(177 days)
The Aortic Arch Cannula is indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass in cases where aortic perfusion is deemed appropriate.
The CHASE Aortic Arch Cannula consists of a curved thin-wall beveled stainless steel tip and a retention collar molded of rigid plastic with an indexing point which indicates the tip orientation when the cannula is in the aorta. The collar has two suture notches for holding the cannula in place. A short length of clear, flexible plastic tubing is attached to the collar. A molded plastic connector of rigid plastic attached to the flexible tube allows connection of the to the cannula.
This device is a physical medical device (Aortic Arch Cannula), not an AI/ML powered device or a diagnostic device. The provided text describes functional testing and material equivalence to a predicate device, which is typical for physical medical devices of its nature. Therefore, many of the requested categories in the prompt regarding AI/ML study design, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "sample size for training set," are not applicable.
Here's a summary of the available information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Leak Test Requirements: | No leaks at 10 psi air on Chase device at 4℃ and 40°C |
| Tubing Bond Strength: | Exceeds 10 lb. tensile strength @ 4°C and 40°C |
| Package Integrity: | Tyvek/Polymylar passed burst test per ASTM F1140-88 |
| Shipping & Distribution Testing: | Per National Safe Transit Ass. vibration and drop tests |
| Accelerated Aging: | Two year shelf life |
Study Information (Not Applicable for AI/ML specific criteria)
- Sample size used for the test set and the data provenance: Not applicable for this type of physical device functional testing. The tests are performed on samples of the manufactured device. Data provenance is internal to the manufacturer's testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device functional tests is based on measurable engineering specifications.
- Adjudication method for the test set: Not applicable. Functional tests have objective pass/fail criteria.
- 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 a physical medical device, not an AI diagnostic/assistance system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used: For the functional tests, the ground truth is the specified engineering performance thresholds (e.g., "no leaks at 10 psi"). For substantial equivalence, the "ground truth" is the performance and material composition of the predicate device (Sarns Aortic Arch Cannula K770429).
- The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML model.
- How the ground truth for the training set was established: Not applicable.
§ 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).