(43 days)
The Stöckert S5 System is intended to be used during cardiopulmonary bypass surgery lasting six (6) hours or less.
The modified Stöckert S5 System, like the parent S5 System, is a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.
This submission describes a device modification to an existing system, rather than a new standalone device, and focuses on demonstrating substantial equivalence to the predicate device. Therefore, the information provided does not fully align with all the requested categories for a typical medical device performance study proving a new device meets acceptance criteria.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states: "Testing of the modified Stöckert S5 System (hardware and software) has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs."
However, specific numerical acceptance criteria (e.g., accuracy percentages, specific thresholds for flow rates, pressure, etc.) and the detailed reported performance values are not explicitly provided in the given text. The submission focuses on demonstrating substantial equivalence rather than presenting a detailed performance study against specific, quantified acceptance metrics.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. The submission does not detail specific "test sets" or data used in the conventional sense of a clinical or performance study for a new device. The testing was likely internal V&V for the modified system.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the given text. The concept of "ground truth" established by experts, as typically found in diagnostic device studies, is not applicable here. The device is a heart-lung machine, and its performance is validated through engineering and functional testing.
4. Adjudication Method
This information is not provided and is not applicable to the type of device and submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
This information is not provided and is not applicable. MRMC studies are typically used for diagnostic imaging or screening devices to assess human reader performance with and without AI assistance. This device is a cardiopulmonary bypass system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not provided. While the device has "software," the submission describes "hardware and software" testing of a system, implying integrated performance, not an isolated "algorithm only" study.
7. Type of Ground Truth Used
The concept of "ground truth" as typically understood (e.g., pathology, expert consensus for diagnosis) is not applicable here. For a heart-lung machine, the "ground truth" for performance would be its ability to consistently and accurately control physiological parameters (flow, pressure, temperature) according to engineering specifications and clinical requirements. This would be established through engineering tests, calibration, and functional verification.
8. Sample Size for the Training Set
This information is not provided and is likely not applicable. The device is a modified heart-lung machine, not an AI/ML-driven diagnostic or predictive algorithm that typically requires a "training set" for model development. The "software" mentioned likely refers to operational control software, not machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the reasons stated in point 8.
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).