The TANITA Ironman Innerscan Body Composition Monitor measures body weight, impedance and estimates total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate(BMR), daily caloric intake(DCI) and metabolic age using BIA (Bioelectrical Impedance Analysis). The device is intended to be used by generally healthy children 7-17 years old and generally healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. Actual measurements made by the BC-558 include weight and impedance. Based upon these measured values, values are calculated for: total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI) and metabolic age.

Device Description

The TANTA Ironman Innerscan Body Composition Monitor BC-558 are a computer-operated body composition analyzer that utilizes BlA (bigledrical impedance analysis) to determine body fat percent, muscle mass, bone weight, visceral fat rating, Basal Metabolic Rate (BMR), metabolism age, physique rating, daily calorie intake (DCI), body water percent and segmental fat percent.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in terms of specific performance metrics or thresholds the device needed to meet. Instead, it relies on a comparison to predicate devices, asserting "substantial equivalence." The "Predicate Devices" section in the summary provides a side-by-side comparison of specifications and functions, implying that matching or exceeding these characteristics (particularly for the new functionalities) constituted meeting the "acceptance criteria" for substantial equivalence.

Since precise quantitative acceptance criteria are not given, the table below will present the comparative specifications as performance indicators for the subject device (BC-558) and its predicates.

Feature	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (TANITA Ironman Innerscan Body Composition Monitor: Model BC-558)
Analytical Method	Segmental BIA or Foot-to-Foot BIA with In-house BIA and DXEA/Deuterium Dilution reference	Segmental BIA with In-house BIA and DXEA reference
Measurement Frequency	50kHz	50kHz
Measurement Current	Max. 500μA or Max. 90μA	Max. 500μA
Number of Electrodes	4 or 8	8
Capacity	150 kg / 330 lb or 200 kg / 440 lb	150 kg / 330 lb
Increments	100 g / 0.2 lb or 50 g / 0.1 lb	100 g / 0.2 lb or 50 g / 0.1 lb
Body Fat % Increment	0.1%	0.1%
User Memory	4	4
Input Age Range	7-99 (Child: 7-17, Adult: 18-99)	7-99 (Child: 7-17, Adult: 18-99)
Input Height Range	100 cm - 220 cm or 90 cm - 249 cm	90 cm - 220 cm
Input Activity Level	1-3	1-3
Input Body Type	Standard / Athlete	Standard / Athlete
Data Memory	4 weeks / 1 week average, 2 months / 1 month average (Predicate K040778)	31 days / 1 day average, 52 weeks / 1 week average, 36 months / 1 month average
Power Supply	AA Batteries or AC Adapter / DC5V 3.5A	AA Batteries
Printer Function	Present on one predicate	Not present
Computer Interface	Present on one predicate	Not present
Weight Measurement	✓	✓
Full Body Fat %	✓	✓
Segmental Body Fat %	✓ (Right arm, Left arm, Right feet, Left feet, Trunk present on predicate K033157)	✓ (Right arm, Left arm, Right feet, Left feet, Trunk)
Body Water %	✓	✓
Full Body Muscle Mass	✓	✓
Segmental Muscle Mass	✓ (Right arm, Left arm, Right feet, Left feet, Trunk present on predicate K033157)	✓ (Right arm, Left arm, Right feet, Left feet, Trunk)
Physique Rating	✓	✓
Bone Mass	✓	✓
Visceral Fat	✓	✓
Visceral Fat Judge	✓ for one predicate, not for another	✓
BMR	✓	✓
DCI	✓	✓
Metabolic Age	✓	✓

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

Sample Size: This document does not specify a sample size for any test set. It refers to "the results of using the previously approved BIA methodology with our whole body BIA," suggesting general validation, but no specific number of subjects is mentioned for a test set.
Data Provenance: Not specified. There is no mention of the country of origin or whether the data was retrospective or prospective.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Not specified. The document does not describe any expert adjudication process.

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

Was it done?: No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The evaluation is based on "substantial equivalence" to predicate devices and the performance of the BIA methodology itself, not on human-in-the-loop performance.
Effect size of improvement: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance Study

Was it done?: Yes, implicitly. The document states, "Based on the results of using the previously approved BIA methodology with our whole body BIA, it was concluded that the TANITA Ironman Innerscan Body Composition Monitor BC-558 performs as well as the predicate devices and therefore have proven its safety and efficacy." This indicates that the device's algorithmic performance in estimating body composition was evaluated in comparison to the established BIA methodology and predicate devices. However, details of this standalone performance are limited to the comparative specifications provided.

7. Type of Ground Truth Used

The document states the analytical method for the BC-558 and its predicates uses "In house BIA and DXEA reference" or "In house BIA and DXEA/Deuterium Dilution reference."
- DXEA (Dual-energy X-ray absorptiometry): This is a widely accepted and highly accurate method for measuring body composition (bone mineral density, fat mass, and lean mass) and is considered a "gold standard" for body composition analysis in research and clinical settings.
- Deuterium Dilution: Another reference method, particularly for total body water, which can be used to derive fat-free mass.
- Therefore, the ground truth used appears to be objective reference methods (DXEA, Deuterium Dilution), which are considered highly accurate and reliable measures of body composition.

8. Sample Size for the Training Set

Not specified. The document does not provide details about a specific training set or its size. The device likely relies on algorithms and equations derived from extensive prior research and data (implied by "previously approved BIA methodology"), rather than a newly trained model for this specific submission.

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

Not specified. Given the reliance on "previously approved BIA methodology" and "in house BIA and DXEA reference," it is inferred that the underlying BIA algorithms and their derived equations were developed and validated using data where ground truth was established by highly accurate methods like DXEA and potentially Deuterium Dilution. However, the specific process for the training set of this particular device (if a separate training phase was conducted beyond the general BIA methodology development) is not described.

Summary

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SUMMARY

This summary of 510(k) safety and effectiveness information is accordance with the requirements of SMDA 1990 and 21 CFR 8807.92

Trade Name: Common Name:

TANITA Ironman Innerscan Body Composition Monitor: Model BC-558 Segmental Body Composition Monitor Classification Name: ANALYZER, BODY COMPOSITION 21 CFR §807.92

DEC 2 8 2006

Description of Applicant Device:

Intended Uses of Applicant Device:

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Aculal measurements made by the BC-558 include weight and impedance. Based upon these measured values, values are calculated for: total and segmental body fat percentage, body water, total and segmental muscle mass, visce ratios be valoc baceratif frating with healthy rang, basal metabolic rate (BMR), daily caloric intake (DCI) and metabolic age.

Predicate Devices

TANITA Body Fat Analyzer Professional and Consumer Models K040778 and K033157

Scientific Concepts and Significant Performance Characteristics: wn in SECTION 9 and APPENDIX 1 1St പ്പി

*Same as shown in SECTION 9. and APPENDIX 1. (Substantial Equivalence Matrix)
	New	Predicate Device#: K040778	Predicate Device#: K033157
	BC-558 Specification	BC-53X Specification	BC-418 Specification
Product Description	Body composition monitor/scale thatutilizes a segmental BIA technology todetermine internal body composition.	Body composition monitor/scale thatutilizes a "foot-to-foot" BIA technologyto determine internal body composition.	Body composition monitor/scale thatutilizes a segmental BIA technology todetermine internal body composition
Analytical Method /Measurement	Segmental BIA In house BIA andDXEA reference	Foot-to Foot BIA In house BIA andDXEA/Deuterium Dilution reference	Segmental BIA In house BIA andDXEA reference
Measurement Frequency	50kHz	50kHz	50kHz
Measurement Current	Max. 500μA	Max. 500μA	Max. 90 μ A
Number of Electrodes	8	4	8
Specifications
Capacity	150 kg / 330 lb	150 kg / 330 lb	200 kg / 440 lb
Increments	100 g / 0.2 lb or 50 g / 0.1 lb	100 g / 0.2 lb	100 g / 0.2 lb
Body Fat %	0.1%	0.1%	0.1%
User Memory	4	4
Input Age	7-997-17: Child18-99: Adult	7-997-17: Child18-99: Adult	7-997-17: Child18-99: Adult
Input Height	90cm~220cm	100 cm - 220 cm	90 cm - 249 cm
Input Activity Level	1 - 3	1 - 3
Input Body Type	Standard / Athlete	Standard / Athlete	Standard / Athlete
Data Memory	31days / 1day average52weeks / 1week average36months / 1month average	4weeks / 1week average2months / 1month average
Power Supply	AA Batteries	AA Batteries	AC Adapter / DC5V 3.5A
Printer Function			✓
Computer Interface	-		RS-232
Functions
Weight	✓	✓	✓
	Full body	✓	✓	✓
	Right arm	✓	-	✓
Body Fat %	Left arm	✓	-	✓
	Right feet	✓	-	✓
	Left feet	✓	-	✓
	Trunk	✓		✓
% Fat JudgeBody Water%		✓	✓	✓
	Full body	✓	✓	✓
	Right arm	✓		✓
Muscle Mass	Left arm	✓		✓
	Right feet	✓		✓
	Left feet	✓	-	✓
	Trunk	✓	-	✓
Physique Rating		✓	✓	-
Bone mass		✓	✓	-
Visceral Fat		✓	✓	✓
Visceral Fat Judge		✓	✓	-
BMR		✓	✓	✓
DCI		✓	✓	✓
Metabolic Age		✓	✓	-

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92

Side by side comparison of the TANITA Ironman Innerscan Body Composition Monitor BC-558 to the predicate that the applicant devices are substantially equivalent to those legally marketed devices.

Based on the results of using the previously approved BlA methodobogy with our whole body BlA, it was concluded that the TANITA i ronman Innerstan Body Composition Moritor BC-558 performs as well as the predicate devices and therefore have proven its safety and efficacy.

Beth Mackey
TANITA Corporation of America Marketing Director

Tel: (847)434-3981
Fax: (847)640-7978

July 7, 2006 Revised in red. December 14. 2006

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure embracing a globe, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

DEC 2 8 2006

Ms. Beth Mackey Marketing Director TANITA Corporation of America, Inc. 2625 South Clearbrook Drive ARLINGTON HEIGHTS IL 60005

Re: K062652

Trade/Device Name: TANITA Ironman Innerscan Body Composition Monitor Model BC-558 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: December 14, 2006 Received: December 15, 2006

Dear Ms. Mackey:

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 (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image is a circular logo or emblem. The central element is the letters "FDA" in a stylized font, with the word "Centennial" written below it in a cursive font. Above the letters "FDA" are the numbers "1906 - 2006". The entire design is surrounded by a circular border with text, and there are three stars below the word "Centennial".

ing and Promoting Public

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Page 2 -

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.

This letter will allow you to begin marketing your device as described in your Section 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:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrlv/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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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Indications for Use

510(k) Number (if known): K 062652

Device Name: TANITA Ironman Innerscan Body Composition Monitor Model BC-558 Indications For Use: The TANITA Ironman Innerscan Body Composition Monitor measures body weight, impedance and estimates total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate(BMR), daily caloric intake(DCI) and metabolic age using BIA (Bioelectrical Impedance Analysis). The device is intended to be used by generally healthy children 7-17 years old and generally healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. Actual measurements made by the BC-558 include weight and impedance. Based upon these measured values, values are calculated for: total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI) and metabolic age.

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

Over-The-Counter Use X (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)

Nancyc Brogdon
(vers 6/25/05)(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K062652

Page 1 of

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.