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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.

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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.

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