The SmartShape Body Composition Analyzer is a noninvasive bioimpedance analyzer intended for use in the estimation of percent body fat by body weight.

Device Description

The SmartShape Body Composition Analyzer is a hand-held device designed to determine body fat composition. The device offers the user the ability to measure their body fat level and store the data for analvsis. It is programmable for up to 10 separate individuals and uses bioelectric impedance technology for the estimation of percent body fat. The device also includes a clock and alarm function.

AI/ML Overview

The provided text describes a 510(k) submission for the SmartShape Body Composition Analyzer 4010. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive de novo clinical studies with predefined acceptance criteria and detailed performance metrics.

Based on the provided text, the following information can be extracted regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Functionality	Not explicitly defined with specific numerical thresholds. The implicit criterion is that the device operates as intended for its stated purpose (estimation of percent body fat).	"All results were shown to be acceptable." "The SmartShape Body Composition Analyzer was shown to perform as intended."
Reliability	Not explicitly defined with specific numerical thresholds. The implicit criterion likely pertains to consistent operation over time and under various conditions.	"All results were shown to be acceptable."
Repeatability	Not explicitly defined with specific numerical thresholds. The implicit criterion suggests that repeated measurements on the same individual under similar conditions should yield consistent results.	"All results were shown to be acceptable."
Reproducibility	Not explicitly defined with specific numerical thresholds. The implicit criterion suggests that measurements taken by different users or with different devices (of the same model) under similar conditions should yield consistent results.	"All results were shown to be acceptable."
Equivalence to Predicate	The implicit criterion is that the SmartShape Body Composition Analyzer demonstrates "substantial equivalence" in performance to the predicate device (Omron Healthcare, Inc. Body Fat Analyzer Model HBF-306). This typically means that the device performs as well as, or comparably to, the predicate device in its intended use, without raising new questions of safety or effectiveness. Specific statistical metrics for comparison (e.g., correlation coefficients, mean absolute difference) are not provided in this summary.	"Results of the testing showed that the SmartShape Body Composition Analyzer was equivalent in performance to the predicate device." "The fundamental technical characteristics and indications for use of the SmartShape Body Composition Analyzer are similar to those of the predicate device."

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

Sample Size: The document does not specify the sample size used for performance testing. It only states that "Performance testing was conducted..." and "comparison testing was performed using the SmartShape Body Composition Analyzer and the predicate device."
Data Provenance: The document does not provide information on the country of origin of the data or 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:

This information is not provided in the document. For a body composition analyzer, "ground truth" would typically refer to a gold-standard method for measuring body fat (e.g., DEXA, hydrostatic weighing). The document does not describe the use of such a ground truth or the involvement of experts for this purpose in the performance testing mentioned. The comparison was primarily against a predicate device.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of a body composition analyzer and the focus on substantial equivalence, a formal adjudication method by experts is not typically described in this type of submission for the performance tests conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. The device (SmartShape Body Composition Analyzer 4010) is an automated device for body fat estimation, not an imaging device requiring human interpretation, and thus MRMC studies are not applicable. The performance testing described is focused on the device's accuracy and equivalence to another device, not on how human readers improve with AI assistance.

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

Yes, the performance testing described is inherently a standalone (algorithm only) evaluation of the device. The SmartShape Body Composition Analyzer is a "noninvasive bioimpedance analyzer intended for use in the estimation of percent body fat" and its "software utilizes the impedance data, patient weight, gender, age, and height data to calculate the patient percent body fat." The performance tests conducted evaluated the device's output independently.

7. The Type of Ground Truth Used:

The primary "ground truth" or reference for the performance testing, as described, appears to be the predicate device (Omron Healthcare, Inc. Body Fat Analyzer Model HBF-306). The document directly states: "comparison testing was performed using the SmartShape Body Composition Analyzer and the predicate device. Results of the testing showed that the SmartShape Body Composition Analyzer was equivalent in performance to the predicate device." There is no mention of using a different, independent "gold standard" ground truth (like DEXA or pathology) for the performance evaluation in this summary.

8. The Sample Size for the Training Set:

This information is not provided. Since this is a 510(k) summary and the primary focus is on substantial equivalence, details about algorithm training data (sample size, characteristics, etc.) are generally not included unless they directly impact the substantial equivalence determination. The document describes the device as using "bioelectric impedance technology for the estimation of percent body fat" and "The device software utilizes the impedance data, patient weight, gender, age, and height data to calculate the patient percent body fat," implying an underlying algorithm or formula, but details of its development or training are absent.

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

This information is not provided. As with the training set sample size, details on how any ground truth for potential algorithm training was established are not mentioned in this 510(k) summary.

Summary

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SUMMARY

This summary of 510K safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. APPLICANT INFORMATION

a. Company Name:	Clio Designs Incorporated
b. Company Address:	63 Herrick Rd.Newton Centre, MA 02459
c. Company Phone:	617-969-7509
d. Contact Person:	Bernard FabricantVice President
e. Date of Summary:	11/10/02

2. DEVICE IDENTIFICATION

a. Trade/Proprietary Name:	SmartShape Body CompositionAnalyzer 4010
b. Classification Name:	Body Composition Analyzer21 CFR 870.2770 MNW
c. Device Class:	Class II

3. IDENTIFICATION OF PREDICATE DEVICE

a. Company:	Omron Healthcare, Inc.
b. Device:	Body Fat Analyzer Model HBF-306
c. 510K No.:	K011652
d. Date Cleared:	11/07/01

4. DEVICE DESCRIPTION

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5. SUBSTANTIAL EQUIVALENCE

The SmartShape Body Composition Analyzer is substantially equivalent to the Omron Healthcare, Inc. Body Fat Analyzer Model HBF-306.

The fundamental technical characteristics and indications for use of the SmartShape Body Composition Analyzer are similar to those of the predicate device. Both devices use bioelectric impedance for the estimation of percent body fat. The body composition analyzer and the predicate devices are indicated for personal home use.

6. INDICATIONS FOR USE

The SmartShape Body Composition Analyzer is a noninvasive bioimpedance analyzer intended for use in the estimation of percent body fat by body weight.

7. TECHNOLOGICAL CHARACTERISTICS

The SmartShape Body Composition Analyzer is a programmable hand-held device designed to determine body fat composition. The device utilizes the technology of bioelectric impedance to determine the transmission speed of a low level electrical current through the user. The device software utilizes the impedance data, patient weight, gender, age, and height data to calculate the patient percent body fat.

A comparison of the technological characteristics and performance testing of the SmartShape Body Composition Analyzer to those of the predicate device reveals that the devices are substantially equivalent.

8. PERFORMANCE DATA

Performance testing was conducted on the SmartShape Body Composition Analyzer for functionality, reliability, repeatability and reproducibility. All results were shown to be acceptable. In addition, coparison testing was performed using the SmartShape Body Composition Analyzer and the predicate device. Results of the testing showed that the SmartShape Body Composition Analyzer was equivalent in performance to the predicate

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device. The SmartShape Body Composition Analyzer was shown to perform as intended.

9. 510(K) CHECKLIST

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.

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Image /page/3/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 a stylized image of an eagle's head, represented by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2003

Mr. Bernard Fabricant Vice President Clio Designs Incorporated 63 Herrick Road NEWTON CENTRE, MA 02459

Re: K023817

Trade/Device Name: SmartShape™ Body Composition Analyzer 4010 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: March 23, 2003 Received: March 27, 2003

Dear Mr. Fabricant:

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); 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.

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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 the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.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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INDICATIONS FOR USE STATEMENT

Applicant's Name:	Clio Designs Incorporated
Device Name:	SmartShape Body Composition Analyzer 4010

The SmartShape Body Composition Analyzer is a noninvasive bioimpedance analyzer intended for use in the estimation of percent body fat by body weight.

Over-the-Counter Use

Nancy C Hogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic 510(k) 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.