(58 days)
The Medtronic Performer CPB Advanced Extracorporeal Circulatory Support System is indicated for use up to 6 hours in the extracorporeal circulation of fluids for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
The centrifugal pump is indicated for use in pumping blood through an extracorporeal perfusion circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).
The Performer CPB, is a next generation heart lung machine that integrates the primary functions and safety features needed to perform cardiopulmonary bypass and related circulatory support procedures, along with enhanced user conveniences, into a reduced sized instrument. The product is designed and manufactured by RAND S.r.1., Medolla, Italy for Medtronic and exclusively distributed by Medtronic Perfusion Systems.
This version of the device has been changed to add conventional bypass capability to the existing device which previously only supported the use of Medtronic Resting Heart Disposable Module. The conventional bypass refers to already marketed cardiopulmonary circuits that utilize a reservoir. Typical conventional circuits include oxygenators, reservoirs, centrifugal pump, filters, tubings, connectors etc. This updated version of the Performer only supports the Medtronic Bio-Medicus centrifugal Pump as the arterial pump.
The changes included in Version 1.5 of the device include the following:
- . Optional Level Detection capability for reservoirs: Level detectors have been added to monitor changes in fluid or blood volume in the reservoirs. The system can be configured by the user to cause the Bio-Pump to either Stop or Coast in response to a level sensor being activated, preventing emptying the reservoir and transmitting air into the circuit. The user can also configure this safety link to not change the Bio-Pump function, but only produce visual and audible alarm cues. The level detection system is only utilized when operating with the reservoirs in the conventional cardiopulmonary bypass mode.
- Optional Retrograde Detection and Occlusion capability: An AutoClamp System . has been added that utilizes a Remote Tube Clamp (RTC), placed on the arterial line which serves to prevent retrograde flow from the aorta into the venous reservoir if the Bio-Pump run mode changes. The AutoClamp System can be configured to automatically clamp the arterial line when the Bio-Pump speed changes, prevent retrograde flow and thereby prevent the potential to entrainment air around the aortic cannulation site. The AutoClamp System is only utilized when operating in the conventional cardiopulmonary bypass mode.
The provided text is a 510(k) summary for the Medtronic Performer CPB System, which is a cardiopulmonary bypass heart-lung machine console. This document is a regulatory submission for a medical device that assists in surgery and not an AI/ML device. Therefore, the requested information for acceptance criteria and a study to prove the device meets those criteria, specifically concerning AI/ML performance, cannot be fully provided from the given text.
The document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against detailed AI/ML-specific acceptance criteria.
However, I can extract information related to the device's enhanced features and the general performance data mentioned:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a formal table of acceptance criteria with specific quantitative thresholds. Instead, it states that "comprehensive testing has been completed on the machine including performance and Software Verification and Validation" and references the results of this testing as supporting substantial equivalence. It highlights the capabilities of the newly added features: Level Sensing and AutoClamp Retrograde Detection.
| Feature/Capability | Reported Device Performance |
|---|---|
| Level Detection Capability | - Monitors changes in fluid or blood volume in reservoirs. |
- System can be configured by the user to cause the Bio-Pump to either Stop or Coast in response to a level sensor being activated, preventing emptying the reservoir and transmitting air into the circuit.
- User can also configure this safety link to not change the Bio-Pump function, but only produce visual and audible alarm cues.
- Utilized only when operating with reservoirs in conventional cardiopulmonary bypass mode. |
| Retrograde Detection and Occlusion Capability (AutoClamp System) | - Utilizes a Remote Tube Clamp (RTC) placed on the arterial line to prevent retrograde flow from the aorta into the venous reservoir if the Bio-Pump run mode changes. - Can be configured to automatically clamp the arterial line when the Bio-Pump speed changes, preventing retrograde flow and potential entrainment of air around the aortic cannulation site.
- Utilized only when operating in the conventional cardiopulmonary bypass mode. |
| Overall Performance | Performance data, such as level sensing capabilities and AutoClamp retrograde detection capabilities, were provided in the 510(k) submission to show equivalence of the Medtronic Performer CPB System to predicate devices (RMR Automatic Tubing Clamp System, Terumo System 1, and Cobe system). In addition, comprehensive testing was completed on the machine including performance and Software Verification and Validation. The conclusion is that the device is "safe and effective for its intended use" based on these tests and similarities to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not detail specific sample sizes for particular tests. It generally refers to "performance data" and "comprehensive testing." The data provenance (country of origin, retrospective/prospective) is not specified. Given this is a device for sale internationally by a US-based company with manufacturing in Italy, the testing location might be in either country, but this is not stated. The type of testing suggests a prospective, controlled validation, but the methodology details are absent.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable to the provided document. The device in question is a medical hardware system, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth on medical images or patient data. The "ground truth" for this device's performance would be engineering specifications and functional testing results.
4. Adjudication Method for the Test Set:
Not applicable for a medical device hardware system as described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for ground truth establishment in AI/ML model validation, neither of which is explicitly described here in detail.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
Not applicable. MRMC studies are used to assess the performance of diagnostic tools (often involving medical imaging) with and without AI assistance, comparing human reader performance. This device is a cardiopulmonary bypass system, not a diagnostic imaging tool. Therefore, no effect size of human readers improving with AI assistance is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
While the device has automated functions (like the AutoClamp and Level Detection triggering pump actions or alarms), the concept of "standalone algorithm only performance" in the context of AI/ML is not directly relevant here. The device itself operates as a standalone system during a procedure, guided by predefined logic and user configuration, without an explicit "AI algorithm" in the modern sense that needs standalone validation. Its performance is integrated into the overall machine functionality.
7. The Type of Ground Truth Used:
The ground truth for this medical device would be based on engineering specifications, functional safety requirements, and established design principles for cardiopulmonary bypass systems. For example, the ground truth for the level detection would be the actual fluid levels in a reservoir, and the device's alarm/response mechanism would be validated against these known levels. For the AutoClamp, the ground truth would involve simulated retrograde flow conditions to verify proper clamping action. The document implies that these functional aspects were tested to show equivalence to predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This document describes a medical device, not an AI/ML model that would have a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of medical device as described.
In summary: The provided 510(k) summary focuses on demonstrating that the Medtronic Performer CPB System is substantially equivalent to existing, legally marketed predicate devices. It affirms that "performance data" and "comprehensive testing" for its new features (level sensing and AutoClamp) were conducted, along with "Software Verification and Validation," to support this equivalence. However, it does not provide the specific detailed breakdown of acceptance criteria and study methodologies typically requested for AI/ML device validation.
§ 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).