The CardioBelt™ is a single patient reusable electrode system intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. The CardioBelt™ is compatible for use with Bluetooth equipped ECG instruments capable of receiving Bluetooth™ Serial Port Protocol.

Device Description

The Monebo CardioBelt™ is a reusable electrode system consisting of an electrode assembly, an elastic chest belt, and an electronics package containing a Bluetooth transceiver. The CardioBelt™ electrodes are positioned against the patient's skin with light pressure, using the elastic chest belt. The CardioBelt™ is designed to be used without electrolytic gels and without adhesives on unprepared skin; that is without the requirements for shaving, abrading, or other skin preparation. The CardioBelt transmits ECG information to a compatible Bluetooth enabled device. The CardioBelt contains a class II Bluetooth radio with a range of approximately 30 feet (spherical range). The CardioBelt™ is powered by a rechargeable lithium ion battery. The electronics package must be physically separated from the electrode belt to charge the battery.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a comprehensive study report with specific performance metrics for the Monebo CardioBelt™ Electrode Belt. Instead, it offers a summary of verification and validation testing, and mentions a comparative study, but lacks the granular data requested in the prompt.

However, based on the information provided, here's what can be extracted and inferred:

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

The document mentions that the device "meets the generally accepted safety testing requirements for an EC38 1.2 c type 3 ECG device" and "meets the clinical requirements." It also states the device was found to be "easy to use and useful for ambulatory monitoring and as a screening tool to determine normal or pathologic ECG's."

Acceptance Criteria (Inferred from testing standards and stated conclusions)	Reported Device Performance
Compliance with EC38, EN60601-1, EN60601-2-27	Device found to meet these standards.
Functional features and safety comparable to predicate device	Successfully underwent bench and clinical testing to demonstrate this.
Clinical utility (ease of use, usefulness for monitoring/screening)	Found to be "easy to use and useful for ambulatory monitoring and as a screening tool to determine normal or pathologic ECG's."
Risk assessment (moderate level of concern met)	System risk assessment 8024-0002-00 Rev1 performed, device characterized as a moderate level of concern.
Biocompatibility	Evaluated and found to be satisfactory.
Accuracy for distinguishing normal/pathologic ECGs (compared to 12-lead ECG)	Found useful for screening to determine normal or pathologic ECG's in a comparative study against a 12-lead ECG.

2. Sample size used for the test set and the data provenance

The text mentions "a study at Bad Oeynhausen Herzzentrum hospital in Germany" that "compared the performance of the single lead Cardiobelt to a 12 lead ECG (Gold Standard)."

Sample Size: Not specified.
Data Provenance: Prospective (implied by "a study"), from Bad Oeynhausen Herzzentrum hospital in Germany.

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

The document does not specify the number or qualifications of experts involved in establishing ground truth for the clinical study. It only mentions the comparison to "a 12 lead ECG (Gold Standard)," implying that the interpretation of the 12-lead ECG by clinicians would serve as the ground truth.

4. Adjudication method for the test set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in the ground truth or the device's output.

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

The document describes a comparative study between the CardioBelt and a 12-lead ECG. However, this was a comparison of the device's performance against a gold standard, not a multi-reader multi-case study evaluating the improvement of human readers with AI assistance versus without. The CardioBelt is described as a "single lead acquisition system that transmits ECG data via Bluetooth™ communication to a generic Bluetooth™ recording and/or analysis system. The device does not perform ECG analysis." Therefore, it's not an AI-assisted device in the context of interpretation.

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

This is not directly applicable as the CardioBelt is an electrode system for acquiring ECG data, not an algorithm for analyzing it. The device itself is "algorithm-only" in the sense that it doesn't involve human interpretation for its primary function (data acquisition). However, the results of the acquired ECG data would then be interpreted by a physician. The statement "The device does not perform ECG analysis" reinforces that it's a data acquisition tool, not an analytical one.

7. The type of ground truth used

For the clinical study, the ground truth was established by comparison to a 12-lead ECG (Gold Standard). This implies expert interpretation of the 12-lead ECG to determine "normal or pathologic ECG's."

8. The sample size for the training set

The document does not mention any "training set." This device is an electrode belt that acquires physiological signals, not an AI/machine learning algorithm requiring a separate training phase. The described testing (bench and clinical) is for verification and validation of the hardware and its ability to acquire data reliably.

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

Not applicable, as there is no mention of a training set for this device.

Summary

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510(k) Summary

Monebo CardioBelt™ Electrode Belt

MAR 2 3 2007

063044 K

Monebo Technologies, Inc Submitter: 1800 Barton Creek Blvd Austin, TX 78735-1606 Telephone: 512.732.0235 512.732.0285 Facsimile: Contact person: Dale J. Misczynski President and CEO

Date of Preparation: October 2, 2006

Device Name:	Proprietary Name: CardioBelt™ Electrode Belt
Common Name:	Electrocardiograph Electrode
Classification Name:	Electrocardiograph Electrode

Regulatory Classification:

Class:	II, 21 CFR 870.2360
Medical Specialty Panel:	Cardiovascular
Product Code:	74 DRX

Devices to Which Substantial Equivalence is Claimed:

Device Name:	AccuHeartTm Electrode Belt
510(k) Number:	K043361
Device Name:	Medi-Trace 200 and Medi-Trace 200-30 ECG Electrodes
510(k) Number:	K960968
Device Name:	CardGuard CG-2211 SelfChek
510(k) Number:	K012223

Device Description:

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The CardioBelt™ is powered by a rechargeable lithium ion battery. The electronics package must be physically separated from the electrode belt to charge the battery.

KO6304

Intended Use:

The CardioBelt™ is a reusable electrode system intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. The CardioBelt™ is compatible for use with Bluetooth equipped ECG instruments capable of receiving Bluetooth™ Serial Port Protocol.

Functional and Safety Testing:

Monebo's CardioBelt™ has successfully undergone both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate device.

The CardioBelt™ was tested and verified in accordance with 3510-0002-01 Rev1 CardioBelt Verification and Validation test plan. The following is a summary of the testing performed on the device. Specific test records can be found in the Monebo Document Control center.

The system risk assessment 8024-0002-00Rev1 was performed and the device was characterized as a moderate level of concern. The system safety and risk analysis conducted for the CardioBelt provided a rigorous design and structural evaluation aimed at identifing potential failures or possible system flaws which could directly or indirectly affect the patient. The device is a single lead acquisition system that transmits ECG data via Bluetooth™ communication to a generic Bluetooth™ recording and/or analysis system. The device does not perform ECG analysis.

Engineering and Verification Testing:

Engineering testing was performed to test compliance with the system requirements and risk assessment documents. Supporting test reports can be found in the Monebo Document control center. The tests were performed in accordance with EC38, EN60601-1 and EN60601-2-27. The device is classified as a Type 3 device using the EC38 1.2 c type definition. The device biocompatibility was evaluated and found to be satisfactory. 8051-0002-01 Rev-1tracability matrix was developed to track the verification of the system requirements 8012-0002-00 and hazard mitigations. The testing was conducted per EC38 test methods and the tests include:

Common Mode Rejection Tests Frequency Response Tests Input Dynamic Range Tests Overall System Error Tests Step Response Tests System Noise Tests Battery Life Tests Communication Test

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K063044 p.314

External Testing and Certification:

Third party testing was performed to assess compliance for Electromagnetic Compatibility, Medical Equipment General Safety requirements and Essential performance requirements for ECG devices.

EMC Testing Laboratories, Inc was used to determine compliance with:
EN301-489-1	ERM and EMC for Radio Equipment and Services
EN301-489-17	EMC for 2.4Ghz Radio Equipment EMC
EN61000-4-2	Electrostatic Discharge Testing
EN61000-4-3	Radiated Electromagnetic Fields
EN61000-4-11	Voltage Dips, Short Interrupts and Voltage Variations
CISPR22	Measurements of Radio Frequency Interference
EN55022	Radio Frequency Interference for Information Technology
EN61000-3-2	Limits of harmonic current emissions
EN61000-3-3	Limitation of voltage fluctuations and flicker in low voltage supplysystems
EN60601-1	Medical electrical equipment - Part 1: General requirements for safety
EN60601-2-27	Particular requirements for the safety, including essentialperformance, of electrocardiographic monitoring equipment

High and low Temperature Tests Leakage Current Tests Dielectric Strength Tests Safe Current Tests Ingress of Liquid Tests EMC and Immunity Tests Mechanical Shock Tests

Third party verification reports are included with this submission and can be found in the Monebo Document Control Center. The reports indicate compliance with the general safety standards and with EN60601-1 and EN60601-2-27 ECG standards mentioned above.

Validation

Validation was conducted in accordance with 3510-0002-00 Rev 1 Verification and Validation test plan. The device and manual were evaluated for safety and clinical utility. The validation report can be found in the Monebo document control center. The report indicates that the device meets the clinical requirements and that the documentation is sufficient for operating the device in a clinical or home care environment. A white paper is included for review. The white paper was generated from a study at Bad Oeynhausen Herzzentrum hospital in Germany. The study compared the performance of the single lead Cardiobelt to a 12 lead ECG (Gold Standard). The CardioBelt was found to be easy to use and useful for ambulatory monitoring and as a screening tool to determine normal or pathologic ECG's.

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Conclusions

Based on verification and validation testing the unit was found to meet the generally accepted safety testing requirements for an EC38 1.2 c type 3 ECG device. The device has a moderate level of concern based on the risk assessment 8024-0002-00. The Cardiobelt constitutes a safe and reliable means for transmitting ECG data. Its material composition and operation present no adverse health effect or safety risks to patients when used as intended.

Monebo's CardioBelt is substantially equivalent to the AccuHeart Electrode Belt.

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Image /page/4/Picture/11 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2007

Monebo Technologies Inc. c/o Dale J. Misczynski President and CEO 1800 Barton Creek Blvd. Austin, TX 78735-1606

Re: K063044

Trade/Device Name: CardioBelt Electrode Belt Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: Class II Product Code: DRX Dated: March 16, 2007 Received: March 19, 2007

Dear Mr. Misczynski:

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. Misczynski

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.

B.H. Mumma 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

Applicant: Monebo Technologies, Inc

510(k) Number (if known)

Device Name: Monebo CardioBelt™ Electrode Belt

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over -the Counter -----

(Please Do Not Write Below This Line - Continue On Another Page if Needed) Concurrence of CDRH Office of Device Evaluation (ODE)

Blummo

Division of Cardlovas 510px) Number

Regulation Number and Section

§ 870.2360 Electrocardiograph electrode.

(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.