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The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are intended for neuraxial use by healthcare professionals for aspiration/injection of fluids.

The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are sterile, single use syringes with ISO 80369-6 (NRFit™) compliant fittings. They are available in 3mL, 5mL and 10mL, lock and slip configurations and 20mL and 50mL lock configurations. The NRFit™ tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale in milliliters (mL), a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is yellow to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.

The provided text does not describe an AI/ML powered medical device, but rather a Becton, Dickinson and Company's (BD) Syringe NRFit Lok and BD Syringe NRFit Slip, which are medical devices that are substantially equivalent to a predicate device. Therefore, the specific details regarding acceptance criteria and studies for AI/ML performance (such as sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or present in this document.

However, based on the provided text, the acceptance criteria and the studies performed to demonstrate equivalence of the BD Syringe NRFit™ Lok and BD Syringe NRFit™ Slip to a predicate device (BD Single Use, Hypodermic Syringe, K980987) are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document details numerous functional, packaging, and biocompatibility tests performed according to specific ISO and ASTM standards. The reported device performance consistently states that the subject device "met all predetermined acceptance criteria for the above-listed performance tests" or comparable phrases indicating successful adherence to the standards. Since the exact numerical criteria and results are not always explicitly stated (e.g., for stress cracking, it doesn't give a specific force value), this table will summarize the type of test and the general outcome.

For the following points, as the device is a syringe and not an AI/ML powered device, these sections are generally not applicable and the provided text does not contain this information.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this type of medical device assessment. The tests involve physical samples of the syringe rather than data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for physical device performance is established through adherence to national and international standards, rather than expert consensus on interpretive tasks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the evaluation is based on objective measurements against specified standard limits, not interpretive judgment.

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/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by international and national consensus standards (ISO, ASTM, USP) that define safety and functional attributes for syringes and medical device materials, along with BD internal requirements for specific characteristics not fully covered by external standards.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.

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