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The Nipro Set - SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis.

The SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. One device package includes 1 arterial line (A226Y), 1 venous line (V813), 1 attached but removable priming set and two pre-attached Transducer Protectors. The SLIMLINE is packaged sterile and labeled for single use only. There is no ability to clean and reuse this device. It is restricted for sale by or on the order of a physician.

The document provided is a 510(k) summary for a medical device called the "Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protectors and Priming Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies. Therefore, much of the information requested about acceptance criteria and studies in the context of AI/diagnostic devices (e.g., sample size, ground truth, expert consensus, MRMC studies) is not applicable here.

However, I can extract information related to the device's performance, the type of testing conducted, and the basis for its clearance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance in the way one might see for an AI diagnostic algorithm's sensitivity/specificity. Instead, it details bench testing conducted to demonstrate that the device is safe and effective and performs equivalently to its predicate. The "acceptance criteria" in this context are implicitly that the device passes these bench tests successfully.

The successful completion of these non-clinical (bench) tests forms the basis for the conclusion that the device performs equivalently to the predicate device and is safe and effective when used as intended.

The following questions are not applicable to this 510(k) submission, as it pertains to a physical medical device (blood tubing set) and relies on bench testing for substantial equivalence, not clinical studies or AI algorithm performance validation.

2. Sample sizes used for the test set and the data provenance: Not applicable. Bench testing, not a diagnostic test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense needed for this device.
4. Adjudication method for the test set: Not applicable.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical device like this is its ability to meet performance specifications and safety criteria through bench testing.
8. The sample size for the training set: Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

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The Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient's blood during Hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.

The Nipro® Blood Tubing Set with Transducer Protector and Priming Set includes arterial and venous dialysis blood tubing with transducer protectors and priming set (non-implanted blood access device) as described in 21 CFR 876.5820. The devices are packaged together for convenient use during hemodialysis procedures. There are 13 different configurations of the arterial line and 6 different configurations of the venous line. The various blood set models are being manufactured for application with various models of dialysis machines. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood and monitor pressure. The devices are packaged sterile and labeled for single use only. There is no ability to clean and reuse these devices. They are restricted for sale by or on the order of a physician.

The provided text describes a 510(k) summary for a medical device called "Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study details, and data provenance for AI/ML performance is not explicitly available in this document.

However, based on the information provided, here's what can be extracted and what is not available:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of discrete acceptance criteria with numerical targets and corresponding device performance values as would be typical for a new AI/ML device. Instead, it states that "Performance testing was conducted to verify that the device is safe and effective for its intended use." The conclusions drawn are that the device "performs equivalent to the predicate device and is safe and effective when used as intended."

Specific tests mentioned (without acceptance criteria or quantitative results):

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

This information is not provided in the document. The document refers to "Performance testing" but does not detail the sample size (e.g., number of units tested), the nature of the test set (e.g., specific blood samples, simulated conditions), or the data provenance.

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

This information is not applicable and not provided. This device is a blood tubing set, not an AI/ML diagnostic or image analysis tool that would require expert consensus for ground truth.

4. Adjudication method for the test set

This information is not applicable and not provided. As above, adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies, which is not relevant to the testing described for a blood tubing set.

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

This information is not applicable and not provided. This document does not describe an AI/ML device, nor does it involve human readers or diagnostic interpretations.

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

This information is not applicable and not provided. This device is a physical medical tubing set, not an algorithm.

7. The type of ground truth used

For this device, "ground truth" would relate to the physical and chemical properties and performance of the tubing set. The document indicates that "Performance testing" and "Biocompatibility testing" were conducted. This implies that the ground truth would be established through:

• Engineering specifications and measurements (e.g., flow rates, pressure resistance, connection integrity).
• Chemical and biological assays according to established standards (e.g., for pyrogenicity, acute toxicity, hemolysis).
• Comparison to the performance characteristics of the predicate device.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML model, so there is no training set in the conventional sense.

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

This information is not applicable and not provided. As it is not an AI/ML model, there is no training set or ground truth established for one.

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