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The TandemHeart System is a centrifugal blood pump system intended to assist in circulation of the patient's blood when part of an extracorporeal circuit including physiologic gas exchange of the patient's blood in adult patients with acute respiratory failure 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 TandemHeart Pump is a low priming volume centrifugal blood pump with a dual chamber design. The upper chamber provides a conduit for the flow of blood; the lower chamber provides communication with the controller, a hydrodynamic bearing, cooling of the motor and local anticoagulation.
The TandemHeart Escort Controller provides the interface between pump and user, the power and electrical signals to drive the pump, and the infusate fluid to the lower chamber of the pump. It is a microprocessor-based electromechanical pump drive and infusion system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport. The controller contains a backup motor control unit, and backup batteries.

This document describes the acceptance criteria and the study that proves the TandemHeart Pump and Escort Controller, a centrifugal blood pump system, meets these criteria. The device is intended to assist in the circulation of a patient's blood as part of an extracorporeal circuit for adult patients with acute respiratory or cardiopulmonary failure.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "Special Controls" outlined in the FDA's Final Order, 81 FR 7451, Feb. 12, 2016. The study compared the TandemHeart pump against "comparator pumps" (non-TandemHeart centrifugal pumps) using data from the ELSO Registry.

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

• Sample Size:
  • Weighted Propensity Score Analysis (January 2016-October 2020):
    • TandemHeart pump: 165 adult ECMO runs
    • Comparator pumps: 3525 adult ECMO runs
  • TandemHeart Pump and Comparator Pumps Analysis (January 2016-January 2019):
    • TandemHeart pump: 79 runs (38 VA mode, 32 VV mode, 79 All modes)
    • Other Centrifugal Pumps: 9801 runs (5214 VA mode, 3905 VV mode, 9801 All modes)
• Data Provenance: The data was extracted from the Extracorporeal Life Support Organization (ELSO) Registry. This registry collects data on ECMO runs globally. While the document mentions "All United States extracorporeal membrane oxygenation (ECMO) runs" for the second analysis, the first analysis does not explicitly state a geographical restriction, implying it might be broader given the ELSO's global nature. The data is retrospective, as it was extracted from an existing database of past clinical events.

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

The propensity score analysis was conducted by the statistical group at ELSO in consultation with clinical experts in the field of ECLS. The exact number of experts is not specified. Their qualifications are described as "clinical experts in the field of ECLS."

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method for the data within the ELSO registry. The data is reported directly from the registry. It's implied that the ELSO registry data itself serves as the "ground truth," which is collected and coded by the reporting institutions. The "clinical experts in the field of ECLS" were involved in guiding the analysis based on specific health risks, rather than adjudicating individual cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

This is not an MRMC comparative effectiveness study in the context of human readers being assisted by AI. This study compares the performance of two different medical devices (TandemHeart pump vs. other centrifugal pumps) directly, rather than evaluating human performance with or without AI assistance. Therefore, there is no information on the effect size of human reader improvement with AI assistance.

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

This is not a study of a standalone algorithm's performance. The study evaluates the performance of the TandemHeart pump, a physical medical device, in a real-world clinical setting using retrospective registry data.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used is primarily outcomes data recorded in the ELSO Registry. This includes clinical outcomes such as pump failure, hemolysis, thrombosis/clots in circuit component, patient death, CNS hemorrhage, renal replacement therapy, pulmonary hemorrhage, and circuit change. These are documented complications and events observed during ECMO runs.

8. The Sample Size for the Training Set

No specific training set is mentioned as this is a device comparison study utilizing retrospective clinical registry data, not an AI model development study that typically involves distinct training and test sets. The entire ELSO dataset used in the analysis serves as the "test set" for the device's performance comparison.

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

As no specific AI training set is described in the document, there is no information on how its "ground truth" would have been established.

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The LifeSPARC System is intended to pump the 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 LifeSPARC Pump is a sterile, single-use, low prime volume centrifygal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient.

The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.

This document is a 510(k) summary for the LifeSPARC System, a non-roller-type blood pump used for cardiopulmonary bypass. It compares the LifeSPARC System to its predicate device, the TandemHeart System (K110493).

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state sample sizes for specific tests. It refers to "test data," "pressure-flow test data," and "testing of the LifeSPARC Controller," implying that these tests were conducted by the manufacturer as part of the device development and validation. The data provenance is internal to CardiacAssist, Inc. (dba TandemLife) and is prospective testing performed on the LifeSPARC System to demonstrate its equivalence to the predicate.

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

This information is not provided in the document. For non-clinical validation studies of medical devices like blood pumps, ground truth is typically established through recognized engineering standards, established test methodologies, and comparison to the performance of a legally marketed predicate device rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the non-clinical testing (e.g., pressure-flow, hemolysis, electrical safety), an adjudication method as typically used in clinical trials with human readers/assessors would not be applicable. The "adjudication" is essentially the direct measurement and comparison of performance parameters against established benchmarks or predicate device data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation where human readers are involved. The LifeSPARC System is a physical medical device (blood pump), and its performance is evaluated through engineering and biocompatibility testing.

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

The concept of "standalone performance" typically applies to AI algorithms. The LifeSPARC System is a physical device with some software components in its controller. The testing described (e.g., pressure-flow, hemolysis, electrical safety) evaluates the device's inherent performance. The "updated software/user interface technology" of the controller was tested for safety and effectiveness, but this isn't analogous to standalone AI algorithm performance.

7. The Type of Ground Truth Used:

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

• Engineering Standards and Benchmarks: For parameters like electrical safety, electromagnetic compatibility, and sterilization.
• Predicate Device Performance Data: For key performance characteristics directly comparable to the predicate TandemHeart System, such as pressure-flow characteristics and hemolysis rates. The predicate device's performance serves as the benchmark for "substantial equivalence."
• Biocompatibility Standards: To ensure the materials in contact with blood are safe.

8. The Sample Size for the Training Set:

This information is not applicable. The LifeSPARC System is a hardware device with embedded software; it is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a system would involve its design, engineering, and manufacturing processes.

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

This information is not applicable as there is no "training set" in the context of AI/ML for this device. The development and validation of the device rely on established engineering principles, regulatory standards, and comparison to the predicate device.

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The Orqis 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 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 Orqis Pump Tubing is indicated for use in extracorporeal circuits for circulatory support lasting six-hours or less.

The Orqis Extracorporeal Blood Pumping System consists of a pump, independent motor unit, a controller, a flow sensor, and some pump tubing. The system also has two accessories: a holster for the pump and motor, and a controller stand.
The Orqis Blood Pump is a sterile, single-use, disposable, non-pulsatile, non-roller pump that utilizes a rotor to impart energy to the blood in an extracorporeal circuit through centrifugal forces. The inlet of the pump runs concentric with the axis of the rotor.
The Orqis Motor is a small, compact, reusable unit that holds the disposable blood pump and drives the rotor inside the blood pump. The Motor turns a magnet that is hermetically sealed in the pump's rotor at a speed that is set by the controller. The outer shell of the motor is built from aluminum and polycarbonate. The motor is provided non-sterile.
The Orqis Controller is a microprocessor-based device, which drives and controls the blood pump, through the motor. The Controller also provides monitoring of motor speed, fluid flow, and pressure through the use of alphanumeric display and audible and visual alarms.
The Orqis Flow Sensor is an ultrasonic flow meter that measures fluid flow through standard 3/8" tubing.
The Orqis Pump Tubing is medical grade PVC tubing used to connect the Blood Pump to external devices. The Pump Tubing is provided sterile.

This document describes the Orqis Extracorporeal Blood Pumping System, a non-roller type blood pump intended for use in extracorporeal circulation for cardiac support for up to six hours.

1. Acceptance Criteria and Reported Device Performance

The provided text indicates that the device underwent "Functional Testing" and was deemed "as safe and effective as the predicate device for its intended use." However, specific quantitative acceptance criteria or detailed performance metrics are not provided in the excerpt. Therefore, I cannot construct a table with specific acceptance criteria and reported performance values. The summary only states:

2. Sample Size for Test Set and Data Provenance

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The study is described as "Functional Testing," which implies laboratory or in-vitro testing rather than a clinical study with human subjects.

3. Number of Experts and Qualifications for Ground Truth Establishment

Not applicable. The "Functional Testing" described is likely engineering or laboratory-based and would not involve experts establishing ground truth in the way a clinical image analysis study or diagnostic device study would.

4. Adjudication Method for Test Set

Not applicable. As the "Functional Testing" appears to be an engineering or laboratory assessment, a clinical adjudication method like 2+1 or 3+1 is not relevant.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The provided text describes "Functional Testing" to demonstrate equivalence to a predicate device, focusing on the device's intrinsic operation rather than its impact on human reader performance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, a standalone performance assessment was conducted. The "Functional Testing" described appears to assess the device's operational capabilities (e.g., pumping blood, controlling speed, measuring flow and pressure) independently. The conclusion states "The Orqis Extracorporeal Blood Pumping System has successfully undergone functional testing demonstrating equivalence to the predicate device," which directly indicates an assessment of the device's inherent performance.

7. Type of Ground Truth Used

The ground truth for the "Functional Testing" would likely be established based on:

• Engineering specifications and design requirements: The device's operation would be tested against pre-defined performance characteristics.
• Performance of the predicate device: The benchmark for "equivalence" would be the known and established performance of the Levitronix CentriMag® Extracorporeal Blood Pumping System (K020271), Cardiac Assist TandemHeart Escort Controller (K061369), and Olsen Medical Sales Plastron Pump Tubing (K013578).
• Standardized test methods and equipment: The "functional testing" would involve using calibrated instruments and established protocols to measure parameters like flow rate, pressure, speed, and potentially hemolysis or other blood-related effects.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical blood pumping system, not an AI/ML algorithm that requires a training set of data. The "Functional Testing" described focuses on the physical and operational performance of the device.

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

Not applicable. As the device is not an AI/ML algorithm, there is no training set or associated ground truth establishment process in that context.

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