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For use with the Medrad Spectris® Solaris™ MR Injection of contrast media or saline to the vascular system for diagnostic purposes.

The MR Syringes for Solaris Injectors (65mL and 115mL syringe) falls into the Cardiovascular Devices Category and are classified as Angiographic Syringes within the classification of Angiographic Injectors and Syringes. The syringe is intended for use with Medrad Spectris® Solaris™ MR Injection System to inject diagnostic fluids (such as contrast media and saline) into a patient. The MR Syringe Dual Pack for Solaris Injectors will be sold as a Dual Pack. The following configurations may be offered:
i. C853-2201 65mL and 115mL Syringe with 96" Coiled extension YLine and Fill Spikes
ii. C853-2202 65mL and 115mL Syringe with 96" Coiled extension Y-Line and Contrast and Saline Spikes
iii. C853-2203 65mL and 115mL Syringe with 96" Coiled extension YLine, Prime Tube, and Fill Spikes
iv. C853-2204 65mL and 115mL Syringe with 96" Coiled extension YLine, Prime Tube, and Contrast and Saline Spikes
v. C853-2205 ~ 65mL and 115mL Syringe with 96" Coiled Extension YLine and Fill Tube
vi. C853-2206 65mL and 115mL Syringe with 96" Coiled Extension Y~Line, Prime Tube, and Fill Tube

This document is a 510(k) summary for the MR Syringe Dual Pack for Solaris Injectors (K161471), a medical device. It does not describe an AI or algorithm-driven device, but rather a physical syringe product. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.

Here's the information extracted from the document that aligns with your request, with "NA" (Not Applicable) for categories that don't fit this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of devices. The document implies that "the product," "syringes and Extension Lines," and individual units were subjected to these tests without specifying the quantity.
• Data Provenance: Not specified, but this is a physical medical device. The testing would have been conducted by the manufacturer (Coeur, Inc.) in a lab setting. It is not patient or case data.

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

• NA, as this is not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The ground truth for physical properties (e.g., pressure resistance, dimensions) is based on engineering specifications and international standards.

4. Adjudication Method for the Test Set

• NA, no adjudication method is mentioned as there are no expert readings or interpretations to adjudicate for this type of device.

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

• NA, this is not an AI device.

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

• NA, this is not an AI device.

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

• The "ground truth" for this device's performance is based on engineering specifications, material properties, and established international standards (e.g., ISO 594-2:1998) for physical medical devices.

8. The sample size for the training set

• NA, this is a physical medical device, not an AI algorithm requiring a training set.

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

• NA, this is a physical medical device, not an AI algorithm.

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