(41 days)
The Quest Medical MPS® 2 Myocardial Protection System, consisting of the MPS 2 Console and the MPS Delivery Set together, is intended for use by perfusionists and physicians to deliver whole blood (from any arterial source) and / or cardioplegia solutions to either an arrested or beating heart for use up to six hours in duration.
The MPS® 2 Myocardial Protection System Console is a single device for myocardial perfusion that incorporates several different functions: heat exchanger, temperature control, pressure control, flow rate control, automatic priming and air detection / removal, and 3 flow modes - normal, cyclic, low volume.
The provided text describes the acceptance criteria and study for the MPS 2 Myocardial Protection System, a medical device used for myocardial perfusion. This device is not an AI-powered diagnostic tool, but rather a physical system with incorporated functions for heat exchange, temperature control, pressure control, flow rate control, automatic priming, and air detection/removal. Therefore, many of the typical questions regarding AI/ML device studies (e.g., ground truth for training set, MRMC studies, effect size of AI assistance) are not applicable.
Here's the information gleaned from the text for this device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| In-House Testing Acceptance Criteria: The device must pass all in-house testing acceptance criteria. (Specific criteria not detailed, but implied to cover the operational functions like heat exchange, temperature/pressure/flow control, priming, air detection, and three flow modes). | The MPS 2 console passed all in-house testing acceptance criteria. |
| UL/IEC 60601-1: 2003 and EN/IEC 60601-1-2:2001 Standards Conformance: The device must conform to these electrical and electromagnetic compatibility safety standards. | UL certified the MPS 2 console as conforming to IEC 60601-1-2:2002 and UL 60601-1:2003 standards. |
| Equivalence to Predicate Device: The new characteristics of the device should not raise new safety or effectiveness questions, and performance data must demonstrate equivalence to the predicate MPS console (K994274). | The safety and effectiveness questions are the same as for the predicate. Performance data, including in-house performance testing and simulated use testing, demonstrated equivalence. The MPS 2 console is substantially equivalent to the MPS console. |
2. Sample Size Used for the Test Set and Data Provenance
Due to the nature of this physical device (a myocardial protection system), the concept of "test set" and "data provenance" (country of origin, retrospective/prospective) in the context of diagnostic data is not directly applicable. The "test set" constitutes the device prototypes themselves undergoing various performance and safety tests.
- Sample Size for Test Set: Not explicitly stated as a number of "samples" in the traditional sense, but refers to the physical devices (MPS 2 consoles) that underwent testing.
- Data Provenance: The testing was "in-house" and specific "UL Laboratories testing methods" were used. This suggests a controlled laboratory environment rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable to the evaluation of a physical medical device like the MPS 2 System. "Ground truth" is established by direct measurement and adherence to engineering and safety standards, rather than expert interpretation of diagnostic images or clinical data. The "experts" involved would be engineers, technicians, and potentially regulatory compliance officers.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" or "3+1" are used in diagnostic studies to resolve discordant expert opinions on ground truth. For a physical device, performance is objectively measured against predefined engineering specifications and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. MRMC studies are typically used to assess the impact of AI assistance on human reader performance in diagnostic tasks. This device is a standalone medical system, not a diagnostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in a sense, a "standalone" evaluation of the device's technical performance was the primary focus. The device's functions (heat exchange, temperature control, etc.) were tested independently of human operation to ensure they met specifications. The conclusion specifically states: "The MPS 2 console passed all in-house testing acceptance criteria. UL certified the MPS 2 console as conforming to IEC 60601-1-2:2002 and UL 60601-1:2003 standards." This demonstrates its standalone performance against established benchmarks.
7. The Type of Ground Truth Used
The ground truth for this device's evaluation was based on:
- Engineering Specifications and Performance Standards: The device's internal performance parameters (e.g., temperature accuracy, flow rate stability, pressure control limits) were measured against its design specifications.
- International Safety and Quality Standards: Conformance to UL/IEC 60601-1:2003 and EN/IEC 60601-1-2:2001, which are widely accepted standards for medical electrical equipment.
- Equivalence to Predicate Device: The predicate device serves as a benchmark for established safety and effectiveness.
8. The Sample Size for the Training Set
This question is not applicable. This device is not an AI/ML system that undergoes "training" with data. Its design and manufacturing process would involve engineering design, prototyping, and iterative testing, but not data-driven machine learning training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for an AI/ML model. The "ground truth" for the device's underlying design and functionality would stem from biomedical engineering principles, clinical requirements for myocardial protection, and established safety standards.
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).