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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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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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The Quest Medical MPS®2 Myocardial Protection System, consisting of the MPS2 console and the MPS Delivery Set 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 beart for use up to six hours in duration.

The MPS 2 console is a single device for myocardial perfusion that incorporates several different functions: heat exchanger, temperature control, pressure control, flow rate control, automatic priming and air detection / removal, and 3 flow modes - normal, cyclic, low volume.

The provided text describes a 510(k) premarket notification for the Quest Medical MPS2 Myocardial Protection System Console, focusing on a labeling modification related to disinfection protocols. The submission asserts substantial equivalence to a predicate device (K041979).

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

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

The document does not explicitly state the sample size used for the disinfection efficacy testing (e.g., number of test articles, number of microbial inoculations). It mentions "bench testing," which implies laboratory-based studies. The provenance information (country of origin, retrospective/prospective) is also not 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)

This section is not applicable as the study is a benchtop disinfection validation, not a clinical study requiring expert interpretation of patient data. The ground truth for microbial reduction (e.g., 6-Log and 3-Log reduction) is established through standardized microbiological testing methods rather than expert consensus on medical images or clinical outcomes.

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

This section is not applicable for a benchtop disinfection validation study. Adjudication methods are relevant for clinical studies where multiple experts interpret data.

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

This section is not applicable. The study described is a benchtop validation of a disinfection protocol for a medical device, not an AI-assisted diagnostic tool. Therefore, no MRMC study was conducted.

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

This section is not applicable. The device is a "Myocardial Protection System Console" and the study focuses on validating a disinfection protocol for its water circulation system. There is no mention of an algorithm or AI functionality for standalone performance testing.

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

The ground truth used for the disinfection efficacy testing is microbiological quantification. This involves:

• Inoculation: Introducing a known concentration of target microorganisms (P. aeruginosa and M. chimaera) onto surfaces or into test systems.
• Disinfection: Applying the validated disinfection protocol.
• Recovery and Enumeration: Quantifying the number of surviving microorganisms after disinfection using standard microbiological techniques (e.g., plating and colony counting).
• Log Reduction Calculation: Comparing the initial microbial load to the post-disinfection load to determine the log reduction.

8. The sample size for the training set

This section is not applicable. There is no mention of a "training set" as this is not a machine learning or AI device that requires training data. The study is a validation of a disinfection protocol.

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

This section is not applicable for the same reason as point 8.

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The Quest Medical MPS® 2 Myocardial Protection System, consisting of the MPS 2 Console and the MPS Delivery Set together, is intended for use by perfusionists and physicians to deliver whole blood (from any arterial source) and / or cardioplegia solutions to either an arrested or beating heart for use up to six hours in duration.

The MPS® 2 Myocardial Protection System Console is a single device for myocardial perfusion that incorporates several different functions: heat exchanger, temperature control, pressure control, flow rate control, automatic priming and air detection / removal, and 3 flow modes - normal, cyclic, low volume.

The provided text describes the acceptance criteria and study for the MPS 2 Myocardial Protection System, a medical device used for myocardial perfusion. This device is not an AI-powered diagnostic tool, but rather a physical system with incorporated functions for heat exchange, temperature control, pressure control, flow rate control, automatic priming, and air detection/removal. Therefore, many of the typical questions regarding AI/ML device studies (e.g., ground truth for training set, MRMC studies, effect size of AI assistance) are not applicable.

Here's the information gleaned from the text for this device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Due to the nature of this physical device (a myocardial protection system), the concept of "test set" and "data provenance" (country of origin, retrospective/prospective) in the context of diagnostic data is not directly applicable. The "test set" constitutes the device prototypes themselves undergoing various performance and safety tests.

• Sample Size for Test Set: Not explicitly stated as a number of "samples" in the traditional sense, but refers to the physical devices (MPS 2 consoles) that underwent testing.
• Data Provenance: The testing was "in-house" and specific "UL Laboratories testing methods" were used. This suggests a controlled laboratory environment rather than patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable to the evaluation of a physical medical device like the MPS 2 System. "Ground truth" is established by direct measurement and adherence to engineering and safety standards, rather than expert interpretation of diagnostic images or clinical data. The "experts" involved would be engineers, technicians, and potentially regulatory compliance officers.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in diagnostic studies to resolve discordant expert opinions on ground truth. For a physical device, performance is objectively measured against predefined engineering specifications and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC study was not done. MRMC studies are typically used to assess the impact of AI assistance on human reader performance in diagnostic tasks. This device is a standalone medical system, not a diagnostic AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, in a sense, a "standalone" evaluation of the device's technical performance was the primary focus. The device's functions (heat exchange, temperature control, etc.) were tested independently of human operation to ensure they met specifications. The conclusion specifically states: "The MPS 2 console passed all in-house testing acceptance criteria. UL certified the MPS 2 console as conforming to IEC 60601-1-2:2002 and UL 60601-1:2003 standards." This demonstrates its standalone performance against established benchmarks.

7. The Type of Ground Truth Used

The ground truth for this device's evaluation was based on:

• Engineering Specifications and Performance Standards: The device's internal performance parameters (e.g., temperature accuracy, flow rate stability, pressure control limits) were measured against its design specifications.
• International Safety and Quality Standards: Conformance to UL/IEC 60601-1:2003 and EN/IEC 60601-1-2:2001, which are widely accepted standards for medical electrical equipment.
• Equivalence to Predicate Device: The predicate device serves as a benchmark for established safety and effectiveness.

8. The Sample Size for the Training Set

This question is not applicable. This device is not an AI/ML system that undergoes "training" with data. Its design and manufacturing process would involve engineering design, prototyping, and iterative testing, but not data-driven machine learning training.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for an AI/ML model. The "ground truth" for the device's underlying design and functionality would stem from biomedical engineering principles, clinical requirements for myocardial protection, and established safety standards.

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The Quest MPS consisting of a control unit, associated disposable cassette sets with a heat exchanger, additive cassettes, and extension sets used together are indicated for delivery of cardioplegic solutions to the heart during open heart surgery

The Quest MPS device consists of a microprocessor based system for monitoring and controlling the mixing, pumping, pressure, and the heating and cooling of cardioplegia solutions. Sterile disposables are part of the system as well as pumping cassettes, and a heat exchanger with an integral bubble trap. The MPS includes a primary pump where blood crystalloid solutions are mixed at defined ratios, and two secondary pumps for the addition of an arresting agent and other physician-defined additives. The device also contains a water circulation system for supplying warm or cold water to the heat exchanger to achieve user-defined cardioplegia temperatures.

The Quest Myocardial Protection System (MPS) is a device indicated for the delivery of cardioplegic solutions to the heart during open-heart surgery. It is a microprocessor-based system that monitors and controls the mixing, pumping, pressure, and heating/cooling of cardioplegia solutions. The safety and effectiveness of the device were established through a combination of substantial equivalence claims to predicate devices and extensive functional testing.

Here's a breakdown of the acceptance criteria and the supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly state a specific "test set" sample size in terms of patient data or clinical trials. The evaluation primarily relies on functional testing of device components and overall system performance. Therefore, the "sample size" for these tests would refer to the number of units or repetitions used for each specific test. This information is not detailed in the summary.

The data provenance is Quest Medical, Inc., indicating these are internal validation tests conducted by the manufacturer. The document does not specify country of origin for the data or whether it's retrospective or prospective, but given it's manufacturer validation for pre-market notification, it's typically prospective testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information (number and qualifications of experts for ground truth) is not applicable to the functional testing described. Functional tests for medical devices typically rely on objective measurements and established engineering standards/specifications rather than expert consensus on a test set. For example, a leak test result is a direct measurement against a predefined threshold, not an expert's interpretation.

4. Adjudication Method

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic or prognostic observations. The tests described are engineering and performance validation tests with objective pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or implied. This type of study is used to assess diagnostic accuracy or the impact of assistive technologies on human performance in interpreting medical images or data. The Quest MPS is a delivery system, and its evaluation focuses on its mechanical, fluidic, and control system performances, not interpretive tasks for human readers.

6. Standalone Performance Study

Yes, a form of standalone performance study was done. The functional testing described ("Functional Testing" section) evaluates the algorithm (microprocessor-based control system) and the hardware components of the device in isolation or as an integrated system, without human intervention in the core operational logic. For example, "Pump Performance at Temperature Extremes" or "Delivery Rate Accuracy" assesses the device's intrinsic capabilities. The "Human-in-the-loop" aspect for this device would be the clinician setting parameters and initiating operation, but the performance criteria are assessed for the device's autonomous function.

7. Type of Ground Truth Used

The ground truth used for these functional tests is based on:

• Engineering specifications and standards: e.g., "Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Taper Fittings," "Meets AAMI recommended 5% accuracy specification for infusion pumps," "UL/CSA requirements for electrical safety."
• Objective physical measurements: e.g., "No leaks at 15 psi," "Detects 100μL size air bubbles," "Delivers within ± 10% of desired concentration."
• Comparison to predicate devices: e.g., "Equivalent to predicate device for level sensing," "Equivalent to predicate device specification of ± 5 mmHg."

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here in the context of machine learning model training. The Quest MPS is a medical device with a microprocessor-based control system, but it's not described as an AI/ML-driven device that undergoes a training phase with a specific dataset. Its performance is validated against established engineering and safety standards, not learned from a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the machine learning sense for this device. The development process would have involved design specifications, engineering principles, and iterative testing, but not a data-driven training phase to establish performance metrics like an AI algorithm.

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