(25 days)
The Trillium™ MYOtherm™ XP Cardioplegia Delivery System is a device intended for the mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.
The Trillium™ MYOtherm™ XP Cardioplegia Delivery System is designed to mix arterial blood from oxygenators with asanguineous cardioplegja solution. The blood/cardioplegia solution is then cooled/warmed and delivered to the patient.
The Trillium™ MYOtherm™ XP Cardioplegia Delivery System is a modification of the existing MYOtherm™ XP Cardioplegia System, with the primary change being the addition of a Trillium™ biopassive surface coating to blood contact surfaces. The study aimed to demonstrate that this modification does not significantly affect the safety and effectiveness of the device compared to predicate devices.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Measure) | Reported Device Performance (vs. Predicate Devices) |
|---|---|
| Biocompatibility | Demonstrated no significant effect on safety and effectiveness. |
| Coating Characteristics (Coating) | Assessed and found acceptable. |
| Coating Characteristics (Leaching) | Assessed and found acceptable. |
| Physical Characteristics (Pressure Integrity) | Assessed and found acceptable. |
| Physical Characteristics (Priming Volume) | Assessed and found acceptable. |
| Performance Characteristics (Ease of Prime) | Assessed and found acceptable. |
| Performance Characteristics (Heat Exchanger Performance) | Assessed and found acceptable. |
| Performance Characteristics (Pressure Drop) | Assessed and found acceptable. |
| Performance Characteristics (Blood Trauma) | Assessed and found acceptable. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the in vitro bench testing or provide details on data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "performance data" and "in vitro bench testing" without giving quantitative details for the tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for a test set in the context of human interpretation of results. The evaluation appears to be based on direct measurements and comparisons of physical and performance characteristics in bench testing.
4. Adjudication method for the test set
Not applicable. The study involved in vitro bench testing and comparison against predicate devices, not subjective interpretation by multiple 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
Not applicable. This device is a medical apparatus, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical system, not an algorithm. The "standalone" performance would refer to the device's operational characteristics, which were tested in vitro.
7. The type of ground truth used
The ground truth was established by:
- Predicate Device Performance: The primary comparison was against the performance of the predicate devices (MYOtherm™ XP Cardioplegia System (K971105) and AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)).
- Established Scientific Methods: The document states that "acceptable scientific methods exist for assessing effects of these new technological characteristics," implying standard laboratory testing methods for medical device components and performance.
- Biocompatibility Standards: Biocompatibility testing would have been conducted against recognized standards for medical device materials.
8. The sample size for the training set
Not applicable. This document describes a medical device, not an AI or machine learning model that requires a training set. The "training" here refers to the design and development process of the device itself.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI model for this device. The design and development of the Trillium™ coating and the cardioplegia delivery system relied on established engineering principles, material science, and prior knowledge from the predicate devices.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.