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The INSPIRA™ ART100 system is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting six hours or less.

The INSPIRA™ ART100 system is a device for pumping blood without direct contact in an extracorporeal blood circulation circuit. The device is prescribed (Rx) by specialists to be used in Cardiopulmonary Bypass (CPB) procedures. The INSPIRA™ ART100 system consists of the following components: Controller Unit, Pump Drive Unit, Manual Pump Drive Unit, Blood Flow and Bubble Detection Sensor, Temperature Sensor, Cable adapters for Pressure Sensors, Cable adapters for Temperature Sensor, Oxygenator and Pump Drive Holders. The system is compatible with a Non-Roller Centrifygal Pump (Capiox iCP Centrifyqal Pump). The Inspira Pump Drives are magnetically coupled exclusively with the Capiox iCP Centrifugal Pump, designed and manufactured by Terumo Cardiovascular Systems Corporation, and can be supplied by Inspira. The INSPIRA™ ART100 system is intended to be used in conjunction with other previously 510(k)-cleared devices and sterile accessories such as cannulas, catheters, oxygenators, luer connectors, pressure sensors, supplied by hospital users or other manufacturers.

The provided text describes a 510(k) premarket notification for the INSPIRA™ ART100 device. While it details the device's technological characteristics, intended use, and comparison to a predicate device, it does not include specific acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity) or a detailed study proving the device meets these criteria in the context of an AI/human-in-the-loop system.

The device, Inspira Art100, is a cardiopulmonary bypass pump speed control system. The testing performed is related to ensuring the device functions as intended and meets safety standards, rather than evaluating specific clinical performance metrics typical of AI/ML-driven diagnostic or prognostic devices.

Therefore, many of the requested details about acceptance criteria and performance studies for an AI device cannot be extracted from this document.

However, I can extract information regarding non-clinical tests performed to demonstrate safety and effectiveness for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance
The document states: "All testing met predetermined acceptance criteria." However, the specific acceptance criteria and detailed reported performance values for each non-clinical test are not explicitly provided in a table format. The reported performance is implicitly that the device passed these tests.

2. Sample size used for the test set and the data provenance: Not applicable. The tests performed are non-clinical, bench, and simulated use tests for a pump speed control device, not a diagnostic or prognostic AI system using patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI models (e.g., disease presence) is not relevant for the type of device and testing described. Expert involvement would be in the design, testing, and validation of the device's engineering and safety aspects.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 type of study was not done. The device is a cardiopulmonary bypass pump speed control system, not an AI assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes standalone device testing (bench tests) for its functional and safety performance, but not in the context of an AI algorithm vs. human performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests described, "ground truth" refers to engineering specifications, performance standards (e.g., for pump speed, flow rate accuracy), and compliance with recognized industry standards (e.g., IEC, ISO, ASTM).

8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set of data.

9. How the ground truth for the training set was established: Not applicable.

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The CentriMag Extracorporeal Blood Pumping System is a non-roller-type cardiopulmonary and circulatory bypass blood pump used to pump a patient's blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i. Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels: or ii. Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava The CentriMag™ Blood Pump for use with the CentriMag™ Acute Circulatory Support System (Motor, Monitor, Console, and Flow Probes) is indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. ECMO is intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patients' blood for adult patients with acute respiratory failure and/or acute cardiopulmonary failure. where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

The CentriMag™ Acute Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. To date, the CentriMag system in the United States (US) is indicated as a component of an extracorporeal bypass circulatory support circuit for use during cardiopulmonary bypass (CPB) surgery (up to 6 hours), it is also indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited. The CentriMag System is composed of: - CentriMag Primary Console - CentriMag Motor - CentriMag Blood Pump - CentriMag Flow Probe - · Mag Monitor The CentriMag Motor is a reusable, non-sterile component of the CentriMag System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. The motor turns the magnet (and impeller) within the blood pump (Full MagLev™ technology) at a speed that is set on the console by the user. When the impeller is rotated, a pressure gradient develops between the center and outside edge of the pump, causing blood to flow from the inflow to the outflow port of the pump. The amount of flow through the pump depends on the speed of the impeller, and the difference between the inlet and outlet pressures.

The provided documents describe a 510(k) submission for the Abbott CentriMag™ Acute Circulatory Support System. This submission is a "Special 510(k)," which means it addresses a modification to an already cleared device. The primary change is an update to the CentriMag Motor, specifically a new "snap-in motor locking feature" replacing a "screw locking feature."

Therefore, the acceptance criteria and performance study described are focused on demonstrating that this change does not negatively impact the safety and effectiveness of the device and that the new design is substantially equivalent to the predicate device.

Here's the breakdown of the requested information based on the provided text:

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

Since this is a Special 510(k) for a design change (motor locking mechanism), the "performance" is about demonstrating that the new design is as safe and effective as the previous one, and that it conforms to requirements for its intended use. The document doesn't list specific numerical acceptance criteria (e.g., a "failure rate must be less than X%"). Instead, it describes categories of testing performed to ensure the new design performs adequately.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for any of the verification or validation tests (e.g., number of motors subjected to durability testing, number of users in human factors testing).
The testing described (Mechanical, Durability, Cleaning, Operating Manual Verification, Human Factors Validation) are typically prospective engineering and usability tests conducted by the manufacturer, not retrospective studies on patient data. The provenance for such tests would be the manufacturer's testing facilities, likely in the US (given the submitter's address in California).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable in the context of this 510(k) submission. The "ground truth" concept, often associated with clinical diagnostic studies requiring expert review of medical images or patient outcomes, is not relevant here. The studies described are hardware and human factors engineering tests. For human factors, users (not necessarily "experts" in the medical sense, but representative users of the device) would participate to validate the user interface changes. Their qualifications are not specified but would typically align with the intended users (e.g., perfusionists, surgeons, nurses).

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

This is not applicable to the type of engineering and human factors testing described. Adjudication methods like "2+1" are used in clinical studies where multiple experts independently review cases and discrepancies are resolved by a third party.

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

This is not applicable. The device is a mechanical circulatory support system (pump, motor, console, flow probe), not an AI-assisted diagnostic or clinical decision support tool that would involve human readers interpreting data.

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

This is not applicable. The device is a physical medical device (mechanical support system), not a software algorithm or AI. Its operation inherently involves a human in the loop (a clinician operating the system).

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

"Ground truth" as traditionally understood in clinical validation studies (e.g., pathology for cancer detection, long-term outcomes for treatment efficacy) is not directly applicable here. For the engineering tests, the "ground truth" is simply the documented design specifications and functional requirements of the device. For human factors, the "ground truth" or success criteria would be based on validated usability principles and the ability of representative users to safely and effectively operate the device with the new feature.

8. The sample size for the training set

This is not applicable. This is a hardware modification to an existing device, not a machine learning or AI algorithm that requires a training set.

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

This is not applicable, as there is no training set for a hardware modification.

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The Anivia SG1000 Pump Console is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass (up to 6 hours).

The Anivia SG1000 Pump Console is a device for pumping blood without direct contact in an extracorporeal blood circulation circuit. The device is prescribed (Rx) by specialists to be used in Cardiopulmonary Bypass (CPB) procedures. The Anivia SG1000 Pump Console consists of the following modules: Display & Control Module, Pump Driver Module, Flow Bubble Sensor Module, Backup Battery Module, and Cart Module. It is intended to be used in conjunction with other previously 510(k)-cleared devices and sterile accessories such as cannulas, catheters, oxygenators, luer connectors and single use centrifugal pump heads, supplied by hospital users or other manufacturers.

Here's the information regarding the acceptance criteria and study proving the device meets them, based on the provided text:

Device Name: Anivia SG1000 Pump Console (K230698)
Regulation Name: Cardiopulmonary Bypass Pump Speed Control

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list "acceptance criteria" in a quantitative performance table format. Instead, it describes various non-clinical tests conducted and states that "All testing met predetermined acceptance criteria." The table below summarizes the types of tests performed and the general outcome.

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

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of number of patient cases or images, as this is a device for regulating pump speed in cardiopulmonary bypass, not an AI/imaging diagnostic device. The testing involved various engineering and systems-level tests.
• Data Provenance: Not applicable in the context of typical AI/imaging studies. The testing described is performance testing of the device itself (hardware, software, electrical, mechanical, reliability) against engineering standards and internal criteria. There is no mention of 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 applicable. The device is a cardiopulmonary bypass pump console, not a diagnostic tool requiring expert interpretation of medical data (like images or clinical reports) to establish ground truth for a test set. The "ground truth" here is adherence to engineering specifications and performance standards, validated through bench testing, not expert consensus on clinical cases.

4. Adjudication method for the test set:

Not applicable, as there is no "test set" in the context of clinical interpretation subject to adjudication. The performance was assessed against predetermined engineering and functional 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:

Not applicable. This device is a cardiopulmonary bypass pump console, which is an electromechanical medical device, not an AI-assisted diagnostic or interpretation tool for human readers. No MRMC study was performed.

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

Not applicable. This is not an AI algorithm. The device operates with human involvement (physicians, perfusionists, etc.) for setup, monitoring, and control during cardiopulmonary bypass procedures. The "standalone" performance refers to the device's functional integrity as a machine.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by:

• Engineering specifications and design requirements.
• International consensus standards (e.g., IEC 60601 series, ISO 14971).
• Internal predetermined acceptance criteria for functional, electrical, mechanical, software, reliability, and safety tests.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. It's an electromechanical medical device.

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

Not applicable, as there is no training set for this type of device.

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The Anivia SG1000 Pump Console is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass (up to 6 hours).

The Anivia SG1000 Pump Console is a device for pumping blood without direct contact in an extracorporeal blood circulation circuit. The device is prescribed (Rx) by specialists to be used in Cardiopulmonary Bypass (CPB) procedures. The Anivia SG1000 Pump Console consists of the following modules: Display & Control Module, Pump Driver Module, Flow Bubble Sensor Module, and Backup Battery Module. It is intended to be used in conjunction with other previously 510(k)-cleared devices and sterile accessories such as cannulas, catheters, oxygenators, luer connectors and single use centrifugal pump heads, supplied by hospital users or other manufacturers.

The provided text describes the Anivia SG1000 Pump Console, a device intended to pump blood through an extracorporeal bypass circuit for cardiopulmonary bypass procedures (up to 6 hours). The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Medtronic Bio-console® 560 Extracorporeal Blood Pumping Console, K131964).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list a table of acceptance criteria with specific numerical targets and corresponding reported device performance values for the Anivia SG1000 Pump Console. Instead, it broadly states that "All testing met predetermined acceptance criteria." The performance characteristics are described in comparison to the predicate and reference devices in the "Technological Characteristics" table, implying that the acceptance criteria for these characteristics are met by being "Same as predicate" or by having differences that "do not raise different questions of safety and effectiveness."

Here's a breakdown of the performance characteristics provided, and where the device's performance aligns with or is considered equivalent to the predicate:

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

The document does not specify a "test set" in the context of clinical data for algorithmic performance, as this device does not involve AI or machine learning that would typically use such a test set. The non-clinical tests involved "system bench testing, mechanical testing, electrical safety and electromagnetic interference and compatibility testing, software testing, reliability, and usability testing." The sample size for these engineering and performance tests is not quantified (e.g., number of devices tested, number of test runs).

Data provenance is not applicable since no clinical data or patient data was used to assess the device's performance in this 510(k) submission. All tests mentioned are non-clinical, benchtop, or simulated use.

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

Not applicable. This device does not involve a "ground truth" derived from expert review or clinical annotations for an algorithm. The evaluation relies on engineering tests and compliance with recognized standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as there is no "test set" in the context of human-reviewed data where adjudication would be necessary.

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 cardiopulmonary bypass pump console, not an AI/ML-driven diagnostic or interpretative tool that would involve human readers or an MRMC study.

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

Not applicable. This device is electro-mechanical hardware with software controls, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this type of medical device (a pump console), "ground truth" is established through engineering specifications, validated test methods (e.g., measuring pump speed, flow rate, alarm accuracy), and compliance with international consensus standards. There is no biological or imaging "ground truth" involved.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set." The software embedded in the device undergoes traditional software verification and validation.

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

Not applicable, as there is no training set.

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The Quantum Centrifugal Drive is a cardiopulmonary bypass speed control device indicated for use for exclusively with the Quantum PureFlow Centrifugal Blood Pump for speedcontrolled pumping through the extracorporeal circuit for typical durations of six hours or less.

The Quantum Centrifugal Drive is a cardiopulmonary speed control device intended to be used for pumping arterial blood through the cardiopulmonary bypass circuit. The Quantum Centrifugal Drive is available in two models - High Pressure and Low Pressure.

The Quantum Centrifugal Drive is designed to work with the Quantum Pump Manager software application, as part of the Quantum Pump Console (K173834). The Quantum Centrifugal Drive is magnetically coupled exclusively with Quantum Pureflow Centrifugal Blood Pumps, designed and manufactured by Qura s.r.l. The operation of the Quantum Centrifugal Drive is managed from the Quantum Workstation (K163657).

The provided document, an FDA 510(k) summary for the Quantum Centrifugal Drive, focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for an AI/device's diagnostic or predictive capabilities.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states:

• "No animal testing was submitted to support the substantial equivalence of the Quantum Centrifugal Drive to the Sorin/LivaNova Stöckert Centrifugal Pump."
• "The following non-clinical testing was performed to support the substantial equivalence of the Quantum Centrifugal Drive to the legally marketed predicate:
  • Electrical safety
  • Electromagnetic compatibility (EMC)
  • Electrosurgery interference
  • Hardware testing
  • Software verification and validation"
• "No clinical data were submitted to support the substantial equivalence of the Quantum Centrifugal Drive to the Sorin/LivaNova Stöckert Centrifugal Pump."

This indicates that the substantial equivalence was primarily based on non-clinical engineering and software validation tests (electrical safety, EMC, electrosurgery interference, hardware, and software V&V) rather than a study evaluating diagnostic performance parameters against ground truth established by experts or other clinical gold standards. The device is a "Cardiopulmonary bypass pump speed control," which is a mechanical device, not typically a diagnostic AI tool that would involve ground truth derived from expert consensus or pathological findings.

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The CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.)

The CentriMag Return (Arterial) Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

The CentriMag Drainage (Venous) Cannula is indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

The CentriMag™ Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. The CentriMag system in the United States (US) is indicated as a component of an extracorporeal bypass circulatory support circuit for use during cardiopulmonary bypass (CPB) surgery (up to 6 hours). The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited.

The CentriMag System is composed of:

• CentriMag Primary Console
• CentriMag Motor
• CentriMag Blood Pump
• CentriMag Flow Probe
• Mag Monitor (optional)

The Thoratec CentriMag Return (Arterial) Cannula Kit consists of the return (arterial) cannula and several accessories used in the surgical placement procedure. The cannula and all kit accessories are sterile, single-use, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System.

The Thoratec CentriMag® Drainage (Venous) Cannula Kit consists of the drainage (venous) cannula and several accessories used in the surgical placement procedure. The cannula and all kit its accessories are sterile, single use, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System.

The provided text is a 510(k) summary for a medical device (CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, and CentriMag Drainage (Venous) Cannula Kit).

Based on the content of the document, the device did not undergo a study to prove its performance against acceptance criteria in the typical sense of a new or modified device requiring such evidence. This 510(k) submission is a "Special 510(k)" which implies that the changes being made are minor and do not affect the device's fundamental performance, design, or intended use. Specifically, the document states:

• "The technological characteristics of the CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit and CentriMag Drainage (Venous) Cannula Kit have not changed from the predicate devices."
• "Components of the CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit and CentriMag Drainage (Venous) Cannula Kit are not affected by the labeling changes proposed in this Special 510(k) premarket notification. The labeling changes make the contraindications consistent among all labeling, add and/or strengthen warnings and precautions, and generally align and update the content for consistency."
• "The performance characteristics of the CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit and CentriMag Drainage (Venous) Cannula Kit have not changed. The labeling changes included in this 510(k) are for the Thoratec (now Abbott's) devices (predicates listed above) and do not require performance data to evaluate the change."
• "Clinical testing was not necessary for the labeling changes stated herein since the changes do not impact the design and performance of the devices."

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details of a study with sample sizes, expert ground truth, adjudication methods, or MRMC studies, as these types of studies were explicitly stated as not necessary for this specific 510(k) submission.

The document argues for substantial equivalence primarily based on the lack of change in technological characteristics and performance from legally marketed predicate devices (K191557, K152161, and K152190).

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The CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

The CentriMag™ Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. To date, the CentriMag system in the United States (US) is indicated as a component of an extracorporeal bypass circulatory support circuit for use during cardiopulmonary bypass (CPB) surgery (up to 6 hours). The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited.

The CentriMag System is composed of:

• CentriMag Primary Console
• CentriMag Motor
• CentriMag Blood Pump
• CentriMag Flow Probe
• Mag Monitor (optional, not shown)

The CentriMag Motor is a reusable, non-sterile component of the CentriMag Acute Circulatory Support System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. The motor turns the magnet (and impeller) within the blood pump (Full MagLev™ technology) at a speed that is set on the console by the user. When the impeller is rotated, a pressure gradient develops between the center and outside edge of the pump, causing blood to flow from the inflow to the outflow port of the pump. The amount of flow through the pump depends on the speed of the impeller, and the difference between the inlet and outlet pressures.

The provided text describes a 510(k) premarket notification for a design modification to the CentriMag™ Acute Circulatory Support System, specifically a redesigned motor cable with enhanced bend protection. This is a medical device, and the submission focuses on proving the substantial equivalence of the modified device to its predicate, rather than establishing clinical effectiveness for a new-to-market device or an AI algorithm.

Therefore, the typical metrics and study designs used for AI/algorithm performance (e.g., sensitivity, specificity, MRMC studies, expert consensus for ground truth of an AI algorithm) do not apply in this context. The acceptance criteria and "study" are focused on mechanical and electrical performance to ensure the modified cable is at least as safe and effective as the original, and does not introduce new safety concerns.

Here's a breakdown of the requested information based solely on the provided text, recognizing its limited scope for AI-specific metrics:

Acceptance Criteria and Device Performance (for a Medical Device Component Modification)

The acceptance criteria for this device modification are focused on maintaining or improving the mechanical and electrical integrity of the motor cable compared to the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Bench Testing for a Device Component Modification):

1. Sample sizes used for the test set and data provenance:

   • Sample Size: The text states "Comparison bench testing was performed" and refers to "both designs" (redesigned and current/original cable designs). It does not specify the number of individual cables or test repetitions for each test (Endurance and Kink test).
   • Data Provenance: The testing was carried out by Thoratec (now part of Abbott) as part of their 510(k) submission, implied to be internal company testing. The country of origin of the data is not explicitly stated beyond the company's US address (Pleasanton, CA). This was not a human clinical study, but rather laboratory bench testing. The term "retrospective or prospective" doesn't directly apply here; it's a controlled bench test evaluating a manufactured component.

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

   • Not Applicable (N/A) / None specified: For these types of mechanical and electrical bench tests, "ground truth" is established by direct measurement and observation of physical parameters, not by expert interpretation in the way it is for diagnostic imaging or clinical outcomes. Engineering specifications and industry standards (like IEC 60601-1) serve as the "truth" against which performance is measured.
   • Qualifications of personnel conducting the tests are not provided, but would typically be engineers or technicians trained in relevant mechanical and electrical testing protocols.

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

   • Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 refer to consensus-building among human readers for subjective data interpretation (e.g., reading medical images). This was a series of objective bench tests with pass/fail criteria based on physical performance and visual inspection. Any "adjudication" would be part of standard quality control and engineering verification processes, not a multi-reader review.

4. 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, Not Applicable (N/A): This was a 510(k) for a physical medical device component (motor cable) and not an AI algorithm. Therefore, an MRMC study comparing human reader performance with or without AI assistance was not conducted, nor would it be relevant.

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

   • No, Not Applicable (N/A): This is a physical device, not an algorithm.

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

   • Engineering Specifications and Industry Standards: The "ground truth" for these tests consisted of predefined pass/fail criteria derived from engineering design specifications and compliance with recognized international standards (e.g., IEC 60601-1). Performance data (e.g., integrity of cable after specified bends, absence of short circuits) formed the direct evidence.

7. The sample size for the training set:

   • Not Applicable (N/A): This device modification did not involve machine learning or AI, so there was no "training set."

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

   • Not Applicable (N/A): As there was no training set, this question is not applicable.

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The Medtronic Bio-Console 560 System with Level Sensing System (LS100) and Level Sensing Tape [LST]) is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).

The Medtronic Performer CPB System with Level Sensing System (Level Sensor [LS100] and Level Sensing Tape [LST]) 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.

Level Sensing System includes the Level Sensor (LS100) and the Level Sensor Tape (LST). The Level Sensor System is one of the optional safety systems that can be used with the Medtronic Bio Console 560 Extracorporeal Blood Pumping System and the Medtronic Performer Cardiopulmonary Bypass System. It is designed to be used only with a Medtronic hardshell reservoir.

The provided text is a 510(k) premarket notification for two medical devices: the Medtronic Bio Console 560 System with Level Sensing System and the Medtronic Performer CPB System with Level Sensing System. The submission claims substantial equivalence to previously cleared predicate devices.

However, the document does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the typical format of a clinical trial report or a comprehensive performance validation study with quantitative acceptance metrics. Instead, it relies on bench testing to demonstrate that the modified device's performance characteristics remain substantially equivalent to the predicate device.

Here's an attempt to extract the requested information based on the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

As per the 510(k) summary, the device is considered substantially equivalent to its predicate. The "acceptance criteria" here are implied to be that the modified device should perform comparably to the predicate device. The "reported device performance" is a general statement that the device passed various bench tests.

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

The document does not specify a "sample size" in the context of clinical or large-scale performance testing. The testing described is bench testing, which typically involves a limited number of units. The data provenance is internal to Medtronic (bench testing), and it is retrospective in the sense that it's comparing a new version of a device to an existing one, rather than a prospective clinical trial on a patient population. No country of origin for specific "data" is mentioned beyond the manufacturing location of the company.

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

This information is not provided in the document. Bench testing typically relies on engineering specifications and standard procedures, not expert adjudication in the way clinical studies do.

4. Adjudication Method for the Test Set

This information is not provided and is not relevant for the type of bench testing described.

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. This type of study is relevant for diagnostic imaging interpretation with AI, which is not the function of this device (a level sensing system for cardiopulmonary bypass). The submission explicitly states: "Clinical testing was not required to establish substantial equivalence."

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

A "standalone" performance evaluation in the context of an algorithm or AI (without human-in-the-loop) is not applicable to this device. The device is a mechanical/electronic level sensing system, not an AI algorithm. Its performance is evaluated through bench testing as listed above.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" would be established by:

• Engineering specifications and design requirements: For tests like visual inspection, dimensions, tensile strength, connector compatibility, electrical safety, emissions/immunity.
• Known physical properties and safe operational ranges: For threshold measurements, free-fall tests, and basic functionality in a circuit with bovine blood. The predicate device's established performance would also serve as a reference point.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI. Therefore, this question is not applicable.

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

As there is no "training set" for this type of device, this question is not applicable.

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The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).

The Bio-Console® 560 Extracorporeal Blood Pumping Console is an electromechanical, software-controlled device intended to allow the user to control a Bio-Pump® or Affinity® CP centrifugal blood pump that is used to return the blood to the body of a patient on cardiopulmonary bypass. As part of the blood pumping circuit, the patient's blood is typically pumped through an oxygenator and a filter on its return path to the patient. The Bio-Console 560 is a reusable non-sterile device.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bio-Console® 560 Extracorporeal Blood Pumping Console:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the given document. The document mentions "software verification and validation testing" and "all test data obtained," but does not specify the sample size (e.g., number of test cases, number of runs) or the provenance (country of origin, retrospective/prospective nature) of the data used for this testing.

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

This information is not provided in the given document. The document describes a technical evaluation of software enhancements, not a study involving human experts establishing ground truth for a test set in the context of diagnostic interpretation or similar medical AI applications.

4. Adjudication Method for the Test Set

This information is not provided in the given document. As there's no mention of human experts establishing ground truth with potential disagreements, an adjudication method would not be relevant in this context.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for software enhancements to an existing device and focuses on substantial equivalence based on technical verification and validation, not on evaluating human performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance evaluation was implicitly done. The "software verification and validation testing" assessed the "software-controlled functional characteristics" of the device in isolation, confirming its function and substantial equivalence. The enhancements relate to internal software corrections and alarm tones, which are tested as part of the device's inherent functionality.

7. Type of Ground Truth Used

The "ground truth" for this submission appears to be derived from documented product and performance specifications and the functional characteristics of the predicate device. The testing aimed to confirm that the updated software met these pre-defined specifications and maintained performance equivalent to the predicate.

8. Sample Size for the Training Set

This information is not provided in the given document. The device is described as an electromechanical, software-controlled device, but there is no indication that it utilizes machine learning or AI that would require a "training set" in the conventional sense of an AI model. The software enhancements are described as corrections and updates to existing functionality.

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

This information is not provided in the given document. As no "training set" is mentioned or implied for a machine learning model, the establishment of ground truth for such a set is not applicable.

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The 2nd Generation CentriMag Primary Console and Mag Monitor are indicated for use with the CentriMag Extracorporeal Blood Pumping System. The CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

The 2nd Generation CentriMag Primary Console is a microprocessor based device. The microprocessor generates the primary motor control signal, monitors system sensors, generates display outputs, interprets the inputs through the front keypad, provides alarm functions and handles the Mag Monitor interface. The Console is intended to be operated on single phase AC power; however, it also has a built-in rechargeable battery with a battery charger. The rechargeable battery is field replaceable. In addition, an optional external modular battery (UPS) can be used to power the CentriMag Primary Console. The human interface of the CentriMag Primary Console consists of a graphical screen to display data and system options and touch pads to change the system status. The 2nd Generation CentriMag Primary Console is intended to be used together with the Mag Monitor: however it can be also operated as a stand-alone unit.

The Mag Monitor provides a redundant user interface containing a display and touch pads. The Mag Monitor is a non-sterile, reusable device that is designed to work only with the 2nd Generation CentriMag Primary Console. The Mag Monitor is a 12V DC-powered device and receives its power directly from 200 Generation CentriMag Primary Console via a power connector that mates with a connector on the back-panel of 2nd Generation CentriMag Primary Console. Based on the design of its power connector, the Mag Monitor cannot be plugged into a hospital AC power outlet. The Mag Monitor's core function is to provide multi-color alphanumerical and graphical displays of information it receives from the 200 Generation CentriMag Primary Console.

The Mag Monitor is a processor based device, with a flat color screen (e.g. LCD). In addition, it is equipped with touch pad to allow the user to enter commands. In the hospital-setting configuration, the user is able to operate and monitor the performance of the CentriMag System through the Monitor. The Monitor can control the functions of the 2nd Generation CentriMag Primary Console, and therefore, of the CentriMag System. The Monitor only displays data and stores user commands without interacting directly with the primary motor control which is managed by the 2nd Generation CentriMag Primary Console. The Mag Monitor is connected to the 200 Generation CentriMag Primary Console through one cable, which includes data and power lines. Power is provided by the 200 Generation CentriMag Primary Console.

The redesigned Mag Monitor is compatible with both the current 200 Generation Console and the redesigned 2nd Generation Console. However, when plugged into the current Console, the redesigned Mag Monitor will only operate when the Console is connected to AC power. It will not operate when the current Console is run on Battery power

The provided text describes a 510(k) summary for the Thoratec 2nd Generation CentriMag Primary Console and Mag Monitor. This documentation focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing a clinical study with specific acceptance criteria and performance metrics for an AI-powered diagnostic device.

Therefore, the information required to answer your prompt, particularly regarding AI device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment, is not present in the provided 510(k) summary.

This document focuses on the device itself (a cardiopulmonary bypass pump console and monitor), its design, intended use, and a comparison of its technological characteristics and performance (functional testing, safety, environmental, etc.) against existing predicate devices. It explicitly states: "Clinical testing was not performed." (Section I. Clinical Performance).

As such, I cannot create the requested table or provide details about AI device performance from this document. If you have a different document describing an AI-powered diagnostic device, please provide it.

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