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The intended use of the proposed device(s) duplicates the predicate device(s), in that, the proposed synthetic rubber cover , a component of the disposable syringe(s) device is used with a powered injector to assist the hospital clinician in the intravascular delivery of contrast media and flushing solutions at controlled flow rates and volumes, to effect computerized tomography, magnetic resonance, and angiographic diagnostic imaging.

The Device is an assembly consisting of a plastic barrel, a plastic plunger, a synthetic rubber cover, and an elastomeric seal. Fluid is drawn into or expelled from the syringe by its piston which is powered and controlled by an automatic injector head. The Device is designed to contain and hold contrast media and assist in delivery of same, to effect computerized tomography and magnetic resonance imaging, as well as, angiographic diagnostics. The product is to be packaged in a white opaque vacuum formed plastic tray, heat sealed to a Tyvek lid. The entire package is compatible with an EtO Sterilization Cycle.

This 510(k) summary (K964642) does not contain the detailed information required to fill out the table and answer all the questions about acceptance criteria and study particulars. This document is a pre-amendment 510(k) (filed in 1996) for a disposable syringe. Generally, such devices at that time would focus on demonstrating equivalence to existing predicate devices based on material biocompatibility, structural integrity, and functional performance (e.g., ability to hold and deliver fluid without leakage or breaking under expected pressures).

Here's a breakdown of what can and cannot be answered based on the provided text, and assumptions about what "performance data" for such a device would likely entail:

Based on the provided text, the following information is available or can be inferred:

• Device Type: Disposable Syringe for contrast media delivery with powered injectors.
• Key Change: Excludes latex as an element of its formulation compared to predicate devices.
• Claim: No change in function, safety, or efficacy, and intended use remains the same despite the material change.
• Performance Data Mentioned: "See laboratory and design verification data, Addendum 5." This implies that some testing was done to support the claims, but the specifics are not in the summary.

Information NOT available in the provided text:

• Specific numerical acceptance criteria.
• Reported device performance values against those criteria.
• Sample sizes for any test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number/qualifications of experts.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training set.
• How ground truth for the training set was established.

Attempted Answers Based on Provided Text and General Understanding of 510(k) for this Device Type (with significant gaps):

1. A table of acceptance criteria and the reported device performance

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. For laboratory/design verification, it would typically be prospective testing conducted by the manufacturer.

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. This device is a mechanical component (a syringe), not an interpretive device requiring expert ground truth for performance evaluation in the clinical sense. Regulatory experts and engineers would evaluate the testing against standards.

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

• Not applicable. Adjudication methods like 2+1 are typically used for clinical endpoints or image interpretation studies, not for the engineering and material performance testing expected for a disposable syringe.

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 not an AI or imaging interpretation device.

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

• Not applicable. This device is not an algorithm.

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

• For a device like this, "ground truth" would be established by engineering specifications, material science standards (e.g., ISO biocompatibility, ASTM mechanical properties), and performance standards for medical syringes. For example, a burst pressure test would have a "ground truth" based on the pressure at which the syringe fails.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not a machine learning or AI-driven product.

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

• Not applicable. No training set is used for this type of device.

Conclusion from available information:

The provided 510(k) summary is for a relatively simple disposable medical device where the primary regulatory focus for this particular submission was to demonstrate that a material change (removal of latex for the synthetic rubber cover) did not adversely affect the safety or efficacy compared to its predicate device. The "Performance Data" mentioned (Addendum 5) would detail the laboratory and design verification tests conducted to prove this equivalence in terms of biocompatibility, mechanical integrity, and functional performance, rather than clinical efficacy studies involving "ground truth" in the diagnostic sense.

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