A body composition analyzer that measures body weight and impedance and estimates percentage of body fat and body water using BIA (bioelectrical impedance analysis) in healthy children (7-17 years old) and healthy adults.

Device Description

The TANITA Scale plus Body Fat Monitor with Body Water Percentage is a computeroperated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat and body water percentage.

AI/ML Overview

The provided text is a 510(k) summary for the TANITA Scale plus Body Fat Monitor with Body Water Percentage. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study for the applicant device. Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, and ground truth establishment is not present in the given document.

Here's a breakdown of the available information:

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

The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., accuracy, precision, bias) for body fat or body water percentage. Instead, it relies on a qualitative statement of substantial equivalence to predicate devices.

Metric / Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Overall Performance	Substantially equivalent to predicate devices (TANITA Body Fat Analyzer Professional and Consumer Models K014009) in determining weight, estimating body fat and total body water using BIA.	"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 Scale plus Body Fat Monitor with Body Water Percentage performs as well as the predicate devices." (This is a general statement of equivalency, not specific performance data).
New Total Body Water Algorithm	"Validation of the new total body water algorithm" (Implicitly, the algorithm should provide estimates comparable to established methods).	No specific performance metrics or results are provided for this validation, only that "No new tests were performed apart from the validation of the new total body water algorithm."

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). It mentions "in-house BIA and DEXA/Deuterium Dilution reference methods" which implies some form of testing was conducted, but details are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

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

This information is not provided in the document.

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

This type of study is not applicable to this device. The device is a "Scale plus Body Fat Monitor" and directly measures/estimates body composition, it is not an AI-powered diagnostic tool requiring human reader interpretation in a medical imaging context.

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

A direct "standalone" performance study with quantifiable results is not explicitly described. The closest indication is the "validation of the new total body water algorithm," but no details on this validation are provided. The general statement of performance is in comparison to predicate devices, implying performance of the device itself.

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

The document mentions "DEXA/Deuterium Dilution reference methods" as ground truth comparators.

DEXA (Dual-energy X-ray absorptiometry) is a widely accepted, gold-standard method for measuring body composition (bone mineral density, lean soft tissue, and fat mass).
Deuterium Dilution (D2O dilution method) is a reference method for determining total body water.

8. The sample size for the training set

This information is not provided in the document. The submission focuses on substantial equivalence based on a previously approved methodology and validation of a new algorithm, not on a machine learning model's training set.

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

This information is not provided in the document, as it does not describe a machine learning model's training process.

Summary

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TANITA Scale plus Body Fat Monitor with Body Water Percentage 510(k) Submission

JUL 2 2 2004

510(k) SUMMARY

This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92

Trade Name:	TANITA Scale plus Body Fat Monitor with Body Water PercentageModels BF-592 and UM-026
Common Name:	Body Composition Analyzer / Body Fat Analyzer / Body Fat Monitor
ClassificationName:	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 total body water with the use of BIA (bioelectrical impedance analysis).

Predicate Devices:

TANITA Body Fat Analyzer Professional and Consumer Models K014009

Scientific Concepts and Significant Performance Characteristics:

	Tanita Body CompositionAnalyzerProfessional ModelsK014009	Tanita BodyComposition AnalyzerConsumer ModelsK014009	Tanita Scale plus BodyFat Monitor with BodyWater PercentageMultiple Models
INTENDED USE:	A combination non-invasive device, whichdetermines weight andestimates body fat andtotal body water usingBIA (bioelectricalimpedance analysis).	A combination non-invasive device, whichdetermines weight andestimates body fat usingBIA (bioelectricalimpedance analysis).	A combination non-invasive device, whichdetermines weight andestimates body fat andtotal body water usingBIA (bioelectricalimpedance analysis).
PRODUCTDESCRIPTION:	Body compositionanalyzer/scale thatutilizes a "foot-to-foot" BIA(bioelectrical impedance)technology to determineinternal bodycomposition.	Body compositionanalyzer/scale thatutilizes a "foot-to-foot"BIA (bioelectricalimpedance) technologyto determine internalbody composition.	Body compositionanalyzer/scale thatutilizes a "foot-to-foot"BIA (bioelectricalimpedance) technologyto determine internalbody composition.
ANALYTICALMETHOD/MEASUREMENT	Foot-to-Foot BIA In-house BIA andDEXA referencemethods	Foot-to-Foot BIA In-house BIA andDEXA referencemethods	Foot-to-Foot BIA In-house BIA andDEXA/DeuteriumDilution referencemethods

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KC4i978
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TANITA Scale plus Body Fat Monitor with Body Water Percentage 510(k) Submission

510(k) SUMMARY, continued

This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92

Side by side comparison of the TANITA Scale plus Body Fat Monitor with Body Water Percentage to the predicate devices clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. No new tests were performed apart from the validation of the new total body water algorithm.

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 Scale plus Body Fat Monitor with Body Water Percentage performs as well as the predicate devices.

Rhoda Lynn Valera TANITA Corporation of America Requlatory Affairs Specialist

2625 S. Clearbrook Dr. Arlington Heights, IL 60005 Phone: (847) 434-3966 (847) 640-7978 Fax:

July 15, 2004

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Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized graphic of three curved lines resembling birds in flight. The text is arranged along the circumference of the circle. The logo appears to be a symbol for an organization or company, with the bird-like figures possibly representing freedom, movement, or environmental themes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2 2004

TANITA Corporation of America c/o Ms. Chantel Carson Mgr. Section 1 Underwriters Laboratories, Inc. Northbrook Division 333 Pfingsten Road NORTHBROOK IL 60062-2096

Re: K040978

Trade/Device Name: Tanita Scale plus Body Fat Monitor with body Water Percentage Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: July 6, 2004 Received: July 7, 2004

Dear Ms. Carson:

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 for ass stated in the encreations of the enactment date of the Medical Device Amendments, or to oonimores provision of they 2011 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 r ou may , ater s , servisions of the Act include requirements for annual registration, listing of general volurole provision 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 r that FDA has made a determination that your device complies with other requirements of the Act that + Drederal 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 rord in the quality afferents (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 martes.ing your antial equivalence of your device to a legally premarket notheation. The PDA misms of easing 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 If you destre specific advice for your do too of 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 Additionally, 101 questions on the promote the regulation entitled, "Misbranding Onlice of Complance at (501) 97 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 by relevelice to premarked nonitous on the Act may be obtained from the Division of Small information on your responsion and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octaess http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

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TANITA Scale plus Body Fat Monitor with Body Water Percentage 510(k) Submission

INDICATIONS FOR USE

510(k) Number:	K040978
Device Name:	TANITA Scale plus Body Fat Monitor with Body WaterPercentage Models BF-592 and UM-026
Indications for Use:	A body composition analyzer that measures body weight andimpedance and estimates percentage of body fat and bodywater using BIA (bioelectrical impedance analysis) in healthychildren (7-17 years old) and healthy adults.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use
(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)

Nancy c Brogdon

(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.