(57 days)
The modified S5 and the Pulse Mode Control for the SCP/S5 are used with the SCP Rhythm System in conjunction with the Stöckert S5 System during cardiopulmonary bypass for procedures 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.
The provided 510(k) summary for the Stöckert S5 System does not contain the detailed information requested regarding specific acceptance criteria, device performance, and study methodology (sample sizes, ground truth establishment, expert qualifications, etc.).
The summary states:
"Testing of the modified Stöckert S5 System (hardware and software) has demonstrated that the System fulfills prospectively defined performance specifications and that the modified System meets user needs."
This is a general statement. To provide the requested table and details, a more comprehensive performance study report or verification and validation documentation would be needed.
Based on the available text, I can only state that:
- Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed. The document only generically states that the system "fulfills prospectively defined performance specifications."
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth Type, Training Set Size/Ground Truth): None of these specific details are provided in the given 510(k) summary. The document is a regulatory submission for substantial equivalence, focusing on comparative technological characteristics rather than a detailed breakdown of a clinical or performance study.
Therefore, I cannot populate the table or provide the detailed study information as requested from the provided input. The document serves as an overview of the device and its regulatory status, not a detailed performance study report.
§ 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).