Body Fat Analyzer and Scale measures body weight and impedance and estimates percentage of body fat, body water and body muscle mass using BIA (bioelectrical impedance analysis). It is intended for use by healthy adults 18 years of age or older who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy for body composition assessment in the home environment.

Device Description

The patient steps on the scale device, where four electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Conmo Electronic Company Limited Body Fat Analyzer and Scale provides weight, calculates the body fat, body water and body muscle mass. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance, height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.

AI/ML Overview

The Conmo Electronic Company Limited Body Fat Analyzer and Scale, Model 5786, measures body weight and impedance and estimates the percentage of body fat, body water, and body muscle mass using Bioelectrical Impedance Analysis (BIA). The provided 510(k) summary states that clinical testing was used to validate the effectiveness and accuracy of the device, with all test results reported as satisfactory. However, the document does not explicitly detail specific acceptance criteria or the study design (e.g., sample size, expert involvement, ground truth methodology) for this clinical testing.

Based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state specific numerical acceptance criteria for accuracy, precision, or other performance metrics. It only states that "Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." Without specific criteria, a direct comparison is not possible.

Performance Metric	Acceptance Criteria (as stated in document)	Reported Device Performance (as stated in document)
Effectiveness	Not explicitly defined (implied satisfactory performance)	"All test results were satisfactory"
Accuracy	Not explicitly defined (implied satisfactory performance)	"All test results were satisfactory"

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

Sample Size for Test Set: Not specified
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "Clinical testing."

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

Number of Experts: Not specified
Qualifications of Experts: Not specified

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. The document does not provide details on how discrepancies in ground truth establishment (if any) were resolved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC comparative effectiveness study was not mentioned or described in the document. This type of study typically involves human readers interpreting diagnostic images or data with and without AI assistance to measure the effect size of AI improvement. The device in question is a standalone measurement device for body composition, not an AI-assisted diagnostic tool.

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

Standalone Performance: While the device functions as a standalone unit (measurements are taken by the device and calculations performed by internal software), the document does not provide a detailed breakdown of a standalone performance study with specific metrics beyond the general statement of "satisfactory" effectiveness and accuracy. The clinical testing mentioned seems to assess the overall device performance which, by its nature, is standalone as it outputs direct measurements.

7. The Type of Ground Truth Used

Type of Ground Truth: The document does not explicitly state the specific "ground truth" method used for the clinical validation of body fat, body water, or body muscle mass. For body composition devices, common ground truth methods include:
- DEXA (Dual-energy X-ray absorptiometry): A gold standard for body composition.
- Hydrostatic weighing: Another accurate method.
- Air displacement plethysmography (Bod Pod): Also considered accurate.
- Calipers: For skinfold thickness.
  Without this information, it's unclear against what highly accurate measurement the device's outputs were compared.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not specified. The document describes a device that performs calculations based on Bioelectrical Impedance, height, weight, age, and gender using "internal software." It does not describe a machine learning or AI model that requires a distinct "training set" in the conventional sense. The "internal software" likely uses established BIA equations rather than a learned model from a large dataset.

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

Ground Truth for Training Set: Not applicable/Not specified. As there is no mention of a training set for a machine learning model, the method for establishing ground truth for such a set is not relevant here. The device's calculations are based on programmed variables and scientific formulas for BIA.

Summary

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MAY 3 0 2014

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: March 21, 2014

Company and Correspondent making the submission:

Name - Conmo Electronic Company Limited

Address - 3/F, Building 3, 1-5, Fusen Industrial Zone, Hangcheng Road, Xixiang

Town, Baoan, Shenzhen City, Guangdong Province, China

Telephone - +86-755-61526855

Fax - +86-755-61526855

Contact - Wei Qi

Email - charliemack@irc-us.com

Device :

Trade/proprietary name: Body Fat Analyzer and Scale, Model 5786

Common Name : Analyzer, Body Fat

Classification Name : Impedance plethysmograph

3. Predicate Devices :

Tanita BC-533, (K040778)

1. Classifications Names & Citations :
  21CFR 870.2770, MNW, Body Fat Analyzer, Class 2

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5. Description :

5.1 General

5.2 Directions:

As discussed in the General description, the Conmo Electronic Company Limited Body Fat Analyzer and Scale is relatively simple to use. The user inputs the variable data of age, height, and gender. The user steps onto the scale and the devices measures the user weight and body impedance (via the Bioelectric Impedance through the four electrodes on the scale). The scale displays the user's weight, body fat composition, body water and body muscle mass.

6. Indication for use :

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1. Comparison with predicate device :
  Conmo Electronic Company Limited believes that the Body Fat Analyzer and Scale, Model 5786 is substantially equivalent to the Tanita BC-533 (K040778).
1. Safety and Performance Data :
  Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1. Electromagnetic compatibility was verified with testing to IEC 60601-1-2. In Vitro cytotoxicity was verified with testing to ISO 10993-5 and skin irritation and sensitization was verified with testing to ISO 10993-10. Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory.
1. Conclusions:
  In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Conmo Electronic Company Limited concludes that the Body Fat Analyzer and Scale, Model 5786 is safe and effective and substantially equivalent to predicate devices as described herein.

END

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 30, 2014

Conmo Electronic Company Limited % Charles Mack Principal Engineer IRC 12226 Washington Lane Parker. AZ 85344

K140594 Re:

Trade/Device Name: Body Fat Analyzer and Scale, Model 5786 Regulation Number: 21 CFR8 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: March 22, 2014 Received: April 1, 2014

Dear Charles Mack,

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.

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Page 2 - Charles Mack

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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for Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K140594

Device Name

Body Fat Analyzer and Scale, Model 5786

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

2014.05.30

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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.