Wi-Fi body scale, model HS5 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults,,who are not ill, feverish, have a chronic or acute disease, or a condition that affect the level of hydration such as pregnancy.

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 uA, at 50 kHz, the Wi-Fi body scale calculates the body fat percentage. 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. Wi-Fi body scale, model HS5 can be used with an iPod Touch, iPhone or iPad.

AI/ML Overview

The provided text describes the "Wi-Fi body scale, model HS5" and its predicate device, the "Body Analysis Scale, Model BG 17 (K110928)". This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical trial results with specific acceptance criteria and performance metrics for a novel device.

Therefore, many of the requested details regarding acceptance criteria, specific study design elements (sample size for test set, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, training set details), and ground truth establishment are not explicitly provided in this document.

However, I can extract the following information based on the text:

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

The document does not provide a table of acceptance criteria with specific quantitative targets for "Wi-Fi body scale, model HS5." It states that "Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." This is a qualitative statement of compliance rather than a presentation of specific performance metrics against predefined acceptance criteria.

The "Comparison to the predicate device" section mentions that the Wi-Fi body scale, model HS5 is "substantially equivalent" to the predicate device. This implies that its performance is considered acceptable if it matches or is sufficiently similar to the predicate device.

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

Sample size for test set: Not explicitly stated. The document refers to "Clinical testing" but does not give the number of participants.
Data provenance: Not explicitly stated. The document does not mention the country of origin of the data or whether the study was retrospective or prospective.

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)

Not applicable or not provided. This device measures physiological parameters directly. While its accuracy might be compared to a "gold standard" measurement method, there's no indication of "experts" establishing a ground truth in the context of interpretation, as might be the case for imaging devices.

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

Not applicable or not provided. Adjudication methods are typically used when multiple human readers interpret data that requires expert consensus for ground truth, which is not the type of data or evaluation described for this device.

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

Not applicable. This device is a standalone measurement tool (a body scale) and does not involve human readers interpreting data or an AI assisting in interpretation. It directly calculates body composition parameters using Bioelectrical Impedance Analysis (BIA).

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

Yes, implicitly. The device itself performs the calculations using the Bioelectrical Impedance Method. The performance described ("Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory.") refers to the device's ability to produce these measurements independently. There is no human interaction in the calculation process or "in-the-loop" assistance for the device's function.

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

Not explicitly stated. For body composition devices like this, the "ground truth" for clinical testing would typically involve comparison to established, more accurate body composition measurement methods (e.g., DEXA scan, hydrostatic weighing, or other validated impedance devices) rather than expert consensus or pathology. The document only mentions "Clinical testing was used to validate the effectiveness and accuracy of the device," without specifying the precise ground truth method.

8. The sample size for the training set

Not applicable or not provided. The document describes a medical device, not a machine learning model that would typically have a "training set" for an algorithm in the traditional sense, though the internal software performs calculations based on an algorithm. The 510(k) summary focuses on the device as a whole and its "clinical testing" or validation, not the development of a specific algorithm within it.

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

Not applicable or not provided, as there is no mention of a "training set" for a machine learning algorithm in the context of this 510(k) summary. The BIA method is a well-established physiological principle, and the device implements this method through internal software.

Summary

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510(k) Summary Jun 2 8 2012

K121527

PAGE 1 OF 4

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

1.0 submitter's information

Name: Shenzhen Healthcare Electronic Technology Co., Ltd. Address: 2/F, Block B, Tsinghua Information Termi North Zone Of Hi-Tech Industrial Park,Na Shenzhen, CHINA 518057 Phone number: 86-755-27179235 Fax number: 86-755-27179236 Contact: Mrs. SHELLY SHI Date of Application: 05/10/2012

2.0 Device information

Trade name:	Wi-Fi body scale, model HS5
Common name:	Body Analysis scale/ Electronic Body Fat Scale
Classification name:	Impedance plethysmograph

3.0 Classification

Production code: MNW- Body Fat Analyzer. Regulation number: 870.2770 Classification: II Panel: Cardiovascular

4.0 Predict device information

Shenzhen Healthcare Electronic Technology Co., Ltd Manufacturer: Body Analysis Scale, Model BG 17 Device: 510(k) number: K110928

5.0 Device description

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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. Wi-Fi body scale, model HS5 can be used with an iPod Touch, iPhone or iPad.

6.0 Intended use

7.0 Summary comparing technological characteristics with predicate device

	Wi-Fi body scale, model HS5	Body Analysis Scale, Model BG 17(K110928)	Same or not?
Intended use	Wi-Fi body scale, model HS5 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults,,who are not ill, feverish, have a chronic or acute disease, or a condition that affect the level of hydration such as pregnancy.	Body Analysis Scale, Model BG 17 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults,,who are not ill, feverish, have a chronic or acute disease, or a condition that affect the level of hydration	Same

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		such as pregnancy.
ProductDescription	Wi-Fi body scale, modelHS5 is indicated tomeasure body weight,estimate body fat,body waterpercentage, bodymuscle mass, bonesmass, visceral fatrating and daily calorieintake (DCI) using BIA(bioelectricalimpedance analysis).	Body Analysis Scale,Model BG 17 isindicated to measurebody weight,estimate body fat,body waterpercentage, bodymuscle mass, bonesmass, visceral fatrating and dailycalorie intake (DCI)usingBIA(bioelectricalimpedance analysis).	Same
Analyticalmethod	BIA(bioelectricalimpedance analysis)	BIA (bioelectricalimpedance analysis)	Same

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

and the comments of the comments of

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8.0 Performance summary

Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 and EN/IEC 60601-1-2. Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory.

9.0 Comparison to the predict device and the conclusion

Our device Wi-Fi body scale, model HS5 is substantially equivalent to the ody Analysis Scale, Model BG 17 whose 510(k) number is K110928.

The two devices are very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Wi-Fi body scale, model HS5 can be used with an iPod Touch, iPhone or iPad.

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three stylized lines that suggest the bird's head, body, and tail.

Public Health Service

JUN 28 2012

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

Shenzhen Healthcare Electronic Technology Co., Ltd. % Ms. Yang Wang Andon Health Co., Ltd. No 3. Jinping Road Ya'an Street, Nankai District TIANJIN 300190 CHINA

Re: K121527

Trade/Device Name: Wi-Fi body scale, model HS5 Regulation Number: 21 CFR& 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: May 23, 2012 . Received: May 30, 2012

Dear Ms. Wang:

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 (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. twho

Benjamin 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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Statement of Indications for Use

510(k) Number :

121527

Device name:

Wi-Fi body scale, model HS5

Indications for use:

Prescription use Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR YES (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Huber Steur

ductive, Gastro-Renal, and

Page 1 of 1

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.