(169 days)
The CMO8 Adult PMP Oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The CMO8 Adult PMP Oxygenator is intended for up to 6 hours. The Tubing Pack is intended for use in extracorporeal crculation during cardiopulmonary bypass procedures, lasting 6 hours or less.
The CMO8 Adult PMP oxygenator (CMO8) is a hollow fiber membrane oxygenator with an integrated heat exchanger. The CMO8 facilitates the gas exchange into and out of the blood, and the regulation of blood temperature during cardiopulmonary bypass. The CMO8 is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces. The qas exchanger part of the CMO8 is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the CMO8 is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated. The Tubing Pack, which contains blood lines, gas lines, a venous reservoir and the CMO8 Oxygenator, is a component of a cardiopulmonary bypass procedure that facilitates extracorporeal circulatory support for a term of up to 6 hours.
The provided text is a 510(k) summary for a medical device (CMO8 Adult PMP Oxygenator with Tubing Pack) and not a report or study describing the acceptance criteria or performance of an AI/ML powered device.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets them from this document. The document primarily discusses the substantial equivalence of a physical medical device (an oxygenator) to predicate devices through in vitro and non-clinical testing.
The questions you asked are highly relevant to AI/ML device submissions, particularly regarding:
- Acceptance Criteria and Performance Table: This is typically a key component of AI/ML device validation.
- Sample Size and Data Provenance: Crucial for understanding the representativeness and generalizability of AI/ML model testing.
- Expert Ground Truth (Number of Experts, Qualifications, Adjudication): Essential for establishing reliable labels for AI/ML training and testing data.
- MRMC Studies: Often used to evaluate the impact of AI on human reader performance.
- Standalone Performance: Evaluating the AI algorithm's capabilities independently.
- Type of Ground Truth: The gold standard used to assess AI accuracy.
- Training Set Details: Information about the data used to develop the AI model.
To answer your request, I would need a document detailing the clinical validation or performance study for an AI/ML-powered medical device.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”