BODY COMPOSITION ANALYZER by JAWON MEDICAL CO., LTD.

These devices calculates and estimates body composition parameters by using measured weight and impedance and entered height, age and gender. It shows body composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, Goal setter.

In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).

These devices can only estimate the body composition parameters with the exception of Weight, BMI, and impedance. These devices are only for use with generally healthy individuals of a specified age range.

Device Description

In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).

AI/ML Overview

The provided text describes the Jawon Body Composition Analyzers (Model X-CONTACT 350, X-CONTACT 350M, X-CONTACT 350S) and their substantial equivalence to predicate devices, but it does not contain specific acceptance criteria with numerical thresholds or a detailed study proving the device directly meets such criteria. Instead, it refers to a "performance test-clinical" to demonstrate that "there is no significant difference in measurements" compared to a predicate device.

Here's an attempt to answer your questions based only on the provided text, highlighting where information is missing:

Acceptance Criteria and Device Performance

There is no explicit table of acceptance criteria with numerical thresholds provided in the document. The general acceptance criterion implied is that the device "demonstrated that there is no significant difference in measurements" compared to the predicate device. The document also states that the devices meet "in-house test criteria" and "the requirements of IEC 60601-1, IEC 60601-1-2" (electrical safety and electromagnetic compatibility standards).

Implied Acceptance Criteria & Reported Performance:

Acceptance Criteria (Implied)	Reported Device Performance
No significant difference in measurements compared to predicate.	"No significant difference in measurements" (Jawon X-Contact 350 vs. predicate)
Compliance with IEC 60601-1	"meets the requirements of IEC 60601-1"
Compliance with IEC 60601-1-2	"meets the requirements of IEC 60601-1-2"
Meet in-house test criteria	"meets...in-house test criteria"

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "results of performance tests using X-Contact 350."
- Data Provenance: Not specified, but the applicant is Jawon Medical Co., Ltd. from Republic of Korea, suggesting the testing might have been conducted there. The document doesn't explicitly state whether the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The study described focuses on comparison to a predicate device, not necessarily establishing a "ground truth" through expert consensus in the traditional sense, but rather through comparison to medically validated measurements or the predicate device's output.
Adjudication method for the test set:
- Not specified. This type of adjudication (e.g., 2+1, 3+1) is typically associated with expert review of medical images or diagnoses, not direct body composition measurements.
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. This is a body composition analyzer, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone body composition analyzer. The "performance test-clinical" likely evaluates the accuracy of the device's measurements and calculations independently, though in comparison to a predicate device. The phrasing "results of performance tests using X-Contact 350 demonstrated that there is no significant difference in measurements" suggests evaluation of the device's direct output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the ground truth or "reference" for the performance study was the measurements from the predicate devices (ioi 353 and EasyBody 202) or other established clinical measurement methods used in that context. It states, "there is no significant difference in measurements" (referring to comparisons against some established standard or the predicate). It does not specify pathology or outcomes data.
The sample size for the training set:
- Not specified. Body composition analyzers often use empirical models or prediction equations, which would be "trained" or developed using a dataset. However, the details of this development are not provided.
How the ground truth for the training set was established:
- Not specified. Assuming a training set for model development, the ground truth would typically be established through highly accurate reference methods for body composition (e.g., DEXA, hydrostatic weighing, dilution methods). However, the document does not provide these details.

Summary

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

February 18, 2015

Jawon Medical Co., Ltd. Won Hee Park President 1208-12, Sinsang-ri, Jinryang-eup Kyungsan-city Kyungsang-Bukdo 712-830 Republic of Korea

Re: K140045

Trade/Device Name: Jawon Body Composition Analyzers, Model X-CONTACT 350; X-CONTACT 350M; X-CONTACT 350S Regulation Number: 21 CFR 870.2770 Regulation Name: Analyzer, body composition Regulatory Class: II Product Code: MNW Dated: November 7, 2014 Received: November 20, 2014

Dear Won Hee Park,

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Herbert P. Lerner -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): K140045

Device Name: Jawon Body Composition Analyzers Model X-CONTACT 350; X-CONTACT 350M; X-CONTACT 350S

Indications For Use:

In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).

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)

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Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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#1208-12 Sinsang-ri Jinryang-eup Kyungsan-City. Kyungsan-Bukdo712-830 Republic of Korea Tel-82-53-856—0993 Fax 82-53-856-0995

Doc. No. 4 510(K) Summary [K140045]

[As required by 21 CFR 807.92]

Date Prepared: 02/18/15

Submitter:	Jawon Medical Co. LTD.#1208-12 Sinsang-ri Jinryang-eup Kyungsan-City.Kyungsan-Bukdo712-830 Republic of KoreaTel-82-53-856-0993 Fax 82-53-856-0995Establishment Registration Number 9616164
Contact:	MEDMONTS Co. Ltd. (W.S. Park)Life-officetel 320, 40 63 ro, Youngdeungpo-gu, Seoul 150-731,
Trade Name:	Body Composition AnalyzerModel X-Contact 350, X-Contact 350M, X-Contact 350S
Common Name:	Body Fat Analyzer/Body Fat Monitor/Body Composition Monitor
Classification Name:	Body Composition Analyzer (Impedance plethysmograph) /MNW
Predicate Device:	Body Composition Analyzer Models ioi 353{K092431) and EasyBody202(K072325)

X-Contact 350, X-Contact 350M, X-Contact 350S A list of 510(k) Devices To Be Cleared

No.	Model Name	Indication for Use
1	X-Contact 350	Whole Body Composition AnalyzerThese devices calculates and estimates body composition parameters by usingmeasured weight and impedance and entered height, age and gender. It shows bodycomposition of Weight, Standard weight, Lean Body Mass, Total Body Water, IntraCellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat,Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control,Goal setter.In case of whole body, it shows more items including Waist to Hip Ratio, Ratio ofE.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).These devices can only estimate the body composition parameters with the exceptionof Weight, BMI, and impedance. These devices are only for use with generally healthyindividuals of a specified age range.
2	X-Contact 350M	Upper Body Composition AnalyzerThese devices calculates and estimates body composition parameters by using

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3	X-Contact 350S	Lower Body Composition AnalyzerThese devices calculates and estimates body composition parameters by usingmeasured weight and impedance and entered height, age and gender. It shows bodycomposition of Weight, Standard weight, Lean Body Mass, Total Body Water, IntraCellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat,Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control,Goal setter.In case of whole body, it shows more items including Waist to Hip Ratio, Ratio ofE.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).These devices can only estimate the body composition parameters with the exceptionof Weight, BMI, and impedance. These devices are only for use with generally healthyindividuals of a specified age range.
TechnologicCharacteristics	These subject devices X-CONTACT 350, X-CONTACT 350M, X-CONTACT350S have same intended use and technology characteristics as predicatedevices. See enclosed document number 9 (Substantial EquivalenceDiscussion). The differences in this submission do not raise new questionsconcerning either their safety or effectiveness.
Non-Clinical andClinical Tests	These subject devices X-CONTACT 350, X-CONTACT 350M, and X-CONTACT350S meets the requirements of IEC 60601-1, IEC 60601-1-2 and in-house testcriteria. The results of performance tests using X-Contact 350 demonstrated thatthere is no significant difference in measurements. See the enclosed documentnumber 15 (Performance Test-Clinical)
Conclusion:	Based on non-clinical and clinical tests, the modified devices X-CONTACT 350,X-CONTACT 350M, and X-CONTACT 350S, are as safe, as effective, andperform as predicate devices perform. (See document number 9-SubstantialEquivalents Discussion). Accordingly the subject devices X-CONTACT 350, X-CONTACT 350M, and X-CONTACT 350S, are substantially equivalent to thepredicate devices

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.