The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in healthcare facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

Device Description

The SmartLinx Vitals Plus Patient Monitoring System consists of the SmartLinx Vitals Plus mobile medical application and externally integrated vital signs modules operating on the SmartLinx Neuron 2 mobile platform. The application controls the modules at the point of care through interfaces on the SmartLinx Neuron 2 mobile platform and presents this to the monitoring purposes. The supported physiological parameters are: non-invasive blood pressure (systolic, diastolic, mean arterial pressure (MAP)), pulse rate, functional arterial oxygen saturation (SpO2), and temperature.

The SmartLinx Vitals Plus Patient Monitoring System is composed of multiple products:

The SmartLinx Vitals Plus mobile medical application
The SmartLinx Vitals Plus NIBP Module with SunTech Medical cuffs and hoses
The Masimo SET uSpO2 Pulse Oximetry Cable
The Exergen TAT-5000S infrared thermometer
The SmartLinx Neuron 2 Mobile Platform
The SmartLinx Vitals Plus Roll Stand

AI/ML Overview

The provided document details the 510(k) premarket notification for the SmartLinx Vitals Plus Patient Monitoring System. It describes the device, its intended use, and a comparison to a predicate device, focusing on functional equivalence. However, the document does not contain detailed acceptance criteria for specific performance metrics (like accuracy or precision for NIBP, SpO2, or temperature) nor does it provide a study report proving the device meets said criteria with specific quantitative results.

Instead, the document generally states that the device "complies with its predetermined specification" based on various types of testing, often referencing compliance with established electrical safety, EMC, and software standards, as well as a clinical performance standard for NIBP (ISO 81060-2:2013).

Therefore, I cannot populate the table or answer all the requested questions with specific data from the provided text. I will indicate where information is not available.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

Parameter/Test Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Software Testing	Designed and developed in accordance with Capsule Technologie software development processes; verified and validated.	"Test results indicated that the SmartLinx Vitals Plus Patient Monitoring System complies with its predetermined specification."
Electrical Safety	Compliance with IEC 60601-1:2005, IEC 60601-1-6:2013, IEC 60601-1-8:2012, IEC 80601-2-30:2013, ISO 80601-2-56:2009, ISO 80601-2-61:2011, ISO 81060-2:2013, IEC 62304:2006, IEC 62366:2014, IEC 62133:2012.	"Test results indicated that the SmartLinx Vitals Plus Patient Monitoring System complies with its predetermined specification."
EMC Testing	Compliance with IEC 60601-1-2:2007.	"Test results indicated that the SmartLinx Vitals Plus Patient Monitoring System complies with its predetermined specification."
Bench Performance	In accordance with internal Capsule Technologie requirements and procedures; covers performance, functional, reliability, environmental, and packaging testing.	"Test results indicated that the SmartLinx Vitals Plus Patient Monitoring System complies with its predetermined specification."
Clinical Performance	In accordance with ISO 81060-2:2013 (likely for NIBP). (Specific criteria within this standard, e.g., mean difference and standard deviation, are not stated in the document). The predicate device's specific performance metrics are also not provided in a similar manner, making a direct numerical comparison difficult from this document.	"Test results indicated that the SmartLinx Vitals Plus Patient Monitoring System complies with its predetermined specification." (No specific numerical results for accuracy, precision for NIBP, SpO2, temp or pulse rate are provided in the document.)
Sterilization	Not designed to be sterilized. Patient-applied parts' sterilization addressed in predicate/reference device submissions.	"The sterilization issues related to these patient applied parts were addressed in the predicate or reference device submissions, and were cleared by FDA."
Shelf Life	Patient-applied parts' shelf life addressed in predicate/reference device submissions. Neuron battery shelf life: three months (not in use). Exergen TAT-5000S 9V battery shelf life: typically seven years.	"The shelf life issues related to these patient applied parts were addressed in the predicate or reference device submissions, and were cleared by FDA." (For batteries, stated shelf lives are provided).
Biocompatibility	Patient-applied parts' biocompatibility addressed in predicate/reference device submissions.	"The biocompatibility issues related to these patient applied parts were addressed in the predicate or reference device submissions, and were cleared by FDA."

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the document. For clinical performance testing (referencing ISO 81060-2:2013), this standard typically requires a certain number of subjects (e.g., 85 subjects for NIBP accuracy) and measurements, but the document does not report the actual sample size used for this specific device's clinical performance trial.
- Data Provenance: Not specified. The document does not indicate the country of origin, nor whether the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document indicates clinical performance testing was done "in accordance with ISO 81060-2:2013". For NIBP validation studies, ground truth (reference measurements) are typically established by trained technicians using a reference device (e.g., auscultation with mercury sphygmomanometer), but the number and qualifications of these individuals are not detailed in this submission.
Adjudication method for the test set:
- Not specified. If ground truth involved multiple measurements or experts, an adjudication method would typically be used, but this information is absent.
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. This device is a vital signs monitor, not an AI-assisted diagnostic imaging device that involves "human readers" or "AI assistance" in that context. Therefore, an MRMC study and AI improvement effect size is not applicable to this type of device and was not conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, to an extent. The performance testing described (Software Testing, Electrical Safety, EMC Testing, Bench Performance Testing, and Clinical Performance Testing conforming to standards like ISO 81060-2:2013) essentially evaluates the device's inherent performance. While the device is intended for use by healthcare providers, these tests assess the accuracy and reliability of the device's measurements and functions independent of a human's interpretation of those measurements in a diagnostic workflow (which is the typical context for "standalone AI performance"). The software and hardware perform their functions (measuring NIBP, SpO2, temp) without direct "human-in-the-loop" assistance for the measurement process itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For NIBP, the ground truth would typically be established by simultaneous auscultatory measurements by trained observers using a reference device, as per the methodology specified in ISO 81060-2.
- For SpO2, ground truth is usually established by CO-oximetry of arterial blood samples.
- For temperature, ground truth would be from a precisely calibrated reference thermometer or other established method.
- The document does not explicitly state the ground truth methodology beyond referencing the ISO standards, but these standards define the accepted methods for ground truth establishment.
The sample size for the training set:
- Not applicable. This document describes a traditional medical device (a vital signs monitor) and its validation. It does not refer to an AI/Machine Learning model that requires a "training set" in the conventional sense. The software development process mentioned is likely for deterministic software, not a learned model.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for an AI/ML model described in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, ribbon-like design at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the image.

Public Health Service

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

Capsule Technologie SAS Peter Kelley Director of QA/RA 300 Brickstone Square, Suite 203 Andover, Massachusetts 01810

Re: K151071

Trade/Device Name: SmartLinx Vitals Plus Patient Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: August 5, 2015 Received: August 12, 2015

Dear Peter Kelley:

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. Iisting 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 requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

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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Indications for Use

510(k) Number (if known):

Device Name: SmartLinx Vitals Plus Patient Monitoring System

Indications for Use:

Prescription Use	X
	AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)	(21 CFR 801 Subpart C)

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

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Submitter	Capsule Technologie SAS9 villa Pierre Ginier75018 Paris, FR
Contact Person	Peter Kelley Director QA/RA300 Brickstone Square, Suite 203Andover, MA 01810Phone: 978-482-2309Email: peterk@capsuletech.com
Date Prepared	MAY 21, 2015
Device Name	SmartLinx Vitals Plus Patient Monitoring System
Common Name	Physiological or Vital Signs Monitor, Patient Monitor
Classification Name	Cardiac monitor (including cardiotachometer and rate alarm)
Regulatory Class	II
Product Code	MWI
Predicate Device	GE Carescape V100 Vital Signs Monitor K102426This predicate has not been subject to a design-related recall
Reference Devices	Zoll R Series Monitor Defibrillators K120907Masimo uSpO2 Pulse Oximetry Cable K121914Exergen TAT-5000S K011291

Device Description

The SmartLinx Vitals Plus Patient Monitoring System is composed of multiple products:

The SmartLinx Vitals Plus mobile medical application
The SmartLinx Vitals Plus NIBP Module with SunTech Medical cuffs and hoses

The Masimo SET uSpO2 Pulse Oximetry Cable

The Exergen TAT-5000S infrared thermometer

The SmartLinx Neuron 2 Mobile Platform

The SmartLinx Vitals Plus Roll Stand

SmartLinx Vitals Plus mobile medical application

The SmartLinx Vitals Plus mobile medical application is a new mobile medical application which operates on the SmartLinx Neuron 2 mobile platform. It provides command/control of user features of vital signs modules, actuators and medical devices. SmartLinx Vitals Plus mobile medical application

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collects vital signs and medical device data at the point of care through sensor, actuator and medical device interfaces on the SmartLinx Neuron 2 mobile platform and presents this to the user for active monitoring purposes. The supported physiological parameters are: NIBP (systolic, mean arterial pressure (MAP)), Pulse Rate, SpO2 and Temperature. The SmartLinx Vitals Plus mobile medical application is used by healthcare providers.

SmartLinx Vitals Plus NIBP Module

The SmartLinx Vitals Plus NIBP Module is a new hardware component, which incorporates the SunTech Medical Advantage A+ NIBP module and associated blood pressure cuffs and hoses, which measure systolic, diastolic and mean arterial (MAP) blood pressures, and pulse rates for adult, pediatric and neonatal patients. This same module is used in the previously cleared Zoll R Series Monitor Defibrillator (K120907), which is cited as a reference device in this 510(k) filing. The module is controlled by the SmartLinx Vitals Plus mobile medical application to manage the inflation of blood pressure cuffs, and to measure blood pressures and pulse rates. The SmartLinx Vitals Plus NIBP module is used by healthcare providers.

Masimo uSp02 Pulse Oximetry Cable

The Masimo uSpO2 Pulse Oximetry Cable, and associated sensors are an in-line patient cable that provides continuous noninvasive monitoring of functional oxygen saturation (SpO2) and pulse rate when installed in a compatible OEM host system, and has its own requlatory clearance (K121914). The SmartLinx Vitals Plus application will control the uSpO2 to measure SpO2 in adult, pediatric and neonatal patients. The uSpO2 is used by healthcare providers.

Exergen TAT-5000S

The Exergen TAT-5000S is an infrared thermometer which has its own requlatory clearances (K011291). It is capable of being used independently or through an interface with other products. The SmartLinx Vitals Plus application will control the operation of the TAT-5000S to measure temperatures in adult, pediatric and neonatal patients. The TAT-5000S is used by healthcare providers.

SmartLinx Neuron 2 Mobile Platform

The SmartLinx Neuron 2 is a mobile computer which utilizes industry standard PC architecture and components, with touch-screen capabilities, and serial. USB, network and Bluetooth interfaces for device connectivity, and which runs a Microsoft Windows operating system. It provides connectivity for SmartLinx applications to vital signs modules and medical devices.

SmartLinx Vitals Plus Roll Stand

The SmartLinx Vitals Plus Roll Stand is an accessory provided to allow the users to ergonomically move and manage the SmartLinx Vitals Plus System and its components. It provides a platform for mounting the Neuron 2 and mechanical interfaces to all of the system components.

Indications for Use

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Comparison of the Subject and Predicate Devices

		Table 1 Technological Characteristics Comparison
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Characteristic	SmartLinx Vitals Plus	GE Carescape V100	Discussion ofDifferences
Intended Use	The SmartLinx Vitals PlusPatient MonitoringSystem is intended formonitoring physiologicparameters, includingnon-invasive bloodpressure (systolic,diastolic, and meanarterial pressure), pulserate, functional arterialoxygen saturation(SpO2), and temperature,on adult, pediatric, andneonatal patients inhealthcare facilities whenused by clinicalphysicians or appropriatemedical staff under thedirection of physicians.	The CARESCAPE VI00 VitalSigns Monitor is intended tomonitor a single adult, pediatricor neonatal patient's vital signsat the bedside or during intra-hospital transport. Vital signsparameters include non-invasive blood pressure(systolic, diastolic, and meanarterial pressure), pulse rate,and/or oxygen saturation (pulseoximetry) and/or temperature.The portable device is designedfor use in numerous clinicalsettings in various hospitaldepartments such asemergency, radiology, recovery,medical/surgical, labor anddelivery, endoscopy, cardiacstep-down. The CARESCAPEVI00 Vital Signs Monitor canalso be used in satellite areas,physicians' office, or alternatecare settings.	Same
	Design	NIBP: SuntechAdvantage A+oscillometric OEM NIBPtechnology module.	NIBP: Proprietary oscillometricdesign.	The NIBP functions usethe same mechanismof action, oscillimetry.Both devices have thesame questions ofsafety andeffectiveness regardingenergy transfer to thepatient.
		SP02: Masimo uSpO2Oximetry Cable usingSET pulse oximetrytechnology.	SPO2: Masimo SET pulseoximetry technology.	Same
TEMP: Exergen TAT-5000S temporal arteryscanner thermometer		TEMP: Exergen TAT-5000temporal artery scannerthermometer	Same
Applied PartMaterials	NIBP: SunTech Durable,Disposable, and Vinylblood pressure cuffs andhoses	NIBP: GE CRITIKON BloodPressure Cuffs and hoses	The applied parts inboth devices have thesame questions ofsafety andeffectiveness regarding

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Characteristic	SmartLinx Vitals Plus	GE Carescape V100	Discussion ofDifferences
			biocompatibility ofpatient applied parts.
	SPO2: Masimo LNCSand LNOP family of SpO2sensors	SPO2: Masimo LNCS andLNOP family of SpO2 sensors	Same
	TEMP: Exergen TAT-5000S temporal arteryscanner thermometer	TEMP: Exergen TAT-5000temporal artery scannerthermometer	Same
EnergySource	12.6V, 2600 mAh,Lithium-Ion Battery Pack.9V alkaline batterypowers the optionalExergen TAT-5000s	6V, 3300 mAh, sealed lead acidbattery powers the main unit. A9V alkaline battery powers theExergen TAT-5000	Questions of safetyrelated to lithium ionbatteries are the sameas for lead acid andalkaline batteries, andthus do not raisedifferent questions ofsafety andeffectiveness.

Performance Testing

Performance testing ensures that the SmartLinx Vitals Plus Patient Monitoring System performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards. The SmartLinx Vitals Plus Patient Monitoring System performance testing is summarized in Table 2.

Category	Testing Summary
SterilizationValidation	The SmartLinx Vitals Plus Patient Monitoring System is not designed to besterilized.
	All patient applied parts used with the SmartLinx Vitals Plus PatientMonitoring System are sourced from the vendors of the vital signs modules.The sterilization issues related to these patient applied parts were addressedin the predicate or reference device submissions, and were cleared by FDA.
	Shelf Life Testing
	All patient applied parts used with the SmartLinx Vitals Plus PatientMonitoring System are sourced from the vendors of the vital signs modules.The shelf life issues related to these patient applied parts were addressed inthe predicate or reference device submissions, and were cleared by FDA.
	The SmartLinx Neuron battery has a shelf life of three months. This limitapplies to batteries that are not in use.
	The Exergen TAT-5000S uses a 9 volt alkaline battery which typically has ashelf life of seven years.
BiocompatibilityTesting	All patient applied parts used with the SmartLinx Vitals Plus PatientMonitoring System are sourced from the vendors of the vital signs modules.The biocompatibility issues related to these patient applied parts wereaddressed in the predicate or reference device submissions, and werecleared by FDA.
Software Testing	Software for the SmartLinx Vitals Plus Patient Monitoring System wasdesigned and developed in accordance with Capsule Technologie softwaredevelopment processes, and was verified and validated. Test resultsindicated that the SmartLinx Vitals Plus Patient Monitoring System complieswith its predetermined specification.
Electrical Safety	The SmartLinx Vitals Plus Patient Monitoring System was tested for patientsafety in accordance with the following applicable standards:IEC 60601-1:2005 IEC 60601-1-6:2013 IEC 60601-1-8:2012 IEC 80601-2-30:2013 ISO 80601-2-56:2009 ISO 80601-2-61:2011 ISO 81060-2:2013 IEC 62304:2006 IEC 62366:2014 IEC 62133:2012 Test results indicated that the SmartLinx Vitals Plus Patient MonitoringSystem complies with its predetermined specification.
ElectromagneticCompatibilityTesting	The SmartLinx Vitals Plus Patient Monitoring System was tested for EMC inaccordance with IEC 60601-1-2:2007. Test results indicated that theSmartLinx Vitals Plus Patient Monitoring System complies with itspredetermined specification.
PerformanceTesting - Bench	The SmartLinx Vitals Plus Patient Monitoring System was tested inaccordance with internal Capsule Technologie requirements and procedures.Test results indicated that the SmartLinx Vitals Plus Patient MonitoringSystem complies with its predetermined specification. This testing includesperformance, functional, reliability, environmental, and packaging testing .
PerformanceTesting - Animal	Animal performance testing was not performed and is not necessary todemonstrate safety and effectiveness of the SmartLinx Vitals Plus PatientMonitoring System.
PerformanceTesting - Clinical	The SmartLinx Vitals Plus Patient Monitoring System was tested for clinicalperformance in accordance with the following applicable standard:ISO 81060-2:2013 Test results indicated that the SmartLinx Vitals Plus Patient MonitoringSystem complies with its predetermined specification.

Table 2 SmartLinx Vitals Plus Patient Monitoring System Performance Testing

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Conclusions

Capsule Technologie SAS considers the SmartLinx Vitals Plus Patient Monitoring System to be as safe, as effective, and its performance is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).