The Polso™ Watch is a wrist-worn device indicated for use in measuring and displaying function of arterial hemoglobin (%SpO2), pulse rate, and respiration rate. The Polso™ Watch is a prescription-use device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions.

The device is not intended to be used for diagnostic applications nor is it intended to independently guide treatment decisions. The device is not an apnea monitor. Physiological parameters will later be provided for remote review by a clinician.

Device Description

The Polso™ Watch is a wearable device intended for non-invasive measurements and display of pulse rate (PR), blood oxygen saturation (SpO2), and respiration rate (RR). It is a prescription-use device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions. The device is not intended to be used for diagnostic applications nor it is intended to independently guide treatment decisions.

The Polso™ Watch is worn on the wrist and features sensors that are located facing the radial artery and at the dorsal wrist, for measurement of physiological information. The Polso™ Watch screen displays measurements, battery status, Bluetooth connection status, and time of day. The Control Button allows navigation between different display screens. The Polso™ Watch is available in sizes S, M and L to cover wrist sizes from 5.5″ to 8.4″ circumference. The Polso™ Watch is powered by a rechargeable lithium-polymer battery.

The Polso™ Watch is paired with a companion mobile application (Polso™ App) on an Android device. The App is used to set up the Polso™ Watch and to review up to 3 months of measurement data.

AI/ML Overview

The information provided primarily describes the Polso™ Watch, a pulse oximeter device, and its regulatory clearance. While it details what was tested (SpO2, Pulse Rate, Respiration Rate accuracy) and how (against gold standards, following ISO standards), it does not explicitly present specific numerical acceptance criteria for these accuracy metrics, nor does it provide the exact reported device performance values in a table as requested. Instead, it states the Polso™ Watch's accuracy for SpO2, Pulse Rate, and Respiration Rate in the comparison table with predicate devices.

Here's an attempt to address your request based on the available information, with clear indications where specific numerical data for acceptance criteria and reported performance is not explicitly detailed in the provided text.

Acceptance Criteria and Device Performance Study for Polso™ Watch

The Polso™ Watch underwent non-clinical and clinical testing to demonstrate its safety and performance and to establish substantial equivalence to predicate devices. The key performance metrics studied were SpO2 accuracy, Pulse Rate accuracy, and Respiration Rate accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for the accuracy tests (e.g., "Must achieve SpO2 accuracy of X% ARMS"). Instead, it compares the Polso™ Watch's stated accuracy to that of its predicate devices. We can infer the "acceptance" is based on demonstrating performance comparable to or better than the predicate, within recognized industry standards (ISO 80601-2-61).

Metric	Acceptance Criteria (Inferred from Predicate/Standard)	Reported Device Performance (Polso™ Watch)
SpO2 Accuracy	Comparable to or better than predicate (e.g., 3% Arms)	2% Arms
Pulse Rate Accuracy	Comparable to predicate (3 BPM Arms)	3 BPM Arms
Respiration Rate Accuracy	Comparable to predicate (3 RPM Arms)	3 BPM Arms (Note: The document uses BPM for RR instead of RPM here)
SpO2 Display Range	70% to 100%	70% to 100%
Pulse Rate Display Range	25-250 BPM	25-250 BPM
RR Display Range	Comparable to predicate (e.g., 4-40 RPM or wider)	5-45 BPM (Note: The document uses BPM for RR instead of RPM here)

Note on RR Accuracy and Display Range Units: The document consistently uses "BPM" (beats per minute) for Respiration Rate (RR) accuracy and display range of the Polso™ Watch, while using "RPM" (respirations per minute) for predicate devices. Assuming this is a clerical error and BPM is intended to mean respirations per minute in this context, the values are directly comparable.

2. Sample Size and Data Provenance

SpO2 and Pulse Rate Validation Study:
- Sample Size: 10 healthy adult subjects initially, with data on two additional subjects provided later, making a total of 12 subjects (for Fitzpatrick scores IV and VI).
- Data Provenance: Not explicitly stated (e.g., specific country), but typical for a medical device regulatory submission, it would likely be from a controlled clinical trial setting. The studies were prospective as they were conducted to validate the device's performance.
Respiration Rate Validation Study:
- Sample Size: 31 adult subjects.
- Data Provenance: Not explicitly stated. The study was prospective.

3. Number of Experts and Qualifications for Ground Truth

The document mentions "manual, clinician-scored End Tidal Carbon Dioxide monitoring" and "arterial blood samples assessed by SaO2 CO-Oximetry" as gold standards. It does not specify the number or specific qualifications of the clinicians/experts involved in establishing these "manual" or "clinician-scored" ground truths.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the ground truth establishment in either of the clinical studies. The "gold standard" methods (arterial blood samples, manual clinician-scored ETCO2) inherently serve as the adjudicated truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess how human readers/clinicians improve with AI vs. without AI assistance. The device is a measurement device (oximeter), not an AI-powered diagnostic imaging tool that typically involves MRMC studies for human reader performance.

6. Standalone (Algorithm Only) Performance

The "Reported Device Performance" listed in the table effectively represents the standalone performance of the Polso™ Watch (i.e., the algorithm/device output accuracy) without human-in-the-loop assistance for the core measurement functions.

7. Type of Ground Truth Used

For SpO2 and Pulse Rate: Arterial blood samples assessed by SaO2 CO-Oximetry (this is an objective, physiological measurement and considered a "gold standard").
For Respiration Rate: Manual, clinician-scored End Tidal Carbon Dioxide (ETCO2) monitoring. This relies on expert observation/scoring of physiological data.

8. Sample Size for the Training Set

The document does not provide details on the training set sample size. It only discusses the clinical validation/test sets. As a measurement device (oximeter) based on photoplethysmography, its core algorithms are likely based on established physiological principles and signal processing, rather than deep learning that requires distinct, large training sets in the same way an imaging AI algorithm would. If machine learning was used in some aspect of signal processing, the training data would be internal and not specified here.

9. How Ground Truth for Training Set Was Established

Not applicable/not provided, as per item 8. The document focuses on the validation studies against established "gold standards," not the internal development/training process.

Summary

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November 18, 2022

Chronisense Medical, Ltd. % Allison Komiyama President, AcKRS Ram+ 2251 San Diego Ave. Ste B-257 San Diego, California 92110

Re: K220351

Trade/Device Name: Polso Watch Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: October 14, 2022 Received: October 31, 2022

Dear Allison Komiyama:

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 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) 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 (OS) 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,

James J. Lee -S

James J. Lee, Ph.D. Divisiion Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K220351

Device Name Polso™ Watch

Indications for Use (Describe)

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 K220351

DATE PREPARED

November 10, 2022

MANUFACTURER AND 510(k) OWNER

ChroniSense Medical, Ltd. 2 Hacarmel St., P.O.B. 399, Yokneam Illit, Israel 2066724 Telephone: Official Contact: Bridget A. Ross, CEO

REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., RAC Pierre Bounaud, Ph.D. RQM+ 2251 San Diego Ave., Ste B-257, San Diego, CA 92110 Telephone: +1 (412) 816-8253 Email: akomiyama@rqmplus.com, pbounaud@rqmplus.com

DEVICE INFORMATION

Proprietary Name/Trade Name:	Polso™ Watch
Common Name:	Oximeter, breathing frequency monitor
Regulation Number:	21 CFR 870.2700, 21 CFR 868.2375
Class:	II
Product Code:	DQA, BZQ
Premarket Review:	Anesthesiology
Review Panel:	OHT1/ Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)

PREDICATE DEVICE IDENTIFICATION

The Polso™ Watch is substantially equivalent to the following predicates:

510(k) Number	Predicate Device Name / Manufacturer	PrimaryPredicate	ReferenceDevice
K181352	Loop System / Spry Health, Inc.	✓
K181956	Masimo MightySat Rx Fingertip PulseOximeter / Masimo Corporation		✓

The predicate devices have not been subject to a design related recall.

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DEVICE DESCRIPTION

The Polso™ Watch is a wearable device intended for non-invasive measurements and display of pulse rate (PR), blood oxygen saturation (SpO2), and respiration rate (RR). It is a prescriptionuse device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions. The device is not intended to be used for diagnostic applications nor it is intended to independently guide treatment decisions.

The Polso™ Watch is paired with a companion mobile application (Polso™ App) on an Android device. The App is used to set up the Polso™ Watch and to review up to 3 months of measurement data.

INDICATIONS FOR USE

The Polso™ Watch is a wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, and respiration rate. The Polso™ Watch is a prescription-use device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions. The device is not intended to be used for diagnostic applications nor is it intended to independently guide treatment decisions. The device is not an apnea monitor. Physiological parameters will later be provided for remote review by a clinician.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

ChroniSense Medical, Ltd. believes that the Polso™ Watch is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has the same intended use as the device cleared in K181352. Both devices are intended to measure pulse rate (PR), blood oxygen saturation (SpO2), and respiration rate (RR) in non-moving adult patients in home environments. The intended population for the subject device includes transitional adolescents, aged 18 to 21. For the intended use of the device, the inclusion of this pediatric population does not raise new questions of safety or effectiveness and is validated by two clinical studies.

The subject device has a similar design as the device cleared in K181352. Both devices have a 'watch' form factor that is worn on the wrist, with measurements displayed on the wearable

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device and transmitted to another location (mobile app, web interface) for additional monitoring. Both devices have internal rechargeable batteries.

The subject device uses similar technology for measurements as the device cleared in K181352. Both devices have PPG sensors to gather data from peripheral arteries.

The main technological differences of the subject device, as compared to the predicate device cleared in K181352, are:

. Sampling frequency. The subject device is intended for spot-checking under non-motion conditions, meaning the user determines when to check for measurements. By contrast, the predicate device is designed for nearly continuous measuring and recording of physiological data when the patient is not in motion. The difference in sampling frequency does not raise new questions of safety or effectiveness.
. SpO2 accuracy. The subject device display range is 70% to 100% and accuracy is 2% Arms while the predicate device has the same display range, but accuracy is 3% Arms. This difference is within the values of the predicate device and is therefore considered equivalent.
RR range. The subject device has a RR range of 5-45 BPM while the predicate device has a RR range of 4-40 RPM. This technical difference has undergone testing to ensure the subject device is as safe and effective as the predicate device.
Data communication. Both devices transmit measurements wirelessly to either a mobile device (subject device) or a web server (predicate). The subject device uses Bluetooth low energy (BLE) methodology while the predicate uses a cellular connection. This technical difference has undergone testing to ensure the subject device is as safe and effective as the predicate device.
Data communication to physician. The predicate device automatically transmits collected data to a remote server for review by a physician, while the subject device stores data on the Watch and the mobile application. Review of the data by the physician is done during clinic visits or data is communicated remotely to the physician by the patient. This technical difference has undergone human factor testing to ensure the subject device is as safe and effective as the predicate device. In addition, the reference device cleared in K181956 uses similar spot-checking technology in a home use environment. Collected data is stored on the reference device. Bluetooth communication to a mobile app is an optional feature for data transfer and review by a physician.

The Polso™ Watch is substantially equivalent to the predicate devices based on the information summarized in the following table:

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P:::lso

	Subject Device	Predicate Device	Reference Device
	ChroniSense Medical Ltd	Spry Health, Inc.	Masimo Corporation
	Polso™ Watch	Loop System	Masimo MightySat RxFingertip Pulse Oximeter
	K220351	K181352	K181956
Indications forUse	The Polso™ Watch is a wrist-worn device indicated for usein measuring and displayingfunctional oxygen saturationof arterial hemoglobin(%SpO2), pulse rate, andrespiration rate. The Polso™Watch is a prescription-usedevice intended for spot-checking measurements ofpatients aged 18 years andolder in the home useenvironment in non-motionconditions.The device is not intended tobe used for diagnosticapplications nor is it intendedto independently guidetreatment decisions. Thedevice is not an apneamonitor. Physiologicalparameters will later beprovided for remote reviewby a clinician.	The Loop System is intendedfor adult patients in the homeenvironment for passive, non-invasive, intermittent datacollection of physiologicalparameters that will later betransmitted to a web serverfor remote review by aclinician.The Loop System measuresand records:• arterial oxygensaturation (SpO2)• heart rate (HR)• respiration rate (RR)All of these measurementsare made when no motion isdetected by the System. TheLoop System device does notprovide physiological alarms	The Masimo MightySat RxFingertip Pulse Oximeter isintended for hospitals,hospital-type facilities, homeenvironments, and transport.The Masimo MightySat RxFingertip Pulse Oximeter isindicated for the noninvasivespot checking of functionaloxygen saturation of arterialhemoglobin (SpO2) and pulserate (PR) for adult andpediatric patients during bothno motion and motionconditions, and for patientswho are well or poorlyperfused.The Masimo MightySat RxFingertip Pulse Oximeter isindicated for the noninvasivespot checking of respirationrate (RRp) for adult patients.
Product Codes/ RegulationNumber	DQA / 21 CFR 870.2700BZQ / 21 CFR 868.2375	DQA / 21 CFR 870.2700BZQ / 21 CFR 868.2375	DQA / 21 CFR 870.2700BZQ / 21 CFR 868.2375
Rx/OTC	Rx	Rx	Rx
Intended users	Adults (aged 18 and older)	Adults	Adults/pediatric (SpO2, pulserate)Adults (respiration rate)
Intended useenvironments	Home environment	Home environment	Hospitals, hospital-typefacilities,home environments, andtransport
Technological Characteristics
Device	• Polso™ Watch	• Loop band	• Fingertip device
Components	• Polso™ App	• Spry server	• Battery
	• Polso™ Watch ChargerStand with micro USB cableand power adapter	• Charging station	• Carrying case

Anatomical siteofmeasurements	Wrist	Wrist	Finger
Samplingfrequency	Spot-checking in non-motionconditions	Intermittent data collectionwhen patient is not in motion	Spot-checking in non-motionand motion conditions
SpO2measurementmethod	Photoplethysmography	Photoplethysmography	Photoplethysmography
SpO2 displayrange	70% to 100%	70% to 100%	70% to 100% (no motion)
SpO2 Accuracy	2% Arms	3% Arms	2% Arms (no motion)
Pulse rate /heart ratemeasurementmethod	Photoplethysmography	Photoplethysmography	Photoplethysmography
Pulse rate /heart ratedisplay range	25-250 beats per minute(BPM)	25-250 BPM	25-240 BPM
Pulse rate /heart rateaccuracy	3 BPM Arms	3 BPM Arms	3 BPM Arms
RRmeasurementmethod	Photoplethysmography	Photoplethysmography	Photoplethysmography
RR displayrange	5-45 breaths per minute(BPM)	4-40 respirations per minute(RPM)	4-70 respirations per minute(RPM)
RR accuracy	3 BPM Arms	3 RPM Arms	3 RPM Arms
Display	AMOLED color display	LED color display	OLED color display
Power source	Internal rechargeable battery	Internal rechargeablebatteries	Two 1.5V AAA batteries
Datacommunication	Wireless (Bluetooth BLEpairing) with Android mobiledevice	Wireless (cellular connection)via charging station to SpryServer	Optional wireless (BluetoothLE)

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SUMMARY OF NON-CLINICAL TESTING

The following tests were performed to demonstrate safety and performance based on current industry standards:

. Biocompatibility testing per ISO 10993-1, 10993-5, 10993-10
. Software V&V per IEC 62304
Electrical Safety and Electromagnetic Compatibility testing per IEC 60601-1, IEC 60601-1-. 2, IEC 60601-1-11, IEC 62133, ISO 80601-2-61
. Compliance to CFR 47 Part 15 Subpart C for BLE transmission
. Bench performance testing for RR range and accuracy

The results of these tests indicate that the Polso™ Watch is substantially equivalent to the predicate device.

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Image /page/8/Picture/0 description: The image shows the logo for Polso. The logo is purple and features the word "Polso" in a sans-serif font. The "o" in "Polso" is replaced by a circle of dots, with some of the dots being a lighter blue color. The logo is simple and modern.

SUMMARY OF CLINICAL TESTING

Two clinical studies were conducted to demonstrate the performance of the Polso™ Watch. Evaluation included participants with a range of demographics including a mix of gender, skin tone (Fitzpatrick scale I-VI), age, and BMI (based on height and weight).

SpO2 and Pulse Rate Validation Study. The objective of this study was to validate the SpO2 accuracy and the pulse rate accuracy of the Polso™ Watch pulse oximeter during non-motion conditions in 10 healthy adult subjects with a range of skin types (2 having a Fitzpatrick score of V or VI). The accuracy of the Polso™ Watch was compared to the gold standard, arterial blood samples assessed by SaO2 CO-Oximetry. Per FDA's request, data on two additional subjects with Fitzpatrick scores of IV and VI were provided to demonstrate the device works on the intended population.
Respiration Rate Validation Study. The objective of this study was to validate the . respiration rate accuracy of the Polso™ Watch pulse oximeter during non-motion conditions in 31 adult subjects with a range of skin types and health conditions. The accuracy of the Polso™ Watch was compared to manual, clinician-scored End Tidal Carbon Dioxide monitoring as the gold standard.

This testing was conducted in accordance with ISO 80601-2-61 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment, and FDA's Guidance Pulse Oximeters - Premarket Notifications Submissions.

CONCLUSION

Based on the testing performed, including biocompatibility, software V&V, EMC and electrical safety, wireless transmission testing, bench performance testing, and clinical testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed Polso™ Watch are assessed to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).