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The Quest MPS 3 ND Myocardial Protection System, consisting of the Quest MPS 3 ND Console, the Quest MPS 3 Controller, and the Quest MPS 3 ND Disposables (Quest MPS 3 ND Delivery Set and optional Accessories) together is intended for use by perfusionists and physicians to deliver whole blood (from any arterial source) and/or cardioplegia solutions to the heart during open-heart surgery on either an arrested or beating heart for use up to six hours in duration.

The Quest MPS 3 ND Myocardial Protection System (MPS 3 ND) is a software controlled system designed to aid the perfusionist in cardioplegia delivery to a patient during Cardiopulmonary Bypass Surgery. The Quest MPS 3 ND System combines blood from the heart-lung machine and crystalloid from the IV-bag in a specified ratio and then adds in the drug (arrest or additive agent) for delivery to the patient. The Quest MPS 3 ND System consists of a reusable MPS 3 ND Console, a reusable MPS 3 Controller, and single use MPS 3 ND Disposables.

The Quest MPS 3 ND Console incorporates two Blood/Crystalloid pumps (B/C pumps), pressure and temperature monitors, a sensor interface, an Arrest Agent pump, an Additive pump and ultra-sonic air detection sensors. The Quest MPS 3 ND Console monitors and controls the blood:crystalloid ratio, drug concentration, flow rate, pressure and delivery route of the cardioplegia solution delivered to the patient. The MPS 3 ND Console also monitors the temperature of the cardioplegia solution which is regulated by an external heater cooler device.

The Quest MPS 3 Controller is a touchscreen user interface utilized by the operator to select all parameters, initiate/stop cardioplegia delivery, monitor delivery parameters and view/save relevant case information and data.

The Quest MPS 3 ND Disposables includes single use delivery sets (also known as the "MPS 3 ND Delivery Sets"), delivery set accessories and blood bypass tubing. The MPS 3 ND Delivery Sets and accessories consist of a flexible cassette, a heat exchanger with water line, drug cartridges and relevant tubing and connectors used to complete the cardioplegia circuit for use with the Quest MPS 3 ND Console. The blood bypass tubing is used as a backup in the event the Quest MPS 3 ND Console becomes unusable.

The provided text is a 510(k) premarket notification for a medical device, the Quest MPS 3 ND Myocardial Protection System. It outlines the device, its intended use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.

However, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop study. The device in question is a medical protection system for cardiopulmonary bypass surgery, not an AI-powered diagnostic or assistive tool.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device and its 510(k) submission.

Here's how to address the request based on the provided document:

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

The document broadly mentions "Performance Specifications" and "Software Verification Tests," "MPS 3 ND System Performance Tests," as well as other bench and nonclinical tests. It concludes that "The collective results of the performance testing demonstrate that the Quest MPS 3 ND Myocardial Protection System (MPS 3 ND) meets the established specifications necessary for consistent performance during its intended use."

However, specific numerical acceptance criteria and their corresponding achieved performance values are not detailed or tabulated in this summary document. This level of detail would typically be found in the full test reports submitted to the FDA, not in the public 510(k) summary.

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

• Test Set Sample Size: Not specified in the provided document. The tests performed are primarily bench and nonclinical (e.g., software verification, electrical safety, system performance). These are not tests on a "test set" of patient data in the way an AI algorithm is evaluated.
• Data Provenance: Not applicable in the context of clinical data for AI. The tests are benchtop, simulated use, and engineering verification.

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

• Not applicable. This device is not an AI diagnostic device that requires expert-established ground truth from medical images or patient data. Its performance is evaluated against engineering specifications and safety standards.

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

• Not applicable. This is not a study involving human readers or interpretation of data beyond standard engineering and quality control procedures.

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, a MRMC study was not done. This is not an AI-assisted device. The device's function is to deliver medical solutions during surgery, not to aid human readers in diagnostic interpretation.

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

• Not applicable. This is a hardware and software system for medical fluid delivery, not an AI algorithm evaluated for standalone performance. Its "performance" refers to its ability to accurately pump, heat/cool, and control fluids as designed.

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

• Not applicable in the context of typical AI ground truth. For this device, "ground truth" would equate to established engineering standards, physical laws (e.g., pressure, flow, temperature measurements), and functional requirements for a medical device of its type. For example, a flow rate "ground truth" would be the expected flow rate based on pump settings and calibration, not a medical diagnosis.

8. The sample size for the training set:

• Not applicable. This device is not an AI system trained on a dataset. Its software is deterministic and based on specified operating parameters.

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

• Not applicable. See point 8.

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