Therefore, I cannot extract the requested information (table of acceptance criteria, device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types, or training set details) from the provided text because it is not a clinical study report for an AI/algorithm-based device.

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