The Transtek Glass Body Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.

Device Description

The TRANSTEK Glass Body Analyzer uses BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water and bone mass. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer. This method simultaneously calculates your personal weight, body fat, total body water, bone mass and muscle mass, giving you a more accurate reading of your overall health and fitness. This scale stores the personal data of up to 8 or 10 users. As well as being an analyzer, this device can be used as a conventional scale.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets said criteria. However, based on the context of a 510(k) summary for a body composition analyzer, we can infer some general information and highlight what is missing.

The document states that the "TRANSTEK Glass Body Analyzer utilizes a "foot-to-foot" bioelectrical impedance analysis (BIA) technology to determine internal body composition" and that "BIA (Bioelectrical Impedance Analysis) technology is same as what is used in Scaleman Body Fat Scales (Model FS-148BW1)." This indicates that the primary "study" for acceptance is a demonstration of substantial equivalence to a predicate device already on the market (K083838, Scaleman Body Fat Scales).

Here's an attempt to answer your questions based on the provided text, while acknowledging the significant gaps in detail regarding a specific performance study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Accuracy of Body Composition Measurements:	The document itself does not provide any specific accuracy metrics (e.g., mean absolute error, R-squared values for correlation with a gold standard) for body fat, total body water, bone mass, or muscle mass measurements. It focuses on demonstrating that the technology (BIA at 50 KHz) and measurement method ("foot-to-foot") are the same as the predicate device.
Weight Measurement Accuracy:	Similar to body composition, no specific accuracy for weight measurement is provided. The device is stated to "measure weight."
Substantial Equivalence:	The core "performance" demonstrated is substantial equivalence to the predicate device, Scaleman Body Fat Scales (Model FS-148BW1), by showing that "the subject devices have all features of the predicate device... except the new features and the power source voltage... These differences do not affect the safety and effectiveness... BIA ... is same as what is used in Scaleman Body Fat Scales."
Intended Use:	The device performs as described in its intended use: "measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only."

2. Sample Size for the Test Set and Data Provenance

The provided 510(k) summary does not contain any information about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The assessment relies on the equivalence to a predicate device, implying that the predicate device's performance is an acceptable benchmark.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set. Since a direct performance study is not detailed, the concept of expert-established ground truth for the device's accuracy isn't applicable in the provided information.

4. Adjudication Method

Not Applicable. No specific test set or ground truth establishment requiring adjudication is described in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. The device is a direct measurement tool (body composition analyzer), not an AI-assisted diagnostic tool requiring human interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only) Performance Study

The provided text does not detail a standalone performance study where the algorithm's accuracy for body composition measurements was rigorously tested against a gold standard. The focus is on demonstrating that the BIA technology used is the same as the predicate device. While BIA itself is an "algorithm" to derive body composition from impedance, the document doesn't provide data on its standalone accuracy.

7. Type of Ground Truth Used

Not explicitly stated for the applicant device. For a body composition analyzer, common gold standards (ground truth) would include DEXA (Dual-energy X-ray absorptiometry) scans, hydrostatic weighing, or isotopic dilution methods. However, the document does not mention that this specific device was tested against such gold standards. Instead, the ground truth is implicitly tied to the accepted performance of the predicate device, which would have undergone such validation during its own clearance process.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This type of information would be relevant if the applicant device involved novel algorithms or machine learning requiring specific training data. Since the device relies on a known technology (BIA) and aims for substantial equivalence, a "training set" in the machine learning sense is not discussed.

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

Since no training set is discussed, the method for establishing its ground truth is not applicable/provided.

Summary

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K102191
PAGE 1 OF 4

WE INSPIRE · WE DELIVER

Section 5 - 510(k) Summary

2 2011

Date of Summary Preparation: 11/22/2010

1. Submitter's Identifications

Submitter's Name: ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. Address: Jin'an Road, Minzhong, Zhongshan City, Guangdong, China Contact Person: Gorden Guo Contact Email Address: gzp@transtek.cn Telephone: 086-760-88282982 ext. 231 Fax: 086-760-85339231

2. Correspondent's Identifications

Correspondent's Name: A03 Lab of BTS Address: No.1 Fanghua Street, Hi-tech Zone, Chengdu City, Sichuan, China Contact Person: Leo Wang Contact Email Address: leo.w@hibts.com Telephone: 086-28-86083300 Fax: 086-4006070050 ext. 8

3. Name of the Device

Device Classification Name: Analyzer, Body Composition (Impedance Plethysmograph) Product Name: TRANSTEK Glass Body Analyzer Trade Name: Transtek Models: GBF-830, GBF-835, GBF-950, SA-15 Classification Panel: Cardiovascular Common/Usual Name: Body Composition Analyzer/Scales Product Code: MNW Device Classification: Class II Contraindications: Do not use the Analyzer if you have a pacemaker or other internal medical device.

4. The Predicate Devices

Fook Tin, Scaleman Body Fat Scales, Model FS-148BW1, K083838

5. Device Description

The TRANSTEK Glass Body Analyzer uses BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water and bone

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mass. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer.

This method simultaneously calculates your personal weight, body fat, total body water, bone mass and muscle mass, giving you a more accurate reading of your overall health and fitness.

This scale stores the personal data of up to 8 or 10 users. As well as being an analyzer, this device can be used as a conventional scale.

6. Intended Use of Device

7. Summary of Substantial Equivalence

Table 1: The difference between TRANSTEK Glass Body Analyzer and the predicate device, Scaleman Body Fat Scales (Model FS-148BW1)

Feature	Proposed Device:TRANSTEK Glass Body AnalyzerModels: GBF-830, GBF-835GBF-950, SA-15	Predicate Device:Scaleman Body Fat ScalesModel: FS-148BW1
510(k) Number	K102191	K083838
Manufacturer	ZHONGSHAN TRANSTEKELECTRONICS CO., LTD	Fook Tin Technologies Ltd.
Classification	21 CFR 870.2770	21 CFR 870.2770
Product Code	MNW	MNW
Indication for use	The Transtek Glass Body Analyzermeasure weight and usesbioelectrical impedance analysis(BIA) technology to estimate bodyfat, total body water percentage,bone mass, and muscle mass ingenerally healthy adults 18 years ofage or older. It is intended for use inthe home/domestic setting only.	The Scaleman Body Fat Scales-Models in "Family Model List 1A"is a series of body compositionanalyzers that measure body weightand impedance and estimatepercentage of body fat and bodywater using BIA (bioelectricalimpedance analysis). They areintended for use by healthy children10-17 years old and healthy adultswith active moderately active to
TRANSTEK		K102191PAGE 3 OF 4
	mass, muscle mass and body fatsimultaneously, thus giving you amore accurate reading of youroverall health and fitness.It is not intended for use by pregnantwomen or children under the age of18.	healthy children 10-17 years oldand healthy adults with active,moderately active, to inactivelifestyles for body compositionassessment in the homeenvironment.
		The Scaleman Body Fat Scales -Models in 'Family Model List 1B' isa series of body compositionanalyzers that measure bodyweight and impedance andestimate percentage of body fatand body water, bone mass andmuscle mass using BIA(bioelectrical impedance analysis).They are intended for use byhealthy children 10-17 years oldand healthy adults with active,moderately active, to inactivelifestyles for body compositionassessment in the homeenvironment.
Devicedescription	TRANSTEK Glass Body Analyzerutilizes a "foot-to-foot" bioelectricalimpedance analysis (BIA)technology to determine internalbody composition.	Scaleman Body compositionanalyzer/scale that utilizes a"foot-to-foot" bioelectricalimpedance (BIA) technology todetermine internal bodycomposition.
Analysismethod	BIA(Bioelectrical Impedance Analysis)	BIA
Operatingparameters	50 KHz	50 KHz
Powersource	GBF-830, 4AAAGBF-835, 2CR2032GBF-950, 4AAASA-15, 2AA	Replaceable 9V or CR2032 or AAAbatteries, depending on the model.
Operatingkeys	GBF-830, GBF-835, GBF-950 (4),SA-15 (3)	Range of 3 to 6, depending on themodel
Number ofelectrodes	4	4 or 2

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Section 5 - 510(k) Summary

Page 3 of 4

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TRANSTEK

8. Conclusions

The subject devices have all features of the predicate device, Scaleman Body Fat Scales (Model FS-148BW1) except the new features and the power source voltage of the device. These differences do not affect the safety and effectiveness of the subject devices : BIA (Bioelectrical Impedance Analysis) technology is same as what is used in Scaleman Body Fat Scales (Model FS-148BW1). Thus, the subject devices are substantially

equivalent to the predicate devices.

--- End of this Section ---

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002

ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. c/o Mr. Leo Wang Consulting Manager A03 Lab of BTS No. 1 Fanghua Street, Hi-tech District Chengdu Sichuan 610041 CHINA

MAY - 2 2011

: Re: K102191

Trade/Device Name: TRANSTEK GLASS BODY ANALYZER Models: GBF-830, GBF-835, GBF-950, SA-15 Regulation Number: 21 CFR $870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: April 8, 2011 Received: April 19, 2011

Dear Mr. 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 of medical device-related

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Page 2

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/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,

Michael Lemur MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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WE INSPIRE · WE DELIVER

Section 4 - Indications for Use

510(k) Number (if known): K102191

Device Name:

TRANSTEK GLASS BODY ANALYZER Models:GBF-830, GBF-835,GBF-950,SA-15

Indications for Use:

Prescription Use _

AND/OR

Over-The-Counter Use ×

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ORH Office of Device

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.