The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Heatthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, SpO2, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed.

The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.

The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow networkbased applications to open windows and display information on other networked monitors.

The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders.

The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

Device Description

The Spacelabs Spacelabs Healthcare Qube Compact Monitor (91390) (Qube) is a component of the Spacelabs Medical Patient Monitoring System. The monitor accepts and displays parameter information, waveform and numeric data, and alarm conditions including arrhythmia information received from the same family of modules as its predicate, the Spacelabs Medical Model 91370 Patient Monitor.

The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders.

The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

AI/ML Overview

The provided text describes the Spacelabs Healthcare Qube Compact Monitor (91390) and its 510(k) premarket notification. However, it does not describe acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning algorithm. The document pertains to a medical device (patient monitor) and its regulatory clearance based on substantial equivalence to a predicate device. The performance testing outlined focuses on electrical safety, electromagnetic compatibility, software validation, usability, and alarm systems, which are standard for such medical devices, not for AI algorithm performance.

Therefore, for aspects related to AI/ML specific criteria (like ground truth, expert consensus, MRMC studies, sample sizes for training/test sets for an algorithm, and improvement with AI assistance), the information is not present in the provided document.

Here's an analysis based on the information available in the provided text:

Acceptance Criteria and Device Performance (Based on available information)

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit from standards)	Reported Device Performance
Software Validation	Compliance with predetermined specifications and IEC 60601-1-4: 1996, Am1: 1999 (Programmable electrical medical systems)	"Test results indicated that the Qube software complies with its predetermined specification and with the applicable Standards."
Electrical Safety	Compliance with IEC 60601-1: 1988, Am1: 1991, and Am2: 1995 (General requirements for safety)	"Test results indicated that the Qube complies with the Standards."
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2: 2007 (Electromagnetic compatibility – Requirements and tests)	"Test results indicated that the Qube complies with the Standards."
Performance Testing	Compliance with internal requirements and: - IEC 60601-1-6: 2010 (Usability) - IEC 60601-1-8: 2006 (Alarm systems) - IEC 62366: 2007 (Application of usability engineering) - ISTA Procedure 1A (Packaged-products under 150 lb (68 kg) non-simulation integrity performance test procedure)	"Test results indicated that the Qube complies with its predetermined specification and with the applicable Standards."
Conclusion/Overall	Safe and effective when used in accordance with intended use and labeling, and substantially equivalent to predicate device.	"Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the Qube. The results of these activities demonstrate that the Qube is safe and effective when used in accordance with its intended use and labeling. Therefore, the Qube is considered substantially equivalent to the predicate device."

Study Details (Based on available information for a medical device, not an AI algorithm)

The document describes performance testing for a medical device (patient monitor), not a study for an AI/ML algorithm. Therefore, many of the requested AI/ML-specific details are not applicable or not present.

A table of acceptance criteria and the reported device performance: (Provided above)
Sample sizes used for the test set and the data provenance:
- The document does not specify sample sizes for any of the performance tests (e.g., number of units tested, duration of tests, or amount of data used for software validation).
- Data provenance is not mentioned. These are typical engineering and regulatory compliance tests performed on the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept of "ground truth" and "experts" as in AI/ML is not applicable to the type of device testing described. The tests are against established engineering standards and internal specifications, not a clinical "ground truth" adjudicated by medical experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not a study assessing human or AI interpretation against a clinical ground truth.
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 MRMC study was conducted or mentioned, as this device is a patient monitor, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device itself is the system; there is no separate "algorithm only" performance reported in the context of an AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI/ML sense. The "ground truth" for the device's performance is adherence to established engineering and medical device safety standards (e.g., IEC standards, internal specifications).
The sample size for the training set:
- Not applicable. This document is for a medical monitor, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

In summary, the provided K120616 document is a 510(k) summary for a patient monitoring device, demonstrating its substantial equivalence to a predicate device through adherence to recognized performance, safety, and electromagnetic compatibility standards. It does not involve artificial intelligence or machine learning algorithms and therefore does not contain information on "acceptance criteria" or "study" as one would expect for an AI/ML-based medical device.

Summary

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K120616

MAR 2 9 2012

510(k) Premarket Notification Spacelabs Healthcare Qube Compact Monitor (91390) 510(k) Summary

Submission Date:	24 February 2012
Submitter:	Spacelabs Medical, Inc.5150 220th Avenue SEIssaquah, WA 98029 USA
Submitter Contact:	Mr. Al Van HoudtSpacelabs Medical, Inc.Phone: +1 (425) 657-7200, ext 5970Fax: +1 (425) 657-7210Email: al.vanhoudt@spacelabs.com
Official Contact:	Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232
Manufacturing Site:	Spacelabs Medical, Inc.5150 220th Avenue SEIssaquah, WA 98029 USA
Trade Name:	Spacelabs Healthcare Qube Compact Monitor (91390)
Common Name:	Monitor, physiological, patient (with arrhythmia detection or alarms)
Classification Name:	Monitor, physiological, patient (with arrhythmia detection or alarms)
ClassificationRegulation:	21 CFR §870.1025
Product Code:	MHX
SubstantiallyEquivalent Devices:	New Spacelabs Model	Predicate510(k) Number	PredicateManufacturer / Model
	Spacelabs HealthcareQube Compact Monitor(91390)	K102422	Spacelabs MedicalPatient Monitors,Models 91367, 91369,91370, 91388

Page 1 of 4

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510(k) Premarket Notification Spacelabs Healthcare Qube Compact Monitor (91390) 510(k) Summarv

Device Description: The Spacelabs Spacelabs Healthcare Qube Compact Monitor (91390) (Qube) is a component of the Spacelabs Medical Patient Monitoring System. The monitor accepts and displays parameter information, waveform and numeric data, and alarm conditions including arrhythmia information received from the same family of modules as its predicate, the Spacelabs Medical Model 91370 Patient Monitor.

The Spacelabs Healthcare Qube Compact Monitor (91390), functioning Intended Use: as either bedside or central monitors; passively displays data generated by Spacelabs Heatthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, SpO2, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed.

The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.

The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow networkbased applications to open windows and display information on other networked monitors.

The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders.

The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

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510(k) Premarket Notification Spacelabs Healthcare Qube Compact Monitor (91390) 510(k) Summary

Technology Comparison:

The Qube employs the same technological characteristics as the predicate device.

Characteristic	Predicate Device	Proposed Device
Bedside, Transport orCentral Station	Bedside/ Transport	Bedside/ Transport /Central Station
Maximum ParameterCapacity	18	Same
Number of InternalModule Slots	1	Same
Maximum Number ofRemote Module HousingsSlots	1	Same
User Interface Methods	Touchscreen, Keyboard,Mouse, Remote Keyboard	Same
Bedside Monitor (Visiblewaveforms)	4 - 6	Same
Display Technology	Color TFT-LCD	Same

Summary of Performance Testing:

Software Validation	The Qube software was tested for performance in accordance with internal requirements and the following Standard:
	•	IEC 60601-1-4: 1996, Aml: 1999, Medical electrical equipment, Part 1-4 – Collateral Standard: Programmable electrical medical systems.
	Test results indicated that the Qube software complies with its predetermined specification and with the applicable Standards.
Electrical Safety Testing	The Qube was tested for performance in accordance with the following Standard:
	•	IEC 60601-1: 1988, Aml: 1991, and Am2: 1995, Medical electrical equipment, Part 1: Particular requirements for safety.
	Test results indicated that the Qube complies with the Standards.

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510(k) Premarket Notification Spacelabs Healthcare Qube Compact Monitor (91390) 510(k) Summary

ElectromagneticCompatibilityTesting	The Qube was tested for performance in accordance with the followingStandard:
	• IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2:General requirements for basic safety and essential performance –Collateral standard: Electromagnetic compatibility – Requirementsand tests.
	Test results indicated that the Qube complies with the Standards.
Performance Testing	The Qube was tested for performance in accordance with internalrequirements and the following Standard:
	• IEC 60601-1-6: 2010, Medical electrical equipment – Part 1-6:General requirements for basic safety and essential performance –Collateral standard: Usability.
	• IEC 60601-1-8: 2006, Medical electrical equipment – Generalrequirements, tests and guidance for alarm systems in medicalelectrical equipment and medical electrical systems.
	• IEC 62366: 2007, Medical devices - Application of usabilityengineering to medical devices.
	• ISTA Procedure 1A, Non-simulation integrity performance testprocedure - Packaged-products under 150 lb (68 kg).
	Test results indicated that the Qube complies with its predeterminedspecification and with the applicable Standards.
Conclusion	Verification and validation activities were conducted to establish theperformance and safety characteristics of the device modificationsmade to the Qube. The results of these activities demonstrate that theQube is safe and effective when used in accordance with its intendeduse and labeling.
	Therefore, the Qube is considered substantially equivalent to thepredicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR 2 9 2012

Spacelabs Medical, Inc. c/o Mr. Thomas Kroenke Speed To Market, Inc. P.O. Box 3018 Nederland, CO 80466

Re: K120616

Trade/Device Name: Spacelabs Healthcare Qube Compact Monitor (91390) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement

and alarm)

Regulatory Class: Class II (two) Product Codes: MHX Dated: February 24, 2012 Received: February 29, 2012

Dear Mr. Kroenke:

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.

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

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Page 2 - Spacelabs Medical, Inc. c/o Mr. Thomas Kroenke

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

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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Indications for Use

K 120616

510(k) Number (if known):

Device Name:

Indications for Use:

Spacelabs Healthcare Qube Compact Monitor (91390)

The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders.

The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
্	and the commend of the comments of the comments of the country of the country of the country of the first of the first of the first of the first of the first of the first of

on of Cardiovascular I

510(k) Number K120616

Page 1 of 1

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.