(29 days)
The Affinity NT Oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
The Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with Trillium™ Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The Affinity® NT Integrated Trillium™ CVR/Membrane Oxygenator is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The Affinity NT™ Oxygenator with Cortiva™ BioActive Surface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
The Affinity NT™ Integrated Uncoated CVR/Oxygenator with Cortiva™ BioActive Surface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
Not Found
This appears to be a 510(k) clearance letter and related "Indications for Use" forms for various models of Medtronic Affinity NT Oxygenators. This type of document from the FDA does not contain the information requested about acceptance criteria and device performance studies (specifically, those related to AI/algorithm or human reader performance).
The purpose of a 510(k) clearance is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to present detailed performance data in the context of controlled clinical trials or AI validation studies with specific acceptance criteria and ground truth methodologies.
Therefore, I cannot fulfill the request using only the provided text. The document is about:
- Device Identification: Medtronic's Affinity NT Oxygenator series.
- Regulatory Clearance: Confirmation of 510(k) clearance (K191029).
- Indications for Use: The medical use (extracorporeal perfusion circuit for oxygenation, CO2 removal, and temperature control during CPB procedures up to 6 hours).
- Regulatory Class: Class II device.
- Prescription Use: All listed devices are prescription-use only.
- General Controls: Reminders about compliance with FDA general controls (registration, listing, GMP, labeling, adverse event reporting, etc.).
There is no information in this document about:
- Acceptance criteria table and reported device performance related to a study.
- Sample size and data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study, or effect size with AI assistance.
- Standalone (algorithm-only) performance.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes).
- Sample size for training set.
- How ground truth for the training set was established.
To provide the requested information, a different type of document would be needed, such as a detailed study report, a clinical trial summary (often found in PMA applications or supplement data, but not typically in a 510(k) summary for a Class II device like this oxygenator), or a specific AI/software validation report.
§ 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.”