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The Miser Contrast Management System is intended for the vascular administration of contrast media and saline.

Merit Miser Contrast Management System consists of the Contrast Spike Assembly and Contrast Burette Assembly.

During use, the spike assembly is inserted into a container of contrast media. The proximal tubing of the burette assembly is attached to the spike assembly and the longer, distal burette tubing segment is attached to a manifold port (not provided).

The burette is filled to the approximate 20mL level by first pinching the 2 wings of the vent valve mechanism together while squeezing the burette chamber, thus forcing air from the burette chamber. The wings are then released, closing the vent. The residual vacuum in the burette draws contrast media through the 2 backflow valves into the chamber until the vacuum is neutralized. The fluid level will remain at this level until the vent valve is opened or the contrast media is depleted.

The shut off (orange ball) valve located at the bottom of the burette chamber minimizes the potential for air to enter the system when the contrast media container is depleted. The filtered stopcock located below the burette chamber may be used to allow the contrast solution remaining in the tubing to be aspirated for injection into the patient.

I am sorry, but based on the provided text, I cannot extract the specific details you've requested about acceptance criteria and a study proving device performance as it does not contain that level of detail.

The document is a 510(k) summary for the "Miser Contrast Management System" and primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. While it mentions "Verification and Validation Studies, conducted to demonstrate control of risks identified in Merit's Miser Clinical Risk Assessment, demonstrate that the modified devices met all of their pre-determined acceptance criteria and acceptably control the identified risks," it does not provide the following information:

1. A table of acceptance criteria and the reported device performance: The document states that acceptance criteria were met but does not specify what those criteria were or the actual performance metrics.
2. Sample size used for the test set and the data provenance: No information on the sample size of the test set or the origin of the data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the testing seems to be for device functionality rather than interpretation of diagnostic images.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The document mentions "user preferences" for modifications, but not MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a medical device for administering contrast media, not an algorithm.
7. The type of ground truth used: Not applicable in the context of diagnostic interpretation. The "ground truth" here would pertain to functional performance standards which are not detailed.
8. The sample size for the training set: Not applicable as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The document is a high-level summary for regulatory filing and refers to underlying V&V studies, but the details of those studies (including specific acceptance criteria and performance data) are not included in this public summary.

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