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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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Special Control)	Reported Device Performance (TandemHeart vs Comparator)
#1: Geometry and design parameters consistent with intended use and circuit compatibility.	The technological characteristics of the device were found to be consistent and compatible with the use of the device to pump blood through an extracorporeal circuit. (No quantitative performance data provided, but implicitly met by design and other testing.)
#2: Devices and accessories in the circuit demonstrated to be biocompatible.	The TandemHeart Pump meets all relevant biological endpoints per ISO10993-1 for a device in contact with circulating blood for a prolonged duration of use (24 hours to 30 days). (No comparative data, but states compliance with standard.)
#3: Sterility and shelf-life testing.	Testing demonstrates the sterility of the subject device as provided and that it maintains its sterility, integrity, durability, and reliability over the stated shelf-life of the device. (No comparative data, but states compliance.)
#4: Non-clinical performance evaluation of bench, mechanical integrity, EMC, software, durability, and reliability.	Reliability testing demonstrates the system achieves 90% reliability at 90% confidence for a 16-day mission. (No direct comparison to predicate, but establishes reliability.)
#5: In vivo evaluation demonstrating performance and effectiveness, especially for specific health risks (pump failure, hemolysis, thrombosis/clots).	Weighted Propensity Score Analysis (Primary analysis using overlap weights): The treatment effect for the TandemHeart pump (relative to the comparator population) for key outcomes was estimated to be:

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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