(160 days)
The COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to six hours.
The COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is a flat sheet membrane blood oxygenator with integral heat exchanger. A surface-modifying material is added to the primary blood contact surfaces of the oxygenator and integral heat exchanger to improve the blood competibility of the device. The product is sterlized by ethylene oxide, is for single use only, and has a nonpyrogenic fluid pathway.
The provided text describes a 510(k) Pre-Market Notification for a medical device, the COBE® CML Duo® With SMAR.T™ Surface Modified Membrane Oxygenator. However, the document does not contain the level of detail requested in the prompt regarding specific acceptance criteria, reported device performance metrics, sample sizes for test and training sets, expert qualifications, or ground truth establishment methods in a format that would allow for the direct completion of all requested sections.
The document primarily focuses on establishing "substantial equivalence" to a predicate device (COBE® CML Duo® Membrane Oxygenator) rather than providing detailed performance studies against pre-defined acceptance criteria.
Here's an analysis of what can be extracted and what is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in a quantitative table. The acceptance criteria for substantial equivalence are implied to be that the "new" device performs at least as well as the predicate device in various tests, and does not significantly affect safety and effectiveness due to the surface-modifying material.
- Reported Device Performance: No specific quantitative performance metrics (e.g., specific gas transfer rates, pressure drop values, or blood cell damage percentages) are provided in the text. The document only lists the types of tests performed.
What can be inferred or extracted for a conceptual table:
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Biocompatibility | Demonstrated |
| In-vitro performance (Stability, SEM, Blood pathway volume, Pressure drop, Gas transfer, Integrity, Unrecoverable blood volume, Blood cell damage, Heat exchanger performance, Leaching, Blood compatibility) | Demonstrated substantial equivalence to predicate device |
| Ex-vivo performance (Perfusion, Animal survivor experiments, Blood compatibility) | Demonstrated substantial equivalence to predicate device |
| Safety & Effectiveness | No significant impact compared to predicate device |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "in-vitro testing" and "ex-vivo testing," including "perfusion and animal survivor experiments." However, the number of samples, animals, or runs for these tests is not provided.
- Data Provenance: The studies were performed by the manufacturer, COBE Cardiovascular, Inc., presumably in the US (location of contact person). The data is retrospective in the sense that it's reported after the fact for the 510(k) submission, but it represents new testing conducted for this specific device modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
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Number of Experts: Not mentioned.
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Qualifications of Experts: Not mentioned.
- Rationale: This type of device (membrane oxygenator) relies on physical and biological performance characteristics, not expert interpretation of data like images. The "ground truth" would be established through laboratory measurements and animal study outcomes, not expert consensus on qualitative data.
4. Adjudication method for the test set:
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Adjudication Method: Not applicable or specified.
- Rationale: As noted above, this device's performance is gauged by quantitative measurements and biological outcomes, not subjective qualitative assessments requiring adjudication among experts.
5. 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:
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MRMC Study: No.
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Effect Size: Not applicable.
- Rationale: This device is a membrane oxygenator, not an AI software or a device that assists human readers in interpreting data. Therefore, an MRMC study and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
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Standalone Performance: Not applicable.
- Rationale: This device is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Type of Ground Truth: The ground truth for evaluating the device's performance relies on:
- In-vitro measurements: Laboratory testing results against established physical and chemical standards for device performance, material properties (e.g., gas transfer rates, pressure drops, blood cell damage, material leaching).
- Ex-vivo animal study outcomes: Physiological measurements and survival rates in animal models to assess biocompatibility and overall function.
- Comparison to the predicate device's known performance as the benchmark for "substantial equivalence."
8. The sample size for the training set:
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Sample Size for Training Set: Not applicable/Not specified.
- Rationale: This device is not an AI algorithm that requires a training set. The "training" in manufacturing physical devices refers to process validation and quality control, not data training.
9. How the ground truth for the training set was established:
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How Ground Truth for Training Set was Established: Not applicable.
- Rationale: As above, no training set in the context of machine learning is involved.
Summary of what's present in the document:
The provided 510(k) summary focuses on demonstrating "substantial equivalence" of a modified medical device to a predicate device. It lists the types of tests performed (biocompatibility, in-vitro, ex-vivo) to support this claim, but it does not provide the specific quantitative acceptance criteria, the detailed results from these tests, or the methodological specifics (like sample sizes or expert involvement) that a direct "study" report would contain. The FDA's letter confirms that the device was found substantially equivalent based on these submissions.
§ 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.”