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The Dynarex Three-Way Stopcock multiple port device is indicated to serve as a flow control and a conduit for I.V. fluid delivery to a patient's vascular system. This device is intended for delivering I.V. drug solutions or fluids, allowing gravity feed, sampling, bolus injection, and elimination or reflux of solutions and fluids during operation. The device may be used for a limited contact duration (24 hours or less).

The Dynarex Three-Way Stopcock is a multiple port and needless access device that can be attached to other intravascular administration set devices by the user at the point of use during infusion therapy or sampling. The single-use disposable device intended for use on continuous or intermittent fluid administration or withdrawal of fluids. An in-line access site and can be connected to female luer adapters to allow needless access to fluid or vascular fluid path, and can control fluid flow by rotating flow control taps. The multiple access sites can be used for administration of drugs and solutions to a common fluid path or patient vascular system through a needle or catheter inserted into a vein.

The provided text describes the submission of a medical device, the Dynarex Three-Way Stopcock, for FDA 510(k) clearance, indicating its substantial equivalence to a predicate device. The information details non-clinical testing performed to demonstrate this equivalence.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes (number of devices tested) for each non-clinical test. It also does not provide information on the country of origin of the data or whether the tests were retrospective or prospective. These are typically details found in the full test reports, which are not included in this summary.

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)

This document describes non-clinical bench testing and material biocompatibility testing for a physical medical device (stopcock), not a diagnostic algorithm or image analysis tool. Therefore, the concept of "experts used to establish ground truth" (e.g., radiologists) in the context of diagnostic interpretation is not applicable here. The "ground truth" for these tests would be established by validated measurement standards and laboratory procedures, performed by trained technicians or engineers.

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

Not applicable. This is not a study involving human interpretation or adjudication.

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 non-clinical bench test report for a physical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a non-clinical bench test report for a physical device, not an algorithm.

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

The "ground truth" (or reference standard) for these tests is based on established industry standards and regulatory requirements for medical devices, such as:

• Physical measurements and engineering specifications: e.g., 6% taper for luers, specified flow rates, pressure ratings.
• Absence/Presence of defects: as defined by visual inspection criteria.
• Chemical analysis: e.g., Bisphenol A content, residual testing.
• Biological safety standards: e.g., ISO 10993 series and ASTM F756 for hemocompatibility, cytotoxicity, sensitization, intracutaneous reactivity, and acute systemic toxicity. These standards define the methods and criteria for evaluating biological responses.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this type of device submission.

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