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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

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.

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The Stockert Air Purge Control (APC) detects air in the venous line and removes air from the venous bubble trap of the Synergy System tubing circuit that is intended to be used with the Stockert S3 Perfusion System. The S3 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S3 System.

The Stöckert Air Purge Control is a modification of the cleared S3 Level Control/Bubble Detector with the new Air Purge Control module replacing the Bubble Detector. The APC System uses the same Level Control module, Level Control sensor as the predicate device above. The modifications being made to the parent Stöckert S3 Level Control and Bubble Detector consist of three changes: (1) a change to the artwork of the display panel to show "APC" rather than "Bubble Detector," (2) replacement of the "Alarm Clear" key with the "Purge Control" key, and (3) firmware and software modifications. No modifications are being made to the hardware or electronics of any of the components.

The provided text is a 510(k) summary for a medical device modification, specifically the Stöckert Air Purge Control (APC) System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to fill out all the aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Stöckert Instrumente GmbH has verified and validated the device modifications and has demonstrated, through the testing provided in the 510(k) that the APC System 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, the specific "specifications" (acceptance criteria) and the quantitative results from the "testing provided in the 510(k)" (reported device performance) are not included in this summary. This document is a high-level summary and doesn't delve into the detailed test report.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The summary mentions "testing provided in the 510(k)," but doesn't detail the nature or origin of the data. Given it's a device modification and verification/validation, it's likely internal testing by the manufacturer, but specifics are absent.

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

• This information is not applicable and not provided. The device (Air Purge Control) is a bubble detector and air removal system. Its "ground truth" would likely be established through physical tests with known air volumes or conditions, rather than expert interpretation of images or observations.

4. Adjudication Method for the Test Set

• Not applicable and not provided. See point 3 above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done? No.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool for human readers. It's an automated control system.

6. Standalone Performance Study

• Was it done? Yes, implicitly. The summary states: "Stöckert Instrumente GmbH has verified and validated the device modifications and has demonstrated, through the testing provided in the 510(k) that the APC System complies with specifications, meets user requirements..." This refers to the device's performance in its intended function (detecting and removing air), which is a standalone performance validation. However, the specific results of this standalone testing are not detailed in the summary.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated but inferred to be based on engineering specifications and physical measurements. For a bubble detector and air purge system, the ground truth would involve controlled introduction of air into the system and verification of the device's ability to detect and remove it according to predetermined thresholds and operational parameters. It would likely involve instrument-based measurements rather than expert consensus or pathology.

8. Sample Size for the Training Set

• Not applicable and not provided. This device is a control system with firmware/software modifications, not a machine learning or AI model that requires a training set in the typical sense. The "firmware and software modifications" would have been developed and tested against established engineering requirements.

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

• Not applicable and not provided. See point 8.

In summary:

The provided text serves as a regulatory submission summary, focusing on demonstrating substantial equivalence for a device modification. It mentions "testing" and "verification/validation" were performed to show the device meets "specifications" and "user requirements," but it does not disclose the specific acceptance criteria, the detailed results, or the methodologies (like sample sizes, ground truth establishment for AI/diagnostic devices, or MRMC studies) that you've requested. These details would typically be found in the actual test reports and validation documents submitted with the 510(k), which are not part of this public summary.

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The Stöckert Centrifugal Pump System with Tubing Clamp (SCP System TC) is a cardiopulmonary bypass speed control device that is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP System TC has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The SCP System TC controls a Tubing Clamp that is positioned at the pump outlet to occlude the arterial line if the reservoir blood level, microbubble activity, or retrograde flow in the extracorporeal circuit reaches alarm levels during a cardiopulmonary bypass procedure.

The Stockert Centrifugal Pump System with Tubing Clamp (SCP System TC) is a modification of the Stöckert Centrifugal Pump (SCP). The proposed SCP System TC is identical in intended use and fundamental scientific technology to the parent SCP. The parent SCP is identical to the proposed SCP System TC with the exception of the addition of an Electrical Remote-Controlled Tubing Clamp (Tubing Clamp) that is positioned at the pump outlet to occlude the arterial line. The Tubing Clamp is designed to automatically close if the reservoir blood level, microbubble activity, flow rate, or retrograde flow in the extracorporeal circuit reaches alarm levels during a cardiopulmonary bypass procedure. The Tubing Clamp can also be manually opened and closed by the operator via membrane keys on the SCP Pump Control Panel.

The proposed Tubing Clamp is connected to the Stöckert Centrifugal Pump Console (SCPC System) or a Stöckert Compact (SC) or Stöckert S3 System (S3) heart-lung machine console via a CAN/24V connection cable. Mains power and emergency power is provided by the connected SCPC System or SC/S3 System. Both automatic and manual operation of the clamp is controlled via the SCP System microprocessor control system.

Given the provided text, here's a breakdown of the acceptance criteria and the study information for the Stöckert Centrifugal Pump System with Tubing Clamp:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the addition of the Tubing Clamp represents a "minor design change that raises no new issues of safety or effectiveness." This implies the existing safety and effectiveness criteria for the predicate Stöckert Centrifugal Pump (K011838) were considered applicable and met. The "acceptance criteria" themselves are broadly defined by the performance tests conducted.

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

The provided text does not specify a sample size for any clinical or in-vitro test set in the conventional sense (e.g., number of patients, number of test runs).

The study described is focused on the device's functional integrity rather than performance on a biological sample.

Data Provenance: Not applicable as the testing described is primarily engineering and functional validation.

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

Not Applicable. The text describes engineering and functional testing ("Functional acceptance testing, hardware and software testing, and validation testing"). There is no mention of human experts establishing ground truth in the context of clinical or diagnostic performance for the described modifications.

4. Adjudication Method for the Test Set

Not Applicable. As the testing was primarily functional and engineering-based, there is no mention of an adjudication method typical for clinical or diagnostic studies requiring expert consensus.

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

No, an MRMC comparative effectiveness study was not done. The device in question is a medical pump system with an added tubing clamp, not an AI-assisted diagnostic or decision-support system. Therefore, AI is not involved, and human reader performance improvement is not relevant to this submission.

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

Not Applicable. This device is a physical mechanical system, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The functional tests described are essentially "standalone" in that they test the device's inherent operation.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing described is the design specifications and user requirements for the Tubing Clamp and the system. The tests confirmed that the device performed as designed and met these predefined requirements.

8. The Sample Size for the Training Set

Not Applicable. This device is a mechanical system, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not Applicable. As there is no training set for a machine learning algorithm, there is no "ground truth for the training set" to be established.

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The Stöckert Pediatric Aortic Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary bypass up to six hours or less.

The Stöckert Pediatric Aortic Cannulae, A272-15 through A272-35 are sterile, non-pyrogenic devices, for single use only, and are not to be resterilized by the user. The devices are wire reinforced aortic cannulae with a curved distal tip.

The cannulae are comprised of two components, the cannula tube and the curved tip. Encapsulated within the cannula outer wall is a helically wound stainless steel wire which allows the cannula tube to resist kinking. The devices range in diameter from 4.5 to 10.5 Fr and have an overall length of 22 cm.

This document is a 510(k) pre-market notification for a medical device, specifically Stöckert Pediatric Aortic Cannulae. It is not a study describing the acceptance criteria or performance of an AI/ML powered device.

Therefore, most of the requested information regarding AI/ML device performance and study design cannot be extracted from this document. This document pertains to traditional medical device approval based on substantial equivalence to a predicate device.

However, I can extract the following relevant information:

1. A table of acceptance criteria and the reported device performance

Since this is a submission for a traditional medical device (cannulae) and not an AI/ML powered device, there are no "acceptance criteria" in the sense of performance metrics like accuracy, sensitivity, or specificity commonly associated with AI/ML. Instead, the document focuses on demonstrating substantial equivalence to a predicate device through:

The study that proves the device meets the acceptance criteria:

The "study" in this context is a comparison to a predicate device using in-vitro performance and biocompatibility tests.

• Predicate Device: Jostra Arterial Perfusion Cannulae (mentioned in the first section) and Research Medical Inc. Pediatric Aortic Cannula (mentioned in the "STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON"). It seems two different predicate devices are referenced for different aspects of the comparison.

The following information cannot be provided as it is not relevant to this type of medical device submission for a cannulae:

• Sample sized used for the test set and the data provenance (Not applicable for a physical device where "test set" implies algorithmic evaluation)
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not applicable)
• Adjudication method (Not applicable)
• 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 (Not applicable, as this is not an AI/ML device)
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done (Not applicable)
• The type of ground truth used (expert consensus, pathology, outcomes data, etc) (Not applicable)
• The sample size for the training set (Not applicable, as there is no "training set" for a physical device)
• How the ground truth for the training set was established (Not applicable)

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The Stöckert Coronary Perfusion Cannulae are intended to be used to cannulate the coronary ostium and to deliver cardioplegic solution during cardiopulmonary surgery for periods of up to six hours.

The Stöckert Coronary Perfusion Cannulae are comprised of either a flexible plastic (PVC) or a malleable stainless steel body, with a soft silicone tip and either a ¼" barbed tubing connector or a luer lock. They are offered in various tip outer diameters ranging from 3.0 to 5.0 mm (9 to 15 Fr). The P605, P607, P615, and P617 Series Stöckert Coronary Perfusion Cannulae are 26 cm long. The P606, P616, and P618 Series Stöckert Coronary Perfusion Cannulae are 14 cm long.

The provided text describes a 510(k) pre-market notification for the Stöckert Coronary Perfusion Cannulae. This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria via a comprehensive study with defined endpoints.

Therefore, many of the requested elements for a study proving acceptance criteria are unfortunately not applicable or not explicitly detailed in the provided document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria with corresponding performance metrics for the Stöckert Coronary Perfusion Cannulae. Instead, it relies on demonstrating equivalence to a predicate device.

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

• Sample Size: Not specified. The document states "In-vitro performance and biocompatibility tests," but does not provide details on the number of samples tested or the methodology.
• Data Provenance: The tests were "in-vitro," meaning conducted in a lab setting rather than on human or animal subjects. The country of origin for the data is not explicitly stated, but the submitting company (Stöckert Instrumente GmbH) is based in Munich, Germany, so it is reasonable to infer the testing was likely conducted in Germany or by a contract lab on their behalf. The data is retrospective in the sense that the testing was completed before the submission.

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

Not applicable. For a 510(k) submission based on substantial equivalence and "in-vitro" testing, ground truth is established through adherence to recognized testing standards and comparison to the predicate device's characteristics, not through expert consensus on a test set in the way one might for an AI image analysis device.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, this type of study was not done. MRMC studies are typically used to evaluate the diagnostic accuracy of AI algorithms and their impact on human reader performance, which is not relevant for this medical device (a coronary perfusion cannula).

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth or basis for the claims of substantial equivalence are:

• Predicate Device Comparison: The Stöckert Coronary Perfusion Cannulae were compared to the Medtronic DLP Coronary Ostial Perfusion Cannulae in terms of intended use, design features, and performance characteristics.
• In-vitro Testing: Biocompatibility and performance tests were conducted in a laboratory setting. The outcomes of these tests, demonstrating equivalent performance, serve as the "ground truth" for the claim of substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm that requires a training set.

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

Not applicable. This is not an AI algorithm.

Summary regarding this specific submission:

This 510(k) notification for the Stöckert Coronary Perfusion Cannulae primarily relies on demonstrating substantial equivalence to an existing predicate device (Medtronic DLP Coronary Ostial Perfusion Cannulae). The "study" mentioned consists of "In-vitro performance and biocompatibility tests," which are generally standard engineering and biological safety tests for medical devices. The details of these tests, including specific methodologies, raw data, acceptance criteria for those tests, and sample sizes, are not provided in the summary document but would have been part of the full 510(k) submission reviewed by the FDA. The FDA determined that, based on these tests and the comparison to the predicate, the device was substantially equivalent and could be marketed.

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The Stöckert V172-28 Venous Femoral Cannula is intended to cannulate the inferior vena cava and the right atrium via femoral access during cardiopulmonary bypass surgery for periods up to six hours.

The Stöckert V172-28 Venous Femoral Cannula is a sterile, non-pyrogenic device, for single use only, and is not to be resterilized by the user. The device is a polyvinyl chloride (PVC) wire reinforced Cannula with a non-wire reinforced proximal end for connecting the device to a cardiopulmonary bypass circuit. The Stöckert V172-28 Cannula is intended to be used to cannulate the femoral vessels during cardiopulmonary bypass surgery. During use, the cannula is inserted into the vena femoralis and advanced into the right atrium, allowing blood from the systemic circulation to enter the extracorporeal circuit. Insertion of the cannula into the vena femoralis during cardiopulmonary bypass surgery is an alternative method for insertion of a cannula into the superior or inferior vena cava.

The Stöckert V172-28 Cannula is 28 Fr and 90 cm in length, with a flexible proximal end that can accommodate a 1/2" connector. The cannula tube contains two sets of side holes, one set for drainage from the right atrium and one set for drainage from the inferior vena cava and hepatic veins. An obturator is provided with each cannula, which seals the inside of the cannula tube in the areas of the side holes to prevent blood leakage from the cannula during insertion. After insertion, the obturator is removed and discarded by the user.

The provided text describes a 510(k) pre-market notification for a medical device, the Stöckert V172-28 Venous Femoral Cannula. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study to establish performance from scratch. Therefore, the information typically associated with AI/software device studies (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, ground truth types) is not present here.

Instead, the study performed is a series of engineering and biological tests demonstrating that the new device performs as safely and effectively as the predicate device.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the Stöckert V172-28 Venous Femoral Cannula is "substantially equivalent to the Medtronic DLP Venous Femoral Cannula." This is the overarching acceptance criterion, meaning the new device must perform comparably to the predicate device in key functional areas. The "reported device performance" is implicitly that the Stöckert V172-28 meets this substantial equivalence through the tests listed.

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

This information is not provided. For this type of device (a physical medical cannula), "test set" typically refers to the number of units tested for each characteristic (e.g., how many cannulas were subjected to pressure drop tests). The data provenance refers to whether the tests were conducted internally by the manufacturer or by an independent lab, and this detail is also not specified.

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

Not applicable for this type of device submission. "Ground truth" for a physical device like a cannula is established through objective engineering and biological test results, not expert consensus interpreting data like images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used in studies involving subjective interpretation of data (e.g., medical images), which is not the nature of these tests.

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

Not applicable. This is a physical medical device, not an AI or software device. Therefore, no MRMC study or AI assistance is relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth is established through objective quantitative measurements from the specified engineering and biological tests (Pressure Drop, Blood Trauma, Leak, Kink Resistance). The "ground truth" for each test would be the empirically measured outcome of the Stöckert V172-28 device compared against the expected performance or against the performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning model. There is no concept of a "training set."

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

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The Stöckert Centrifugal Pump Console (SCPC System) is a software-controlled cardiopulmonary bypass device containing an uninterruptable power supply (UPS) and S3 Sensor Modules that is designed for operation of the Stöckert Centrifugal Pump (SCP) and monitoring the cardiopulmonary bypass circuit. The SCPC System, in combination with the SCP and the COBE Revolution Pump Head, is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.

The SCPC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The SCPC System provides electrical power and sets specific operational parameters for the Stöckert Centrifugal Pump Control Panel and Drive Unit described in K011838. The SCPC System also monitors the following parameters of the cardiopulmonary bypass circuit:

• . Pressure
• Temperature .
• Level monitoring/bubble detection .
• Elapsed time .

The SCPC System provides procedural flexibility for use of the Stöckert Centrifugal Pump, allowing the pump to be used as a component of other legally marketed heartlung machine consoles.

The provided document, K020571 for the Stöckert Centrifugal Pump Console, describes performance testing but does not explicitly detail acceptance criteria in a quantitative table or the specific results against such criteria for the device itself. Instead, it broadly states that testing was performed to confirm that the proposed SCPC System performed as designed and met user requirements.

The document outlines the types of testing performed rather than specific performance metrics against pre-defined acceptance thresholds.

Re-interpreting for Acceptance Criteria and Study Information:

Given the nature of the device (a cardiopulmonary bypass system console) and the information provided, the "acceptance criteria" can be inferred to be compliance with relevant standards and successful functionality as per design specifications and user requirements. The "study" refers to the performance testing conducted.

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The document refers to "testing" performed, which generally implies a test set of devices or scenarios, but no specific numbers are given for units tested or duration of tests beyond the "typical durations of six hours or less" for use.
• Data Provenance: Not explicitly stated, but based on the manufacturer's location (Munich, Germany) and the regulatory submission to the FDA (USA), the testing was likely conducted in a controlled environment, potentially in Germany, for submission to US regulatory bodies. The nature of the device suggests in-vitro testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable and hence not provided in the document. This device is a medical instrument console, not an AI/diagnostic software. "Ground truth" in the context of expert consensus or pathology is typically relevant for diagnostic devices or AI algorithms. The "ground truth" for this device would be its adherence to engineering specifications and regulatory standards, evaluated by engineers and regulatory compliance experts.

4. Adjudication method for the test set:

• Not applicable as this is not a diagnostic device involving human interpretation requiring adjudication. Performance was assessed against engineering and regulatory standards.

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:

• Not applicable. This device is a physical medical instrument (a pump console), not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a hardware console with integrated software, not a standalone algorithm. Its performance is assessed as an integrated system.

7. The type of ground truth used:

• The "ground truth" for this device is its adherence to:
  • Engineering specifications and design requirements: The device was tested to confirm it "performed as designed."
  • User requirements: Confirmed it "met user requirements."
  • Regulatory standards: Demonstrated "conformance with the appropriate standards" for electrical safety and EMC.
  • Compatibility: Demonstrated successful interaction with other specified heart-lung machine consoles.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "training" for such devices involves design, prototyping, and testing phases to ensure functionality, not data-driven model training.

9. How the ground truth for the training set was established:

• Not applicable for the same reasons as point 8.

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The Stöckert Centrifugal Pump (SCP) is a cardiopulmonary bypass speed control device (21 CFR 870.4380) indicated for use exclusively with the COBE Revolution Pump Head, for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.

The SCP has been qualified only for typical durations of six hours or less, appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The Stöckert Centrifugal Pump, developed to address the needs of the health care marketplace, consists of the following components:

• SCP Control Panel .
• SCP Drive Unit .
• Flow Probe .
• Emergency Drive Unit .

The SCP is designed to be used exclusively with the COBE® Revolution Disposable Pump Head and in connection with Stöckert S3 and SC Systems. The power supply voltage (24 V DC) as well as the CAN Bus connection is provided through a connection cable. The SCP utilizes the battery backup power from the S3/SC System Uninterruptible Power Supply in case of mains power failure.

1. Acceptance Criteria and Reported Device Performance

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