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The Quest Myocardial Protection System, consisting of the MPS Console and the MPS Delivery Set used together, is intended for use by perfusionist and physicians to deliver whole blood (from any arterial source) and / or cardiopleqia solutions to the heart during open heart surgery on either an arrested or beating heart

Device Description

The MPS is designed to deliver whole blood or cardioplegia solution. The MPS pumping subsystem coordinates the pumping and mixing of the blood and additives to deliver the desired composition of cardioplegia solution. The pumping subsystem consist of an electro-mechanical pumping device acting on a variety of disposable cassettes to deliver fluid. A set of four pump pistons, each driven by a stepper motor, displace the contents of the mechanically restrained fluid filled cassettes. Pressure sensors located on the end of each piston diagnose the adequacy of the pumping and filling process. The main blood pump consist of two motor driven pistons and a symmetrically designed pump cassette with two chambers. Each chamber is designed to alternately fill and pump blood. A set of valves operate on channels formed within the cassette to control the flow of fluids into and out of the chamber. As one chamber is filled, the other chamber is delivering solutions. This overlapping and alternating operation of the pumping system provides an essentially constant fluid output

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Quest Myocardial Protection System Perfusion Assisted Direct Coronary Artery Bypass (PADCAB) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text states: "The function test data to support the safety and efficacy of the device has not changed from the predicate device submission. Please refer to paragraph 3 of pages 15 – 16 of TAB 20 of Volume 4 of original submission (#K953838). A copy has been enclosed for your convenience."

Since the detailed K953838 submission is not fully provided, we cannot determine the exact sample sizes for each specific functional test. The data provenance is not explicitly stated as country of origin, nor is it specified as retrospective or prospective, however, functional testing usually implies lab-based, prospective testing conducted by the manufacturer.

For K994274, the provided text directly lists functional testing results, but does not explicitly state sample sizes for these tests.

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

This information is not provided in the given text. The studies described are primarily functional and engineering tests, not clinical studies involving expert interpretation of data or images to establish a ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the given text. As the studies are functional and engineering tests, an adjudication method like 2+1 or 3+1 typically used for clinical assessments or image interpretation algorithms is not applicable.

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

A MRMC comparative effectiveness study was not done. The provided document is for a medical device (Cardioplegia Delivery System), not an AI algorithm for diagnostic interpretation that would involve human readers. The document focuses on the functional performance and safety of the device itself, often in comparison to predicate devices, but not on human performance with or without AI assistance.

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

This question is not applicable as the device is a physical medical system (Cardioplegia Delivery System), not an algorithm.

7. The Type of Ground Truth Used

For the functional tests, the "ground truth" is established by engineering specifications, recognized industry standards (e.g., ISO, AAMI, ANSI/HIMA, ASTM), and direct measurement against those specifications. For example:

"No leaks at 15 psi" implies the ground truth for leakage is verified by applying 15 psi and observing.
"Detects 100uL size air bubbles" implies the ground truth for air detection is based on the known size of simulated air bubbles.
"Accuracy of 95% of the flow rates" implies that the true flow rate (ground truth) is measured independently.

8. The Sample Size for the Training Set

This information is not provided in the given text. This device is a hardware system, not an AI algorithm that typically has a "training set." The development of such a device involves design, prototyping, and iterative functional testing, but not machine learning training sets in the conventional sense.

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

This question is not applicable as the device is not an AI algorithm with a training set. The "ground truth" for the device's design and performance during its development would be based on engineering principles, clinical needs, and established medical device standards.

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K Number

K953838

Device Name

MYOCARDIAL PROTECTION SYSTEM

Manufacturer

QUEST MEDICAL, INC.

Date Cleared

1996-03-06

(203 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K810079,K923311,K904171,K864619,K862836

Intended Use

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

Device Description

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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Leak Test Requirements	No leaks at 15 psi.
Pull Test Requirements	No leaks at 5 lbs for small bore and 10 psi for large bore tubing.
Luer Connections	Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Taper Fittings.
Package Integrity	Tyvek/Polystyrene tray and Tyvek/Polymylar pouches passed burst test in accordance with ASTM F1140-88.
Shipping and Distribution Testing	Passed Distribution Simulation Test I/NSTA Project 1A. ASTM D-775-80 and D-999-75.
Accelerated Aging	One (1) year with no effects on performance characteristics.
Heat Exchanger Corrosion Test	Resists corrosion for periods of up to 72 hours.
Air In-line Detection	Detects 100μL size air bubbles in blood and saline.
Hemolytic Characteristics	MPS disposable and instrument lower than predicate devices.
Level Sensing and Autoventing	Meets performance specifications for venting and is equivalent to the predicate device for level sensing.
Pressure Control Delivery	Allows greater control of pressure than does the predicate device.
Pressure Alarm Verification	Operates within predicate device's alarm range of 0% to ± 10% of preset value. Allows ability to set lower pressure limits.
Pressure Sensor Accuracy	Equivalent to predicate device specification of ± 5 mmHg.
Pump Performance at Temperature Extremes	MPS has a mean accuracy of 95% of the flow rates (50, 150, 500 ml/minute) delivered at 36°C and 5°C.
Use with Crystalloid Filter	Pressure cuffs allow MPS to provide maximum settable flow rate with the use of a crystalloid filter.
Arrest Agent/Additive Concentration Delivery	Adjustable from 4-40 mEq/L and delivers within ± 10% of desired concentration.
Blood/Crystalloid Ratio Accuracy	Less than 3% of each component's required proportion.
Delivery Rate Accuracy	Meets AAMI recommended 5% accuracy specification for infusion pumps.
Pump Output Flow Profile	Depicts a more linear flow rate than the predicate device at 50, 300, 500 ml/minute.
Environmental Tests	Meets temperature, humidity specification requirements and UL External Surface Temperature Safety requirements.
Electrical Safety	Meets UL/CSA requirements for electrical safety.
Temperature Sensor Accuracy	Meets temperature sensor accuracy specifications of 5% of the reading.
Warm and Cold Temperature Control	Heats and cools cardioplegia solution within operating flow rate ranges.

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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Page 1 of 1

Test Category	Acceptance Criteria	Reported Device Performance
Material Safety	Fluid contact materials comply with ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing" for short-term devices.	Fluid contact materials comply with ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing" for short-term devices.
Sterilization	Validated Ethylene Oxide Sterilization per AMI / ISO 11135 – 1994 and EN 550 SAL of 10-6. (NOTE: K994274 states Radiation Sterilization).	Validated Ethylene Oxide Sterilization per AMI / ISO 11135 – 1994 and EN 550 SAL of 10-6. (K994274 states Validated METHOD-1 Radiation Sterilization SAL 10-6)
Pyrogenicity	Non-Pyrogenic per USP Pyrogen Test (LAL).	Non-Pyrogenic per USP Pyrogen Test (LAL).
Functional Testing	(Details from K994274, as the K953838 reference is not fully provided)
Leak Test Requirements	No leaks at 15 psi.	No leaks at 15 psi.
Pull Test Requirements	No leaks at 5 lbs for small bore and 10 psi for large bore tubing.	No leaks at 5 lbs for small bore and 10 psi for large bore tubing.
Luer Connections	Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Taper Fittings.	Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Taper Fittings.
Package Integrity	Tyvek/Polystyrene tray and Tyvek/Polymylar pouches passed burst test with in accordance with ASTM F1140-88.	Tyvek/Polystyrene tray and Tyvek/Polymylar pouches passed burst test with in accordance with ASTM F1140-88.
Shipping and Distribution Testing	Passed Distribution Simulation Test I/NSTA Project 1A, ASTM D-775-80 and D-999-75.	Passed Distribution Simulation Test I/NSTA Project 1A, ASTM D-775-80 and D-999-75.
Accelerated Aging	One (1) year with no effects on performance characteristics.	One (1) year with no effects on performance characteristics.
Heat Exchanger Corrosion Test	Resists corrosion for periods of up to 72 hours.	Resists corrosion for periods of up to 72 hours.
Air In-line Detection	Detects 100uL size air bubbles in blood and saline.	Detects 100uL size air bubbles in blood and saline.
Hemolytic Characteristics	MPS disposable and instrument lower than predicate devices.	MPS disposable and instrument lower than predicate devices.
Level Sensing and Autoventing	Meets performance specifications for venting and is equivalent to the predicate device for level sensing.	Meets performance specifications for venting and is equivalent to the predicate device for level sensing.
Pressure Control Delivery	Allows greater control of pressure than does the predicate device.	Allows greater control of pressure than does the predicate device.
Pressure Alarm Verification	Operates within predicate device's alarm range of 0% to ± 10% of preset value. Allows ability to set lower pressure limits.	Operates within predicate device's alarm range of 0% to ± 10% of preset value. Allows ability to set lower pressure limits.
Pressure Sensor Accuracy	Equivalent to predicate device specification of ± 5 mmHg.	Equivalent to predicate device specification of ± 5 mmHg.
Pump Performance at Temperature Extremes	MPS has a mean accuracy of 95% of the flow rates (50, 150, 500 ml/minute) delivered at 36°C and 5°C.	MPS has a mean accuracy of 95% of the flow rates (50, 150, 500 ml/minute) delivered at 36°C and 5°C.
Use with Crystalloid Filter	Pressure cuffs allow MPS to provide maximum settable flow rate with the use of a crystalloid filter.	Pressure cuffs allow MPS to provide maximum settable flow rate with the use of a crystalloid filter.
Arrest Agent/Additive Concentration Delivery	Adjustable from 4-40 mEq/L and delivers within ± 10% of desired concentration.	Adjustable from 4-40 mEq/L and delivers within ± 10% of desired concentration.
Blood/Crystalloid Ratio Accuracy	Less than 3% of each components required proportion.	Less than 3% of each components required proportion.
Delivery Rate Accuracy	Meets AAMI recommended 5% accuracy specification for infusion pumps.	Meets AAMI recommended 5% accuracy specification for infusion pumps.
Pump Output Flow Profile	Depicts a more linear flow rate than the predicate device at 50, 300, 500 ml/minute.	Depicts a more linear flow rate than the predicate device at 50, 300, 500 ml/minute.
Environmental Test	Meets temperature, humidity specification requirements and UL External Surface Temperature Safety requirements.	Meets temperature, humidity specification requirements and UL External Surface Temperature Safety requirements.
Electrical Safety	Meets UL/CSA requirements for electrical safety.	Meets UL/CSA requirements for electrical safety.
Temperature Sensor Accuracy	Meets temperature sensor accuracy specifications of 5% of the reading.	Meets temperature sensor accuracy specifications of 5% of the reading.
Warm and Cold Temperature Control	Heat and cools cardioplegia solution within operating flow rate ranges.	Heat and cools cardioplegia solution within operating flow rate ranges.