The Cheetah Reliant is a portable, non-invasive Cardiac Output monitoring device based on bio-impedance Cardiography. The Cheetah Reliant system is intended to monitor and display a patient's Cardiac Output in units of Ltr/min.

Device Description

The Cheetah Reliant is a portable, non-invasive, Cardiac Output measurement system. The Cheetah Reliant measures the Cardiac Output by employing the electrical bio-impedance measurement technique. Electrical bio-impedance is the characteristic impedance of a volume of tissue and fluid. In the case of Cardiac Output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Cheetah Reliant device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness of the device	Bench testing protocols, module, integration, and system level testing demonstrated safety and effectiveness.
Performance vs. Predicate Device (first generation NICOM System)	Bland-Altman analysis showed symmetrical distribution for CO measurement differences around the bias, and a confidence level of 95% when compared to the 1st generation NICOM System. The device was found to be substantially equivalent.
Compliance with relevant standards	Mechanical and EMC testing was conducted per IEC/EN60601-1, UL 60601-1, and CSA C22.2 No. 601.1.
Ability to monitor and display Cardiac Output in Ltr/min	The study implicitly demonstrates this, as it compares the device's CO measurements to the predicate. The intended use explicitly states this capability ("intended to monitor and display a patient's Cardiac Output in units of Ltr/min").
No adverse health effects or safety risks	Concluded that the device "presents no adverse health effects or safety risks to patients when used as intended."
Substantial equivalence to predicate device	"The device was extensively tested - both Bench and in the human - against its predicate, and was found to be substantially equivalent," and the FDA's letter confirms the determination of substantial equivalence (though this is the FDA's regulatory decision, not directly a study finding).

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

Test Set 1 (Bench Testing - Raw Data):
- Sample Size: 44 patients
- Data Provenance: Retrospective, Intensive Care Unit of Ambroise Pare Hospital in France.
Test Set 2 (Human Testing):
- Sample Size: 23 volunteers
- Data Provenance: Prospective (implied by "testing in the Human (23 volunteers)"). Country of origin is not explicitly stated.

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

This information is not provided in the document. The "ground truth" for the comparative study was the measurements from the 1st generation NICOM System (K042144), which is the predicate device. It's not clear if human experts were involved in establishing the "truth" for either the predicate or the new device's measurements, beyond the doctors/nurses using the equipment in the ICU.

4. Adjudication Method for the Test Set

This information is not provided in the document. The study describes a "comparative study" and "Bland-Altman analysis," which is a statistical method for comparing two measurement techniques, not an adjudication method for reconciling expert opinions.

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, an MRMC comparative effectiveness study was not done.
This device is a Cardiac Output monitoring system, not an AI-based diagnostic tool that assists human readers/interpreters of medical images or data in the traditional sense of an MRMC study. The comparison was between two devices measuring the same physiological parameter.

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

Partially, yes. The device itself is described as "standalone" in the sense that it's compact and uses an embedded processing unit, replacing an external laptop PC. The study compares the performance of this standalone device (Cheetah Reliant) against another device (1st generation NICOM System). The "algorithm only" aspect is inherent to its function as an automated measurement device. There isn't a human-in-the-loop component being evaluated in the study; it's a device-to-device comparison.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this comparative study was the measurements obtained from the 1st generation Cheetah NICOM System (K042144), which served as the predicate device. The study aimed to show substantial equivalence to this established device. It's a comparison to a "standard device measurement" rather than an independent expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not provided in the document. The document describes testing and validation, but not the development or training of an algorithm in the machine learning sense. The device is based on existing bio-impedance measurement techniques.

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

This information is not provided in the document, as there's no mention of a "training set" or algorithm training in the context of machine learning. The device's operation is based on established bio-impedance principles, not on a trained AI model.

Summary

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K072662
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SECTION 5: 510(k) Summary

Submitter

Cheetah Medical Inc. 2138 East 62nd Street, Suite 132 indianapolis, IN 46250 USA office: 317-842-3566 cell: 317-603-1822 fax: 203-413-6721

Contact Person

Benny Arazy Arazy Group Mizpe Aviv. Industrial Park 13 M. P. Misgav 20187. ISRAEL Tel: +972 (4) 994-7880 Fax: +972 (4) 994-4224 e-mail: benny@aarazygroup.com

Image /page/0/Figure/16 description: The image shows a logo for Cheetah Medical, Inc. The logo features a stylized outline of a cheetah in motion. The text "CHEETAH MEDICAL, INC." is printed below the cheetah graphic in a simple, sans-serif font.

JAN 16 2008

Date Prepared

January 2008

Device Information

Trade name: Cheetah Reliant Common name: Portable, non-invasive Cardiac Output monitoring device Classification Name: DSB - (21 CFR 870.2770, "Impedance plethymograph")

Devices to which substantial equivalence is claimed:

510(k) number	Trade or propriety name	Manufacturer
K042144	Cheetah NICOM System	Cheetah Medical, Inc.

Device Description

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K072662
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Intended Use

Device Modification

13 generation Cheetah NICOM System (K042144) was modified to produce a compact, stand alone version - Cheetah Reliant. Modification includes the following: Smaller overall dimensions, the use of an embedded processing unit instead of an external laptop PC, and the addition of an integral LCD display.

A series of bench testing protocols were carried out, throughout the various stages of product development. Final testing included Module level testing, Integration level testing, and finally System level testing. Testing demonstrated the safety and effectiveness of the tested devices.

Validation and verification protocols also included a comparative study of the Reliant performance vs. that of 1st generation NICOM System:

Bench testing, consisting of Raw Data obtained in advance from 44 patients in the Intensive Care unit of Ambroise Pare Hospital in France, as well as testing in the Human (23 volunteers), against 155 generation Nicom. The Bland-Altman showed symmetrical distribution for CO measurement differences around the bias, and a confidence level of 95%.

Mechanical and EMC testing was conducted per IEC/EN60601-1, UL 60601-1, and CSA C22.2 No. 601.1

Conclusion

The Cheetah Reliant, the subject of this submission, constitutes a safe, reliable and effective medical device, meeting all the declared requirements of its intended use. The device presents no adverse health effects or safety risks to patients when used as intended.

The Cheetah Reliant has the same intended use and fundamental scientific technology as the predicate device - 1st generation Cheetah NICOM System (K042144).

The device was extensively tested - both Bench and in the human - against its predicate, and was found to be substantially equivalent

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three overlapping, curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

JAN 16 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cheetah Medical, Inc. c/o Mr. Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M.P. Misgav 20187 ISRAEL

Re: K072662

Trade/Device Name: Cheetah Reliant Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Code: DSB Dated: December 5, 2007 Received: December 21, 2007

Dear Mr. Arazy:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Benny Arazy

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bram Zuckerman, MD Division 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): K072662

Device Name: Cheetah Reliant

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
K Number K072667

Regulation Number and Section

§ 870.2770 Impedance plethysmograph.

(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.