(42 days)
This product is intended for use with cardiopulmonary bypass as an arterial return cannula.
The EOPA Elongated One-Piece Arterial Cannulae have a flexible, thin wall wirewound body with a tapered distal tip. The tip features depth markings and an adjustable radiopaque suture ring to indicate insertion depth. The proximal end of the cannula terminates in a vented or non-vented 3/8" (0.95 cm) connector. A plastic tapered tip introducer with porous plug is provided to facilitate cannula insertion and priming. The introducer features a guidewire port for use with a 0.038" (0.1 cm) guidewire. Some models include a guidewire while some do not. The devices are marketed in 18, 20, 22, and 24 Fr. diameters. The devices may include a Carmeda® coating.
The provided text is a 510(k) summary for a medical device (EOPA Elongated One-Piece Arterial Cannula), but it does not contain the specific information requested in the prompt regarding acceptance criteria, a detailed study proving performance, sample sizes, expert involvement, or ground truth establishment for AI/ML device evaluation.
The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, which is a different regulatory pathway than providing detailed performance metrics against pre-defined acceptance criteria, especially in the context of AI/ML performance.
Therefore, I cannot populate the table or answer the specific questions about the study's methodology as the information is not present in the provided document.
Here's what I can extract based on the available text, noting the limitations:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available | In vitro visual, dimensional, simulated use and functional testing was used to establish the performance characteristic of the modifications. |
| For Carmeda® coated devices: coverage, bio-activity, leaching and functional testing was performed. | |
| (No specific quantifiable criteria or pass/fail thresholds are mentioned) | (Results are summarized as demonstrating "substantial equivalence" to predicate devices, without detailed metrics) |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (implied to be internal Medtronic testing, but country/retrospective/prospective not mentioned).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This study refers to functional and physical testing of a medical device, not the interpretation of data/images by experts to establish ground truth for an AI/ML algorithm.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Not applicable. This was not a study involving human-in-the-loop data adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a physical medical cannula, not an AI/ML-driven diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used:
- For the physical tests (visual, dimensional, functional, coverage, bio-activity, leaching), the "ground truth" would be established by engineering specifications, material standards, and validated laboratory methodologies. It is not "expert consensus, pathology, or outcomes data" in the typical AI/ML context.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML algorithm.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).