The TANITA Body Composition Analyzer is indicated for use in the measurement of weight and impedance, and the estimation of body mass index (BMI), total body fat percent, total body water percent and weight, muscle mass (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass, using BIA (Bioelectrical Impedance Analysis).

The device is indicated for use for healthy children 5-17 years old and healthy adults with active, moderately active, to inactive lifestyles.

Device Description

The TANITA Body Composition Analyzer SC-331 is a composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body mass index (BMI), total body fat percent, total body water percent and weight, muscle (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass for use by adults and children.

AI/ML Overview

This document focuses on the Tanita Body Composition Analyzer Model SC-331, a device that uses Bioelectrical Impedance Analysis (BIA) to measure and estimate various body composition parameters. The provided text is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Tanita Body Composition Analyzer SC-331 are implicitly established by demonstrating substantial equivalence to its predicate devices (TANTA Body Fat Analyzer Professional and Consumer Models K014009 and K040778, and the TANITA Body Composition Analyzer: Model BC-53X).

The table directly from the 510(k) summary compares the specifications and indicated outputs of the SC-331 with its predicate devices. The "reported device performance" is the statement that the SC-331 "performs equivalently" to these predicate devices based on "the results of [its] whole body BIA."

Feature/Parameter	Predicate Device (K014009) Performance/Specification	Predicate Device (K040778) Performance/Specification	Predicate Device (BC-53X) Performance/Specification	TANITA Body Composition Analyzer SC-331 Performance/Specification (Reported)	Acceptance Criteria (Implied by Substantial Equivalence and Comparison)
Analytical Method / Measurement	Patented "Foot-to-Foot" BIA, In house BIA and DEXA reference	Patented "Foot-to-Foot" BIA, In house BIA and DEXA reference	Patented "Foot-to-Foot" BIA, In house BIA and DEXA reference	Patented "Foot-to-Foot" BIA, In house BIA and DEXA reference	Must use "Foot-to-Foot" BIA, utilize in-house BIA and DEXA references.
Measurement Frequency	50kHz	50kHz	50kHz	50kHz	Must operate at 50kHz.
Number of Electrodes	4	4	4	4	Must use 4 electrodes.
Weight Capacity	New / 270 kg / 600 lb	270 kg / 600 lb	150 kg / 330 lb	600 lb / 270 kg or 450 kg / 1,000 lb	Must meet or exceed predicate weight capacities. (SC-331 exceeds some.)
Weight Increments	New / 100 g / 0.2 lb	100 g / 0.2 lb	100 g / 0.2 lb	0.2 lb / 100 g or 0.1 lb / 50 g	Must offer increments comparable to or better than predicate devices.
Body Fat % Increments	0.1%	0.1%	0.1%	0.1%	Must have 0.1% body fat increments.
Input Age	5 - 99 (5-17: Child, 18-99: Adult)	7 - 99 (7-17: Child, 18-99: Adult)	7 - 99 (7-17: Child, 18-99: Adult)	5 - 99 (5-17: Child, 18-99: Adult)	Must support similar or wider age ranges. (SC-331 offers wider child range).
Input Height	3' - 7' 11.5" / 90 - 249.9cm	3' - 7' 11.5" / 90 - 249.9cm	3' 4.0" - 7' 3.0" / 100-220cm	3' - 7' 11.5" / 90 - 249.9cm	Must cover similar or wider height ranges. (SC-331 has wider range).
Input Body Type	Standard / Athlete	Standard / Athlete	Standard / Athlete	Standard / Athlete	Must accommodate "Standard" and "Athlete" body types.
Indicated Measurements/Estimates	Similar to predicates (Weight, Impedance, FAT %, FAT M, FFM, Muscle M, Physique Rating, TBW, TBW %, BMR/DCI, Metabolic Age, Visceral Fat Rating, Bone Mass, BMI)	Yes (matching detailed table rows)	Yes (matching detailed table rows)	Yes (matching detailed table rows)	Must have the same or a superset of the measurements/estimates as the predicate devices.

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

The provided text does not explicitly state the sample size used for the test set. It mentions "the results of [TANITA's] whole body BIA" as the basis for performance claims.
The data provenance is not specified. It does not mention the country of origin of the data, nor whether it was retrospective or prospective. The term "in house BIA and DEXA reference" suggests internal validation data.

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

This information is not provided in the document. The statement "in house BIA and DEXA reference" for analytical method/measurement implies that DEXA (Dual-energy X-ray absorptiometry) was used as a reference standard, which is considered a gold standard for body composition. However, it does not specify how many experts, if any, were involved in generating or interpreting this ground truth data, nor their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done nor is it applicable to this device. This is a body composition analyzer, not an imaging analysis AI intended to assist human readers. The assessment is purely on the device's accuracy in measuring body composition parameters.

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

Yes, a standalone performance assessment was implicitly performed. The device itself, the TANITA Body Composition Analyzer SC-331, is an algorithm-only device in the sense that it automatically processes BIA measurements to output body composition parameters. The study involves comparing its outputs ("whole body BIA") to "in house BIA and DEXA reference" measurements, meaning its performance is evaluated directly against a reference standard without human interpretation as part of the primary measurement.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The type of ground truth used is DEXA (Dual-energy X-ray absorptiometry) reference. The document states "in house BIA and DEXA reference" as part of its analytical method. DEXA is widely considered a gold standard for body composition analysis, providing highly accurate measurements of bone mineral density, lean soft tissue mass, and fat mass.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. While it mentions "in house BIA and DEXA reference" for the analytical method, it doesn't differentiate between data used for model development/training and data used for testing/validation.

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

The document implies that the ground truth for establishing the algorithms (which would be analogous to a training set for model development) was established using "in house BIA and DEXA reference." This means that the device's impedance measurements were correlated with and validated against highly accurate DEXA measurements to develop and refine the equations used to estimate various body composition parameters. This process would typically involve a dataset where subjects undergo both BIA measurements with the device and DEXA scans, with the DEXA results serving as the ground truth.

Summary

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510(k) SUMMARY

submitted in accordance with the requirements of SMDA 1990 and 21 CFR Section 807.92

Trade Name Common Name: Classification Name:

JUL - 7 2009

Description of Applicant Device:

The TANTA Body Corposition Analyzer SC-331 is a composition analyzer that tillizes BA (biolectical inqedance analysis) to deternine body mass inter (BM), tata body tat percent, todal body water per cont and veine and smooth, plysique rating, bone mass, visceral lat rathy rang, boss) meabolic race (BMF), day caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass for use by adults and children.

Indications For Use:

The TANTA Body Composition is indicated tor use in the measure, and the estmain of tody mass index (BM), total boty valent, todal body vater percent and weight, must (skeletal and smooth), the mass, visceral lat raing with healty rare (BMP), daily cale (BMP), daire intake (DC), metablic intake (CC), metablic age, and target body fat percent with predicted weight and fat mass, using BlA (Binelectrical Impedance Analysis).

The device is indicated for use for healthy children 5-17 years old and healthy active, moderately active, to inaclive lifestyles.

Predicate Devices:

BMI - Indicator

TANTA Body Fat Analyzer Professional and Consumer Models K014009 and K040778.

TANITA Bady Composition Analyzer: Model SC-331

ANALYZER, BODY COMPOSITION 21 CFR $807.92

Body Composition Analyzer

Scientific Concepts and Significant Performance Characteristics:

*Same as shown in SECTION 9. and APPENDIX 1. (Substantial Equivalence Matrix)
	Body Composition AnalyzerSC-331 Specification		Body Composition Analyzer		Body Composition Monitor
			TBF-215/300/310/410, BF-35D		BC-53X
510(k) number		NewK014009		K040778
Product Description	Body composition analyzer that utilizes a BIAtechnology to determine internal bodycomposition.		Body composition analyzer that utilizes a BIAtechnology to determine internal bodycomposition.		Body composition analyzer that utilizes a BIAtechnology to determine internal bodycomposition.
Analytical Method / Measurement	Patented "Foot-to-Foot" BIA, In house BIA andDEXA reference		Patented "Foot-to-Foot" BIA, In house BIA andDEXA reference		Patented "Foot-to-Foot" BIA, In house BIA andDEXA reference
Measurement Frequency	50kHz		50kHz		50kHz
Number of Electrodes	4		4		4
Specifications
Weight Capacity	600 lb / 270 kg or 450 kg / 1,000 lb		270 kg / 600 lb		150 kg / 330 lb
Weight Increments	0.2 lb / 100 g or 0.1 lb / 50 g		100 g / 0.2 lb		100 g / 0.2 lb
Body Fat % Increments	0.1%		0.1%		0.1%
User Memory	4		4		4
Input Age	5 - 995-17: Child18-99: Adult		7 - 997-17: Child18-99: Adult		7 - 997-17: Child18-99: Adult
Input Height	3' - 7' 11.5" / 90 - 249.9cm		3' - 7' 11.5" / 90 - 249.9cm		3' 4.0" - 7' 3.0" / 100-220cm
Input Activity Level					1 - 3
Input Body Type	Standard / Athlete		Standard / Athlete		Standard / Athlete
Recall Function						✓
Power Supply	AC Adapter / DC7V		AC Adapter / DC5V		AA Batteries
Printer Function	✓		✓
Computer Interface	RS-232C & USB		RS-232C
Indicate for Use
	Print-Out	Display	Print-Out	Display	Print-Out	Display
Actual:
Weight	✓	✓	✓	✓	✓	✓
Impedance	✓	-	✓	-	-	-
Estimated:
FAT %	✓	✓	✓	✓	-	✓
FAT Mass	✓	-	✓	-	-	-
FAT % - Indicator	✓	-	In the manual	-	-	-
Predicated Fat Mass	✓	-	✓	-	-	-
Predicated Weight	✓	-	✓	-	-	-
FFM	✓	-	✓	-	-	✓
Muscle Mass	✓	-	✓	-	-	✓
Muscle Mass - Indicator	✓	-	✓	-	-	In the manual
Physique Rating	✓	-	✓	-	-	✓
Total Body Water	✓	-	✓	-	-	✓
Total Body Water %	✓	-	✓	-	-	✓
BMR / DCI	✓	-	✓	-	-	✓
BMR - Indicator	✓	-	-	-	-	In the manual
Metabolic Age	✓	-	✓	-	-	✓
Visceral Fat Rating	✓	-	✓	-	-	✓
Visceral Fat Level - Indicator	✓	-	-	-	-	✓
Bone Mass	✓	-	✓	-	-	✓
BMI	✓	-	✓	-	-	-

in the manual

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K090479
PAGE 2 OF 2

510(k) SUMMARY

submitted in accordance with the requirements of SMDA 1990 and 21 CFR Section 807.92

Suble by side compaison of the TANTA Body Compssition Analyzer SC-331 to the predical clements that the applicant trence are substantaly equivaler to those early marked devices.

eleased on the results of ission in the least of the II ANTA's whole body BA, the TANTA Body Composition Analyzer SC-331 performs equivaltity of the prelicate devicas and therefore is subtantially equivalent.

Toshihiko Ishikawa
TANITA Corporation of America Product Manager

Tel: (847) 640-9241 Fax (847) 640-9261

Սսո 30th, 2009

্

. * .

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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wavy lines representing the department's commitment to health, services, and human well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 7 2009

Mr. Toshihiko Ishikawa Product Manager Tanita Corporation of America, Inc. 2625 South Clearbrook Drive ARLINGTON HEIGHTS IL 60005

Re: K090479

Trade/Device Name: TANITA Body Composition Analyzer Model SC-331 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Codes: MNW Dated: June 30, 2009 Received: July 1, 2009

Dear Mr. Ishikawa:

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.

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

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device-related 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K 090479

Device Name:

TANITA Body Composition Analyzer Model SC-331

Indications For Use:

The device is indicated for use for healthy children 5-17 years old and healthy adults with active, moderately active, to inactive lifestyles.

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)

(vers 6/25/05)

Hebert Lerner

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

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.