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The CAPIOX® Cardiotomy Reservoir is designed to facilitate the removal of particulate matter and micro air bubbles from blood that is aspirated from the thoracic cavity and/or the left ventricle, and store it during extra corporeal circulation. The device may be used for procedures lasting up to 6 hours.

The design of the CAPIOX® Cardiotomy Reservoir is comprised of a hardshell casing that serves as a blood containment system within the bypass circuit. The upper portion of the reservoir consists of a hardshell lid assembly that contains the necessary inlet ports and vent ports. The total capacity of the reservoir is 1000 mL. The cardiotomy section of the CAPIOX® Cardiotomy Reservoir contains a defoamer and a filter to facilitate air removal and the removal of particulates from suctioned blood entering the reservoir.

Here's a breakdown of the acceptance criteria and the study information for the CAPIOX® Cardiotomy Reservoir, based on the provided text:

Summary of Acceptance Criteria and Device Performance

The device's acceptance criteria are implicitly tied to demonstrating "substantial equivalence" to predicate devices. This means that its performance must be comparable to, and not raise new questions of safety or effectiveness compared to, established devices already on the market. The study aims to prove this equivalence.

• Pressure Drop Cardiotomy Section:
• Filtration Efficiency Cardiotomy Section:
• Effects Upon Cellular Blood Components:
• Pressure Integrity Testing:
• Tubing Connection Strength:
• Filter Breakthrough Time:
  (Detailed results for these specific tests are not provided in the text, only that the tests were conducted.) |

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated. The document refers to "comparative studies" and "tests were conducted" without providing specific numbers of devices or test runs. Given the nature of medical device testing (e.g., sterilization, biocompatibility, mechanical performance), it would involve a sufficient number of units to ensure statistical validity and representativeness, but the exact count is not given.
   • Data Provenance: Not explicitly stated. However, given that Terumo Cardiovascular Systems (a US-based company) is submitting a 510(k) to the FDA, it is highly likely the testing was conducted in the US or in facilities compliant with US regulatory standards. The testing appears to be prospective in nature, as it was conducted specifically to demonstrate equivalence for this new device submission.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • This type of device (a cardiotomy reservoir) does not typically involve expert consensus for "ground truth" in the way a diagnostic AI algorithm might. The "ground truth" for its performance is established through objective engineering and biological tests (e.g., measuring filtration efficiency, pressure drop, cellular damage, sterility, biocompatibility) against predetermined specifications or established predicate device performance.
   • Therefore, no information on the number or qualifications of experts establishing "ground truth" in this context is provided or relevant. The "ground truth" comes from the physical and chemical properties of the device and its interaction with blood.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations (e.g., image reading by radiologists) used to establish ground truth for AI algorithms. For medical devices like this, the performance is measured objectively through assays and tests, not subjective expert judgment.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The CAPIOX® Cardiotomy Reservoir is mechanical blood processing device, and its evaluation does not involve human "readers" or diagnostic tasks that would benefit from such a study.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Not applicable. This device is not an algorithm or AI system. Its performance is inherently standalone in the sense that it functions physically and biologically without human "input" for its core operation (processing blood). The "standalone performance" is what the various engineering and biological tests were designed to assess.

6. Type of Ground Truth Used:

   • The "ground truth" is based on objective measurements, laboratory test results, and established standards. This includes:
     • Biocompatibility test results: Against ISO 10993 standards.
     • Sterilization validation: Against AAMI guidelines for SAL.
     • Physical performance measurements: Such as filtration efficiency, pressure drop, pressure integrity, tubing connection strength, and filter breakthrough time, benchmarked against predicate devices.
     • Cellular effects: Assessment of impact on blood components.

7. Sample Size for the Training Set:

   • Not applicable. This device is not an AI or machine learning model, so there is no concept of a "training set." The device itself is manufactured, and its performance is evaluated, not "trained."

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for a mechanical medical device like this.

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The CAPIOX® Cardiotomy Reservoir is designed to facilitate the removal of particulate matter and micro air bubbles from blood that is aspirated from the thoracic cavity and/or the left ventricle, and store it during extra corporeal circulation. The device may be used for procedures lasting up to 6 hours.

The design of the CAPIOX® Cardiotomy Reservoir is comprised of a hardshell casing that serves as a blood containment system within the bypass circuit. The upper portion of the reservoir consists of a hardshell lid assembly that contains the necessary inlet ports and vent ports. The total capacity of the reservoir is 4000 mL. The cardiotomy section of the CAPIOX® Cardiotomy Reservoir contains a defoamer and a filter to facilitate air removal and the removal of particulates from suctioned blood entering the reservoir.

The provided text describes a medical device (CAPIOX® Cardiotomy Reservoir) and its premarket notification, largely focusing on demonstrating substantial equivalence to a predicate device. This type of submission does not typically include a study with explicit acceptance criteria for device performance based on a statistical analysis of a test set, particularly in the way that an AI/ML algorithm or diagnostic device approval would.

Instead, the "acceptance criteria" here are implied by the demonstration of "substantial equivalence" through various performance tests conducted on the device. The study is a series of engineering and performance tests designed to show that the new device performs equivalently to the predicate device.

Here's how to interpret the request within the context of the provided document:

Acceptance Criteria and Performance Study for CAPIOX® Cardiotomy Reservoir

Since this is a submission for a physical medical device demonstrating substantial equivalence to a predicate, the "acceptance criteria" are not quantitative thresholds for metrics like sensitivity, specificity, or AUC, but rather the demonstrated equivalence in specified functional performance areas. The "study" refers to the performance evaluations conducted.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated. The tests are likely performed on a representative number of manufactured units, rather than a "test set" of data in the AI/ML sense.
• Data Provenance: Not specified, but generally, these are laboratory tests conducted on manufactured device samples. The data would be prospective, as the tests are performed specifically to evaluate the new device. Country of origin for testing is not mentioned but would typically be at the manufacturer's R&D or testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This concept doesn't directly apply here. For a physical device like this, "ground truth" is established by direct measurement of physical or chemical parameters (e.g., pressure, filtration efficiency, residual chemicals, sterility) using established engineering and scientific methods, rather than expert consensus on a diagnostic outcome. The "experts" would be the engineers and scientists conducting and validating the tests, adhering to industry standards.

4. Adjudication method for the test set

• Not applicable. Performance is determined by objective measurements against engineering specifications or comparative data from the predicate, not by expert adjudication.

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

• Not applicable. This is a physical blood reservoir, not an AI/ML diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable for a physical medical device. The device operates standalone as a component in a cardiopulmonary bypass circuit.

7. The type of ground truth used

• The "ground truth" for these tests is based on objective physical and chemical measurements against established engineering specifications, safety standards (e.g., AAMI for sterility), and direct comparison to the well-characterized performance of the predicate device's cardiotomy section.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a "training set." The design and manufacturing process are informed by general engineering principles and experience with similar devices, not machine learning training.

9. How the ground truth for the training set was established

• Not applicable.

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