ANNE One is a wireless vital signs and physiological data monitoring platform indicated for the measurement of heart rate, respiratory rate, step count, fall count, skin temperature, and body temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended for use on critical care patients. The device is not intended to monitor or measure respiratory rate or heart rate on ambulatory patients.

Device Description

ANNE One is a wireless multi-parameter vital signs monitoring system that consists of the following components, and subsystems:
A. ANNE Tablet (Samsung Galaxy Tablet) - manufactured by Samsung
B. ANNE View Mobile Application (software) manufactured by Sibel Inc.
C. ANNE Chest Sensor manufactured by Sibel Inc.
D. ANNE Limb Sensor manufactured by Sibel Inc.
E. ANNE Wireless Charger manufactured by Sibel Inc.
The ANNE Chest Sensor is a battery-operated, skin-mounted sensor with wireless transceiver capabilities worn on the upper body to measure heart rate, respiratory rate, step count, fall count, and skin temperature.
The ANNE Limb Sensor is an additional battery-operated skin-mounted sensor with wireless transceiver capabilities worn on the finger to measure skin temperature. When placed underneath the axillae, the ANNE Limb Sensor can measure body temperature.
Both the ANNE Chest and ANNE Limb Sensors continuously gather vital signs data from the person being monitored and then transmit the encrypted data to the ANNE Tablet operating the ANNE View Mobile Application-a mobile device software application.

AI/ML Overview

The provided text describes the ANNE One device, a wireless vital signs and physiological data monitoring platform, and its FDA 510(k) submission (K211305). While the document details various performance tests and validation methods, it does not provide specific acceptance criteria in a numerical format for each vital sign, nor does it present the reported device performance against such criteria in a table. It mostly states what was tested and how it was tested (e.g., according to specific ISO/IEC standards or against FDA-cleared reference devices).

Therefore, I cannot construct a table with acceptance criteria and reported device performance as requested, because that data is not explicitly present in the provided document. The document lists the types of measurements the device takes (heart rate, respiratory rate, step count, fall count, skin temperature, body temperature) and broadly states that bench and simulated use testing was conducted to demonstrate effectiveness and conformity to specifications.

However, I can extract information about the studies performed to demonstrate the device's capabilities:

Summary of Device Performance Studies for ANNE One (K211305)

The provided document describes various performance tests conducted to support the substantial equivalence determination for the ANNE One device. It does not explicitly state numerical "acceptance criteria" and "reported device performance" in a table format for each physiological parameter. Instead, it describes compliance with relevant standards and comparative studies against reference devices.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, specific numerical acceptance criteria and reported performance values are not provided in the given text. The document broadly states that tests were performed to verify device specifications and ensure mechanical and electrical requirements were met, and that effectiveness was validated according to standards or against reference devices.

For example, for temperature measurement, it states: "Laboratory accuracy testing according to ISO 80601-2-56:2017 Section 201.101.2 validated the effectiveness of the ANNE Chest and Limb sensor for skin temperature measurements and the Limb Sensor for body temperature measurements when placed under the axillae." This indicates compliance with the standard but doesn't give a numerical accuracy. Similar statements are made for heart rate and respiratory rate.

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

Heart Rate:
- Simulated Use Study: 35 healthy subjects.
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective. The phrase "healthy subjects" implies volunteers, likely from a single or a few sites.
Respiratory Rate:
- Study: 50 healthy subjects.
- Data Provenance: Not explicitly stated, but generally prospective for such studies.
Skin Temperature, Step Count, Fall Detection:
- Simulated Use Testing: n=10 subjects.
- Data Provenance: Not explicitly stated, but generally prospective.
Biocompatibility Testing: All patient-contacting materials were tested.
Electrical Safety & EMC Testing: Conducted on the device.
Software Verification & Validation Testing: Conducted on the software.
Animal Studies: Not required or performed.
Clinical Studies: Not required or performed for safety and effectiveness. (Instead, substantial equivalence was supported by Bench and Simulated Use testing).
Usability Testing: Conducted, but sample size not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish a "ground truth" in the context of human reader studies (e.g., for image interpretation). Instead, the ground truth for physiological measurements was established using FDA-cleared reference devices or manual observation.

4. Adjudication Method for the Test Set

Not applicable. The studies described are not "human-in-the-loop" studies requiring expert adjudication of reader performance. Measurements were compared against reference devices or manual counts.

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

No, an MRMC comparative effectiveness study was not performed, nor was it relevant to this device's function. The ANNE One is a vital signs monitoring device, not an imaging analysis AI intended to assist human readers in diagnosis. Therefore, there is no information on how human readers might improve with AI assistance. The performance studies focused on the accuracy of the device's measurements compared to established reference methods.

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

Yes, the performance studies described (accuracy of heart rate, respiratory rate, temperature, step count, fall count) essentially describe the standalone performance of the ANNE One system in measuring these vital signs. The device generates the data, and its accuracy is validated against gold standards (reference devices or manual counts). There isn't a human processing the algorithm's output for further interpretation in the way one might with an AI for medical image analysis.

7. The Type of Ground Truth Used

The ground truth for the vital signs measurements was primarily established using:

FDA-cleared reference devices: For heart rate (against an FDA-cleared reference device) and respiratory rate (against an FDA-cleared End Tidal Carbon Dioxide (EtCO2) reference device).
Reference standard/protocol conformance: For temperature (Laboratory accuracy testing according to ISO 80601-2-56:2017).
Manual counts: For step and fall counts, demonstrated to conform to design specifications through comparison to manual counts.

8. The Sample Size for the Training Set

The document does not specify any training set size. This is likely because the device is a hardware sensor system with associated software for data collection and display, rather than a machine learning model that requires a large separate training dataset in the typical sense of AI/ML-driven diagnostics. The "software verification and validation testing" refers to the traditional software development lifecycle testing, not machine learning model training.

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

As no training set is mentioned in the context of a machine learning model, this question is not applicable. The device's functionality is based on established physiological measurement principles and signal processing, not a trained AI model in the common sense.

Summary

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September 14, 2021

Sibel Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K211305

Trade/Device Name: ANNE One Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG, MWI, FLL Dated: July 23, 2021 Received: July 27, 2021

Dear Dave Yungvirt:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211305

Device Name ANNE One

Indications for Use (Describe)

ANNE One is a wireless vital signs and physiological data monitoring platform indicated for the measurement of heart rate, respiratory rate, step count, fall temperature, and body temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended for use on critical care patients. The device is not intended to monitor or measure respiratory rate on heart rate on ambulatory patients.

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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510(K) Summary

Submitter: .

Sibel Inc. 6650 W. Touhy Avenue, Niles, IL 60714 Tel: (224) 251-8859

Official Correspondent: Peter Xu, VP of Quality Assurance and Regulatory Affairs 6650 W. Touhy Avenue, Niles, IL 60714 Tel: (224) 251-8859

Date Prepared: 9/7/2021

ll. Device Information

Name of Device: ANNE One 510K Number: K211305 Common or Usual Name: Wireless Remote Monitoring System Classification Name: Radiofrequency Physiological Signal Transmitter and Receiver Review Panel: Cardiovascular Regulation: 21 CFR §870.2910 Regulatory Class: Class II

Product Classification Code: DRG, MWI, FLL

. Predicate Device

Predicate - Trade Name: Patient Status Engine Predicate 510(k): K172329 Predicate device manufacturer: Isansys Lifecare Ltd

IV. Reference Device

Reference device – Trade Name: Fever Scout Continuous Monitoring thermometer Reference 510(k): K162137 Reference Manufacturer: Vivalnk Inc.

V. Device Description

ANNE One is a wireless multi-parameter vital signs monitoring system that consists of the following components, and subsystems:

A. ANNE Tablet (Samsung Galaxy Tablet) - manufactured by Samsung

B. ANNE View Mobile Application (software) manufactured by Sibel Inc.

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C. ANNE Chest Sensor manufactured by Sibel Inc.
D. ANNE Limb Sensor manufactured by Sibel Inc.
E. ANNE Wireless Charger manufactured by Sibel Inc.

The ANNE Chest Sensor is a battery-operated, skin-mounted sensor with wireless transceiver capabilities worn on the upper body to measure heart rate, respiratory rate, step count, fall count, and skin temperature.

The ANNE Limb Sensor is an additional battery-operated skin-mounted sensor with wireless transceiver capabilities worn on the finger to measure skin temperature. When placed underneath the axillae, the ANNE Limb Sensor can measure body temperature.

Both the ANNE Chest and ANNE Limb Sensors continuously gather vital signs data from the person being monitored and then transmit the encrypted data to the ANNE Tablet operating the ANNE View Mobile Application-a mobile device software application.

VI. Indications for Use

	Subject deviceSibel Inc.	Predicate deviceIsansys Lifecare Ltd	Variances / Equivalence
Trade Name	ANNE One	Patient Status Engine
510(k) Number	K211305	K172329	N/A
Class	II	II	Equivalent
Product Code	DRG, MWI, FLL	DRG	Equivalent
RegulationNumber andRegulation Name	870.2910Transmitters andReceivers, PhysiologicalSignal, Radiofrequency	870.2910Transmitters and Receivers,Physiological Signal,Radiofrequency	Equivalent
	Subject deviceSibel Inc.	Predicate deviceIsansys Lifecare Ltd	Variances / Equivalence
Indications forUse	ANNE One is a wirelessvital signs andphysiological datamonitoring platformindicated for themeasurement of heartrate, respiratory rate,step count, fall count,skin temperature, andbody temperature byqualified healthcareprofessionals inhealthcare settings. Thedevice is intended foruse on general carepatients who are 18years of age or older asa general patient monitorto provide continuousphysiological informationas an aid to diagnosisand treatment. Thedevice is not intended foruse on critical carepatients. The device isnot intended to monitoror measure respiratoryrate or heart rate onambulatory patients.	The device is a wirelessremote monitoring systemintended for use byhealthcare professionals forcontinuous collection ofphysiological data in homeand healthcare settings.This includes heart rate,heart rate variability (R-Rinterval), ECG derivedrespiration rate data (EDR),skin temperature, activity,posture and optional SpO2and noninvasive BloodPressure (BP). Data istransmitted wirelessly fromthe sensors to the PatientGateways and from thePatient Gateways to acentral Server where it isstored for analysis. ThePatient Status Engine caninclude the ability to notifyhealthcare professionalswhen physiological data falloutside selectedparameters.	SimilarANNE One does not includeoptional SpO2 andnon-invasive BPmeasurements. ANNE Onedoes not measure heart ratevariability. ANNE One does notinclude the ability to notifyhealthcare professionals whenphysiological data fall outsideselected parameters. ANNEOne does not store data forfuture analysis. ANNE One isnot intended to monitor ormeasure respiratory rate orheart rate on ambulatorypatients. The differences donot affect safety oreffectiveness.
Intended Use	ANNE One is intendedfor use on general carepatients who are 18years of age or older asa general patient monitor,to provide continuousphysiological information.	The device is intended foruse on general care patientswho are 18 years of age orolder as a general patientmonitor, to providephysiological information.	Equivalent
Use Environment	Healthcare Settings	Home and HealthcareSettings	DifferentANNE One does not offerHome use. The differences donot affect safety oreffectiveness.
Heart Rate	Yes	Yes	Equivalent
	Subject deviceSibel Inc.	Predicate deviceIsansys Lifecare Ltd	Variances / Equivalence
R-R Interval	No	Yes	DifferentANNE One is not indicated forthe display of R-R interval.However, it does calculate theR-R interval to determine HR.This difference does not affectsafety or effectiveness.
Respiration Rate	Yes	Yes	EquivalentBoth the ANNE One andPatient Status Engine deriverespiratory rate from ECGalone (EDR).
Skin Temperature	Yes	Yes	Equivalent
BodyTemperature	Yes on axilla/armpit	Yes*	EquivalentThe differences do not affectsafety or effectiveness.
SpO2	No	Yes - optional with a FDAcleared SpO2 oximeter	DifferentWithout the optional SpO2oximeter, the devices areequivalent. The differencedoes not affect safety oreffectiveness.
Activity	Yes	Yes	EquivalentThe ANNE One specificallymeasures activity as stepcount. The differences do notaffect safety or effectiveness.
Posture	Yes	Yes	EquivalentThe ANNE One specificallymeasures posture only as itrelates to fall count. Thedifferences do not affect safetyor effectiveness
Non-InvasiveBlood Pressure(NIBP)	No	Yes - optional with a FDAcleared NIBP device	DifferentWithout the optional NIBPdevice, the devices areequivalent. The differencedoes not affect safety oreffectiveness.
	Subject deviceSibel Inc.	Predicate deviceIsansys Lifecare Ltd	Variances / Equivalence
Data	Data transmittedwirelessly via Bluetoothfrom sensors to mobiledevice	Data is transmittedwirelessly via Bluetooth fromthe sensors to the PatientGateways and from thePatient Gateways to acentral Server where it isstored for analysis.	EquivalentANNE One does not offer datatransmission to a centralServer or data download. Thedifferences do not affect safetyor effectiveness.
Notification	No notification ability	The Patient Status Enginecan include the ability tonotify healthcareprofessionals whenphysiological data falloutside selectedparameters.	DifferentANNE One does not offer anotification but provides areal-time display. Thisdifference does not affectsafety of the device.Performance datademonstrates that this changedoes not affect effectiveness.

Table 5-1: Substantial Equivalence for Indication for Use

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*The labeling for the Patient Status Engine states that the LifeTemp Sensor can be used for body temperature measurement if placed under the axilla, but this feature is not included in the device's indications for use.

Validation methods and laboratory accuracy data for body temperature measurements from the Fever Scout reference device were further utilized to demonstrate substantial equivalence to ANNE One.

VII. Performance Data

Verification and Validation tests established the safety and effectiveness of ANNE One. The following performance data have been provided in support of the substantial equivalence determination:

Sterilization & Shelf-life Testing

ANNE One is non-sterile, and therefore sterilization data is not provided. The shelf-life study under accelerated aging data has been provided to support the labeled shelf-life claim for ANNE One. Additional peel force testing established the safety of the ANNE adhesive compared to standard FDA-cleared medical adhesives.

Biocompatibility Testing

Biocompatibility testing was performed for all patient-contacting materials used in ANNE One, and the results indicated that all patient-contacting materials in the ANNE One system are biologically compatible and satisfy the requirements defined in ISO 10993 Part 1, entitled 'Use of International Standard ISO-10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

Electromagnetic Compatibility and Electrical Safety

Electrical safety and electromagnetic compatibility testing were conducted on ANNE One. The device complies with the ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-1-2:2014

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standards. The device also complies with the FCC CFR 47 Part 15 Subpart C standards for wireless communication. The device was tested and demonstrated to be safe in case of defibrillation according to Section 8.5.5 of ANSI/AAMI ES60601-1:2005/(R)2012.

Software Verification and Validation Testing

Software verification and validation testing demonstrated the safety and effectiveness of ANNE One. Based on the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software level of concern for ANNE One is determined to be Moderate.

Benchtop Testing and Simulated Use Testing

Bench testing was performed to verify device specifications and to ensure mechanical and electrical requirements were met. Laboratory accuracy testing according to ISO 80601-2-56:2017 Section 201.101.2 validated the effectiveness of the ANNE Chest and Limb sensor for skin temperature measurements and the Limb Sensor for body temperature measurements when placed under the axillae. Heart rate measurements with ANNE One were verified according to IEC 60601-2-27 Sections 201.12.101.15 and 201.12.1.101.17. A simulated use study validated heart rate measurements in 35 healthy subjects against an FDA-cleared reference device. Respiratory rate measurements with ANNE One were validated in 50 healthy subjects against an FDA-cleared End Tidal Carbon Dioxide (EtCO-) reference device. The step and fall count features were demonstrated to conform to their design specifications through comparison to manual counts.

Simulated use testing validated the measurements of skin temperature, step count, and fall detection by the ANNE One system in n=10 subjects. The ANNE Hydrogel adhesive was also assessed for skin adhesion, pain upon removal, irritation, and comfort. The study demonstrated the functionality and accuracy of the system.

Animal Studv

Animal testing was not required to demonstrate the safety and effectiveness of ANNE One.

Clinical Study

Clinical testing was not required to demonstrate the safety and effectiveness of ANNE One. Instead, substantial equivalence is supported by Bench and Simulated Use testing.

Usability Testing

Studies related to human factors engineering and ease of use of the ANNE One were conducted in accordance with the principles of IEC 62366, Medical devices - Applications of usability engineering to medical devices and the document entitled Applying Human Factors and Usability Engineering to Medical Devices.

VII. Conclusion

The results of the substantial equivalence assessment, taken together with the performance testing data, demonstrate that ANNE One's performance characteristics are substantially equivalent to the predicate device in both design and intended use.

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It has been shown through the documents provided in this 510(k) submission that the minor differences between ANNE One and the predicate device of Patient Status Engine, as well as the reference device of the Fever Scout Continuous Monitoring thermometer, do not raise any new questions regarding its safety and performance. Any differences between the subject device and the predicate/reference devices have no significant effect on safety or effectiveness as established through performance testing.

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).