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The Modrad Swabbable Valve Transfer Set (SVTS) is intended to be used in the delivery of contrast media and saline into a syringe. The SVTS is a needle-free system. Use of a needle-free system may aid in the prevention of needle-stick injuries.

Device Description

The Medrad Swabbable Valve Transfer Set (SVTS) is a modified Medrad Transfer Set (K022431). The SVTS is a medical disposable device used to transfer contrast media and saline from a spikeable container to a power injector syringe. The SVTS is works in conjunction with the MR-CT Fill Station, and facilitates the delivery of contrast agent and/or saline into a syringe.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device modification, specifically the Medrad Swabbable Valve Transfer Set (SVTS). This type of document is a regulatory submission to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than a study proving performance against acceptance criteria in the way a clinical trial for an AI/ML device would.

Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, and MRMC studies) are not applicable to this submission. The document focuses on comparing the modified device to a predicate device and demonstrating substantial equivalence.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to the design specifications and safety requirements that the modified device must meet and be "substantially equivalent" to in comparison with the predicate device. The performance is reported in terms of meeting these specifications and maintaining existing safety standards.

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance (vs. Predicate)
Device Components	Tubing Length	23.0 in. (Predicate: 20.0 in.) - Change
	Tubing Inner Diameter	0.120 in. (Predicate: 0.110 in.) - Change
	Female Luer	Polycarbonate, Clear, Merit Medical Female Luer (Predicate: None) - Addition
	Dust Cap	No Dust Cap (Predicate: Polypropylene Dust Cap) - Removal
	Valve Type	Swabbable Threaded Valve (Halkey-Roberts) (Predicate: One-way Stopcock, Pinch Clamp) - Change
	Other Components (Spike, Adhesive)	Same as Predicate
Safety Requirements	Biocompatibility	Tested to ISO/AAMI 10993-7 (Same as Predicate)
	Sterility	Ethylene Oxide (EtO) Sterilized (Same as Predicate)
Intended Use	Delivery of contrast media and saline into a syringe.	No change to the intended use. The SVTS is a needle-free system, potentially aiding needle-stick injury prevention.
Mechanical/Functional (Implied)	Functionality as a transfer set for contrast/saline with a power injector.	Implied "substantial equivalence" to the predicate, meaning it performs the same function safely despite modifications. No specific performance metrics like flow rates or durability are listed as "acceptance criteria" directly in this summary, but these would be part of an underlying design validation.

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

Not applicable in the context of this 510(k) submission. This is a device modification submission, not a study evaluating an AI/ML diagnostic or prognostic tool. The "test set" would typically refer to physical units of the device tested against engineering specifications and biocompatibility standards, not a dataset for an algorithm. Clinical trials or large-scale human data collection are generally not required for these types of Class II device modifications unless significant new risks are introduced.

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

Not applicable. There is no "ground truth" established by experts in the sense of AI/ML or clinical diagnosis. The "truth" here is engineering compliance and biocompatibility. The regulatory body (FDA) reviews the submission.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication" of device performance in the sense of expert review for ambiguous cases. Device compliance is determined through testing against predetermined specifications and standards (e.g., ISO for biocompatibility).

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 physical medical device (a transfer set), not an AI/ML diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for this device modification is compliance with established engineering specifications, safety standards (e.g., ISO/AAMI for biocompatibility), and demonstration that the modified design maintains the intended function without raising new questions of safety or effectiveness when compared to the predicate device. This is based on design verification and validation testing results, not clinical outcomes or expert consensus on diagnostic images.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device.

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