Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Body Shape Graph

Actual: Weight [except for Model InBodyS10, which requires the manual entry of weight], Body Mass Index (BMI) and Impedance Values, Height [except for Model InBody S10 and InBody H20/InBody H20® which requires the manual entry of Height], Resistance Values [only for InBody770, InBody S10], Reactance Values [for InBody 510], Phase Angle [for InBody770, InBody S10] The InBody H20 and the InBody H20(B) are identical except that the (B) model has Bluetooth capability for data transfer.

Device Description

InBody770, InBody570, InBody H20/InBody H20%are impedance plethysmograph body composition analyzers. These devices determine body composition parameters based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both resistance and capacitance components. Impedance plethysmographic devices are used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. Multi-frequency and segmental bioelectrical impedance analysis can estimate the distribution of body water (total body water; intra-cellular water; extra-cellular water), and can correlate with fluid compartmentalization. Assuming that body lean mass is hydrated in a constant and uniform manner; bioelectrical impedance analysis can be used to estimate body lean mass and fat mass. Body composition analysis results may be of value to health care professionals in their management of the relative balance and levels of fat and lean tissue. The InBody H2O and the InBody H20() are identical except that the (5) model has Bluetooth capability for data transfer.

AI/ML Overview

The provided 510(k) summary describes a comparative performance study rather than a study with pre-defined acceptance criteria against a ground truth. The primary goal of these studies was to demonstrate substantial equivalence to predicate devices, not to meet specific performance targets with absolute metrics like sensitivity or specificity.

Here's a breakdown of the available information based on your request, with explicit notes where the requested information is not present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document does not explicitly state numerical acceptance criteria for performance metrics. Instead, the "acceptance" was based on demonstrating comparable performance to the predicate devices (InBody J30, InBody 170, InBody 3.0) through comparison tests. The conclusion states: "As compared to our predicate devices (our own brand) these new models have very similar technological characteristics and performed comparably to our predicates."

Reported Device Performance:
The document does not provide quantitative performance results (e.g., accuracy, precision measurements) for the new devices or their comparison to the predicate devices. It simply states that "comparison performance tests" were conducted and that the new devices "performed comparably."

Performance Metric	Acceptance Criteria (from document)	Reported Device Performance (from document)
Clinical Performance	Performed comparably to predicate devices (InBody J30, InBody 170, InBody 3.0)	"comparison performance test...was conducted" and the devices "performed comparably to our predicates." (No specific quantitative metrics like sensitivity, specificity, or correlation coefficients are provided for estimated body composition parameters).
Safety and Effectiveness	Equivalent to the predicate device	"results of bench and software testing indicates that the new devices are as safe and effective as the predicate device."

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

InBody570 vs. InBody J30: 68 examinees for the comparison test.
InBody770 vs. InBody J30: 40 examinees for the comparison test.
InBody S10 vs. InBody3.0: 43 examinees for the comparison test.
InBody H20/InBody H20(B) vs. InBody J30: 40 examinees for the comparison test.

Data Provenance: The document does not specify the country of origin of the data nor whether the study was retrospective or prospective.

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

Not applicable. The studies described are comparison performance tests against a legally marketed predicate device (InBody J30, InBody 170, InBody 3.0), not against an independently established "ground truth" using experts. The predicate device itself acts as the reference for comparison.

4. Adjudication Method for the Test Set

Not applicable. Since the studies are comparison performance tests against a predicate device, there is no mention of an adjudication method in the context of expert consensus or labeling of cases, as would be common in diagnostic imaging studies.

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

Not applicable. This device is an Impedance Plethysmograph (Body Composition Analyzer) that directly measures and estimates body composition parameters. It is not an AI-assisted diagnostic imaging device that human readers would interpret. Therefore, an MRMC study with human readers and AI assistance is not relevant to this device.

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

The device itself is a standalone measurement system. The clinical performance tests conducted were effectively "standalone" in the sense that they evaluated the device's output against a reference device, without human interpretation as part of the primary output. The device generates estimated body composition parameters directly.

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

For the described clinical performance tests, the "ground truth" was the measurements obtained from the legally marketed predicate devices (Biospace Body Composition Analyzer Model InBody J30, InBody 170, InBody 3.0). The study aim was to demonstrate "comparable performance" to these predicates, not to an independent gold standard like DEXA or hydrostatic weighing.

8. The Sample Size for the Training Set

Not applicable. The document describes clinical performance validation studies performed to demonstrate substantial equivalence, not the development or training of an algorithm. There is no information provided about a "training set" for the underlying bioelectrical impedance analysis (BIA) algorithms used by the InBody devices. These algorithms are based on scientific principles and likely developed over time, not typically "trained" on a dataset in the way a modern machine learning model would be.

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

Not applicable. As mentioned in point 8, the document does not describe a training set or the establishment of ground truth for it. The BIA technology relies on established physiological models and electrical properties of tissues. The derivation of "Segmental Body Water" is mentioned as being "based on a computation that is Segmental Body Water is calculated using Segmental Lean Mass supported by reference papers: that is already submitted in InBody J30 (K110689). Body Water can be calculated by Lean Body Mass (= Fat Free Mass) according to fact which is founded in the attached reference papers. As in papers they tell body water/fat free mass is 0.73." This indicates reliance on scientific literature and prior device approvals rather than a new "training set" with established ground truth.

Summary

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510(k) Summary K123228

Biospace Corporation Limited Donghyun Building, 518-10 Dogok 2 - Dong Gangnam-Gu, Seoul, KOREA 135-854 Tel : +82-2-501-3939, Fax : +82-2-501-3978 Homepage : http://www.inbody.com DATE PREPARED: January 30, 2013 Contact: Kichul Cha, CEO

1. Identification of the Device: Proprietary-Trade Names: InBody770, InBody570, InBody S10, InBody H20/inBody H20(B) Classification Names: ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter Regulation Description: Impedance plethysmograph. Classification Panel: Cardiovascular Product Code: MNW Regulation Number: 870. 2770 Classification: II
Equivalent legally marketed devices: (Predicate device Information) Biospace Body Composition 2. Analyzer Model InBody170, Model InBodyJ30 InBodyS10 K110689
Indications for Use InBody770, InBody570, InBody S10, InBody H20/InBody H20(B) 3. For use only in healthy subjects for Measurement of:

Description of the Device: InBody770, InBody570, InBody H20/InBody H20%are 4. impedance plethysmograph body composition analyzers. These devices determine body composition parameters based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both
MAR 8 2013

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resistance and capacitance components. Impedance plethysmographic devices are used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. Multi-frequency and segmental bioelectrical impedance analysis can estimate the distribution of body water (total body water; intra-cellular water; extra-cellular water), and can correlate with fluid compartmentalization. Assuming that body lean mass is hydrated in a constant and uniform manner; bioelectrical impedance analysis can be used to estimate body lean mass and fat mass. Body composition analysis results may be of value to health care professionals in their management of the relative balance and levels of fat and lean tissue. The InBody H2O and the InBody H20() are identical except that the (5) model has Bluetooth capability for data transfer.

1. Safety and Effectiveness, comparison to predicate device. The results of bench and software testing indicates that the new devices are as safe and effective as the predicate device.

Devices	InBody170	InBodyJ30	InBodyS10	InBody770	InBody570	InBodyS10	InBody H20/H20(B)(B) hasBluetoothdatamodule.
510(k)number	K110689	K110689	K110689	New	New	New	New
Manufacturer	Biospace	Biospace	Biospace	Biospace	Biospace	Biospace	Biospace
Measurementof Estimated :	Extra-CellularWater(ECW)	V	V	V	V	V	V	V
	Intra-CellularWater(ICW)	V	V	V	V	V	V	V
	TotalBodyWater(TBW)	V	V	V	V	V	V	V
	SkeletalMuscleMass	V	V	V	V	V	V	V
	Body FatMass	V	V	V	V	V	V	V
	LeanBodyMass	V	V	V	V	V	V	V
	Dry LeanMass	V	V	V	V	V	V	V
	BasalMetabolicRates	V	V	V	V	V	V	V
Devices		InBody170	InBodyJ30	InBodyS10	InBody770	InBody570	InBodyS10	InBody H20/H20ⒷⒷ has Bluetoothdata module.
	Segmental Lean Mass	V	V	V	V	V	V	V
	ECW/TBW	V	V	V	V	V	V	V
	Segmental Body Fat mass	V	V	V	V	V	V	V
	% Segmental Body Fat	V	V	V	V	V	V	V
	Energy expenditure of activity	V	V	V	V	V	V	V
	VisceralFat Area	V	V	V	V	V	V	V
	Segmental Body Water				V	V	V	V
Measurementof Actual:	Weight	V	V		V	V		V
	Height		V
	Body MassIndex (BMI)	V	V	V	V	V	V	V
	Impedance Values	20, 100kHz	5, 50,250kHz	1, 5, 50, 250,500,1,000kHz	1, 5, 50, 250,500,1,000kHz	5, 50,500kHz	1, 5, 50, 250,500,1,000kHz	20,100kHz
	Reactance Values			5,50,250 kHz	5,50,250 kHz		5,50,250kHz
	Phase Angle			5,50,250kHz	5,50,250kHz		5,50,250kHz
Measurement method		BioelectricalImpedance	BioelectricalImpedance	BioelectricalImpedance	BioelectricalImpedance	BioelectricalImpedance	BioelectricalImpedance	BioelectricalImpedance
Devices	InBody170	InBodyJ30	InBodyS10	InBody770	InBody570	InBodyS10	InBody H20/H20B® hasBluetoothdatamodule.
Electrodetype	4 electricpoles 8points Touchtypeelectrodemeasure-ment	4 electricpoles 8points Touchtypeelectrodemeasure-ment	4 electricpoles 8points Touchtypeelectrodemeasure-ment	4 electricpoles 8points Touchtypeelectrodemeasure-ment	4 electricpoles 8points Touchtypeelectrodemeasure-ment	4 electricpoles 8points Touchtypeelectrodemeasure-ment	4 electricpoles 8points Touchtypeelectrodemeasure-ment
Power Source	Input power:AC 100-120/200-240V,50/60 Hz,1.2AOutputpower:DC12V, 3.4A	Input power:AC 100-120/200-240V,50/60 Hz,1.2AOutputpower:DC12V, 3.4A	Input power:AC 100-120/200-240V,50/60 Hz,1.2AOutputpower:DC12V, 3.4A	Input power:AC 100-120/200-240V,50/60 Hz,1.2AOutputpower:DC12V, 3.4A	Input power:AC 100-120/200-240V,50/60 Hz,1.2AOutputpower:DC12V, 3.4A	Input power:AC 100-120/200-240V,50/60 Hz,1.2AOutputpower:DC12V, 3.4A	DC 6V (AAtype battery,1.5V×4EA)
Equipment weight	14.3kg	29kg	2kg	38kg	24kg	2kg	2.7kg
Equipment size	396(W) x608(L) x955(H) : mm	360(W) x640(L) x2235(H) :mm	202(W) x322(L) x53(H): mm	526(W) x854(L) x1175(H):mm	522(W) x893(L) x1113(H):mm	202(W) x322(L) x53(H): mm	310.3(W) x356.4(L) x58.3(H) :mm
Measurementtime	30 seconds	30 seconds	110 seconds	50 seconds	50 seconds	110 seconds	5 seconds
Measurementage	From age 3 ~age 99	From age 3 ~age 99	From age 3 ~age 99	From age 3 ~age 99	From age 1 ~age 99	From age 3 ~age 99	From age 3 ~age 99
Measurement weight	10 ~ 250kg	10 ~ 250kg	10 ~ 250kg	10 ~ 270kg	5 ~ 250kg	10 ~ 250kg	10 ~ 200kg

Comparison Table 6.

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K123228
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1. Discussion of Non-Clinical Testing: Electromagnetic and Safety Testing was conducted to IEC 60601-1 and IEC 60601-1-2. Software validation was conducted. Literature was compiled and reviewed.
1. Discussion of Clinical Testing:

In order to verify InBody570's clinical performance, we conducted comparison performance test between InBody570 and InBody J30 that obtained FDA premarket notification under FDA law. The test was conducted with a group of 68 examinees.

In order to verify InBody770's clinical performance, we conducted comparison performance test between InBody770 and InBody J30. The test was conducted with 40 examinees. In order to verify InBody S10's clinical performance, we conducted comparison performance test between InBody $10 and InBody3.0 that obtained FDA premarket notification under FDA law. The test was conducted with a group of 43 examinees.

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K123228 PAGE 5 OF 5

In order to verify InBody H20/InBody H20(B)'s clinical performance, we conducted comparison performance test between InBody H20/InBody H20() and InBody J30. The test was conducted with 40 examinees.

There is only one difference in the indications for use between our new devices and 9. Conclusion: our predicates: The addition of Segmental Body Water. This is based on a computation that is Segmental Body Water is calculated using Segmental Lean Mass supported by reference papers: that is already submitted in InBody 130 (K110689). Body Water can be calculated by Lean Body Mass (= Fat Free Mass) according to fact which is founded in the attached reference papers. As in papers they tell body water/fat free mass is 0.73. So, InBody using this fact can measure segmental body water from segmental lean mass (segmental fat free mass).
As compared to our predicate devices (our own brand) these new models have very similar technological characteristics and performed comparably to our predicates. The same scientific principles are used to produce the measurements. We therefore conclude that our new models are substantially equivalent to our predicates cleared in 2011.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 8, 2013

Biospace Corporation Limited Kamm & Associates % Mr. Daniel Kamm Principal Engineer 8870 Ravello Ct NAPLES FL 34114

Re: K123228

Trade/Device Name: 1) Biospace Body Composition Analyzer, Model InBody770

Biospace Body Composition Analyzer, Model InBody570
Biospace Body Composition Analyzer, Model InBody S10

1. Biospace Body Composition Analyzer, Model InBody H20/InBody H20(B)
  Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: January 30, 2013 Received: February 5, 2013

Dear Mr. Kamm:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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 (reporting of medical 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

HerbertLerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123228

Device Name:

Biospace Body Composition Analyzer, Model InBody770 1)
Biospace Body Composition Analyzer, Model InBody570 2)
1. Biospace Body Composition Analyzer, Model InBody S10
1. Biospace Body Composition Analyzer, Model InBody H20/InBody H20(B)

Indications for use:

For use only in healthy subjects for Measurement of:

Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water. Body Shape Graph

Actual: Weight [except for Model InBodyS10, which requires the manual entry of weight], Body Mass Index (BMI) and Impedance Values, Height [except for Model InBody S10 and InBody H20/InBody H20(B, which requires the manual entry of Height], Resistance Values [only for InBody770, InBody S10], Reactance Values [for InBody770, InBody S10], Phase Angle [for InBody770, InBody S10]. The InBody H20 and the InBody H20B) are identical except that t he (B) model has Bluetooth capability for data transfer.

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(Part 21 CFR 801 SubpartAcres of the confession for the contributed and the contributed to the contributed to the contributed to the contributed to the contributed to the contributed to the contribu------------------------------------------------------------------------------------------------------------------------------------------------------------------------------		121 CER 807 Subpart ( 1)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sign-Off) n of Reproductive. Gastro-Renal, and 100k) 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.