(75 days)
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The RMI Internal Mammary Artery Cannula is composed of a chrome-plated brass female luer hub and 304 stainless steel tubing with smooth bulb tip.
The provided text describes a medical device, the RMI Internal Mammary Artery Cannula, and its comparison to a predicate device, the DLP I.M.A. Cannula, for the purpose of a 510(k) premarket notification. However, the information provided does not pertain to the performance of a software algorithm or AI-based device, but rather a physical medical instrument. Therefore, most of the requested categories related to AI/algorithm performance and study design are not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description / Outcome |
|---|---|
| Substantial Equivalence to Predicate Device | Acceptance Criteria: To demonstrate substantial equivalence to the predicate "DLP I.M.A. Cannula, Code #31001." Specifically, regarding flow rates, the RMI cannula should not have a flow rate that results in "pressure needed to create the desired flow is too high" compared to the predicate. |
| Reported Device Performance: A comparative performance test found that the flow rate of the RMI Internal Mammary Artery Cannula (IMA-001) is approximately 25% greater than (better than) the DLP I.M.A. Cannula (I.M.A. 31001). The conclusion drawn is that "in terms of flow rates, the RMI Internal Mammary Artery Cannula, IMA-001, is substantially equivalent to the DLP I.M.A. Cannula, I.M.A. 31001." |
Note: The text explicitly states "Since the flowrate through a cannula indicated for flushing the internal mammary artery with a vasodilator is only an issue if the pressure needed to create the desired flow is too high, it may be concluded that in terms of flow rates, the RMI Internal Mammary Artery Cannula, IMA-001, is substantially equivalent to the DLP I.M.A. Cannula, I.M.A. 31001." This implies that a higher flow rate, as long as it doesn't lead to excessive pressure, is acceptable and contributes to substantial equivalence.
Study Details (as much as can be extracted or inferred for a physical device)
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Sample size used for the test set and the data provenance:
- Sample Size: The text mentions "A comparative performance test... was completed" but does not specify the number of cannulae tested (i.e., the sample size) for either the RMI or DLP devices.
- Data Provenance: Not specified. It's an internal comparative performance test, likely conducted by the manufacturer or a contracted lab. Neither country of origin nor retrospective/prospective status is mentioned, but given it's a physical device performance test, these classifications are less standard than for clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a performance test for a physical device (flow rate measurement), not an interpretative task requiring expert ground truth in the way medical imaging or diagnostic algorithms do. The "ground truth" would be the measured flow rates themselves, established by the testing methodology.
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Adjudication method for the test set:
- Not Applicable. No expert adjudication is described or needed for a physical performance test like a flow rate comparison.
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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 not an AI/software device, and no MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
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The type of ground truth used:
- For the flow rate comparison, the "ground truth" is the measured flow rate of each cannula, determined empirically through the specified performance test.
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The sample size for the training set:
- Not Applicable. This is a physical device; there is no "training set" in the context of machine learning.
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How the ground truth for the training set was established:
- Not Applicable. No training set for an algorithm.
§ 870.1300 Catheter cannula.
(a)
Identification. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.(b)
Classification. Class II (performance standards).