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Disposable device intended to recirculate, filtrate and perfuse physiologically compatible sterile solution (i.e. saline solution) in the thoracic or abdominal cavity. The device is intended for use in a single procedure.

The Hang&Go PAC, just like the Hang&Go HT Basic, is a disposable, single use kit intended to circulate and filtrate physiologically compatible sterile solution (i.e. saline solution) in the thoracic or abdominal cavity. The Hang&Go PAC is supplied sterile and packaged in a proprietary-design container and it is intended to be used only with the PERFORMER HT. The Hang&Go PAC, just like the Hang&Go HT Basic, includes all necessary tubing and components for the treatment execution: circulation tubing, heater bag, reservoir, table pack (Patient inlet and outlet tubing) with thermal protections. The Flow Reverse is a disposable, sterile component of the Hang&Go PAC. It is supplied sterile, individually packaged and included in the Hang&Go PAC carton box. The crossed layout of the 4 tubing segments allow to exchange the Patient's inlet and outlet flows by selectively opening / closing two segments at a time with the provided manual clamps.

I am sorry, but the provided text does not contain the specific information required to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification from the FDA regarding an infusion pump named "Hang&Go PAC." While it details the device's indications for use, comparison to a predicate device, and a list of non-clinical tests and applicable standards, it does not provide a table of acceptance criteria with reported device performance or information about sample sizes for test sets, expert involvement, adjudication methods, or specific details of standalone or MRMC studies.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and compliance with recognized standards for general safety, biocompatibility, sterilization, and packaging. It mentions specific tests conducted (e.g., static priming volume, pressure drops, temperature probe qualification, physical integrity verification for the Flow Reverse component), but it does not present the acceptance criteria for these tests nor the detailed results in a format that would allow filling out the requested table.

Therefore, I cannot provide the detailed information you requested based on the input text.

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The intended use of the PERFORMER HT is to provide isolated hyperthermic perfusion in the thoracic or peritoneal cavity by means of extra-corporeal circulation of warmed, physiologically compatible sterile solution, according to a protocol to be selected by the physician.

The device must be used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The PERFORMER HT is a prescription electromechanical device intended to provide isolated hyperthermic perfusion in the thoracic or peritoneal cavity by means of extracorporeal circulation of warmed. physiologically compatible sterile solution.

The PERFORMER HT equipment is designed to:

• operate the treatment execution by means of a color touch-screen display .
• . control the temperature of solution perfused to the Patient through the extracorporeal circuit
• control the flow rates of roller pumps .
• control the volume in the extracorporeal circuit and Patient's body cavity .
• monitor Patient's body cavity temperatures .
• monitor the extracorporeal circuit pressures .
• . detect air in the circuit
• change the fluid path in the extracorporeal circuit by means of 2 two-ways pinch valves .

The Central Information Display (CID) enables the User to interact with the PERFORMER HT equipment. The touch-screen display allows the User to:

• inout Patient information .
• operate the various treatment phases
• display treatment parameters (e.g, flows, pressures, temperatures) .
• set treatment parameters .
• . set alarm limits
• display graphical trending of temperature probes connected to the HTS module
• · read alarm and alert messages

The PERFORMER HT is intended to be used with the HANG&GO HT BASIC, a disposable, single use kit intended to circulate and filtrate the clear solutions in the thoracic or abdominal cavity.

The HANG&GO HT BASIC includes all necessary lines and accessories for the treatment execution:

• · circulation line
• ·. heater bag
• · reservoir
• · table pack (Patient inlet and outlet lines) with thermal protections

The HANG&GO HT BASIC is supplied sterile, packaged in a proprietary-design container, and is intended to be used only with the PERFORMER HT.

The Performer HT is a prescription electromechanical device for isolated hyperthermic perfusion. It circulates warmed, physiologically compatible sterile solution in the thoracic or peritoneal cavity. It controls solution temperature and flow rates, monitors volumes/pressures/temperatures, and detects air. The device is intended for use by qualified medical professionals.

Here's an analysis of its acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

• Quality management (ISO 14971, EN ISO 13485, EN ISO 14971)
• Packaging and labeling (EN 980, EN 1041, ASTM D4169-04a)
• Biocompatibility (AAMI ANSI ISO 10993 series)
• Electrical safety (IEC 60601 series)
• Sterility (AAMI ANSI ISO 11135, ISO 11607 series, ASTM F1980-07, AAMI ANSI ISO 11737)
• Human Factors (IEC 62366, EN 62366)
• Software (IEC 62304, EN 62304) | The PERFORMER HT is designed to, complies with, and has been tested to, the FDA Recognized Consensus Standards listed in the table. |
  | Software ability to meet performance specifications. | Verified through described tests at unit, integration, and system level for all functions, actuators, and parameters. |
  | User interface optimization and mitigation of user- and patient-safety risks concerning human factors. | Demonstrated that task-risks and errors have been identified, addressed, and either eliminated or reduced in a simulated use environment. |

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

The document does not explicitly state a "sample size" for a specific test set in the context of clinical trials or retrospective studies on actual patient data. The testing primarily involved non-clinical tests conducted on the PERFORMER HT system (equipment and disposable).

Data Provenance: The tests were performed by the manufacturer, RanD S.r.l. in Italy, as part of their 510(k) submission. Therefore, the data provenance is from the manufacturer's testing environment and simulated use, and it is prospective in the sense that the tests were designed and executed to evaluate the device's performance against pre-defined specifications. It is not patient or clinical data.

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

Not applicable. The ground truth for this medical device primarily relates to its engineering specifications, safety standards, and functional performance as verified through non-clinical testing. There is no mention of a ground truth established by human experts in a diagnostic or clinical context. The "ground truth" is defined by the technical specifications and recognized consensus standards that the device is tested against.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers (e.g., radiologists) interpret medical images or data, and their interpretations are compared against a consensus ground truth.

In this case, the device's performance was evaluated against predefined engineering specifications and recognized standards. The "adjudication" would involve technical experts (engineers, quality assurance personnel) verifying that the test results met these objective criteria.

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. This is not an AI/CAD (Computer-Aided Detection/Diagnosis) device, nor is it a device that is typically evaluated through MRMC studies. The PERFORMER HT is an electromechanical device for hyperthermic perfusion.

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

Yes, in essence. The performance tests described comprehensively evaluate the PERFORMER HT system (equipment and disposable) in its standalone capacity, to ensure it meets its functional and safety specifications. Even though it's an electromechanical device and not an algorithm, the tests assess its "standalone" operational capabilities without human intervention beyond initiating and monitoring the tests. The human factors study separately assessed user interaction, but the core performance tests were for the device itself.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests is based on pre-defined engineering specifications, recognized consensus standards, and established operational parameters. For example:

• Temperature control: The ability to heat and maintain fluid temperature within a specified range defines the ground truth for this function.
• Flow rate accuracy: The specified acceptable deviation from target flow rates serves as the ground truth.
• Alarm functionality: The system's response to simulated unsafe conditions (e.g., sensor failure) according to its design is the ground truth.
• Compliance with standards: The requirements outlined in international and European standards (e.g., ISO 14971, IEC 60601-1) form the ground truth for safety, quality, and electrical compatibility.

8. The Sample Size for the Training Set

Not applicable. This device is an electromechanical system, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development. The device's design and functionality are based on engineering principles and validated through testing, not learned from data.

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

Not applicable. As stated above, there is no "training set" for this type of device.

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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.

• 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.

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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.l., Medolla, Italy for Medtronic and exclusively distributed by Medtronic Perfusion Systems.

It's initial configuration and features are optimized for use with the Medtronic Resting Heart System (K03170).

The key differences between the competitive heart lung machines and the Performer CPB arc:

• . A small foot print for the machine and pump's layout optimized (vertical orientation) for extracorporcal volume reduction. Collapsible feature for storage and easy transportation.
• . Electrically adjustable height and stability system.
• . Integrated Active Air Removal System.
• . A built in printer.
• Pre configured roller pump rotation . (unidirectional) and built in Handcrank in roller pumps for emergencies.
• . Integrated "Memory Card" for treatment data recording and software updates.
• . Integrated SatO2/Hct and Tcmperature monitoring system.
• . Cardioplegia delivery air detector with pump stop feed back.
• Selectable alcrt/alarm tones (including voice). .
• . Active Air removal with arterial flow servo control.
• . Predominant 'icon' based GUI.
• Independent status colored LED system (traffic . light style) for alerts and alarms in addition to the audio and visual set ups on the actual user interface screen.
• Roller pump cover sensors.
• . . Real time integrated parameters' trending.

This document describes a 510(k) submission for the Medtronic Performer CPB System, a heart-lung machine. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance criteria against predefined acceptance thresholds in the typical sense of a new medical AI device.

Therefore, many of the requested categories are not applicable to this submission. The document focuses on demonstrating equivalence to existing legally marketed predicate devices through performance testing and comparison of technological characteristics.

Here’s a breakdown of the information that can be extracted or deduced, along with an explanation of why other requested categories are not directly addressed:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not present in the provided text. The submission aims to show "equivalence" rather than meeting pre-defined, quantitative acceptance criteria for novel performance claims. The performance data mentioned is for demonstrating this equivalence.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "performance data" and "comprehensive testing" but does not detail the number of units or test subjects involved in these tests.
• Data Provenance (country of origin, retrospective/prospective): Not explicitly stated. The manufacturing site is RanD S.r.l., Medolla (MO) – ITALY. The testing would likely have been conducted by or for the manufacturer. The nature (retrospective/prospective) of the performance data tests is not specified.

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

Not applicable. For a device like a heart-lung machine, "ground truth" is not established by expert consensus on interpretations but rather by physical measurements and engineering validation against established standards or predicate device performance. The performance data would involve technical measurements and comparisons.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is typically relevant for studies involving human interpretation (e.g., radiology images) where expert consensus resolves discrepancies. For a mechanical medical device, direct measurements and engineering analysis are performed.

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 not an AI-assisted diagnostic or interpretive device. It is a cardiopulmonary bypass system.

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. Performance tests would inherently be "standalone" in the sense that the device's functional outputs are measured, but it's not an "algorithm only" study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly stated using these terms. For a physical device, "ground truth" for performance would be established through objective physical measurements, engineering specifications, and comparison against established performance benchmarks of predicate devices. For example, air handling capabilities would be measured using technical equipment and compared to the predicate's measured capabilities or accepted standards.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. This device is not an AI/ML model.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence of a physical medical device to already approved predicate devices through performance data and comparison of technological characteristics, rather than establishing performance against novel statistical acceptance criteria typical of AI/ML or diagnostic devices.

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