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The Quest Medical MPS 3 Myocardial Protection System, consisting of the MPS 3 Controller, and the MPS 3 Disposables (MPS 3 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 surgery on either an arrested or beating heart for use up to six hours in duration.

The MPS 3 Myocardial Protection System (MPS 3) is a software controlled system designed to aid the perfusionist in cardioplegia delivery to a patient during Cardiopulmonary Bypass Surgery. The MPS 3 System combines blood from the heartlung 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 MPS 3 System consists of a reusable MPS 3 Console, a reusable MPS 3 Controller, and single use MPS 3 Disposables.

The MPS 3 Console incorporates two Blood/Crystalloid pumps (B/C pumps), a temperature- controllable water circulation system, pressure and temperature monitors, a sensor interface, an arrest agent pump, an additive pump and ultra-sonic air detection sensors. The MPS 3 Console monitors and controls the blood:crystalloid ratio, drug concentration, flow rate, pressure, temperature, and delivery route of the cardioplegia solution delivered to the patient.

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

The provided text describes the 510(k) premarket notification for the Quest Medical, Inc. MPS 3 Myocardial Protection System. However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device, as implied by the structure of the requested output (e.g., ground truth, MRMC study, training sets).

The MPS 3 Myocardial Protection System is a hardware system for delivering cardioplegia solutions during heart surgery, and its 510(k) submission is based on demonstrating substantial equivalence to a predicate device (MPS 2 Myocardial Protection System) through non-clinical bench testing. It is not an AI/algorithm-driven diagnostic or assistive device that would typically involve the types of studies outlined in your request (e.g., assessing sensitivity/specificity based on expert consensus, multi-reader multi-case studies, or standalone algorithm performance).

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document explicitly states:

• "Clinical Testing Summary [807.92(b)(2)] Not applicable. Clinical testing was not performed to support this 510(k) submission." This means there was no human clinical trial assessing the device's performance in patients in the manner that would generate the data for the requested metrics (e.g., accuracy against ground truth).
• The performance data sections detail bench and nonclinical tests (e.g., sterilization, shelf-life, biocompatibility, electrical safety, system performance, mechanical hemolysis, human factors/usability, disposables performance), which are standard for hardware medical devices but do not involve the types of acceptance criteria you've outlined for an AI/algorithm.

To directly answer your request based on the provided document:

1. A table of acceptance criteria and the reported device performance:
* N/A. The document does not present quantitative acceptance criteria or reported performance metrics in the format of precision, recall, accuracy, sensitivity, specificity, etc., which are typical for AI/algorithm-driven devices. Instead, it lists various non-clinical tests (e.g., "Sterilization, Shelf-Life, and Packaging Testing", "System Performance Tests", "Mechanical Hemolysis Test," "Leak Test," "Efficiency Test") that would have their own internal acceptance criteria (e.g., sterility must be maintained, pressure must hold, flow rate within tolerance). These specific criteria and their results are not detailed in this summary document. The document simply states "The collective results of the performance testing demonstrate that the MPS 3 Myocardial Protection System (MPS 3) meets the established specifications necessary for consistent performance during its intended use."

2. Sample sized used for the test set and the data provenance:
* N/A. As no clinical or AI-centric performance study was conducted, there are no "test sets" of patient data in the context of an AI/algorithm. The "samples" used would be the physical devices and components subjected to various bench and non-clinical tests (e.g., multiple units for reliability testing, materials for biocompatibility). The document does not specify the number of units/samples for each bench test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* N/A. Not relevant for this type of device and its non-clinical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* N/A. Not relevant.

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. The device is a hardware system, not an AI assisting human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* No. The device is a hardware system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* N/A. Not applicable for the bench testing performed. Ground truth for the device's function would be based on engineering specifications and physical measurements (e.g., flow rate accuracy measured against a calibrated standard, pressure measurements).

8. The sample size for the training set:
* N/A. Not applicable as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established:
* N/A. Not applicable.

In summary, the provided document details the regulatory submission for a physical medical device (Myocardial Protection System) and relies on demonstrating substantial equivalence through non-clinical performance testing. It does not involve an AI component or the types of clinical/AI performance studies that would generate the specific data points requested in your prompt.

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