These devices are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), TBW(Total Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user.

These devices are intended for use only in healthy subjects between the age of 7-89.

Device Description

The X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 are body composition analyzers intended for use only in healthy subjects between the age of 7-89. The devices employ BIA(Bio-electrical Impedance Analysis) method and 8 electrodes placed on hands and feet (or ankles), and then measure body composition using an experimentally derived algorithm. For only XBIA 500, optional ankle electrode is not supplied. The devices are powered by AC100~230V 50/60Hz.

AI/ML Overview

The provided document is a 510(k) summary for Jawon Medical Co., Ltd.'s Body Composition Analyzers. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the current device meets specific acceptance criteria through a novel study. As such, the document does not contain the detailed information typically found in a clinical study report that directly addresses acceptance criteria and device performance in the way requested.

Here's a breakdown of the information that can be extracted or inferred, and what is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document as a set of acceptance criteria for the new devices (X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, and XBIA 900).

Instead, the document states:

"The results of clinical comparison tests with predicate device ZEUS 9.9 demonstrate that there is no significant difference between the modified devise and the predicate device."
"Conclusion: II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 are as safe, as effective, and perform as well as the predicate devices VENUS 5.5 and ZEUS 9.9."

This implies that the acceptance criterion was "no significant difference" in performance compared to the predicate devices (VENUS 5.5 and ZEUS 9.9). The reported device performance is that this criterion was met. However, specific metrics (e.g., accuracy for PBF, LBM etc., and the numerical performance values) for either the new or predicate devices are not provided.

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

Sample Size for Test Set: Not specified. The document mentions "clinical comparison tests" but does not give the number of subjects or measurements.
Data Provenance: The study was a "clinical comparison test" conducted in South Korea by Jawon Medical Co., Ltd. The document does not specify if it was retrospective or prospective, but clinical comparison tests are typically prospective.

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

Number of Experts: Not applicable/Not specified. The document describes a "clinical comparison test" against a predicate device, not a study where experts establish ground truth for a diagnostic finding. The ground truth for body composition analyzer performance is typically established by comparing against a reference method (e.g., DEXA, hydrostatic weighing) or by demonstrating equivalence to an already validated device, rather than expert consensus on images.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not specified. Similar to the previous point, an adjudication method is not relevant for this type of equivalence testing where the primary goal is comparison to a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No. This document describes a "clinical comparison test" of a body composition analyzer, which is a device that provides quantitative measurements, not a device used for visual interpretation by multiple readers like an imaging device. Therefore, an MRMC study is not applicable.

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

Standalone Performance: Yes, implicitly. Body composition analyzers are standalone devices that provide measurements directly. The comparison test likely evaluated the device's measurements directly against the predicate device's measurements. There is no "human-in-the-loop" component in the operation of the algorithm itself for these devices.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the new device's performance was its equivalence to the predicate device (ZEUS 9.9). The predicate device itself would have been validated against a more direct "ground truth" (e.g., DEXA, hydrostatic weighing, or other accepted reference methods) in its own regulatory submission, but this document does not detail that.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not specified. Body composition analyzers (especially BIA-based ones) use experimentally derived algorithms. While these algorithms are "trained" or developed using data, the document does not specify the sample size used for developing the underlying algorithm for the new devices or the predicate devices.

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

How Ground Truth for Training Set was Established: Not specified. The document states the devices "measure body composition using an experimentally derived algorithm." This implies that the algorithm was developed using a dataset where actual body composition (likely measured by gold-standard methods like DEXA or hydrostatic weighing) was known. However, the details of this process, including the specific ground truth methods or how they were established, are not provided in this 510(k) summary.

Summary

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长071884 PAGE 1 OF 3

Attachment 4

AUG - 9 2007

510(k) Summary

[As Required by 21 CFR 807.92]

Date Prepared:	July 05, 2007
Submitter:	Jawon Medical Co., Ltd.
	#1208-12, Sinsang-Li, Jinryang-Myun, Kyungsan-city, Kyungsang-Bukdo,
	712-830, Republic of Korea
	Tel: 82-53-856-0993
	Establishment Registration Number: 9616164
Contact Person:	MI Consulting Co., Ltd. (Mr. HL Jung)
	RM 624, Life Officetel, 61-3, Yoido-dong, Youngdeungpo-gu, Seoul, 150-731,
	Republic of Korea
	Tel: 82-2-6264-9001
	Fax: 82-2-6269-9001
	Email: jung_halyong@yahoo.com
Trade Name:	Body Composition Analyzer
	Models X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900
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 VENUS 5.5 and ZEUS 9.9 (K053556)
Device Description:	The X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 are body composition analyzers intended for use only in healthy subjects between the age of 7-89. The devices employ BIA(Bio-electrical Impedance Analysis) method and 8 electrodes placed on hands and feet (or ankles), and then measure body composition using an experimentally derived algorithm. For only XBIA 500, optional ankle electrode is not supplied. The devices are powered by AC100~230V 50/60Hz.
Intended use:	These devices are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), TBW(Total Body Water),

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Image /page/1/Picture/0 description: The image shows the text "K671884 PAGE 2 OF 3". The text appears to be handwritten. The numbers are slightly distorted, and the text is not perfectly aligned.

BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user.

These devices are intended for use only in healthy subjects between the age of 7-89.

Technologic characteristics: Modified devices X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 have the same intended use and technology characteristics as predicate devices VENUS 5.5 and ZEUS 9.9. The differences in this submission don't raise new questions concerning either safety or effectiveness.

Non-clinical and clinical tests: Modified devices X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 meet the requirements of IEC 60601-1, EN 60601-1-2 and in-house test criteria. The results of clinical comparison tests with predicate device ZEUS 9.9 demonstrate that there is no significant difference between the modified devise and the predicate device.

Based on non-clinical and clinical tests, the modified devices X-SCAN PLUS Conclusions: II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 are as safe, as effective, and perform as well as the predicate devices VENUS 5.5 and ZEUS 9.9. Accordingly the modified devices are substantially equivalent to the predicate devices.

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Item	510(k) #	Number/Placement ofElectrodes	OperatingParameters	ElectricalCurrentapplied duringmeasurement	Powerconsumption	Power supply	Input height	Display LCD	Protocolconnecting toPC	Protocolconnecting toprinter	BloodPressure' port	DimensionsW x D x H;Unit: mm)	Weight(mainunit)
< Differences between predicate devices and modified devices >	VENUS 5.5/ZEUS 9.9K053556	8 electrodes placed onhands and feet (or ankle)(Tetra-polar electrodemethod)	Frequency:1, 5, 50, 250,550, 1000kHz	Maximum current360uA	50VA	AC120V 50/60Hz	110~200 cm	Digital LCD (640 x 480pixel) - black	RS-232C (9 pin serialport), USB port	IEEE 1284(25pin parallel)port printer or PCB 3protocol supplied printer	None	470 x 655 x 1220	45kg
	X-SCAN PLUS II	Modified device	Same	Maximum current180uA	70VA	AC100~230V50/60Hz	110~200 cm	Digital LCD (6.4",800 x 600 pixel) -color	USB port	IEEE 1284(25pinparallel) port	Yes	496 x 836 x 1150	45kg
	GAIA 359 PLUS	Modified device	Same	Maximum current500uA	40VA	AC100~230V50/60Hz	100~200 cm	Digital LCD (6.4",640 x 480 pixel) -color	USB port	None	Yes	460 x 660 x 1000	24kg
	PLUSAVIS 333	Modified device	Same	Maximum current500uA	40VA	AC100~230V50/60Hz	100~200 cm	Digital LCD (6.4",480 x 320 pixel) -black	USB port	USB port,Thermal printer	Yes	460 x 660 x 1000	24kg
	XBIA 500	Modified device8 electrodesplaced on handsand feet(Tetra-polarelectrode method)	Frequency:5, 50, 250kHz	Maximum current280uA	40VA	AC100~230V50/60Hz	100~200 cm	Digital LCD (6.4",640 x 480 pixel) -color	USB port	USB port	Yes	400 x 673 x 972	24kg
	XBIA 900	Modified device	Same	Maximum current280uA	70VA	AC100~230V50/60Hz	80~200 cm	Digital LCD (12.1",800 x 600 pixel) -color	USB port	Bluetooth Function	Yes	476 x 848 x 1062	45kg

UNDER DIAGNOSTIC DEVICES AND IN VITRO DIAGNOSTIC DEVICES

4 - 3

KOT 1884
PAGE 3 OF 3

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. 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 symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG - 9 2007

Jawon Medical Co., Ltd. c/o Mr. HL Jung, Manager MI Consulting Co., Ltd. Room 624, LifeOfficetel 61-3 Yoido-dong, Youngdeungpo-gu, Seoul 150-731 REPUBLIC OF KOREA

Re: K071884

Trade/Device Name: Body Composition Analyzers - Models X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, & XBIA 900 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: July 5, 2007 Received: July 10, 2007

Dear Mr. Jung:

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/3/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "FDA Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. The logo is surrounded by a dotted border and stars.

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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); 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.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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Attachment 1

Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Jawon Medical Body Composition Analyzer Device Name: Models X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900

Indications for Use:

These devices are intended for use only in healthy subjects between the age of 7-89.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hebert Leun

(Division Sign-Off) 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.