MODELS TBF-300A, TBF-310, TBF-410, TBF-215, BF-350: A body composition analyzer that measures body weight and impedance and estimates body fat percent. BMI, fat mass, fat free mass, basal metabolic rate, and total body water using BIA (bioelectrical impedance analysis). MODELS TBF-611, TBF-612, TBF-621, TBF-622, BF-623, BF-625, BF-626, BF-541, BF-555, BF-542, TBF-551, BF-556, BF-558, BF-559, BF-572, TBF-521, Ultimate Scale 2001: A body composition analyzer that measures body weight and impedance and estimates body fat percent using BIA (bioelectrical impedance analysis).

Device Description

The TANITA Body Fat Monitor/Scales (multiple models) are designed to determine body weight and body fat composition. Each model will offer a range of features. The system consists of two subdivided stainless steel footpad electrodes mounted on a platform scale. The four-foot electrodes are designed where each foot makes contact with a heel and toe electrode. Impedance of the lower extremities and body weight is measured simultaneously while the subject stands on the scale.

AI/ML Overview

The provided text describes a 510(k) submission for TANITA Body Fat Analyzer TBF/BF/Ultimate Scale devices, asserting their substantial equivalence to a predicate device (TANITA Body Fat Analyzer Model TBF-105 K930599). However, it does not contain the detailed information necessary to fully answer all components of your request regarding acceptance criteria and the specific study proving the device meets those criteria.

The document largely focuses on establishing substantial equivalence based on the intended use, product description, and analytical method used, rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, many sections below will indicate that the information is "Not provided in the document."

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Puntative Acceptance Criteria based on predicate device equivalence
Accuracy of Body Weight Measurement: (Implied, to be equivalent to predicate)	Not explicitly stated – the document asserts the new device "perform[s] as well as the predicate device" in determining body weight. No specific accuracy metrics (e.g., ±X kg, % deviation) are provided as acceptance criteria or reported performance for either the applicant or predicate device.
Accuracy of Body Fat Composition Estimation: (Implied, to be equivalent to predicate)	Not explicitly stated – the document asserts the new device "perform[s] as well as the predicate device" in estimating body fat composition. No specific accuracy metrics (e.g., correlation coefficient, mean absolute error, % agreement with DEXA) are provided as acceptance criteria or reported performance for either the applicant or predicate device. The document mentions "DEXA reference methods" in the analytical method description, suggesting DEXA might be used for comparison, but no results from such a comparison are presented.
Reproducibility/Precision of Measurements: (Implied, to be equivalent to predicate)	Not explicitly stated.
Safety and Efficacy: (General assertion for substantial equivalence)	The conclusion states: "Based on the results of using the previously approved "Foot-to-Foot" BIA methodology with our patented in-house BIA it was concluded that the TANITA Body Fat Analyzer(s) TBF/BF/Ultimate Scales perform as well as the predicate device and therefore have proven its safety and efficacy." No specific metrics or data are provided to substantiate this claim beyond the assertion of equivalence to the predicate, which itself is only described by its method.
Consistency with "Foot-to-Foot" BIA methodology & patented in-house BIA and DEXA reference methods	The document states both the predicate and applicant device utilize and are consistent with these methodologies. This is a characteristic of the analytical method rather than a specific performance metric, but successful implementation and consistency are implied. There are no results explicitly detailing how this consistency was confirmed or measured in a study, only that it was used and resulted in the conclusion of substantial equivalence.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not provided in the document. The document refers to "results of using the previously approved 'Foot-to-Foot' BIA methodology with our patented in-house BIA" but does not specify a sample size for any comparative study.
- Data Provenance: Not provided in the document.
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/Not provided. This device is a body composition analyzer. The "ground truth" would likely refer to a reference method (like DEXA or hydrostatic weighing) not expert consensus. The use of "DEXA reference methods" is mentioned, but without details on how it was applied or the expertise involved in its application for the study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers reviewing medical images or data. For a device like a body fat analyzer, the "ground truth" establishment would typically involve a reference measurement method rather than expert adjudication.
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 body composition analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The comparison describes the performance of the device itself (the "algorithm only," in a sense, as it performs the BIA measurement and calculation) against its predicate. The conclusion states, "the TANITA Body Fat Analyzer(s) TBF/BF/Ultimate Scales perform as well as the predicate device," which suggests an evaluation of the device's inherent measurement capabilities. However, specific standalone performance metrics are not given, only the assertion of equivalence.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document mentions "DEXA reference methods" as part of the analytical method/measurement for both the predicate and applicant device. This implies that DEXA (Dual-energy X-ray Absorptiometry), a widely accepted reference method for body composition, would be the primary type of "ground truth" or reference standard if a direct comparison study was performed. However, no specific study results using DEXA as ground truth are presented.
The sample size for the training set
- Not applicable/Not provided. This document describes a medical device, not a machine learning model that would typically have a specific training set. The BIA methodology is physics-based, not learned from data in the same way an AI algorithm is a "training set" in the context of deep learning. While calibration data might exist, it's not referred to as a "training set" here.
How the ground truth for the training set was established
- Not applicable/Not provided, as there is no mention of a "training set" in the context of an AI/ML model. If "training set" refers to calibration data or development data, the document does not elaborate on how ground truth was established for that data, other than mentioning "patented in-house BIA and DEXA reference methods."

Summary

{0}------------------------------------------------

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 Body Fat Analyzer TBF/BF/ Ultimate Scale
Common Name:	Body Fat Analyzer/ Body Fat Monitors/ Body Composition Analyzers/Body Composition Monitors
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 composition with the use of BIA (bioelectrical impedance analysis).

Predicate Device:

TANITA Body Fat Analyzer Model TBF-105 K930599

Scientific Concepts and Significant Performance Characteristics:

	Body Fat Analyzer Model TBF-105K930599	TANITA Body Fat AnalyzerTBF/BF/ Ultimate Scale
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 using BIA(bioelectrical impedanceanalysis).
PRODUCT DESCRIPTION:	Body composition analyzer/scalesutilize a “foot-to-foot” BIA (bio-electrical impedance) technology -to determine internal bodycomposition.	Body composition analyzer/scalesutilize a “foot-to-foot” BIA (bio-electrical impedance) technologyto determine internal bodycomposition.
ANALYTICALMETHOD/MEASUREMENT	• “Foot-to-Foot” BIA• Patented in-house BIA andDEXA reference methods	• “Foot-to-Foot” BIA• Patented in-house BIA andDEXA reference methods

{1}------------------------------------------------

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 Body Fat Analyzer TBF/ BF/ Ultimate Scale to the predicate device Body Fat Analyzer Model TBF-105 clearly demonstrate that the applicant device is substantially equivalent to the legally marketed device.

Based on the results of using the previously approved "Foot-to-Foot" BIA methodology with our patented in-house BIA it was concluded that the TANITA Body Fat Analyzer(s) TBF/BF/Ultimate Scales perform as well as the predicate device and therefore have proven its safety and efficacy.

Carol Alloian (Benson) TANITA Corporation of America Manager Requiatory Affairs Manager Phone: (847) 640-9251 ext. 116 (847) 640-7978 Fax:

November 30, 2001

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name around the perimeter of the circle. Inside the circle is a stylized emblem with three wave-like shapes.

JUN 2 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol Alloian (Benson) Regulatory Affairs Manager TANITA Corporation of America 2625 South Clearbrook Drive ARLINGTON HEIGHTS IL 60005 Re: K014009 Trade/Device Name: Body Fat Analyzer, Professional Series: Models TBF-300A. TBF-310. TBF-410, TBF-215, and BF-350; Consumer Body Fat Monitor/Scale Series: Models TBF-611, TBF-612, TBF-621, TBF-622, BF-623, BF-625, BF-626, BF-541, BF-555, BF-542, TBF-551, BF-556, BF-558, BF-559, BF-572, TBF-521 Ultimate Scales 2000, 2001, and 2001T Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: March 25, 2002 Received: March 26, 2002

Dear Ms. Alloian:

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. Iisting 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 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): 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.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your 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 one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C.Bogdon

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

Enclosure

{4}------------------------------------------------

K014009 510(k) Number (if known):

Tanita Body Fat Analyzer Device Name:

Indications for Use:

MODELS TBF-300A, TBF-310, TBF-410, TBF-215, BF-350:

A body composition analyzer that measures body weight and impedance and estimates body fat percent. BMI, fat mass, fat free mass, basal metabolic rate, and total body water using BIA (bioelectrical impedance analysis).

MODELS TBF-611, TBF-612, TBF-621, TBF-622, BF-623, BF-625, BF-626, BF-541, BF-555, BF-542, TBF-551, BF-556, BF-558, BF-559, BF-572, TBF-521, Ultimate Scale 2001:

A body composition analyzer that measures body weight and impedance and estimates body fat percent using BIA (bioelectrical impedance analysis).

(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)

(Division Sign-Off)

Division of Reproductive, Abdominal,

Revised: 6/24/02

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.