Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly Labs software. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease. Patient management decisions should not be made solely on the results of the Cleerly ISCHEMIA analysis.

Device Description

Cleerly ISCHEMIA is an add-on software module to Cleerly Labs (K202280, K190868) that determines the likely presence or absence of coronal vessel ischemia based on quantitative measures of atherosclerosis, stenosis, and significant vascular morphology from typically-acquired Coronary Computed Tomography Angiography images (CCTA). Cleerly ISCHEMIA, in conjunction with Cleerly Labs, outputs a Cleerly ISCHEMIA Index (CII), a binary indication of negative CII (likely absence of ischemia) or positive CII (likely presence of ischemia) with its threshold equivalent to invasive FFR >0.80 vs. ≤0.80, respectively, as identified in professional societal practice guidelines.

AI/ML Overview

The provided document describes the Cleerly ISCHEMIA device and its clinical validation. Here's a breakdown of the requested information based on the text:

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

The document does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity of X% and specificity of Y%). Instead, it presents the results of the primary endpoint analysis from the CREDENCE Trial and then pooled results from additional studies. Therefore, the reported device performance serves as the basis for demonstrating acceptable clinical performance.

Metric (Per-vessel territory)	Reported Device Performance (CREDENCE Trial, Primary Endpoint)
Sensitivity	75.9% (167/220)
Specificity	83.4% (521/625)

Additional performance data from pooled US and OUS cohorts are also provided:

Metric (Pooled US + OUS, Per-vessel territory)	Estimate	95% CI
Sensitivity	76.2%	71.9%, 80.3%
Specificity	85.2%	82.8%, 87.4%
PPV	65.9%	61.2%, 70.3%
NPV	90.5%	88.5%, 92.3%
LR+	5.15	-
LR-	0.28	-

Metric (Pooled US + OUS, Per patient territory)	Estimate	95% CI
Sensitivity	86.6%	82.1%, 90.1%
Specificity	69.8%	64.4%, 74.7%
PPV	73.2%	68.2%, 77.7%
NPV	84.6%	79.5%, 88.6%
LR+	2.87	-
LR-	0.19	-

The conclusion states, "Cumulatively, these data demonstrate acceptable clinical performance," implying that the presented performance values met the internal acceptance standards for regulatory submission.

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

Test Set (CREDENCE Trial Validation Set): 305 patients.
Data Provenance: The CREDENCE Trial was a prospective, multicenter trial conducted across 17 centers (later mentioned as 23 centers in the pooled data description, implying evolution or different reporting) between 2014 and 2017. It recruited patients with stable symptoms and without a prior diagnosis of CAD, referred for non-emergent ICA. The primary endpoint analysis was based on the validation set from this trial. The document states a "US/OUS cohort population" was used for pooled data, and then breaks down the pooled data into "Pooled US" (N=149 subjects) and "Pooled OUS" (N=433 subjects). The CREDENCE trial, being a large multi-center study, likely spanned multiple countries, but the specific breakdown of US vs. OUS for the initial CREDENCE derivation/validation sets isn't explicitly detailed; however, subsequent pooled data clearly delineate US and OUS categories.

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

The document states, "Clinical validation testing was done to validate the diagnostic performance of Cleerly ISCHEMIA for non-invasive determination of the functional significance of CAD, as referenced to direct invasive measurement of FFR as the reference standard." It also mentions, "All index tests were interpreted blindly by core laboratories."

Number of Experts: Not explicitly stated for the interpretation of FFR.
Qualifications of Experts: Not explicitly stated, though "core laboratories" implies a standard of expertise in cardiology and interventional procedures necessary for FFR measurement and interpretation.

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

The document mentions that FFR was the "reference standard." Invasive FFR measurement is an objective physiological assessment, rather than a subjective interpretation requiring adjudication. For the interpretation of the CCTA images that serve as input to Cleerly Labs (and subsequently Cleerly ISCHEMIA), it states, "All index tests were interpreted blindly by core laboratories." The specific adjudication method (e.g., consensual read vs. single reader) by these core laboratories for CCTA interpretation is not detailed. However, the ground truth for Cleerly ISCHEMIA is directly linked to the quantitative invasive FFR values.

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 involving human readers with and without AI assistance is described in this document. The study focuses on the standalone diagnostic performance of the Cleerly ISCHEMIA algorithm against an invasive reference standard (FFR). It is presented as a "diagnostic aid" for use by an interpreting healthcare provider, implying it provides information to the provider, but the study doesn't quantify interaction or improvement.

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

Yes, a standalone performance evaluation was clearly done. The clinical validation section explicitly describes the performance of the "Cleerly ISCHEMIA" device in detecting likely ischemia as referenced to invasive FFR. The results (sensitivity, specificity, etc.) are reported for the algorithm's output.

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

The ground truth used was invasive fractional flow reserve (FFR), described as the "reference standard" for determining the functional significance of coronary artery disease. A Cleerly ISCHEMIA Index (CII) of positive (likely ischemia) corresponds to invasive FFR ≤0.80, and negative CII corresponds to FFR >0.80.

8. The sample size for the training set

The CREDENCE Trial cohort was divided into two subsets: "the first half of enrollees at each site assigned to the derivation (n = 307) and the second half to the validation (n = 305) data set." The derivation set (n=307) would typically serve as the training/development set for the algorithm. The document doesn't explicitly refer to it as the "training set," but "derivation" implies its use in developing/optimizing the algorithm.

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

For the derivation set, the ground truth would have been established in the same manner as for the validation set: direct invasive measurement of FFR. The CREDENCE trial collected FFR data for all enrollees, which were then allocated to either the derivation or validation sets.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

September 8, 2023

Cleerly, Inc % John Smith Partner Hogan Lovells US LLP 555 13th St. NW Washington, District of Columbia 20004

Re: K231335

Trade/Device Name: Cleerly ISCHEMIA Regulation Number: 21 CFR 870.2200 Regulation Name: Adjunctive cardiovascular status indicator Regulatory Class: Class II Product Code: OXZ Dated: August 11, 2023 Received: August 11, 2023

Dear John Smith:

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,

Robert T. Kazmierski -S

for

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

510(k) Number (if known)

K231335

Device Name

Cleerly ISCHEMIA

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Cleerly, Inc.'s Cleerly ISCHEMIA

1. General Information

Sponsor	Cleerly, Inc.
Address	110 16th StreetSuite 1400 #104Denver, CO 80202
Phone	917-671-7746
Contact Person	Candice Bautista-Biddle
Date Prepared	September 8, 2023

2. Device Information

Name of Device	Cleerly ISCHEMIA
Classification Name	21 CFR 870.2200 (Adjunctive Cardiovascular Status Indicator)
Regulatory Class	II
Product Code	QXZ

3. Predicate Device Information

Name of Device	EchoGo Heart Failure (K222463)
Classification Name	21 CFR 870.2200 (Adjunctive Cardiovascular Status Indicator)
Regulatory Class	II
Product Code	QUO

4. Device Description

5. Intended Use / Indications for Use

6. Summary of Technological Characteristics

Cleerly ISCHEMIA is an add-on software module to Cleerly Labs that calculates vessel-specific likely ischemia presence based on quantitative measures of atherosclerosis, and vascular morphology from typically acquired CCTA.

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The Cleerly ISCHEMA data workflow begins after the Cleerly Labs outputs are approved for a study. A pre-processing module evaluates the eligibility of a study or vessels within the study for the Cleerly ISCHEMIA algorithm. The presence of certain identified anomalies can make an entire study ineligible, whereas the presence of a stent or exclusion in a vessel can make just that vessel ineligible. For all eligible vessels within a study, relevant Cleerly Labs outputs are aggregated from the default segment level to vessel level as the inputs to the Cleerly ISCHEMIA alqorithm to determine the likely presence of ischemia. The results will then be evaluated by a post-processing module, which ensures that vessels subtended to a likely ischemic vessel are also marked as likely ischemic. The Cleerly ISCHEMIA algorithm outputs a Cleerly ISCHEMIA Index (CII), a binary indication of likely ischemia presence vs absence for a given vessel, which is equivalent to invasive FFR ≤0.80 vs. >0.80, respectively. Invasive FFR is a widely accepted gold-standard for determining vessel-specific ischemia. The Cleerly ISCHEMIA algorithm is "locked," meaning it is not a continuous learning algorithm.

Cleerly ISCHEMIA Index (likely ischemia / not likely ischemia) is displayed visually by Cleerly Labs to show the likely presence or absence of ischemia within epicardial coronary artery vessels. Vessels with Cleerly ISCHEMIA Index indicating likely ischemia presence (positive CII) are illuminated red, while vessels with Cleerly ISCHEMA Index indicating likely ischemia absence (negative CII) are not illuminated. Cleerly ISCHEMIA analysis is intended to non-invasively support the functional evaluation of clinically stable symptomatic patients with coronary artery disease (CAD).

Characteristic	Cleerly ISCHEMIA Device(Subject device)	EchoGo Heart Failure (K222463)
Regulation	21 CFR 870.2200	21 CFR 870.2200
Generic Device Type	Adjunctive cardiovascular statusindicator	Adjunctive cardiovascular statusindicator
SaMD	Yes	Yes
Intended Use	Providing adjunctive information apatient's cardiovascular condition(diagnostic aid for ischemiaassociated with coronary arterydisease)	Providing adjunctive informationon a patient's cardiovascularcondition (diagnostic aid for HeartFailure with Preserved EjectionFraction (HFpEF))
Indications for Use	Cleerly ISCHEMIA analysissoftware is an automatedmachine learning-based decisionsupport tool, indicated as adiagnostic aid for patientsundergoing CT analysis usingCleerly Labs software. Whenutilized by an interpretinghealthcare provider, this softwaretool provides information that maybe useful in detecting likelyischemia associated withcoronary artery disease. Patientmanagement decisions shouldnot be made solely on the resultsof the Cleerly ISCHEMIAanalysis.	EchoGo Heart Failure 1.0 is anautomated machine learning-based decision support system,indicated as a diagnostic aid forpatients undergoing routinefunctional cardiovascularassessment usingechocardiography. When utilisedby an interpreting clinician, thisdevice provides information thatmay be useful in detecting heartfailure with preserved ejectionfraction (HFpEF). EchoGo HeartFailure 1.0 is indicated in adultpopulations over 25 years of age.Patient management decisionsshould not be made solely on theresults of the EchoGo Heart

Table 1. Substantial Equivalence Comparison Between Subject and Predicate Device

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Characteristic	Cleerly ISCHEMIA Device(Subject device)	EchoGo Heart Failure (K222463)
		Failure 1.0 analysis. EchoGoHeart Failure 1.0 takes as inputan apical 4-chamber view of theheart that has been captured andassessed to have an ejection
		fraction $≥50%$ .
Anatomical Site	Cardiovascular	Cardiovascular
Users	Healthcare provider	Interpreting clinician
Machine Learning-Based Algorithm	Yes	Yes
Operating Platform	Client-Server Google ChromeApplication.	Hosted on Ultromics' platform oron third party infrastructure.
Risk Management	In accordance with ISO14971:2019	In accordance with ISO14971:2019
Usability	Usability assessment determinedthere were no critical tasksassociated with the use of thedevice.	Complies with IEC 62366-1:2020and general use of FDA guidancedocuments on usabilityengineering. Formative andsummative evaluations conductedwith accredited cardiacphysiologists (N=2) andcardiologists (N=5).
Pre-clinical	No animal studies were	No animal studies were
Performance Testing	conducted.	conducted.
Bench PerformanceTesting	Technical validation.	Technical validation, numericalstability, and regression testing.
Clinical PerformingTesting	Validated on a US/OUS cohortpopulation, comprising 23independent clinical sitesrepresentative of the intendeduse population.	Validated on a US cohortpopulation, comprising 8independent clinical sitesrepresentative of the intendeduse population.

7. Performance Data

Non-clinical Testing

Risk assessment, performance, and cybersecurity of Cleerly ISCHEMIA have been evaluated and verified in accordance with software pre-defined specifications and applicable performance standards through software verification testing. Verification testing confirmed that the software requirements fulfilled the pre-defined acceptance criteria.

The nonclinical verification test results established that the device meets its design requirements and intended use. During the development, potential hazards were evaluated and controlled through risk management activities. The performance testing demonstrates that the device meets all its specifications.

Clinical Testing

Clinical validation testing was done to validate the diagnostic performance of Cleerly ISCHEMIA for non-invasive determination of the functional significance of CAD, as referenced to direct invasive

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measurement of FFR as the reference standard. The Cleerly ISCHEMIA validation study used data from the CREDENCE Trial (Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia), a prospective, multicenter trial of 612 stable subjects with suspected, but unconfirmed, CAD who were referred for non-emergent clinically indicated ICA based upon MPI and/or CCTA. CREDENCE enrollees were recruited across 17 centers between 2014 and 2017. Eligibility criteria included referral to non-emergent ICA. All index tests were interpreted blindly by core laboratories. The study population comprised 612 patients with stable symptoms and without a prior diagnosis of CAD referred for non-emergent ICA. Patients were recruited across 23 centers. Trial participants were assigned to 2 subsets with the first half of enrollees at each site assigned to the derivation (n = 307) and the second half to the validation (n = 305) data set.

The primary endpoint analysis is provided in Table 2 below.

Endpoint	Result	Lower 95% Confidence Limit
Sensitivity, per-vessel territory	75.9%(167/220)	70.7%
Specificity, per-vessel territory	83.4%(521/625)	80.2%

Table 2. Primary Endpoint Results

In addition to the CREDENCE data, device performance was supported by additional studies performed both in the US and outside of the US (OUS). Cumulative results of the CREDENCE data with these other data sources are provided in Tables 3 and 4 as follows:

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	Pooled US(N=149 subjects, 285vessel territories)		Pooled OUS(N=433 subjects, 1236vessel territories)		Pooled US + Pooled OUS(N=582 subjects, 1521vessel territories)
	Estimate	95% CI	Estimate	95% CI	Estimate	95% CI
Sensitivity	79.5%(58/73)	70.7%,87.8%	75.5%(259/343)	70.6%,80.2%	76.2%(317/416)	71.9%,80.3%
Specificity	82.5%(175/212)	76.5%,88.1%	85.8%(766/893)	83.3%,88.1%	85.2%(941/1105)	82.8%,87.4%
PPV	61.1%(58/95)	51.1%,70.9%	67.1%(259/386)	61.8%,72.0%	65.9%(317/481)	61.2%,70.3%
NPV	92.1%(175/190)	88.1%,95.6%	90.1%(766/850)	87.9%,92.3%	90.5%(941/1040)	88.5%,92.3%
LR+	4.54	-	6.78	-	5.15	-
LR-	0.25	-	0.36	-	0.28	-

Table 3. Pooled Per-Vessel Territory Diagnostic Performance Estimates by US, Outside US (OUS), and Combined US and OUS Patient Cohorts, Along with 95% Confidence Intervals (CI)

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Table 4. Per patient territory diagnostic performance estimates by region and in aggregated with 95% Cl.

	Pooled US(N=149 subjects)		Pooled OUS(N=433 subjects)		Pooled US + Pooled OUS(N=582 subjects)
	Estimate	95% CI	Estimate	95% CI	Estimate	95% CI
Sensitivity	87.5%(56/64)	77.0%,93.8%	86.4%(190/220)	81.2%,90.3%	86.6%(246/284)	82.1%,90.1%
Specificity	75.3%(64/85)	65.1%,83.3%	67.6%(144/213)	61.1%,73.5%	69.8%(208/298)	64.4%,74.7%
PPV	72.7%(56/77)	61.8%,81.5%	73.4%(190/259)	67.7%,78.4%	73.2%(246/336)	68.2%,77.7%
NPV	88.9%(64/72)	79.3%,94.5%	82.8%(144/174)	76.4%,87.7%	84.6%(208/246)	79.5%,88.6%
LR+	3.54	-	2.67	-	2.87	-
LR-	0.17	-	0.20	-	0.19	-

Cumulatively, these data demonstrate acceptable clinical performance.

8. Cybersecurity

As an add-on module to Cleerly Labs, controls over Cybersecurity risks for Cleerly ISCHEMIA are enacted within Cleerly Labs. Cleerly Labs has implemented security features for device and data protection. Cybersecurity requirements, risk analysis, and mitigation was addressed in accordance with FDA guidance, "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."

9. Conclusions

Cleerly ISCHEMIA is as safe and effective as the predicate EchoGo Heart Failure device (K222463). Cleerly ISCHEMIA has a similar intended use and indications for use, as well as similar technological characteristics and principles of operation as its predicate device. The minor differences between the indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between Cleerly ISCHEMA and its predicate device raise no new issues of safety or effectiveness. Cleerly ISCHEMIA is as safe and effective as the predicate EchoGo Heart Failure (K222463). Thus, Cleerly ISCHEMIA is substantially equivalent.

Regulation Number and Section

§ 870.2200 Adjunctive cardiovascular status indicator.

(a)
Identification. The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software description, verification, and validation based on comprehensive hazard analysis must be provided, including:
(i) Full characterization of technical parameters of the software, including any proprietary 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; and
(iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on accuracy of patient reports.
(2) Scientific justification for the validity of the status indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm using a data set separate from the training data must demonstrate the validity of modeling.
(3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.
(4) Clinical data must be provided in support of the intended use and include the following:
(i) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output measure(s) represent(s) the predictive measure(s) that the device provides in an accurate and reproducible manner;
(ii) 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;
(iii) Agreement of the measure(s) with the reference measure(s) must be assessed across the full measurement range; and
(iv) 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;
(ii) A description of what the device measures and outputs to the user;
(iii) Warnings identifying sensor reading acquisition factors that may impact measurement results;
(iv) Guidance for interpretation of the measurements, including warning(s) specifying adjunctive use of the measurements;
(v) Key assumptions made in the calculation and determination of measurements;
(vi) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance; and
(vii) A detailed description of the patients studied in the clinical validation (
e.g., age, gender, race/ethnicity, clinical stability) as well as procedural details of the clinical study.