(50 days)
These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
The EOPA 3D™ Cannulae have clear flexible, thin wall wire-wound PVC bodies with a tapered distal tip. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The EOPA 3D™ Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body has multiple depth markings, catalog code, and French size marked. Overall cannula length is 12.5" (31.8 cm). It will be available in 20 and 22 Fr sizes and either uncoated or with a Carmeda coating.
The provided text describes a 510(k) summary for the EOPA 3D™ Arterial Cannula. It outlines the device, its indications for use, and a comparison to predicate devices. However, the document does NOT contain information about specific acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a software or AI/ML device.
This submission is for a physical medical device (an arterial cannula), and the performance data described is "In vitro visual and functional testing" including "blood trauma testing." The criteria for substantial equivalence are based on "design, test results, and indications for use" compared to predicate devices.
Therefore, many of the requested fields are not applicable to this type of device submission as the prompt's questions are geared towards AI/ML device studies.
Here's an analysis based on the provided text, highlighting where information is unavailable or not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visual equivalence to predicate | Met through in vitro visual testing |
| Functional equivalence to predicate | Met through in vitro functional testing |
| Blood trauma comparison to predicate | Met through in vitro blood trauma testing |
Note: The document states "In vitro visual and functional testing was used to establish the performance characteristic of the changes from the predicate devices This includes visual, functional, and blood trauma testing." It doesn't provide specific numerical acceptance criteria or detailed results, but concludes that the device is "substantially equivalent."
2. Sample size 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 document.
- Data Provenance: Not specified, but generally, in-vitro testing for physical devices like this is conducted in a controlled lab environment by the manufacturer. It's not "retrospective or prospective" data in the context of patient studies.
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. "Ground truth" in the context of expert consensus is typically relevant for interpretative tasks, often in AI/ML or imaging. For a physical device's in-vitro testing, performance is measured against physical specifications or established benchmarks, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, not for physical device testing.
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 is not an AI/ML device or an imaging interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of "Ground Truth": The performance was assessed against established physical and functional parameters of the predicate device and engineering specifications. This is more akin to compliance with product design specifications and direct measurement (e.g., flow rates, material properties, visual inspection) rather than clinical ground truth from patients.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI/ML model that requires a training set and associated ground truth.
§ 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).