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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.

• Pump Failure: -0.7% (95% CI -1.4%, 0.1%) (TandemHeart had 0.2% vs. 0.8% for comparator)
• Hemolysis: -3.6% (95% CI -14.2%, 7.2%) (TandemHeart had 8.4% vs. 11.9% for comparator, but not statistically significant)
• Thrombosis/Clots in Circuit Component: -2.2% (95% CI -4.8%, 0.4%) (TandemHeart had 1.5% vs. 3.8% for comparator)

The confidence intervals for these treatment effects generally covered 0%, indicating no statistically significant difference in these outcomes between the TandemHeart pump and comparator pumps in the primary analysis. The analysis concluded that the TandemHeart Pump is substantially equivalent to other pumps. |

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 TandemHeart pump 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 TandemHeart System consists of two major components, the Escort Controller (K061369), and the TandemHeart Blood Pump (K991783), along with a number of accessory components required to setup and utilize the Pump. The system is intended for extracorporeal circulatory support using an extracorporeal bypass circuit.

The provided document is a 510(k) summary for the TandemHeart System, a non-roller type cardiopulmonary bypass blood pump. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way one might expect for a novel AI/software medical device.

Based on the available text, here's what can be extracted and what cannot:

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

   • Acceptance Criteria (Implicit): The primary acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device. For the specific performance test mentioned, the implicit acceptance criterion was that the TandemHeart System demonstrate "adequate flow performance with the inclusion of an Oxygenator in the extracorporeal circuit, and that the flows were substantially equivalent to those provided by the predicate AB-180 XC System."
   • Reported Device Performance:
     • "The HQ testing results demonstrated adequate flow performance with the inclusion of an Oxygenator in the extracorporeal circuit, and that the flows were substantially equivalent to those provided by the predicate AB-180 XC System."

   Table:

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

   • Sample Size: Not specified. The document mentions "subsequent testing of the TandemHeart System" for "flow vs. pressure drop (HQ)," but does not provide details on the number of units tested, the duration of tests, or any patient data sample sizes.
   • Data Provenance: Not specified. As the testing was to verify performance, it's likely internal lab testing, but specific country or retrospective/prospective nature regarding patient data is not applicable/provided.

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)

   • Not applicable. This device is a mechanical blood pump, not an AI/diagnostic imaging device. "Ground truth" in the context of expert review or clinical outcomes is not pertinent to the "flow vs. pressure drop" testing described.

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

   • Not applicable. This is not a study involving expert adjudication for diagnostic accuracy. The performance testing described (flow vs. pressure drop) would likely involve objective measurements against engineering specifications or comparative measurements with a predicate, not expert adjudication.

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 device.

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

   • Not applicable. This is a mechanical device.

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

   • For the "flow vs. pressure drop (HQ)" testing, the ground truth would be based on physical measurements and engineering principles, likely comparing the device's performance against established specifications or the performance of the predicate device. It's not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable. As above, this is a mechanical device, not an AI system.

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