(174 days)
The Peak Left Ventricular Vent Cannula is indicated for use in venting the left ventricle during cardiopulmonary bypass procedures for durations up to 6 hours. The entrance is made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve.
The Peak Left Ventricular Vent Cannula is a single lumen, PVC cannula intended for use in venting the left ventricle during cardiopulmonary bypass with entrance made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve. The 36cm Cannula has an open end at the distal tip and a series of side holes at the distal end of the cannula to allow for venting when inserted into the left ventricle. The device is designed with an open-ended smooth, tapered tip to minimize trauma to the tissues. The cannula body slip connector allows for connection to ¼" tubing for venting by the physician. The device is supplied with a malleable PVC Introducer which has a length of stainless steel wire enclosed within the Introducer sheath. The Introducer has a smooth rounded tip at the distal end. When the Introducer is inserted into the cannula body, the luer hub fits into the internal diameter of the slip connector. When the luer hub is seated in the cannula slip connector, the smooth rounded end of the introducer extends beyond the open tip of the Cannula. The device is provided sterile and is intended for single-use.
I am sorry, but based on the provided text, there is no information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device.
The document is a 510(k) premarket notification for a Peak Left Ventricular Vent Cannula, which is a physical medical device used during cardiopulmonary bypass procedures. The performance data section describes biocompatibility testing and performance testing (e.g., flow testing, pressure testing, kink resistance) for this physical device. These tests are to demonstrate the physical and biological characteristics of the cannula, not an AI/ML algorithm's performance or diagnostic accuracy.
Therefore, I cannot provide details on:
- A table of acceptance criteria and the reported device performance for an AI/ML device.
- Sample size used for the test set and data provenance in the context of an AI/ML model.
- Number of experts and qualifications to establish ground truth for an AI/ML model.
- Adjudication method for an AI/ML model test set.
- MRMC comparative effectiveness study for an AI/ML device.
- Standalone performance for an AI/ML algorithm.
- Type of ground truth used for an AI/ML model.
- Sample size for the training set for an AI/ML model.
- How the ground truth for the training set was established for an AI/ML model.
§ 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).