The Personalized Physiology Engine (PPA Engine) is intended to be used with data from already cleared sensors measuring physiological parameters, including heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home. The device provides a time series Multivariate Change Index (MCI) which indicates whether the relationships among the patient's monitored vital signs change from those measured at baseline, which has been derived from measurements previously obtained during routine activities of daily living. The MCI is based on an integrated computation evaluating changes in the parameters and their relationships to each other.

The PPA Engine is an adjunct to and is not intended to replace vital signs monitoring. The MCI is intended for daily intermittent, retrospective review by a qualified practitioner. The PPA Engine is intended to provide additional information for use during routine patient monitoring. The MCI is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes.

Device Description

The PhysIQ Personalized Physiology Analytics Engine ("PPA Engine") is a computerized analysis software program that is designed for detecting change in the relationships among the patient's vital signs throughout dynamic physical activity, based on data input from multi-parameter vital sign monitoring devices. The PPA Engine first "learns" a patient's personalized baseline, defined by the relationship among the vital signs derived from measurements obtained during routine activities of daily living. Once the baseline vital sign relationships are established, it analyzes the subsequent data to assess how the relationships among the vital signs incoming during the monitoring period compare to the established baseline. The PPA Engine can analyze data collected wherever the patient is monitored, reflecting a patient's activities of daily living. The device is intended for monitoring ambulatory patients.

The PPA Engine requires vital sign inputs of Heart Rate (HR), Respiration Rate (RR) and Activity (ACT) (body motion). The PPA Engine can accept input from commercial vital sign monitors or combinations of monitors that can provide multivariate observations of these vital signs.

The PPA Engine calculates the Multivariate Change Index (MCI), a scalar index between 0 and 1, which represents the likelihood that the relationships among the patient's vital signs are different from those at baseline, which was established during routine activities of daily living. An MCI value closer to zero (0) indicates that the monitored relationships among the vital signs are similar to the learned baseline. An MCI value closer to one (1) indicates that the patient's monitored relationships among the vital signs are likely to be different from the learned baseline.

The MCI is also presented as a time series (MCI over time) and it is intended to for retrospective review by the clinician The MCI is not intended to replace standard patient monitoring. Rather, it was designed to supplement standard monitoring of ambulatory patients.

AI/ML Overview

The provided 510(k) summary for the Personalized Physiology Analytics Engine (PPA Engine) indicates a substantial equivalence determination based on various testing. However, it does not explicitly provide a table of acceptance criteria with corresponding performance metrics in the format requested. The document describes the types of testing performed and the conclusions drawn from those tests, but not specific quantifiable targets or results.

Here's a breakdown of the available information based on your request:

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

The provided document does not contain a table with specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and their corresponding reported device performance metrics. Instead, it states that the device "performs as intended per its specifications" and that its output "correlates with changes in the relationships among vital signs compared with baseline."

Summary of Device Performance (as reported implicitly):

Bench Testing:
- Verification testing confirmed the device meets its specifications.
- Validation testing showed correlation of MCI with changes in vital sign relationships compared to baseline.
Clinical Testing (Healthy Volunteers):
- Demonstrated that the MCI correlates with changes in monitored vital sign relationships compared to the subject's baseline, fulfilling its intended use.

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

Test Set Sample Size: Not explicitly stated. The document refers to "human physiological data collected" from a "perturbed clinical data study" and a "simulator data study" for bench testing validation, and "healthy volunteer studies" for clinical testing. The number of participants in these studies is not provided.
Data Provenance:
- Bench Testing: "Perturbed clinical data study" (unspecified origin) and "Simulator data study."
- Clinical Testing: "Healthy volunteer studies were conducted under an IRB-approved non-significant risk protocol" (suggests prospective data collection). The country of origin is not specified but given the FDA submission, it's likely within the US or compliant with US standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not provided. The document describes "changes in the relationships among vital signs compared with baseline" as the ground truth concept, often influenced by physiological events rather than expert interpretation of an image or signal.

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

Not applicable. The ground truth for this device appears to be based on physiological changes, not expert interpretation requiring adjudication.

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

No MRMC comparative effectiveness study is mentioned. The device is described as providing a "Multivariate Change Index (MCI)" for "daily intermittent, retrospective review by a qualified practitioner" as an adjunct to vital signs monitoring. It explicitly states it is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes, which suggests it's not a primary diagnostic tool to be compared in an MRMC study.

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

Yes, the testing described appears to be a standalone performance evaluation of the algorithm. The "Perturbed clinical data study" and "Simulator data study" for bench testing and the "healthy volunteer studies" for clinical testing assessed how the MCI output correlated with physiological changes, thus evaluating the algorithm's performance in generating the MCI.

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

The ground truth used appears to be objective physiological changes or perturbations.

For bench testing, this involved validating correlation of MCI "with changes in the relationships among vital signs compared to baseline."
For clinical testing, "healthy volunteer studies... during a trip with a substantial altitude change (causing natural perturbation in relationships among vital signs)" were used, and results demonstrated the MCI correlates with "change in the monitored relationships among the vital signs compared to the subject's baseline."

8. The sample size for the training set

Not provided. The document mentions the PPA Engine "learns" a patient's personalized baseline from "measurements previously obtained during routine activities of daily living," but it does not specify the sample size or duration of this "learning" phase for general model development, nor does it distinguish between training and testing sets in a conventional machine learning sense for the submitted evidence. The learning described is patient-specific baseline establishment.

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

The document describes a personalized baseline for each patient, established from "measurements previously obtained during routine activities of daily living." This implies that the system identifies a "normal" or baseline state for an individual based on their own physiological data during typical activities. There is no mention of external expert labeling or a separate "ground truth" for a training set in the typical sense of a supervised learning model, as the device's normality is patient-specific and learned from their own data.

Summary

{0}------------------------------------------------

Public Health Service

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

June 11, 2015

VGBio, Inc. (DBA PhysIO) % Michael Billig Regulatory Consultant Experien Group 755 N Mathilda Avenue Suite 100 Sunnyvale, California 94085

Re: K142512

Trade/Device Name: Personalized Physiology Analytics Engine Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: PLB (Multivariate vital signs index) Dated: May 4, 2015 Received: May 5, 2015

Dear Michael Billig,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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

{1}------------------------------------------------

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 vours.

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration.

Indications for Use

510(k) Number (if known) K142512

Device Name Personalized Physiology Analytics Engine

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)

Form Approved: OMB No. 0910-0120.

Expiration Date: January 31, 2017

See PRA Statement below.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

PSC Publishing Services (301) 443-6740 EF

{3}------------------------------------------------

SECTION 5 510(k) SUMMARY

This summary of the 510(k) premarket notification for the Personalized Physiology Analytics Engine is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR§807.92.

{4}------------------------------------------------

510(k) Notification K142512

GENERAL INFORMATION

Applicant:

PhysIQ 1415 West Diehl Road Suite 150 Naperville, IL 60563 U.S.A. Phone: 630-251-5214

Contact Person:

Michael J. Billig Regulatory Consultant for PhysIQ Experien Group, LLC 755 N. Mathilda Ave, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: 408-400-0856 FAX: 408-400-0865 Email: mjb@experiengroup.com

Date Prepared: June 10, 2015

DEVICE INFORMATION

Trade Name:

Personalized Physiology Analytics Engine

Generic/Common Name:

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Classification:

Class II, 21 CFR$870.2300, Cardiac monitor (including cardiotachometer and rate alarm)

Product Code:

PLB

PREDICATE DEVICES

Oxford BioSignals Ltd, BioSign™ (K053112) ●
OBS Medical, Visensia® with Alert (K081140) ●

{5}------------------------------------------------

INDICATIONS FOR USE

PRODUCT DESCRIPTION

{6}------------------------------------------------

SUBSTANTIAL EQUIVALENCE

The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the PPA Engine. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the PPA Engine is substantially equivalent to the predicate devices. A comparison of the PPA Engine to the predicate devices is provided in Table 1.

{7}------------------------------------------------

Feature	PhysIQPersonalized PhysiologyAnalytics Engine(K142512)	Oxford Biosignals Ltd.BioSignTM(K053112)	OBS MedicalVisensia® with Alert(K081140)
General Characteristics
Classification	Class II,21CFR§870.2300	Class II,21CFR§870.2300	Class II,21CFR§870.1025
Product Code	MWI	MWI	MHX
PatientEnvironment	Ambulatory	Bedside or ambulatory	Bedside or ambulatory
PatientPopulation	Monitored non-pediatricpatients	Monitored non-pediatrichigh dependency patients	Monitored non-pediatrichigh dependency patients
Technological Characteristics
Components	Software only	Software only	Software only
IndexProduced	Non-linear combination ofvital parameters	Unknown combination ofvital parameters	Non-linear combination ofvital parameters
IndexMeaning	Index represents howdifferent the relationshipsamong the patient's vitalsigns are with respect tonormality.	Index represents howdifferent the relationshipsamong the patient's vitalsigns are with respect tonormality.	Index represents howdifferent the relationshipsamong the patient's vitalsigns are with respect tonormality.
IndexAlgorithmNormality	Normality is defined as thepatient's own baseline.	Normality is defined aspopulation normality.	Normality is defined aspopulation normality.
Index Display	• Single numeric value oflatest index• Trend graph• Table	• Trend graph	• Single numeric valueof latest index• Trend graph• Table
Vital SignsData Source	Clinical Information Systems	Physiological PatientMonitors / ClinicalInformation Systems	Physiological PatientMonitors / ClinicalInformation Systems
Alert System	No	No	Audible and Visual

Table 1: Summary Substantial Equivalence Table

{8}------------------------------------------------

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary bench and clinical testing was conducted on the PPA Engine to support a determination of substantial equivalence to the predicate devices.

Bench Testing Summary:

The PPA Engine was tested to ensure that it performs as intended per its specifications. and to verify that technological differences between the PPA Engine and the predicate devices do not raise new issues of safety or effectiveness for providing a change index. The bench testing included:

. Verification testing for the PPA Engine (to verify that the device meets its specifications)
. Validation testing of the PPA Engine's MCI output (to validate correlation of MCI with changes in the relationships among vital signs compared to baseline in order to meet its intended use), including analysis of vital sign changes in human physiological data collected:
- o Perturbed clinical data study
- o Simulator data study

The collective results of the bench testing demonstrate that the software design of the PPA Engine meets the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the PPA Engine index output correlates with changes in the relationships among vital signs compared with baseline, as do the indices of the predicate devices. Thus, the PPA Engine does not raise new questions of safety or effectiveness for vital sign monitoring when compared to the predicate devices.

Clinical Testing Summary:

To validate that the PPA Engine's MCI output correlates with changes in the relationships among vital signs compared with baseline, healthy volunteer studies were conducted under an IRB-approved non-significant risk protocol, where volunteers collected vital sign data during standard activities of daily living and during a trip with a substantial altitude change (causing natural perturbation in relationships among vital signs). Study results demonstrate the MCI correlates with change in the monitored relationships among the vital signs compared to the subject's baseline; thus, the PPA Engine meets its intended use.

CONCLUSION

The PPA Engine has a subset of the elements of intended use, patient population, as well as highly similar technological characteristics as those of the predicate devices, the BioSign and Visensia. The differences in technological characteristics have been analyzed and addressed through performance testing that demonstrates that the PPA Engine meets its intended use. Any differences between the PPA Engine and the predicate devices do not raise any new issues of safety or effectiveness. As such, the PPA Engine is substantially equivalent to the predicate devices.

{9}------------------------------------------------

SUMMARY

The PPA Engine is substantially equivalent to the predicate devices.

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).