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The MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe.

The MED-RX Transfer Set is offered in four (4) different models: 10-1227TS, 10-1300TS, 10-1305TS, and 10-1306TS. The MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe. The MED-RX Transfer Sets each consist of a spike, tubing, and either a valve (swabbable or dual check) or 3-way stopcock. All sets but the 10-1306TS also have a pinch clamp. The tube is made of polyvinyl chloride (PVC) and is available in lengths from 18″ – 44″. The MED-RX Transfer Sets are provided sterile and are not to be resterilized.

This is a 510(k) premarket notification for a medical device (MED-RX Transfer Set), not an AI/ML device. Therefore, the requested information about acceptance criteria and study details related to AI/ML device performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC study, standalone performance, training set size, ground truth for training set) is not applicable and not available in the provided document.

The document describes the acceptance criteria and study results for the physical and functional performance of the MED-RX Transfer Set, which is an intravascular administration set. The study aims to demonstrate substantial equivalence to predicate devices (Medrad Transfer Set K022431 and Medrad Swabbable Valve Transfer Set K031808), not to prove AI/ML performance.

Here's a breakdown of the acceptance criteria and study results based on the provided text, modified to fit the context of a medical device (not AI/ML):

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)

• Sample Size: The document does not specify the exact sample sizes (N value) for each individual non-clinical performance and biocompatibility test. It generally states that "samples met" or "product code X was determined," implying that sufficient samples were tested to meet the respective standards.
• Data Provenance: Not explicitly stated, but the testing would have been conducted by Benlan Inc. (located in Oakville, ON, Canada) or its designated testing facilities, following international (ISO, ASTM, USP) and national (ANSI/AAMI) standards. The nature of these tests is prospective: samples of the MED-RX Transfer Set are deliberately subjected to these tests to evaluate their performance against established criteria.

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 question is not applicable. The "ground truth" for a medical device like a transfer set is established by objective, standardized laboratory testing procedures as defined by the international and national standards listed (e.g., ISO, ASTM, USP, ANSI/AAMI). It does not involve expert interpretation or consensus in the way an AI/ML diagnostic algorithm's output would. The results are quantitative (e.g., force applied, levels of contamination, presence/absence of hemolysis) or qualitative (pass/fail) based on predefined thresholds in the standards.

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

Not applicable. As described above, the tests are objective, standardized laboratory assessments, not subjective evaluations requiring expert 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 not an AI/ML device; it is a physical medical device. MRMC studies are used for evaluating diagnostic performance, often involving human readers and AI assistance.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is derived from objective, standardized test methods and criteria defined by established international and national standards (e.g., ISO 8536-4 for infusion equipment, ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11135 for sterilization). These standards specify the test conditions, measurement methods, and acceptable limits or outcomes for various performance parameters (e.g., leakage, tensile strength, sterility, biocompatibility).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, 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 physical medical device.

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