The AHI System is intended for use by healthcare professionals managing patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG) in hospitals.

AHI provides a frequently updated binary output over time based on pattern analysis of a lead-II ECG waveform intended to describe a patient's hemodynamic status and indicate if a patient is showing signs of hemodynamic stability or instability. Signs of hemodynamic instability (HI) are defined as hypotension (systolic blood pressure <90 mmHg or mean arterial pressure (MAP) <70 mmHg) combined with tachycardia (heart rate ≥ 100 bpm).

AHI-PI provides the clinician with physiological insight into a patient's likelihood of a future episode of HI. An episode of HI is defined as 10 continuous minutes or more where HI is present.

The goal of this adjunctive monitoring method is to enable identification of patients who are likely to experience a future episode of HI, and to allow clinicians an opportunity to increase vigilance. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

Device Description

The AHI System is a multiparameter system designed to meet clinicians' need to identify patient hemodynamic status and predict patient hemodynamic instability episodes using two analytics:

Analytic for Hemodynamic Instability (AHI) (as granted in DEN200022): Utilizing data from a single existing lead of a non-invasive electrocardiograph (ECG), AHI analyzes heart rate variability (HRV) and ECG morphology features to rapidly detect signs of hemodynamic stability or instability and categorize each window of data as either "AHI Stable" or "AHI Unstable." Time trending of AHI outputs is also provided.
Analytic for Hemodynamic Instability Predictive Indicator (AHI-PI): Utilizing AHI outputs from up to the most recent 30 minutes of ECG data, AHI-PI indicates the likelihood of a future episode of hemodynamic instability, defined as ten continuous minutes or more where signs of hemodynamic instability are present.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (AHI-PI)
Distinguish Risk Levels for Hemodynamic Instability	Probability of HI in next 1 hour: - Low Risk (Green): 0.7% (CI: 0.4%, 1.3%) - Moderate Risk (Yellow): 6.5% (CI: 3.7%, 10.3%) - High Risk (Red): 35.9% (CI: 28.1%, 44.0%)
Likelihood of HI compared to Low Risk	- Moderate Risk: 9x more likely to have an episode of HI in the next 1 hour than Low Risk. - High Risk: 51x more likely to have an episode of HI in the next 1 hour than Low Risk.
Prediction of patient deterioration (among those who had HI)	89% of cases correctly predicted.
Lead Time for Prediction	Median lead time of 48 minutes.
Clinical Benefit	Demonstrate significant discrimination between risk of future hemodynamic instability events, providing adjunctive information to clinicians to facilitate fewer missed diagnoses of emerging HI/patient deterioration.

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

Sample Size: 65,969 "windows" (data points representing a period of time for which an AHI-PI indicator was generated). The exact number of patients is not explicitly stated, but the note mentions: "The unit of analysis here is at the windows level and not the patient level." The study used bootstrapping to account for multiple measurements per subject.
Data Provenance: Prospectively collected from consecutive patients at Michigan Medicine. This indicates the data is from the United States and is prospective.
Targeted Patient Population: Hospitalized patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG) and are not contraindicated. Due to study design considerations, the primary study population was limited to patients who were invasively monitored with an arterial line.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set.

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 for the AHI-PI system. The study focuses on the standalone performance of the AHI-PI algorithm. The device is intended for "adjunctive use" meaning it supports human healthcare professionals, but specific studies on human improvement with AI assistance are not described here.

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

Yes, a standalone performance study was done for the AHI-PI. The reported data in the table directly reflects the algorithm's ability to predict hemodynamic instability without human intervention in the prediction process itself. The study compared AHI-PI outputs to a vital signs reference standard.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Outcomes Data/Physiological Reference Standard: The ground truth for hemodynamic instability (HI) was defined using a "hemodynamic vital signs reference standard" based on continuous vital signs:
- Hypotension (systolic blood pressure <90 mmHg or mean arterial pressure (MAP) <70 mmHg) combined with
- Tachycardia (heart rate ≥ 100 bpm)
An "episode of HI" was further defined as 10 continuous minutes or more where these HI conditions are present.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. It only describes the validation data.

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

The document does not specify how the ground truth for the training set was established. It only describes the ground truth for the validation set.

Summary

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December 3, 2021

Fifth Eye Inc. % Donna-Bea Tillman Senior Consultant Biologics Consulting Group 1555 King Street. Suite 300 Alexandria, Virginia 22314

Re: K212219

Trade/Device Name: AHI System Regulation Number: 21 CFR 870.2220 Regulation Name: Adjunctive hemodynamic indicator with decision point Regulatory Class: Class II Product Code: QNV, QNL Dated: November 3, 2021 Received: November 4, 2021

Dear Donna-Bea Tillman:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR 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.

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212219

Device Name AHI System

Indications for Use (Describe)

The AHI System is intended for use by healthcare professionals managing patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG) in hospitals.

AHI-PI provides the clinician with physiological insight into a patient's likelihood of a future episode of HI. An episode of HI is defined as 10 continuous minutes or more where HI is present.

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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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for the AHI System is provided below.

1. SUBMITTER

Applicant:	Fifth Eye Inc.110 Miller Avenue, Suite 300Ann Arbor, MI 48104
Contact:	Jen BairdChief Executive OfficerFifth Eye Inc.734.260.4800jbaird@fiftheye.com
Submission Correspondent:	Donna-Bea Tillman, Ph.D.Senior ConsultantBiologics Consulting1555 King St, Suite 300Alexandria, VA 22314410.531.6542dtillman@biologicsconsulting.com
Date Prepared:	November 2, 2021

2. DEVICE

Device Trade Name:	AHI System
Device Common Name:	Hemodynamic Indicator
Classification Name	21 CFR 870.2220 Adjunctive HemodynamicIndicator with Decision Point
Regulatory Class:	II
Primary Product Code:	QNV
Subsequent Product Code:	QNL

3. PREDICATE DEVICE

Predicate Device: Analytic for Hemodynamic Instability (AHI) - DEN200022 Secondary Predicate Device: CLEWICU System (ClewICUServer And ClewICUnitor) -K200717

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DEVICE DESCRIPTION 4.

The AHI System is a multiparameter system designed to meet clinicians' need to identify patient hemodynamic status and predict patient hemodynamic instability episodes using two analytics:

Analytic for Hemodynamic Instability (AHI) (as granted in DEN200022): Utilizing data from a single existing lead of a non-invasive electrocardiograph (ECG), AHI analyzes heart rate variability (HRV) and ECG morphology features to rapidly detect signs of hemodynamic stability or instability and categorize each window of data as either "AHI Stable" or "AHI Unstable." Time trending of AHI outputs is also provided.
Analytic for Hemodynamic Instability Predictive Indicator (AHI-PI): Utilizing AHI outputs from up to the most recent 30 minutes of ECG data, AHI-PI indicates the likelihood of a future episode of hemodynamic instability, defined as ten continuous minutes or more where signs of hemodynamic instability are present.

INTENDED USE/INDICATIONS FOR USE 5.

The AHI System is intended for use by healthcare professionals managing patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG) in hospitals.

AHI-PI provides the clinician with physiological insight into a patient's likelihood of a future episode of HI. An episode of HI is defined as 10 continuous minutes or more where HI is present.

The goal of this adjunctive monitoring method is to enable identification of patients who are showing HI or are likely to experience a future episode of HI, and to allow clinicians an opportunity to increase vigilance. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

6. SUBSTANTIAL EQUIVALENCE

Comparison of Indications

The subject device and both of the predicate devices are all software decision support systems that receive patient data, process it, and display calculated insights into patient hemodynamic and cardiovascular status to support meaningful clinical decisions.

The subject and both predicate devices are all prescription devices intended for use by healthcare professionals. They are intended for use in adult patients 18 years and older and are intended for adjunctive use with other monitoring and patient information and are not intended to

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independently direct therapy. The subject device and primary predicate device are both intended for use on patients in hospitalized settings who are receiving continuous physiological monitoring with electrocardiography (ECG). The subject device and secondary predicate device both are intended to provide physiological insight into a patient's likelihood of future hemodynamic instability.

Technological Comparisons

The table below compares the key technological feature of the subject devices to the predicate devices.

	AHI System	Primary Predicate	Secondary Predicate
510(k)Number	AHI System	DEN200022	K200717
Applicant	Fifth Eye Inc.	Fifth Eye Inc.	CLEW Medical Ltd.
Device Name	AHI System	Analytic forHemodynamic Instability(AHI)	CLEWICU System(ClewICUServer AndClewICUnitor)
ClassificationRegulation	860.2220. AdjunctiveHemodynamic IndicatorWith Decision Point870.2210. Medium-TermAdjunctive PredictiveCardiovascular Indicator	860.2220. AdjunctiveHemodynamic IndicatorWith Decision Point	870.2210. Medium-TermAdjunctive PredictiveCardiovascular Indicator
ProductCode	QNV, QNL	QNV	QNL
Type ofDevice	Software-as-a-medical-device	Software-as-a-medical-device	Software-as-a-medical-device
Timing ofAnalyticInputs	Near-real-time patienthealth data	Near-real-time patienthealth data	Near-real-time patienthealth data
AnalyticInputs	Inputs are based on signalsreceived from FDA-cleared patient monitoringsystems, specifically:For AHI: ECG-IIFor AHI-PI: AHI Outputs	Inputs are based on signalsreceived from FDA-cleared patient monitoringsystems, specifically:ECG-II	Inputs are based on signalsreceived from FDA-cleared patient monitoringsystems and other valuesstored in the electronichealth record (EHR)system, specifically:Up to 80 EHR inputsincluding vital signs,nursing assessments,
	AHI System	Primary Predicate	Secondary Predicate
			flowsheet data,medications, and lab data
TechnicalMethod	Uses analysis of patientdata (ECG-II) to detectcurrent signs of ahemodynamic condition(AHI) and combinespatient data from patientmonitors to produce asingle value (AHI-PI) thatestimates the likelihood ofa future adversecardiovascular event orcondition from a singlemodel mathematicallyderived from AHI inputs.	Uses pattern analysis ofpatient data (ECG-II) todetect current signs of ahemodynamic condition	Combines patient datacollected from patientmonitors and/or electronichealth records to produce asingle value that estimatesthe likelihood of a futureadverse cardiovascularevent or condition usingtwo models, a high riskmodel and a low riskmodel.
AnalyticOutputs	AHI: A frequently updatedbinary output over timeAHI-PI: A single indicatorthat estimates thelikelihood of a futureadverse cardiovascularevent (hemodynamicinstability episode)	AHI: A frequently updatedbinary output over time	Single CLEWICUindicator that estimates thelikelihood of a futureadverse cardiovascularevent (hemodynamicinstability)
Visual Alerts	AHI: Signs ofhemodynamic statusprovided by red and greencolor-coded indicatorsAHI-PI: Risk of futurehemodynamic episodeprovided by red, yellow,and green color-codedindicators	AHI: Signs ofhemodynamic statusprovided by red and greencolor-coded indicators	CLEWICU: Risk ofhemodynamic instabilityprovided by red, yellow,and green color-codedindicators

Table 1: Technological Comparison

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In conclusion, the differences in the intended use and technological characteristics do not raise new questions of safety and effectiveness. Based on the detailed comparison between the predicate devices and the subject device, the performance testing, and conformance with applicable standards, the AHI System can be found substantially equivalent to the predicate devices.

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7. PERFORMANCE DATA

Biocompatibility Testing

The AHI System is a software only device. There are no direct or indirect patient-contacting components of the subject device; therefore, patient contact information is not needed for this device.

Electrical safety and electromagnetic compatibility (EMC)

Not applicable. The AHI System is a software-only device. It contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a moderate level of concern. Testing was conducted to ensure the AHI System works as designed.

Bench Testing

Fifth Eye conducted a summative usability study according to the FDA 's guidance on Applying Human Factors and Usability Engineering to Medical Devices. Fifth Eve recruited 30 users to participate in the study. The results of the human factors validation study were positive and demonstrated that mitigations addressing use-related risk made during device development were effective.

Animal Testing

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

Clinical Data

The clinical data to support AHI was provided in DEN200022. There have been no changes to AHI since that submission.

To validate that AHI-PI predicts a patient's likelihood of a future hemodynamic instability episode, defined as 10 continuous minutes or more where signs of hemodynamic instability are present, we compared AHI-PI outputs to episodes of hemodynamic instability as observed using a hemodynamic vital signs reference standard - Hypotension (systolic blood pressure <90mmHg or mean arterial pressure (MAP) <70 mmHg) combined with tachycardia (heart rate ≥100 bpm).

The targeted patient population for the AHI System is hospitalized patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG) and are not contraindicated. While ideally the clinical study would reflect the full spectrum of levels of care for ECG-monitored patients, study design considerations required limiting the primary study population to only patients who were invasively monitored with an arterial line. Therefore,

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beginning at the study start date, data were prospectively collected from consecutive patients in equipped beds (those that could store continuous measures of ECG, arterial line numeric data, and other vital signs) at Michigan Medicine.

As requested by FDA, and using bootstrapping to account for multiple measurements per subject, Fifth Eye has demonstrated that AHI-PI can distinguish the risk of developing hemodynamic instability for patients in different risk groups, i.e., those that are at low risk (green), moderate risk (yellow), and high risk (red).

AHI-PI Indicator	Windows inPrimary AnalysisSet (total 65,969windows) n (%)[2]	Probability of an Episode ofHemodynamic Instability inthe next 1 hour measuredusing continuous vital signs [1](Observed [95% confidenceinterval])	Likelihood Ratio
AHI-PI Low RiskIndicator(Green)	43,443(65.8%)	0.7%[0.4%, 1.3%]	N/A
AHI-PI Moderate RiskIndicator (Yellow)	4,999(7.6%)	6.5%[3.7%, 10.3%]	An AHI-PI Moderate Riskindication is 9x more likely tohave an episode ofhemodynamic instability in thenext 1 hour than an AHI-PILow Risk Indicator.
AHI-PI High RiskIndicator (Red)	17,527(26.6%)	35.9%[28.1%, 44.0%]	An AHI-PI High Riskindication is 51x more likelyto have an episode ofhemodynamic instability in thenext 1 hour than an AHI-PILow Risk Indicator.

Probability estimates of the occurrence of an episode of hemodynamic instability in Table 2: the prediction window for each of the AHI-PI indicators (Study Population).

[1] The unit of analysis here is at the windows level and not the patient level.

[2] Windows included in the analysis total 65,969 to ensure that a full one hour is available for each AHI-Pl in order to determine whether an episode of hemodynamic instability is present or not.

As seen in Table 2, with the prevalence of 10.5% seen in the Primary Analysis Set population using the continuous vital signs reference standard, the probability of an episode of hemodynamic instability in the next 1 hour measured using continuous vital signs was 0.7%, 6.5%, and 35.9% for green, yellow, and red AHI-PI indicators respectively. An AHI-PI High Risk (red) indication is 51 times more likely and an AHI-PI Moderate Risk (yellow) indication is 9 times more likely to have an episode of hemodynamic instability in the next hour as compared to an AHI-PI Low Risk (green) indication. Thus, the risk predication and likelihood performance data show significant discrimination between the risk of future hemodynamic instability events between the different AHI-PI indications, demonstrating a clinical benefit by providing

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adjunctive information to the clinician to facilitate fewer missed diagnoses of emerging hemodynamic instability/patient deterioration.

The other relevant metric is lead time. Of those patients who had an episode of hemodynamic instability, AHI-PI High Risk predicted patient deterioration in 89% of cases. The median lead time was calculated as 48 minutes. Although this lead time is less that the 3 hours reported for CLEWICU, it still provides an advance warning to clinicians that the patient is at risk of future hemodynamic instability. The differences in the performance do not impact the safety or effectiveness, as neither device is intended to be the sole factor upon which a patient's clinical care is based.

CONCLUSION 8.

The subject AHI System and the predicate devices have equivalent intended uses. The differences in technological characteristics do not raise different questions of safety and effectiveness, and the results of software verification, human factors and clinical validation demonstrate that the subject device performs in accordance with specifications and meets user needs and intended uses. Therefore, the AHI System has been demonstrated to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.2220 Adjunctive hemodynamic indicator with decision point.

(a)
Identification. An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software description, verification, and validation based on comprehensive hazard analysis and risk assessment must be provided, including:
(i) Full characterization of technical parameters of the software, including algorithm(s);
(ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications;
(iii) Specification of acceptable incoming sensor data quality control measures;
(iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on output accuracy; and
(v) The sensitivity, specificity, positive predictive value, and negative predictive value in both percentage and number form for clinically meaningful pre-specified time windows consistent with the device output.
(2) Scientific justification for the validity of the hemodynamic indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm must use an independent data set.
(3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.
(4) Clinical data must support the intended use and include the following:
(i) The assessment must include a summary of the clinical data used, including source, patient demographics, and any techniques used for annotating and separating the data;
(ii) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output represents the measure(s) that the device provides in an accurate and reproducible manner;
(iii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified;
(iv) Where continuous measurement variables are displayed, agreement of the output with the reference measure(s) must be assessed across the full measurement range; and
(v) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment.
(5) Labeling must include the following:
(i) The type of sensor data used, including specification of compatible sensors for data acquisition, and a clear description of what the device measures and outputs to the user;
(ii) Warnings identifying factors that may impact output results;
(iii) Guidance for interpretation of the outputs, including warning(s) specifying adjunctive use of the measurements;
(iv) Key assumptions made in the calculation and determination of measurements; and
(v) A summary of the clinical validation data, including details of the patient population studied (
e.g., age, gender, race/ethnicity), clinical study protocols, and device performance with confidence intervals for all intended use populations.