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The Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set is intended for use during hernodialysis to provide access to a patient's blood. When used in hemodialysis, they are part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions.

The Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set that we intend to market includes the following three components: a Nipro® Arterial and Venous Blood Tubing Set for Hemodialysis; a Nipro® Disposable Solution Set ; and, a transducer/ protector. These devices are packaged together for convenient use during hemodialysis procedures. The Arterial and Venous Blood Tubing Sets that we intend to include within the kits include various models of blood tubing sets are available for application with different dialysis machines. A series of 27 arterial line models (A001 - A021, A026, A029 -A032, and A035) and a series of 14 venous line models (V600 - V607, V609 - V613, and V616) have been described. The Disposable Solution Infusion Set that we intend to include in the kit will be one of the 4 types of designs: NNC-3L, NNC-3CL. NNC-3C. and NNC-3CS. A transducer/protector is also included in the kit. The materials used for the components of the blood tubing sets include polyethylene (PE), polyvinylchloride (PVC), acrylonitrate butadiene styrene (ABS), polyoxymethylene (POM), polypropylene (PP), polyethylene high density (PEHD), and polycarbonate (PC). The materials used for the disposable solution infusion set include polyethylene (PE), polyvinylchloride (PVC), polypropylene (PP), and acrylonitrate butadiene styrene (ABS). The transducer/protector component of this kit is fabricated from either rigid PVC and a 0.2 micron Gore membrane (PTFE and polypropylene) or rigid PVC and PTFE and polyester.

The provided text describes a 510(k) submission for a medical device (Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set) seeking substantial equivalence to a legally marketed predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as an existing, legally marketed device. It does not typically involve the kind of performance studies with explicit acceptance criteria related to AI output, ground truth establishment, or human reader performance as would be seen for AI/ML-based medical devices.

Therefore, many of the requested categories are not applicable to this document. The study described is primarily focused on biocompatibility and comparison of technical characteristics to a predicate device.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for biocompatibility tests. For the comparison to the predicate device, it appears to be a qualitative comparison of device characteristics rather than a quantitative test set with a specific sample size.
• Data Provenance: Not specified, but generally, biocompatibility testing is performed in a laboratory setting.

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

• Not Applicable. This type of information is not relevant to a 510(k) submission primarily focused on material safety and equivalence to a predicate device. Biocompatibility results are typically based on laboratory assay outcomes.

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

• Not Applicable. This concept is relevant for expert review of medical images or other complex data where ground truth is ambiguous. It does not apply to the described biocompatibility testing or comparison of device characteristics.

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 a physical medical device, not an AI/ML-based diagnostic or assistive technology.

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

• Not Applicable. This is a physical medical device.

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

• Biocompatibility ground truth: Standards for
  • Cytotoxicity
  • Mutagenicity
  • Hemolysis
  • Acute Systemic Toxicity
  • Intracutaneous Reactivity
  • Implantation toxicity (e.g., irritation, inflammation)
  • Pyrogenicity
  • Sensitization
• Equivalence ground truth: Characteristics of the legally marketed predicate device (Medisystems Corporation ReadySet™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors).

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI/ML system.

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

• Not Applicable. This is a physical medical device, not an AI/ML system.

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