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The NIPRO SafeTouch TULIP™ Safety Fistula Needle is intended for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood. Secondly, it is designed with an active sharp safety feature requiring physical action by the clinician to aid in the prevention of accidental needlesticks. The compatibility of available configurations is the responsibility of the physician in charge.

The NIPRO SafeTouch TULIP™ Safety Fistula Needle is a sterile, single use, safety AVF needle. It consists of an arterial and venous adaptor, flexible tube and needle with an active sharps safety feature (non-implanted blood access device) as described in 21 CFR 876.5540.

The NIPRO SafeTouch TULIP™ Safety Fistula Needle includes 2 basic types of designs; fixed wing type (stationary) and turnable wing type (rotating). These two designs are offered in 64 configurations with options that include needle gauge, needle length, type of needle (with or without backeye), and tubing length.

The integrated sharps injury prevention feature requires physical action by the clinician to activate and is designed to cover the cannula after treatment. Correct uses of this anti-stick feature will eliminate accidental needlesticks.

These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.

The provided text is a 510(k) summary for the NIPRO SafeTouch TULIP™ Safety Fistula Needle, which is a medical device. This type of document focuses on establishing substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of characteristics, rather than extensive clinical studies with acceptance criteria, human readers, and ground truth as would be typical for an AI/CADe device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device and submission.

However, I can extract the acceptance criteria (inferred from performance testing) and the study that proves the device meets these criteria based on the provided information.

Here's a summary tailored to the provided document:

Acceptance Criteria and Device Performance for NIPRO SafeTouch TULIP™ Safety Fistula Needle

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a non-clinical performance testing and substantial equivalence comparison study as described in the 510(k) summary.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not explicitly stated for performance tests. As this is a non-clinical device, "test set" typically refers to the samples of the device components/materials subjected to engineering and material strength tests rather than patient data.
• Data Provenance: Not applicable in terms of country of origin of patient data, as the tests are non-clinical material and component tests performed by the manufacturer. The tests evaluate the physical properties and functionality of the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

• Not Applicable. For a medical device 510(k) submission, "ground truth" typically refers to the clinical diagnosis or outcome in patient studies. Here, the "ground truth" for the performance tests would be the accepted engineering standards, material specifications, and functional requirements for the device. These are established by engineering and quality control professionals, but specific numbers and qualifications of "experts" are not detailed in this type of summary.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods like "2+1" or "3+1" are specific to clinical studies involving human interpretation of medical images or data. The performance testing conducted for this device would follow standard engineering and quality control protocols for verifying physical and functional parameters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CADe devices where human readers interpret medical images or data, with or without AI assistance. This device is a physical medical instrument (needle).

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

• Not Applicable. This concept applies to AI algorithms. This device is a physical medical instrument.

7. The Type of Ground Truth Used:

• The "ground truth" for the performance tests mentioned (biocompatibility, material strength, connection force, fluid flow rate, safety feature activation force, bond strength) is based on established engineering standards, material specifications, and functional requirements for similar medical devices. The predicate device (Medisystems Masterguard™ AVF Needle and Nipro AVF Needle) also served as a benchmark for comparison.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" in the context of this device's submission. Training sets are used to develop AI algorithms.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As there is no training set.

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