The Quantum Diagnostic Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Diagnostic Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Diagnostic Module include:

· Measurement of up to three blood flow channels and arterial and venous flow differential
· Indication of gas bubbles
· Extracorporeal gas flow measurements (02, CO2, gas flow, and CO2 removal)
· Predicted PO2 and PCO2
· Temperature
· Up to three circuit pressure channels
· Reservoir level indication

The Quantum Diagnostic Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.

Device Description

The Quantum Diagnostic Module is an accessory to the Quantum Workstation that provides continuous non-invasive monitoring of critical clinical parameters during procedures requiring extracorporeal circulation. The Quantum Diagnostic Module is connected to the Quantum Workstation via a cable and positioned between the gas blender and the oxygenator devices in the extracorporeal circuit. When paired with the Quantum Workstation, the combination of the Quantum Workstation and Quantum Diagnostic Module is known as the Quantum Diagnostic System.

The Quantum Diagnostic Module performs three functions:

1. Provides measurements from embedded and attached sensors to monitor gases into and out of a blood oxygenator.
1. Provides measurements from attached sensors for blood flow, bubble detection, pressure, level and temperature to monitor an extracorporeal blood loop.
1. Sends these physiological measurements to the Quantum Workstation for display to the user.

The Quantum Diagnostic Module, with its attached sensors, can measure flow, pressure, reservoir level, temperature and gas diagnostics. The Quantum Diagnostic Module only works with the Quantum Workstation.

AI/ML Overview

The provided text is a 510(k) premarket notification summary for a medical device called the Quantum Diagnostic Module. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a comprehensive clinical study as one might expect for a new, novel device.

Therefore, the document does not contain the detailed information required to answer all parts of your request in the format provided, particularly regarding a multi-reader multi-case study, standalone algorithm performance, or extensive ground truth establishment as would be present for an AI/ML device.

However, I can extract the relevant information regarding performance data and the non-clinical testing performed to support substantial equivalence.

Here's a breakdown of what is and isn't available in the document:

1. Table of acceptance criteria and reported device performance:

The document mentions "In vitro evaluation testing (comparison testing)" as non-clinical testing. While this implies performance was assessed, specific acceptance criteria and detailed reported performance metrics (like accuracy, sensitivity, specificity, etc.) are not explicitly listed in a table within this 510(k) summary. The summary states that the Quantum Diagnostic Module and the predicate M4 Monitor have "equivalent sensor performance" and that the "principles of operation of its sensors are identical or equivalent." This suggests a comparative approach rather than meeting predefined numerical thresholds.

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

The document mentions "In vitro evaluation testing (comparison testing)" but does not specify the sample size used for this test set nor the data provenance (e.g., country of origin, retrospective/prospective).
It also states: "No animal testing was submitted to support the substantial equivalence of the Quantum Diagnostic Module to the M4 Monitor."

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

This information is not provided in the document. The nature of the device (a monitor for physical parameters) suggests that ground truth would likely be established through calibrated reference instruments rather than expert human interpretation.

4. Adjudication method for the test set:

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No MRMC study was done or reported. This type of study is typically for image-based diagnostic AI, which this device is not. The document specifically states: "No clinical data were submitted to support the substantial equivalence of the Quantum Diagnostic Module to the M4 Monitor."

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

The device is a monitor that displays physiological measurements to a user. While it generates data, the concept of "standalone algorithm performance" as typically applied to AI/ML is not directly relevant or discussed in this context. The document mentions "Software verification and validation," which would include testing the algorithms within the device, but not in a "standalone" AI sense.

7. The type of ground truth used:

Given the nature of the device (monitoring blood flow, gas, temperature, pressure, reservoir level), the ground truth for "in vitro evaluation testing" would likely be established using calibrated reference instruments or standardized test methods known to provide highly accurate measurements of these physical parameters. Explicit details are not provided.

8. The sample size for the training set:

This information is not provided. The device is a monitor, not an AI/ML model that undergoes a training phase with a dataset.

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

This information is not provided, as the concept of a "training set" in the AI/ML sense does not apply to this device.

Summary of Device Performance (Extracted from the document):

The regulatory submission for the Quantum Diagnostic Module argues for substantial equivalence to the predicate device (Spectrum Medical Ltd's M4 Monitor, K110957) based on several factors, including:

Identical/Equivalent Principles of Operation: "the principles of operation of its sensors are identical or equivalent to those of the M4 Monitor."
Equivalent Sensor Performance: "Spectrum Medical Ltd's M4 Monitor and Quantum Diagnostic Module have the same manufacturer, clinical application, clinical setting, target patient population, and equivalent sensor performance."
Non-Clinical Testing:
- Electrical safety
- Electromagnetic compatibility (EMC)
- Electrosurgery interference
- Hardware testing of printed circuit boards
- Software verification and validation
- In vitro evaluation testing (comparison testing)
- Usability validation

The document concludes that "Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to predicate devices, the Quantum Diagnostic Module has been shown to be substantially equivalent to legally marketed predicate devices."

In essence, the "study" proving the device meets acceptance criteria in this context is the collection of non-clinical tests demonstrating that the Quantum Diagnostic Module performs equivalently to its predicate and meets safety/performance standards, rather than a clinical trial with specific performance metrics against a defined ground truth for complex diagnostic tasks.

Summary

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March 28, 2018

Spectrum Medical Ltd Mark Drain Chief Financial Officer Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester, GL2 9OL Gb

Re: K173591

Trade/Device Name: Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas Regulation Number: 21 CFR 870.4330 Regulation Name: Cardiopulmonary Bypass On-Line Blood Gas Monitor Regulatory Class: Class II Product Code: DRY Dated: February 23, 2018 Received: February 26, 2018

Dear Mark Drain:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Nicole G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K173591

Device Name

Quantum Diagnostic Module

Indications for Use (Describe)

· Measurement of up to three blood flow channels and arterial and venous flow differential
· Indication of gas bubbles
· Extracorporeal gas flow measurements (02, CO2, gas flow, and CO2 removal)
· Predicted PO2 and PCO2
· Temperature
· Up to three circuit pressure channels
· Reservoir level indication

The Quantum Diagnostic Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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SpectrumMedical

I. SUBMITTER

Spectrum Medical Ltd Harrier 4, Meteor Business Park Cheltenham Road East Gloucester GL2 9QL United Kingdom

Phone: +44 (0) 1242 650 120 Fax: +44 (0) 8452 808 127

Contact Person: Mr. Mark Drain, Chief Financial Officer Date Summary Prepared: November 17, 2017

II. DEVICE

Proprietary Name:	Quantum Diagnostic Module
Common Name:	Blood Gas Monitor
Classification Name:	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass(21 CFR 870.4330)
Regulatory Class:	II
Product Code:	DRY
Panel:	Office of Device Evaluation (ODE) /Division of Cardiovascular Devices (DCD)Circulatory Support Devices Branch (CSDB)

III. PREDICATE DEVICE

Spectrum Medical Ltd's M4 Monitor (K110957)

This predicate has not been subject to a design-related recall.

Spectrum Medical Ltd's Quantum Workstation (K163657) was used as a reference device.

IV. DEVICE DESCRIPTION

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SpectrumMedical

the extracorporeal circuit. When paired with the Quantum Workstation, the combination of the Quantum Workstation and Quantum Diagnostic Module is known as the Quantum Diagnostic System.

The Quantum Diagnostic Module performs three functions:

1. Provides measurements from embedded and attached sensors to monitor gases into and out of a blood oxygenator.
1. Provides measurements from attached sensors for blood flow, bubble detection, pressure, level and temperature to monitor an extracorporeal blood loop.
1. Sends these physiological measurements to the Quantum Workstation for display to the user.

V. INTENDED USE / INDICATIONS FOR USE

. Measurement of up to three blood flow channels and arterial and venous flow differential
Indication of gas bubbles
. Extracorporeal gas flow measurements (O2. CO2 gas flow, and CO2 removal)
. Predicted PO2 and PCO2
. Temperature
. Up to three circuit pressure channels
. Reservoir level indication

The Quantum Diagnostic Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Spectrum Medical Ltd's M4 Monitor and Quantum Diagnostic Module have the same manufacturer, clinical application, clinical setting, target patient population, and equivalent sensor performance. The Quantum Diagnostic Module has the same intended use

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SpectrumMedical

when connected to the Quantum Workstation and the principles of operation of its sensors are identical or equivalent to those of the M4 Monitor.

Whereas the user interface is integrated into the M4 Monitor, the Quantum Diagnostic Module uses the Quantum Workstation to display the information and to power the module. The Quantum Diagnostic Module also has the capability to measure circuit pressures and blood reservoir levels.

These differences in technological characteristics do not raise new issues of safety or effectiveness.

VII. PERFORMANCE DATA - NON-CLINICAL TESTING

No animal testing was submitted to support the substantial equivalence of the Quantum Diagnostic Module to the M4 Monitor. The following non-clinical testing was performed to support the substantial equivalence of the Quantum Diagnostic Module to the M4 Monitor:

Electrical safety .
. Electromagnetic compatibility (EMC)
Electrosurgery interference ●
Hardware testing of printed circuit boards
Software verification and validation ●
In vitro evaluation testing (comparison testing)
Usability validation ●

VIII. PERFORMANCE DATA - CLINICAL TESTING

No clinical data were submitted to support the substantial equivalence of the Quantum Diagnostic Module to the M4 Monitor.

IX. CONCLUSIONS

Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to predicate devices, the Quantum Diagnostic Module has been shown to be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.

(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).