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Medrad Qwik-Fit Syringes are indicated to contain and hold contrast media and assist in delivery of same, to effect CT and MRI diagnostics. They are indicated for single-use only.

The Medrad Quik-Fit Syringe comprises a clear plastic syringe barrel with anta plunger assembly that moved within the need and flushing solutions for delivery by the injector into humans.

This 510(k) premarket notification (K013815) is for modifications to the Medrad Quik-Fit Syringe, specifically concerning the plunger assembly. It is a "Special 510(k)" indicating that the changes are minor and do not significantly alter the intended use, fundamental scientific technology, or safety and effectiveness of the device. Therefore, the submission focuses on demonstrating substantial equivalence to the previously cleared predicate device (K964642) rather than conducting a full de novo study with extensive acceptance criteria and performance evaluations comparable to a new device.

The study presented here is an equivalence study to demonstrate that the modified device is as safe and effective as the predicate device, not a study to prove a specific level of clinical performance against defined acceptance criteria in a clinical setting. The "acceptance criteria" in this context refer to demonstrating that the modified device performs comparably to the predicate device in relevant physical and functional characteristics.

Here's an breakdown based on your requested information, acknowledging the nature of this 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

For this Special 510(k), the "acceptance criteria" are implied by the features of the predicate device and the successful completion of testing to show that the modified device performs equivalently. The "reported device performance" is essentially the determination that the modified device meets the predicate device's performance.

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

Since this is a Special 510(k) focused on material changes to a plunger in an existing device, a "test set" in the sense of patient data is not applicable. The testing would have involved bench testing and engineering evaluations of the modified syringe.

• Sample Size: The document does not specify the exact sample sizes for the engineering tests conducted. These would typically be determined by internal quality control and verification protocols for the specific tests performed (e.g., burst pressure, leakage, plunger movement force, material compatibility).
• Data Provenance: The data provenance would be from internal Medrad Inc. testing and engineering evaluations conducted in the USA. The type of data would be retrospective in the sense that it's comparing a modified component to an already established predicate, but generated prospectively for the purpose of this submission.

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

Not applicable for this type of submission. "Ground truth" in the context of clinical diagnostics or image analysis (where experts define disease presence/absence) is not relevant here. The "truth" for this device relates to its physical performance characteristics and adherence to engineering specifications. These are assessed through objective measurements, not expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data, which is not part of this device's evaluation. Engineering tests rely on objective measurements and established pass/fail criteria.

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 device is a syringe, not an AI-powered diagnostic tool. MRMC studies are for evaluating the performance of diagnostic tools (often AI-based) and their impact on human reader performance.

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

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

7. The Type of Ground Truth Used

For this device, the "ground truth" is defined by:

• Engineering Specifications: The established performance parameters (e.g., pressure capabilities, material integrity, sterility).
• Predicate Device Performance: The known and demonstrated performance of the previously cleared Medrad Disposable Syringes (K964642), against which the modified device is evaluated for equivalence.
• Regulatory Standards: Adherence to relevant FDA regulations and consensus standards for medical devices and syringes.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

Not applicable, as there is no training set for this device.

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