A body composition analyzer that measures body weight and impedance and estimates total and segmental body fat percent, body mass index (BMI), fat mass, fat-free mass, regional muscle mass, basal metabolic rate, and total body water using BIA (bioelectrical impedance analysis) in healthy children (7-17 years old) and healthy adults.

Device Description

The TANITA BC-418, Segmental Body Composition Analyzer is a computer-operated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent and regional muscle mass.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a dedicated section. Instead, it relies on a comparison to a predicate device to establish substantial equivalence.

Characteristic / Performance Metric	Acceptance Criteria (Implied by Predicate)	Reported Device Performance
Intended Use	A combination non-invasive device, which determines weight and estimates body fat composition using BIA (bioelectrical impedance analysis).	A combination non-invasive device, which determines weight and estimates body fat composition and muscle mass using BIA (bioelectrical impedance analysis). (Note: Applicant device adds "muscle mass" and "segmental" BIA, which is a key differentiator).
Product Description	Body composition analyzer/scale that utilizes a "foot-to-foot" BIA (bio- electrical impedance) technology to determine internal body composition.	Body composition analyzer/scale that utilizes segmental BIA (bio- electrical impedance) technology to determine internal body composition.
Analytical Method/Measurement	• Foot-to-Foot BIA • In-house BIA and DEXA reference methods	• Segmental BIA • In-house BIA and DEXA reference methods
Safety and Efficacy	Safe and effective as demonstrated by the predicate device's prior approval.	"Performs as well as the predicate device and therefore have proven its safety and efficacy."

Explanation of "Acceptance Criteria" in this context: For a 510(k), the primary "acceptance criterion" is often that the new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use, and the same technological characteristics, or if it has different technological characteristics, it does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the predicate device. The document implies that the performance of the predicate (Model TBF-410) serves as the benchmark for acceptable performance.

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

Sample Size: The document does not specify a sample size for the test set. It mentions "Side by side comparisons" and "results of using the previously approved BIA methodology," but no numerical data for the number of subjects or measurements.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. The study appears to be an internal comparison ("in-house BIA and DEXA reference methods") conducted by Tanita.

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

The document mentions "in-house BIA and DEXA reference methods" for establishing ground truth, but it does not specify the number of experts or their qualifications who were involved in operating the DEXA or BIA reference methods, or in interpreting the results to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. The comparison seems to be direct performance against the predicate and reference methods rather than an expert consensus process on specific cases.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a comparison of the new device to a predicate device and reference methods, not an assessment of human reader performance with or without AI assistance. The device itself is a measurement tool, not an AI for interpretation.

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

Yes, the study described is essentially a standalone performance assessment of the device (algorithm only). The device is a diagnostic measurement tool. The evaluation focuses on its analytical performance (body composition measurements) compared to reference methods and a predicate, without considering a human-in-the-loop aspect for interpretation or decision-making.

7. The Type of Ground Truth Used

The ground truth was established using:

"In-house BIA and DEXA reference methods."
- DEXA (Dual-energy X-ray absorptiometry) is widely considered a gold standard for body composition measurement.
- "In-house BIA" (of the predicate device) is used as a reference point for substantial equivalence, implying its output is accepted as valid.

8. The Sample Size for the Training Set

The document does not provide any information about a separate "training set" or its sample size. This type of device relies on established BIA principles and internal calibration, rather than a machine learning model that requires a distinct training set in the typical sense. The "training" here would likely refer to the development and calibration data used to create the BIA algorithms for body composition estimation embedded in the device, which is not detailed.

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

As no separate training set is explicitly mentioned or detailed, there is no information on how its ground truth was established. For BIA devices, the algorithms are typically derived from extensive research correlating impedance measurements with direct body composition methods (like DEXA or hydrostatic weighing) in general populations. The "in-house BIA and DEXA reference methods" mentioned likely refer to the validation of the device's algorithms, not a distinct training process for a machine learning model.

Summary

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APR = 8 2004

SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92

Trade Name:	TANITA BC-418, Segmental Body Composition Analyzer
Common Name:	Body Composition Analyzer / Body Fat Analyzer
Classification Name:	ANALYZER, BODY COMPOSITION21 CFR § 870.2770

Description of Applicant Device:

Intended Uses of Applicant Device:

Intended to be used as a body fat analyzer that determines body weight and estimates body fat and skeletal muscle mass with the use of BIA (bioelectrical impedance analysis). Other outputs include BMR (basal metabolic rate), TBW (total body water), and BMI (body mass index).

Predicate Device:

TANITA Body Fat Analyzer Professional Model TBF-410 K014009

Scientific Concepts and Significant Performance Characteristics:

	Body Fat AnalyzerModel TBF-410K014009	Segmental Body CompositionAnalyzerModel BC-418
INTENDED USE:	A combination non-invasivedevice, which determines weightand estimates body fatcomposition using BIA(bioelectrical impedanceanalysis).	A combination non-invasivedevice, which determines weightand estimates body fatcomposition and muscle massusing BIA (bioelectricalimpedance analysis).
PRODUCT DESCRIPTION:	Body composition analyzer/scalethat utilizes a "foot-to-foot" BIA(bio- electrical impedance)technology to determine internalbody composition.	Body composition analyzer/scalethat utilizes segmental BIA (bio-electrical impedance) technologyto determine internal bodycomposition.
ANALYTICALMETHOD/MEASUREMENT	• Foot-to-Foot BIA• In-house BIA and DEXAreference methods	• Segmental BIA• In-house BIA and DEXAreference methods

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510(k) SUMMARY, continued

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92

Side by side comparisons of the TANITA BC-418, Segmental Body Composition Analyzer to the predicate device Body Fat Analyzer Professional Model TBF-410 clearly demonstrate that the applicant device is substantially equivalent to the legally marketed device.

Based on the results of using the previously approved BIA methodology with our whole body BIA, it was concluded that the TANITA BC-418, Segmental Body Composition Analyzer performs as well as the predicate device and therefore have proven its safety and efficacy.

Rhoda Lynn Valera TANITA Corporation of America Requlatory Affairs Specialist

Phone: (847) 434-3966 (847) 640-7978 Fax:

September 26, 2003

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Image /page/2/Picture/12 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2004

Ms. Rhoda Lynn N. Valera Regulatory Affairs Specialist Tanita Corporation of America, Inc. 2625 South Clearbrook Drive ARLINGTON HEIGHTS IL 60005

Re: K033157

Trade/Device Name: Tanita Segmental Body Composition Analyzer BC-418 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: January 9, 2004 Received: January 12, 2004

Dear Ms. Valera:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatived of the enactment date of the Medical Device Amendments, or to comments provision to May 20, 1978, are cance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). allo Cosmette Her (110) that to novice, subject to the general controls provisions of the Act. The r ou may, dicrolore, mains of the Act include requirements for annual registration, listing of gencial controls provisions of ractice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 and 10) . 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 i that FDA has made a determination that your device complies with other requirements of the Act that I D.A has made a actuations administered by other Federal agencies. You must or any I ederal statutes and registements, including, but not limited to: registration and listing comply with and rice broquent (FR Part 801); good manufacturing practice requirements as set (21 CFR Part 007), assemis (QS) regulation (21 CFR Part 820); and if applicable, the clectronic forth in the quant) 05 sections (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin markering of substantial equivalence of your device to a legally prematication. The PDF maily to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desite specific advice for your control to the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Augulany, for questions on the personal prosse note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general by releasence to premarked notification (er the Act may be obtained from the Division of Small Information on your responsionaliss and Consumer Assistance at its toll-five number (800) 638-2041 or Mandiacturers, Theemadonal ans Colless http://www.fda.gov/cdrl/dsmaldsmamain.html.

Sincercly yours,

Nancy C. Brogdon

Srogdon Nancy C. F Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:	K033157
Device Name:	TANITA BC-418, Segmental Body Composition Analyzer
Indications for Use:	A body composition analyzer that measures body weight andimpedance and estimates total and segmental body fatpercent, body mass index (BMI), fat mass, fat-free mass,regional muscle mass, basal metabolic rate, and total bodywater using BIA (bioelectrical impedance analysis) in healthychildren (7-17 years old) and healthy adults.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

(Optional Format 1-2-96)

Nancy Hodgson
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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.