(28 days)
The COBE® SMARxT® Optimin™ is indicated for use in surgical procedures requiring extracorporeal gas exchange support and blood procedure control. It is intended to be used in procedures requiring a tomporature comrow rate of 5 liters/min and lasting up to six hours.
The COBE SMARxT Optimin is a sterile device with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. The device is a blood oxygenator with integral heat exchanger, intended to be used in surgical procedures requiring extracorporeal gas exchange support and blood temperature control, requiring a maximum blood flow rate of 5 liters/minute and lasting up to six hours. The size and specifications of the device make it particularly suited for smaller adult and pediatric patients.
The provided text is a 510(k) summary for a medical device modification, specifically the COBE SMARxT Optimin Surface Modified Hollow Fiber Membrane Oxygenator. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a de novo study with acceptance criteria and performance metrics for a new device.
Therefore, the requested information elements (acceptance criteria table, sample sizes, expert qualifications, MRMC studies, standalone performance, ground truth types, and training set information) are not applicable in the context of this 510(k) summary.
Here's why and what information can be extracted:
Why the requested information is not applicable:
- Substantial Equivalence: The primary goal of a 510(k) submission, especially for a modification, is to show that the new device is as safe and effective as a legally marketed predicate device. This is achieved by demonstrating that it has the same intended use and fundamentally similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
- No New Acceptance Criteria: The device is not being evaluated against a new set of functional or clinical acceptance criteria as if it were a novel device. Instead, its performance is compared to the predicate's established performance to ensure no degradation or new risks.
- No De Novo Clinical Study: The "STUDY" described in this document is a series of "in-vitro tests" designed to show equivalency, not a large-scale clinical trial to establish new performance metrics or compare against human readers.
What information can be extracted/inferred from the document regarding the "study":
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Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implied): That the COBE SMARxT Optimin's in-vitro performance (e.g., gas exchange, heat exchange, blood compatibility) must be comparable to or better than the predicate device (COBE Optimin Hollow Fiber Membrane Oxygenator, K991452) and meet the established safety and performance profile for such devices. The document explicitly states the modification "improves the blood compatibility of the device," implying this was a key parameter assessed.
- Reported Device Performance: The document states: "In-vitro tests were performed to demonstrate that the COBE SMARXT Optimin Hollow Fiber Oxygenator described in this submission is substantially equivalent to the COBE Optimin Hollow Fiber Oxygenator (K991452)." It does not provide specific numerical performance results from these in-vitro tests in this summary, but rather a concluding statement of substantial equivalence.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the summary document. In-vitro tests typically involve multiple units but the exact number isn't provided.
- Data Provenance: The tests were "In-vitro tests" conducted by the manufacturer, COBE Cardiovascular, Inc. (location: Arvada, CO). These would be prospective laboratory tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As this was an in-vitro engineering and performance comparison, expert review in the sense of clinical ground truth (e.g., radiologist consensus) is not relevant. The "ground truth" would be established by validated laboratory measurement techniques against predetermined, engineering specifications or performance ranges of the predicate device.
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Adjudication method for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically for clinical interpretation (e.g., image reading). For in-vitro performance testing, the results are objectively measured and compared to specifications or predicate performance.
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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:
- No. This device is a blood oxygenator, not an AI-powered diagnostic tool. Therefore, MRMC studies and "improvement with AI vs without AI assistance" are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware medical device with a surface modification, not an algorithm.
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The type of ground truth used:
- For the in-vitro tests, the "ground truth" would be objective laboratory measurements of various performance parameters (e.g., gas exchange efficiency, heat exchange capacity, thrombogenicity/blood compatibility metrics) taken from the device itself, compared to the established performance characteristics and specifications of the predicate device.
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The sample size for the training set:
- Not Applicable. There is no "training set" in the context of an in-vitro comparison between two physical devices. The device is not based on a machine learning algorithm.
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How the ground truth for the training set was established:
- Not Applicable. (See point 8).
§ 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.”