(22 days)
The Stöckert SCP Rhythm is an accessory to the S3 Cardiopulmonary Bypass Console that allows for cyclically controlled delivery of blood with the Stöckert SCP during cardiopulmonary bypass for periods of up to six hours.
The Stöckert SCP Rhythm is a modification of the S3 Cyclic RPM Control Module. The modifications consist of two changes: ( 1 ) a change to the artwork of the display panel to show SCP Rhythm rather than Cyclic RPM Control and (2) firmware and software modifications. No modifications are being made to the hardware or electronics of any of the components. The Stöckert SCP Rhythm is intended for use with the SCP System as mounted on an S3 Cardiopulmonary Bypass Console.
Here's an analysis of the provided text regarding the Stöckert SCP Rhythm device, focusing on the requested information about acceptance criteria and the supporting study:
Important Note: The provided text is a 510(k) summary for a device modification, focusing on establishing substantial equivalence to a predicate device. It explicitly states: "Stöckert Instrumente GmbH has verified and validated the device modifications and has demonstrated, through the testing provided in the 510(k), that the Stöckert SCP Rhythm complies with specifications, meets user requirements, and the differences between the parent and the proposed device do not raise new issues of safety or effectiveness."
However, this type of summary does not typically include detailed performance study results or acceptance criteria in the format you've requested for AI/medical imaging devices. The "testing provided in the 510(k)" would ordinarily be in a separate, more comprehensive test report that is referenced but not fully detailed in the 510(k) summary itself. The text provided is a high-level regulatory document.
Therefore, many of the specific details you've asked for (like a table of acceptance criteria with reported performance, sample sizes for test/training sets, expert details, MRMC studies, standalone performance, and ground truth specifics) are not present in this document. The document mainly focuses on the nature of the modification and the claim of substantial equivalence based on underlying verification and validation.
Despite the limitations of the provided text, I will address each of your points based on what can be inferred or what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in this document. The document claims the device "complies with specifications" and "meets user requirements." | Not explicitly stated in this document. The document implies successful performance through general statements of compliance and equivalence. |
Explanation: The 510(k) summary does not list specific numerical performance metrics or acceptance thresholds. It broadly states that the modifications (artwork, firmware, and software) were "verified and validated" to ensure compliance with specifications and user requirements, and that they "do not raise new issues of safety or effectiveness." This suggests that the device performs as intended and similarly to its predicate, but no quantitative performance data is provided here.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in this document.
- Data Provenance (e.g., country of origin, retrospective or prospective): Not specified in this document.
Explanation: The document mentions "testing provided in the 510(k)," but it doesn't detail the methodology, sample sizes, or type of data used for that testing. Given it's a modification to a mechanical/electronic control system, the "testing" would likely involve engineering verification and validation (e.g., functional tests, electrical safety, software validation) rather than clinical data from patients in the way an AI diagnostic device would.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable/Not specified.
- Qualifications of Experts: Not applicable/Not specified.
Explanation: This type of information (experts, ground truth) is typically relevant for diagnostic devices, especially those using AI to interpret medical images or signals where human expert consensus or pathology is used as the reference standard. For a device like the Stöckert SCP Rhythm, which is an accessory controlling cyclic RPM for a cardiopulmonary bypass pump, the "ground truth" would be established through engineering specifications, functional testing, and safety parameters—not through expert clinical interpretation of outputs.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified.
Explanation: Similar to point 3, adjudication methods (like 2+1, 3+1 consensus) are used when there is subjective interpretation involved, usually in diagnostic image or signal analysis to establish a definitive "ground truth." This is not relevant for the functional testing of a pump control accessory.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No.
- Effect Size of Human Readers Improvement: Not applicable.
Explanation: MRMC studies are used to assess the impact of a diagnostic aid (e.g., AI) on human reader performance. The Stöckert SCP Rhythm is a device controlling a pump's cycling, not a diagnostic tool that humans read or interpret. Therefore, an MRMC study is not relevant or applicable for this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- Standalone Study: The verification and validation mentioned ("verified and validated the device modifications") would constitute "standalone" testing of the device's functionality. However, it's not a "standalone algorithm performance" study in the context of AI.
Explanation: For a mechanical/software control system, "standalone" performance is its inherent functional operation according to its design specifications. The 510(k) summary implies that such testing was performed to demonstrate that the device functions correctly on its own and in conjunction with the S3 Cardiopulmonary Bypass Console. The text does not detail the specifics of this testing (e.g., specific parameters measured, test environments).
7. The Type of Ground Truth Used
- Type of Ground Truth: Engineering specifications, functional requirements, and safety parameters.
Explanation: For this device, "ground truth" refers to the established engineering design parameters, performance specifications (e.g., accuracy of RPM control, cyclical nature of delivery), and safety standards the device must adhere to. The "testing provided in the 510(k)" would have compared the device's actual performance against these predefined technical and functional requirements.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable.
Explanation: This device is a control system with firmware and software; it's not described as an AI/machine learning device that would require a "training set" in the conventional sense for a diagnostic algorithm. The software modifications would have been developed via standard software engineering practices (requirements, design, coding, testing) rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
Explanation: As explained in point 8, there's no mention or indication of a "training set" for an AI/ML model for this device. The "ground truth" for the software's functionality would stem from its detailed design specifications and requirements.
§ 870.4380 Cardiopulmonary bypass pump speed control.
(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).