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The Stöckert S3 Cyclic RPM Control Module is an accessory to the S3 Cardiopulmonary Bypass System Console which allows for the cyclicapm control offan;S3:pump.

The Stöckert S3 Cyclic RPM Control Module is an accessory module to the Stöckert S3 (cardiopulmonary bypass) Perfusion System, and is intended to allow the roller pump or double head pump to operate in the pulsed flow mode. The predicate and predecessor device to the S3 Cyclic RPM Control Module is the Stöckert-Shiley CAPS PFC 100 S Control unit (K883456). Similar devices have been used for many years for this same intended purpose. The new S3 Cyclic RPM Control Module is a simple upgrade of the technological aspects of the predicate device, e.g., the software controls and have been updated and the control and display panels have been updated for user convenience in operating the system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Stöckert S3 Cyclic RPM Control Module:

Limitations of the Provided Information:

It's important to note that the provided document is a 510(k) summary, which is a high-level overview. It describes the device, its intended use, and states that testing was performed to support substantial equivalence. However, it does not provide detailed acceptance criteria, specific reported performance data, or the methodologies of the studies in the granularity typically requested.

Therefore, many sections of your request will be answered by stating that the information is either not provided or not applicable based on the context of this specific document.

Description of Acceptance Criteria and Study for Stöckert S3 Cyclic RPM Control Module

The Stöckert S3 Cyclic RPM Control Module is an accessory to the Stöckert S3 Perfusion System, designed to enable pulsed flow operation for the roller pump or double head pump during cardiopulmonary bypass. The device is a technological upgrade of a predicate device, the Stöckert-Shiley CAPS PFC 100 S Control unit (K883456).

The provided 510(k) summary indicates that the device underwent testing to demonstrate substantial equivalence to its predicate. The testing conducted included:

• Electrical testing: To ensure compliance with electrical safety standards.
• Functional acceptance testing: To verify that the device performs its intended functions correctly.
• Software verification and validation testing: To ensure the software controls operate as designed and meet specified requirements.

The device also conforms to applicable international standards: IEC 601 and IEC 62a.

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the 510(k) summary. The document states "extensive testing results characterizing device performance" but does not detail the sample sizes for any test sets or the provenance (e.g., country of origin, retrospective/prospective nature) of data. Given that this is a hardware and software control module, the "test set" would typically refer to the number of units tested or specific scenarios run, rather than patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided and is largely not applicable in the context of this type of device (a control module for a perfusion system). Ground truth, in this case, would be established by engineering specifications and objective measurements, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable for the type of testing described (electrical, functional, software V&V for a control module). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review where subjective interpretation is involved.

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

An MRMC study was not done and is not applicable for this device. This device is a control module for a perfusion system, not an AI-assisted diagnostic or clinical decision support system that involves human readers interpreting cases.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

The device itself (the Cyclic RPM Control Module) is essentially a standalone control algorithm that modulates the pump's RPM. The "standalone" performance testing would be categorized under the "functional acceptance testing" and "software verification and validation testing" mentioned. The document states these tests were performed, but does not provide details on the specific performance metrics or results of these standalone tests.

7. The Type of Ground Truth Used

The ground truth for the testing of this device would be based on:

• Engineering specifications and design requirements: For electrical performance, functional parameters like RPM control accuracy, and software logic.
• Established international standards: IEC 601 and IEC 62a.

It would not involve expert consensus, pathology, or outcomes data in the typical sense for a medical device.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. The Stöckert S3 Cyclic RPM Control Module is described as possessing updated software controls, implying traditional software engineering and validation rather than a machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no indication that a "training set" for a machine learning model was used. The software controls would have been developed and validated against engineering specifications and functional requirements.

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