The CipherOx™ CRI MI is indicated for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor),and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia.

For patients with a finger thickness of 0.3'' to 1'' in hospital and pre-hospital settings.

CRI trends with changes in intravascular volume relative to the individual patient's response to hypovolemia, and should only be used by qualified medical providers as an adjunct to rather than as a replacement for traditional hemodynamic measures. CRI is indicated for adults (19-36 years old) in the supine position under non-motion conditions and without cardiovascular disease. CRI has not been studied in trauma patients.

Device Description

The CipherOx CRI™ M1 is a modification of the predicate device, the CipherOx CRI Tablet (DEN160020). The M1 is a smaller version of the Tablet that is designed for increased portability.

The CipherOx CRITM M1 is a non-invasive, continuous, and multi-parameter monitor that displays SpO2, HR, and the Compensatory Reserve Index (CRI). CRITM is a physiologic parameter that trends changes in intravascular volume, which help to assess a patient's hemodynamic status.

The CRI™ algorithm trends intravascular volume using non-invasive arterial pulsatile waveform signals by continuously comparing extracted waveforms to a reference model. CipherOx™ CRI system operates on the photoplethysmograph (PPG) waveform used in pulse oximetry to estimate CRI.

The CipherOx CRI™ M1 incorporates:

1. CRI™ algorithm
Nonin pulse ox sensor (8000AA K080255) 2.
1. M1 User Interface module which is a small, portable, battery powered unit that displays heart rate. SpO2, and CRI™.

AI/ML Overview

The provided document, a 510(k) summary for the CipherOx CRI M1, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with new acceptance criteria for the CRI algorithm itself. The key information regarding the CRI algorithm's performance is explicitly stated to rely on the validation performed for the predicate device, the CipherOx CRI Tablet (DEN160020).

Therefore, the acceptance criteria and study details for the CRI M1 directly reference the previous submission.

Here's a breakdown of the requested information based on the provided text:

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

The document does not specify new acceptance criteria or performance derived specifically from the CipherOx CRI M1 for the Compensatory Reserve Index (CRI). Instead, it states that the CRI algorithm is identical to that in the predicate device, the CipherOx CRI Tablet (DEN160020). The performance in terms of "Accuracy" for CRI is listed as "0-1.0 numeric with graph". For SpO2 and Pulse rate, which are standard measurements, the accuracies are provided.

Metric	Acceptance Criteria (Implied / Stated)	Reported Device Performance (CipherOx CRI M1)
Compensatory Reserve Index (CRI)	Identical to DEN160020	0-1.0 numeric with graph
SpO2 Accuracy	$\pm$ 2 digits (as per predicate)	$\pm$ 2 digits
Pulse Rate Accuracy	18-321 BPM $\pm$ 3 digits (as per predicate)	18-300 $\pm$ 3 digits

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

The document primarily relies on the clinical validation of the predicate device (DEN160020) for the CRI algorithm. It does not provide details of the sample size or data provenance for a test set specifically for the CRI M1's algorithm, as the algorithm itself is considered identical.

For SpO2 accuracy, the document states: "The clinical study determining the SpO2 accuracy for the Nonin OEM III." The Nonin OEM III board is integrated into the M1. No specific sample size or provenance for this SpO2 study is given in this document, but it refers to the prior clearance of the Nonin OEM III.

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)

This information is not provided in the document. The scientific justification for the CRI algorithm's validity and clinical data requirements are stated as being fulfilled because "The CRI algorithm is identical to that in DEN160020." Therefore, this information would reside within the predicate device's 510(k) submission.

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

This information is not provided in the document. As with point 3, this would be detailed in the predicate device's submission.

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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is not mentioned. The device provides a Compensatory Reserve Index (CRI) as an adjunct to traditional hemodynamic measures, not a system that assists human readers in interpreting images or complex data in an MRMC study context. The focus is on the device providing a physiological parameter (CRI) for clinicians to use.

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

The document implicitly confirms standalone performance for the CRI algorithm. The CRI algorithm is stated to be identical to the predicate and is responsible for calculating the CRI value based on non-invasive arterial pulsatile waveform signals. The device itself (CipherOx CRI M1) processes these signals and displays the CRI. This is an "algorithm only (without human-in-the-loop performance)" scenario for the calculation and display of CRI. However, the interpretation and use of CRI is explicitly "as an adjunct to rather than as a replacement for traditional hemodynamic measures," requiring a qualified medical provider.

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

The document states that the "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." However, it then reiterates, "The CRI algorithm is identical to that in DEN160020." This implies the ground truth and reference methods were established during the validation of the predicate device. The specific type of ground truth (e.g., invasive hemodynamic measurements, controlled blood loss studies) is not detailed in this submission but would be in DEN160020.

8. The sample size for the training set

This information is not specified in the document for the CRI M1. As the CRI algorithm is entirely referenced to the predicate device (DEN160020), any training set details would be found in that submission.

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

This information is not specified in the document for the CRI M1, for the same reason as point 8.

Summary

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July 24, 2018

Flashback Technologies, Inc. Paul Dryden Consultant 80 Health Park Drive, Suite 20 Louisville, Colorado 80027

Re: K173929

Trade/Device Name: CipherOx CRI M1 Regulation Number: 21 CFR 870.2200 Regulation Name: Adjunctive Cardiovascular Status Indicator Regulatory Class: Class II Product Code: PPW Dated: June 20, 2018 Received: June 21, 2018

Dear Paul Dryden:

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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Shawn W. Forrest -A for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K173929

Device Name

CipherOx™ CRI M1

Indications for Use (Describe)

For patients with a finger thickness of 0.3'' to 1'' in hospital and pre-hospital settings.

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K173929

510(k) Summary Page 1 of 7 23-Jul-18

Company:	Flashback Technologies, Inc.80 Health Park Drive, Suite 20Louisville, CO 80027
Official Contact:	Dr. Greg Grudic, CO-Founder, CO-President, CTOPhone: 720-204-2575
Proprietary or Trade Name:	CipherOx CRITM M1
Common/Usual Name:	Adjunctive cardiovascular status indicator
Classification Name:	21 CFR 870.2200Procode – PPWAdjunctive cardiovascular status indicatorClass II
Predicate Device:	DEN160020- Flashback Technologies – CipherOx CRITM Table

Device Description:

The CipherOx CRI™ M1 is a modification of the predicate device, the CipherOx CRI Tablet (DEN160020). The M1 is a smaller version of the Tablet that is designed for increased portability.

The CipherOx CRI™ M1 incorporates:

1. CRI™ algorithm
Nonin pulse ox sensor (8000AA K080255) 2.
- a. The 8000AA is an off-the-shelf finger clip sensor. It is designed to be used with the Nonin OEM III pulse oximetry module integrated in the M1 User Interface Module.
1. M1 User Interface module which is a small, portable, battery powered unit that displays heart rate. SpO2, and CRI™.
- a. It contains a color display, processor, and the Nonin OEM III internal pulse oximeter module.
  - i. Nonin designed the OEM III specifically for integration into devices such as the M1. The OEM III converts analog signals from the attached finger sensor into a stream of digital data that provides heart rate, SpO2, and PPG.

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510(k) Summary Page 2 of 7 23-Jul-18

Indications for Use:

The CipherOx™ CRI M1is indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia.

For patients with a finger thickness of 0.3" to 1" in hospital and pre-hospital settings.

Patient Population:

Based upon the validation studies - supine adults (19-36 years old) under non-motion conditions excluding patients with cardiovascular diseases.

Environment of Use:

Hospital and pre-hospital settings. a

Contraindications:

The contraindications of the CipherOx™ CRI M1

Do not use the device in an MR environment, in an explosive atmosphere, or on infant or neonatal patients.
This device is not defibrillation proof per IEC 60601-1. ●

Predicate Device Comparison

Table 1 - Comparison to the Predicate

CHARACTERISTICS	Subject Device"CipherOx CRI M1"	Predicate"CipherOx CRI Tablet"DEN160020
Indications for Use	The CipherOx CRI M1 is indicated forcontinuous noninvasive monitoring offunctional oxygen saturation of arterialhemoglobin (SpO2), pulse rate (measuredby an SpO2 sensor), and theCompensatory Reserve Index (CRI),which trends changes in intravascularvolume relative to the individual patient'sresponse to hypovolemia.	The CipherOx CRI Tablet is indicated forcontinuous noninvasive monitoring offunctional oxygen saturation of arterialhemoglobin (SpO2), pulse rate (measuredby an SpO2 sensor), and the CompensatoryReserve Index (CRI), which trends changesin intravascular volume relative to theindividualpatient's response to hypovolemia.
	For patients with a finger thickness of 0.3"to 1" in hospital and pre-hospital settings.CRI trends with changes in intravascularvolume relative to the individual patient'sresponse to hypovolemia, and should onlybe used by qualified medical providers as	For patients with a finger thickness of 0.3"to 1" in hospital and pre-hospital settings.CRI trends with changes inintravascular volume relative to theindividual patient's response tohypovolemia. and should only be used by
Type of use	Continuous	Continuous
Motion	Non-motion	Non-motion
Patient Population	adults (19-36 years old)	adults (19-36 years old)
Perfusion	Well	Well
Environment of Use	Hospital and prehospital settings	Hospital and prehospital settings
Technology	Transmissive	Transmissive
Batteries	1.5V AAA batteries	3400Wh Lithium Ion Battery
Characteristics
SpO2 Display Range	0% to 100% SpO2	0% to 100% SpO2
Pulse rate declared accuracy range	18-321 BPM	18-321 BPM
Compensatory Reserve Index	0-1.0 numeric with graph	0-1.0 numeric with graph
Accuracy
SpO2	$\pm$ 2 digits	$\pm$ 2 digits
Pulse rate	18-300 $\pm$ 3 digits	20-250 $\pm$ 3 digits
Display
LCD	Daylight readable TFT-color, 2.4"	Multi-pixel 3 digits
Pulse strength indicator	None	None
Data Displayed	SpO2, pulse rate, CRI, trend (CRI)	SpO2, pulse rate, CRI, trend (CRI)
Application site	Digits	Digits
Data output	Front panel easy-to-read display (LCD)	Front panel easy-to-read display (LCD)
Operation mode	Continuous	Continuous
LED wavelengths (multiple)	660 and 910 nm	660 and 910 nm
Compensatory Reserve Index
Hardware	Nonin OEM III internal pulse oximeter module, Nonin 8000AA sensor microcontroller based	Nonin 9560 Pulse Oximeter with integrated sensorTablet
Software	Flashback CRI algorithm	Flashback CRI algorithm
Physical
Degree of protection against electric shock	Type BF - applied part	Type BF - applied part
Functional and safety testing	ES 60601-1IEC 60601-1-2IEC 60601-1-12ISO 80601-2-61	ES 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-1-12ISO 80601-2-61
Biocompatibility	Surface contactSkinLimited duration (<24 hours)	Surface contactSkinLimited duration (<24 hours)

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510(k) Summary Page 3 of 7

23-Jul-18

Substantial Equivalence Discussion

Indications –

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510(k) Summary Page 4 of 7 23-Jul-18

The CipherOx CRI M is indicated for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia. For patients with a finger thickness of 0.3' to 1' in hospital and pre-hospital settings.

Patient Population -

The patient population is identical - adults (19-36 years old)

Environment of Use -

The environment of use for use is identical - hospital and pre-hospital settings

Prescriptive -

The "CipherOx CRI M1" and "CipherOx CRI Tablet" are prescriptive.

Design and Technology -

The "CipherOx CRI M1" and "CipherOx CRI Tablet" have equivalent technological and design features. They both calculate SpO2 and pulse by use of the same technology – the ratio of red and infrared signals of light propagated through the tissue between light sources and detector. Both devices use Photoplethysmography (PPG) signals of red and infrared light through tissue to calculate SpO2 and pulse rate. Both device use PPG signals to calculate the Compensatory Reserve Index.

Performance Specifications -

The "CipherOx CRI M1" and "CipherOx CRI Tablet" have equivalent specifications.

Compliance with standards -

The "CipherOx CRI M1" complies with AAMI/ANSVES60601-1, IEC 60601-1-2, IEC 60601-1-12, and ISO 80601-2-61. The predicate complied with these plus IEC 60601-1-11.

Non-clinical performance testing

Bench -

We have performed bench tests and found that the CipherOx CRI M1 met all requirements specifications and standards requirements and was found to be equivalent in comparison to the predicate. Testing includes the following:

. Verification Testing
Testing for compliance to AAMI/ANSI/ES 60601-1 ●
Testing for compliance to IEC 60601-1-2
Testing for compliance to IEC 60601-1-12
Testing for compliance to IEC 80601-2-61

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510(k) Summary Page 5 of 7 23-Jul-18

The results demonstrate that the devices perform as intended, are substantially equivalent to the performance of the predicate and in accordance with applicable standards.

Biocompatibility / Materials -

The patient contacting materials are part of the Nonin 8000AA sensor. The sensor has been cleared as part of K080255. The Nonin 8000AA sensor used with the CipherOx CRI™ M1 is identical to the cleared device.

Clinical Testing -

The clinical study determining the SpO2 accuracy for the Nonin OEM III.

Differences -

Differences are primarily related to the predicate "CipherOx CRI Tablet" used a discreet SpO2 monitor (Nonin 9560) that communicated via wireless to a tablet where compensatory reserve data was calculated and displayed. The tablet also mirrored data from the Nonin 9560. The "CipherOx CRI M1" connects directly to a sensor and contains hardware and software for calculating HR, SpO2 and compensatory reserve index. The SpO2 calculations are performed by the Nonin OEM III board. The OEM III board has been demonstrated by UL to function in the CipherOx CRI M1 and has previously been FDA cleared as part of multiple medical devices.

Other differences relate to the battery and range of detected beats per minute which do not alter the function or raise concerns of safety.

We maintain these differences do not raise different questions of safety or effectiveness when compared to the predicate device for the proposed indications for use.

Special Controls

These devices have Special Controls requirements we have reviewed the Special controls which include.

Control	Evidence
1. Software description, verification and validation based oncomprehensive hazard analysis must be provided including:

a. Full characterization of technical parameters of the software,including any proprietary algorithm(s);	Software Description

b. Description of the expected impact of all applicable sensoracquisition hardware characteristics on performance and anyassociated hardware specifications;	Software Description


c. Specification of acceptable incoming sensor data qualitycontrol measures;	Software Description

d. Mitigation of impact of user error or failure of anysubsystem components (signal detection and analysis, datadisplay, and storage) on accuracy of patient reports;	Software Description


23-Jul-18
2. Scientific justification for the validity of the status indicatoralgorithm(s) must be provided. Verification of algorithmcalculations and validation testing of the algorithm using a dataset separate from the training data must demonstrate thevalidity of modeling;	The CRI algorithm is identical tothat in DEN160020. Critical aspectsof hardware such as bandpass,sample rate are identical.
3. Usability assessment must be provided to demonstrate thatrisk of misinterpretation of the status indicator is appropriatelymitigated;	Usability assessment provided.
4. Clinical data must be provided in support of the intended useand include the following:
a. Output measure(s) must be compared to an acceptablereference method to demonstrate that the output measure(s)represent(s) the predictive measure(s) thatthe device provides in an accurate and reproducible manner;	The CRI algorithm is identical tothat in DEN160020. Critical aspectsof hardware such as bandpass,sample rate are identical.
b. The data set must be representative of the intended usepopulation for the device. Any selection criteria or limitationsof the samples must be fully described andjustified;	The CRI algorithm is identical tothat in DEN160020. Critical aspectsof hardware such as bandpass,sample rate are identical.
c. Agreement of the measure(s) with the reference measure(s)must be assessed across the full measurement range;	The CRI algorithm is identical tothat in DEN160020. Critical aspectsof hardware such as bandpass,sample rate are identical.
d. Data must be provided within the clinical validation study orusing equivalent datasets to demonstrate the consistency of theoutput and be representative of the range of data sources anddata quality likely to be encountered in the intended usepopulation and relevant use conditions in the intended useenvironment;	The CRI algorithm is identical tothat in DEN160020. Critical aspectsof hardware such as bandpass,sample rate are identical.
5. Device labeling must include the following:
a. The type of sensor data used, including specification ofcompatible sensors for data acquisition;	User manual includes this warning
b. A description of what the device measures and outputs to theuser;	User manual includes thisinformation
c. Warnings identifying sensor reading acquisition factors thatmay impact measurement results;	User manual includes thisinformation
d. Guidance for interpretation of the measurements, includingwarning(s) specifying adjunctive use of the measurements;	User manual includes thisinformation
e. Key assumptions made in the calculation and determinationof measurements;	User manual includes thisinformation
f. The measurement performance of the device for all presentedparameters, with appropriate confidence intervals, and thesupporting evidence for this performance; and	User manual includes thisinformation
g. A detailed description of the patients studied in the clinicalvalidation (e.g., age, gender, race/ethnicity, clinical stability) aswell as procedural details of the clinical study	User manual includes thisinformation

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510(k) Summary Page 6 of 7

23-Jul-18

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510(k) Summary Page 7 of 7 23-Jul-18

Substantial Equivalence Conclusion -

The "CipherOx CRI M1" is substantially equivalent to the predicate in: indications for use, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. The differences do not raise different questions of safety or effectiveness when compared to the predicate device for the proposed indications for use.

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.