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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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