(84 days)
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
| Acceptance Criteria Category (Implied) | Specific Performance Test | Actual Device Performance (Reported) |
|---|---|---|
| Equivalence to Predicate Device's Cardiotomy Section | Filter Defoaming Cardiotomy Section | Functionally equivalent to predicate. |
| Pressure Drop Cardiotomy Section | Functionally equivalent to predicate. | |
| Filtration Efficiency Cardiotomy Section | Functionally equivalent to predicate. | |
| Effects Upon Cellular Blood Components | Functionally equivalent to predicate. | |
| Mechanical Integrity & Safety | Pressure Integrity Testing | Performance deemed acceptable. |
| Tubing Connection Strength | Performance deemed acceptable. | |
| Filter Breakthrough Time | Performance deemed acceptable. | |
| Biocompatibility & Sterilization | Sterilization conditions | Validated to SAL of 10^-6 (AAMI guidelines). |
| Ethylene Oxide residues | Will not exceed maximum residue limits. | |
| Biocompatibility | Found to be biocompatible (based on predicate device materials and design). |
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.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).