The Alio Medical Remote Monitoring System is a wireless remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data in home use settings. The data includes skin temperature, auscultation sound data and heart rate. Data is transmitted wirelessly from the SmartPatch wearable sensor to a web-based portal for the healthcare provider's (HCP) review.

The Alio Medical RMS is intended for use on general care patients who are 18 years of age or older. The SmartPatch sensor is indicated to measure skin temperature and pulse rate where clinically indicated. The SmartPatch sensor is indicated to record and transmit auscultation sound data where clinically indicated.

The device is not intended for use in critical care or other high-acuity environments. The Alio Medical RMS is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices.

Device Description

Alio Medical Remote Monitoring System, or "Alio Medical RMS", utilizes a wearable device (SmartPatch) on the skin to gather physiological data and then transmits it to a device (Bedside Hub) located in the subject's home. The Bedside Hub then relays this raw data to the Alio Medical Cloud where it is processed and analyzed using Alio's proprietary algorithms. Data is accessible to Healthcare Professionals and the Alio clinical team via a web-based Clinician Portal. The SmartPatch and Bedside Hub are intended to be used on general care patients who are 18 years of age or older in a non-clinical environment. The web-based Clinical Portal is to be used by healthcare professionals in an office environment.

The Alio Medical Remote Monitoring System includes the following components:

SmartPatch
Bedside Hub
Alio Medical Cloud (backend only - not user facing)
Clinician Portal

SmartPatch: A flexible, silicone-encased patch that can be worn where clinically indicated for up to seven days at a time. It houses numerous sensor technologies, which include a microphone, accelerometer, temperature sensors, and a PPG sensors collect physiological data including skin temperature, auscultation sound data, and heart rate. Data is transmitted to the Cloud, via the Hub, where it is analyzed and sent to a Healthcare Professional via the Web Portal.

Bedside Hub: The Bedside Hub has the form and finish of an at-home device. It automatically communicates with the activated SmartPatch and uploads physiological data to the Alio Medical Cloud.

Alio Medical Cloud: The Cloud features a database that supports storage, analytics, system monitoring and visualization capabilities. The Alio Medical Cloud is encrypted and HIPAA compliant. All patient data is fully traceable to device and patient ID via the database.

Clinician Portal: The Clinician Portal is the interface tool between a user (healthcare professional users only) and the system that enables the user to visualize and interact with data being generated by the system.

AI/ML Overview

The provided text is a 510(k) summary for the Alio Medical Remote Monitoring System. It details the device's indications for use, components, and a comparison to predicate and reference devices, as well as listing compliance with various safety and performance standards. However, it does not contain the specific acceptance criteria or the study data that proves the device meets those criteria.

The section titled "9. Performance Data" states that "Nonclinical verification and validation test results established that the device meets its design requirements and intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new issues of safety and effectiveness were raised." It also mentions "extensive safety and performance testing as shown in the test results provided in this submission."

Despite these statements, the actual acceptance criteria, reported device performance (e.g., accuracy metrics for heart rate or temperature), sample sizes, ground truth establishment, or details of a multi-reader multi-case study are not included in this summary. The summary focuses on regulatory compliance and substantial equivalence argument rather than detailed performance study results against specific criteria.

Therefore, I cannot populate the requested table and answer many of the questions based solely on the provided text. To fulfill the request, one would need access to the full submission documents, specifically the detailed performance study reports.

Based on the provided text, the following information is available (and what is not):

1. A table of acceptance criteria and the reported device performance:

Not provided in the text. The text only generally states that "the device meets its design requirements and intended use." Specific numerical acceptance criteria for measured parameters (skin temperature, auscultation sound, heart rate) and corresponding achieved performance values are absent.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not provided in the text. The text mentions "extensive safety and performance testing" but does not specify the sample sizes of patients or data points for any performance tests. Data provenance is also not mentioned.

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

Not provided in the text. No information about expert involvement in establishing ground truth is present.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not provided in the text. No details on adjudication methods for test sets are mentioned.

5. 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:

Not applicable/Not mentioned. The device described is a "remote monitoring system" that collects physiological data for review by HCPs. It is not an AI-powered diagnostic imaging device typically subject to MRMC studies comparing human reader performance with and without AI assistance. The text does not describe any AI component that directly assists in human interpretation or diagnosis.

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

Partially inferred/Limited information: The system uses "Alio's proprietary algorithms" to process and analyze raw data in the Alio Medical Cloud. While a standalone algorithm performance evaluation would logically be done internally to ensure accuracy of processed data (heart rate, temperature, sound data), the detailed results of such a standalone performance or how its accuracy was quantitatively measured against a gold standard are not provided in this summary. The stated function is to transmit data for HCP review, implying the algorithm's role is data processing rather than a standalone diagnostic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not provided in the text. The method for establishing ground truth for any measurements (e.g., a clinically validated temperature probe for skin temperature, or a gold standard ECG for heart rate) is not detailed.

8. The sample size for the training set:

Not applicable/Not provided. While the system uses "proprietary algorithms," the document does not explicitly state that these algorithms are machine learning models requiring "training sets" in the typical sense. Even if they are, the training set size is not mentioned.

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

Not applicable/Not provided. As with the training set itself, the method for establishing ground truth for any potential training data is not mentioned.

In summary, the provided 510(k) summary serves as a high-level overview for regulatory purposes, demonstrating substantial equivalence. It does not delve into the detailed technical performance study results, acceptance criteria, or statistical validations typically found in comprehensive study reports.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 24, 2022

Graftworx, Inc. dba Alio Allison Komiyama, PhD, RAC Principal Consultant ROM+ 2251 San Diego Ave. Suite B-257 San Diego, California 92110

Re: K211365

Trade/Device Name: Alio Medical Remote Monitoring System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, DOD Dated: March 21, 2022 Received: March 23, 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

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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 medical devices and radiation-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 External Heart Rhythm and Rate Team 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) K211365

Device Name Alio Medical Remote Monitoring System

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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Image /page/3/Picture/0 description: The image shows the logo for Alio Medical. The word "alio" is stacked on top of the word "MEDICAL". The letters "ali" are gray, and the "o" is purple. The word "MEDICAL" is gray.

510(k) Summary

General Information 1.

510(k) Sponsor	Alio, Inc.
Address	544B Bryant StSan Francisco, CA 94107
Correspondence Person	Allison C. Komiyama, Ph.D., R.A.C.RQM+
Contact Information	Email: akomiyama@rqmplus.comPhone: +1 (412) 816-8253
Date Prepared	March 24, 2022

2. Proposed Device

Proprietary Name	Alio Medical Remote Monitoring System
Common Name	Alio Medical RMS
Classification Name	Radiofrequency physiological signal transmitter and receiver
Regulation Number	21 CFR 870.2910
Product Code	DRG, DQD
Regulatory Class	II

3. Predicate Device

Proprietary Name	Vital Connect Platform
Premarket Notification	K152139
Classification Name	Radiofrequency physiological signal transmitter and receiver
Regulation Number	21 CFR 870.2910
Product Code	DRG, DSI, MHX
Regulatory Class	II

4. Reference Device

Proprietary Name	Eko Core
Premarket Notification	K200776
Classification Name	Stethoscope
Regulation Number	21 CFR 870.1875
Product Code	DQD
Regulatory Class	II

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Image /page/4/Picture/0 description: The image shows the logo for Alio Medical. The logo consists of the word "alio" in a sans-serif font, with the "a", "l", and "i" in gray and the "o" in purple. The "o" is stylized to resemble a target or a medical symbol. Below the word "alio" is the word "MEDICAL" in a smaller, gray, sans-serif font.

5. Reference Device

Proprietary Name	BB-613 WP
Premarket Notification	K190792
Classification Name	Oximeter, non-invasive blood pressure measurement system
Regulation Number	21 C.F.R. 870.2700 Oximeter, 870.1130 Noninvasive blood pressuremeasurement system
Product Code	DQA, DXN, DRG
Regulatory Class	II

6. Device Description

The Alio Medical Remote Monitoring System includes the following components:

SmartPatch
Bedside Hub
Alio Medical Cloud (backend only - not user facing)
Clinician Portal

SmartPatch

A flexible, silicone-encased patch that can be worn where clinically indicated for up to seven days at a time. It houses numerous sensor technologies, which include a microphone, accelerometer, temperature sensors, and a PPG sensors collect physiological data including skin temperature, auscultation sound data, and heart rate. Data is transmitted to the Cloud, via the Hub, where it is analyzed and sent to a Healthcare Professional via the Web Portal.

Bedside Hub

The Bedside Hub has the form and finish of an at-home device. It automatically communicates with the activated SmartPatch and uploads physiological data to the Alio Medical Cloud.

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Image /page/5/Picture/1 description: The image shows the logo for Alio Medical. The logo consists of the word "alio" in two different colors. The "al" part of the word is in gray, and the "io" part of the word is in purple and is shaped like a circle. Below the word "alio" is the word "MEDICAL" in gray.

Alio Medical Cloud

The Cloud features a database that supports storage, analytics, system monitoring and visualization capabilities. The Alio Medical Cloud is encrypted and HIPAA compliant. All patient data is fully traceable to device and patient ID via the database.

Clinician Portal

The Clinician Portal is the interface tool between a user (healthcare professional users only) and the system that enables the user to visualize and interact with data being generated by the system.

Note - none of the above components/accessories of the Alio Medical RMS have received prior 510(k) clearance.

7. Intended Use/ Indications for Use

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Image /page/6/Picture/0 description: The image shows the logo for Alio Medical. The logo consists of the word "alio" in gray, with the "o" in purple and divided into four sections by white lines. Below the word "alio" is the word "MEDICAL" in gray, in a smaller font size.

Substantial Equivalence 8.

Feature/Function	Device:Alio Medical RMS	Predicate Device:Vital Connect Platform(K152139)
Indicationsfor Use	The Alio Medical RemoteMonitoring System is a wirelessremote monitoring systemintended for use by healthcareprofessionals to intermittentlycollect physiological data in homeuse settings. The data includes skintemperature, auscultation sounddata and heart rate. Data istransmitted wirelessly from theSmartPatch wearable sensor to aweb-based portal for thehealthcare provider's (HCP) review.The Alio Medical RMS is intendedfor use on general care patientswho are 18 years of age or older.The SmartPatch sensor is indicatedto measure skin temperature andpulse rate where clinicallyindicated. The SmartPatch sensor isindicated to record and transmitauscultation sound data whereclinically indicated.The device is not intended for usein critical care or other high-acuityenvironments.The Alio Medical RMS is asecondary, adjunct patient monitorand is not intended to replaceexisting standard-of-care patientmonitoring practices.	The Vital Connect Platform is a wirelessremote monitoring system intended foruse by healthcare professionals forcontinuous collection of physiologicaldata in home and healthcare settings.This can include heart rate,electrocardiography (ECG), heart ratevariability, R-R interval, respiratory rate,skin temperature, activity (including stepcount), and posture (body positionrelative to gravity including fall). Dataare transmitted wirelessly from the VitalConnect Sensor for storage and analysis.The Vital Connect Platform can includethe ability to notify healthcareprofessionals when physiological datafall outside selected parameters. Thedevice is intended for use on generalcare patients who are 18 years of age orolder as a general patient monitor, toprovide physiological information. Thedata from the Vital Connect Platform areintended for use by healthcareprofessionals as an aid to diagnosis andtreatment. The device is not intendedfor use on critical care patients.
Rx or OTC	Rx	Rx
IntendedUsers	Adult - 18+	Adult - 18+
IntendedEnvironment	Home	Home & healthcare settings
Application	Patch - SmartPatch only	Patch
Single-use	Yes - SmartPatch only	Yes - patch only

Data transmitted	Skin temperatureElectronic stethoscope for sound auscultation dataHeart rate	- heart rate- ECG- heart rate variability- R-R interval- respiratory rate- skin temperature- activity (including step count)- posture (body position relative to gravity including fall)
Sensor Type	ThermistorMicrophoneAccelerometerPPG	- ECG electrodes to detect heart rate- 3-axis MEMS accelerometer to detect motion- Thermistors to detect body temperature
Temperature Data	Skin temperature15°C - 50°C	Skin temperature15°C - 50°C
Sound Data	- heart- lungs- bowel- arteries- veins	N/A
Sound Amplification	Yes	N/A
Record and Playback Sound	Yes (Playback via Clinician Portal)	N/A
Operating Mode	Intermittent	Continuous
Data Transmission	Bluetooth - SmartPatch onlyRadio Frequency: 2.4 - 2.5 GHz(Cellular) - SmartHub only	Bluetooth
Energy Source	SmartPatch only - battery (Li-ion)Hub - 5V Mains DC	Sensor only -battery (Li-ion)
Standards	IEC 60601-1 3rd ed.IEC 60601-1-11:2010IEC 80601-2-56:2017IEC 80601-2-61:2017IEC 62471:2008IEC 60529:2013IEC 60086-4:2019IEC 60601-1-2:2007/2014IEC 62304:2006/A1:2016IEC 62366-1:2007/2015FCC CRF47Part 15 Subpart BISO 10993-5:2009	ISO 10993-1:2009IEC 60601-1IEC 60601-1-11IEC 60601-1-6IEC 60601-2-25IEC 60601-2-47IEC 60601-1-2IEC/TS 62657-2FCC CRF47Part 15 Subpart C
Feature/Function	Device:Alio Medical RMS	Reference Device:BioBeat BB-613P(K190792)
Application	Skin - SmartPatch only	Wrist area and skin
Monitoring	Intermittent	Spot Check/Intermittent
Principle ofOperation	Pulse reflectance technology.Light source is comprised of 6LEDs (2x green, 2x red, 2x IR),reflected light is detected by 4photodiodes. An accelerometerprovides additional heart ratedata.	Pulse reflectance technology, Four LED (red+ IR) and photo diode absorbs reflectedlight. Tracking changes of blood pressure isdone by pulse wave transit time (PWTT)which is obtained utilizing pulsemeasurements from the integrated skinattached SpO2 sensor
Emitted light peakwavelength	530 nm (Green), 650 nm (Red),940 nm (IR)	880nm (IR), 650nm (Red)
MeasurementRange, HR	30-200 bpm	40-250bpm
Arms, HR	5 bpm	±3%
Application Method	Biocompatible adhesive patch	Biocompatible adhesive patch

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Image /page/7/Picture/1 description: The image shows the logo for Alio Medical. The logo consists of the word "alio" in gray, with the "o" replaced by a purple circle with a white cross inside. Below the word "alio" is the word "MEDICAL" in gray, in a smaller font size. The logo is simple and modern, and the use of purple and gray gives it a professional look.

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Image /page/8/Picture/0 description: The image shows the logo for Alio Medical. The word "alio" is in gray, with the "o" being a purple circle with a white plus sign in the center. Below the word "alio" is the word "MEDICAL" in gray, with the letters being smaller than the letters in "alio."

Technological Characteristic Comparison with Reference Devices

Feature/Function	Device:Alio Medical RMS	Reference Device:EKO Device(K200776)

Auscultation Data
MeasurementFrequency Range	55 - 2000 Hz	unknown
Sound Amplification	Yes	Yes
Connectivity	Bluetooth	Bluetooth
Record and Save	Yes	Yes

9. Performance Data

Nonclinical verification and validation test results established that the device meets its design requirements and intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new issues of safety and effectiveness were raised. The Alio

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Image /page/9/Picture/1 description: The image shows the logo for Alio Medical. The word "alio" is in gray, with the "o" being a purple circle made of smaller circles. Below the word "alio" is the word "MEDICAL" in gray.

Medical RMS was designed, verified, and validated according to the company's Design Control process and has been subjected to extensive safety and performance testing as shown in the test results provided in this submission. Verification and Validation testing data demonstrate that the device meets all of its specifications including compliance with the following standards:

Safety

IEC 60601-1 3rd Ed. ●
IEC 60601-1-11:2010
IEC 80601-2-56:2017 ●
IEC 80601-2-61:2017 ●
IEC 62471:2008 ●
IEC 60529:2013
IEC 60086-4:2019 ●

EMC

. IEC 60601-1-2:2007/2014
FCC Part 15 Radio Frequency Devices, Subpart B - Unintentional Radiators

Software

. IEC 62304:2006/A1:2016
FDA Guidance document, "Guidance for the Content of Premarket Submissions for . Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."

Usability

. IEC 62366-1:2007/2015
. FDA Guidance document, "Applying Human Factors and Usability Engineering to Medical Devices"

Biocompatibility

. ISO 10993-5:2009
ISO 10993-10:2010 ●

10. Conclusion

Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, Alio Medical Remote Monitoring System raises no new questions of safety and effectiveness and is substantially equivalent to the predicate devices in terms of safety, efficacy, and performance.

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).