The modified Sonamet Body Composition Analyzer, also known as the PEA POD® Infant Body Composition System (the PEA POD), is indicated for measuring body mass and estimating the body composition (i.e., the body fat and lean body mass) of infants between 1 and 8 kilograms. It is not intended for use with infants requiring life support.

Device Description

The modified Sonamet Body Composition System ("The PEA POD") is designed to measure the mass and estimate the body composition of infants with body weights ranging between 1 and 8 kilograms, who do not require life support. The PEA POD estimates body composition using a densiometric approach (i.e. by determining the density of the entire body). A weighing apparatus is used to-measure the subject's mass. Air displacement plethysmography is used to measure the subject's volume. Using this data, the subject's density is calculated. The - subject's body composition is then estimated using several algorithms derived from scientific research. The device components are housed in a movable cart, which contains the reference chamber, calibration volume, air circulation system, Air Temperature Control System, electronic components, printer and CPU.

AI/ML Overview

The provided text describes a 510(k) submission for the Modified Sonamet Body Composition Analyzer (PEA POD for infants). However, it does not contain detailed information about specific acceptance criteria or a dedicated study proving device performance against those criteria. The document states:

"The results of verification testing demonstrate that the PEA POD Body Composition Analyzer is substantially equivalent to the predicate devices. Test results indicate that the device satisfies functional performance requirements safely and accurately when used as indicated."

This is a general statement of compliance rather than a detailed report of a study with specific acceptance criteria and outcome metrics.

Therefore, many of the requested details cannot be extracted from the given text.

Here's an attempt to answer the questions based only on the provided information, noting where information is absent:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Substantial equivalence to predicate devices	"The results of verification testing demonstrate that the PEA POD Body Composition Analyzer is substantially equivalent to the predicate devices."
Satisfies functional performance requirements safely and accurately when used as indicated	"Test results indicate that the device satisfies functional performance requirements safely and accurately when used as indicated."
Indicated for measuring body mass and estimating body composition (body fat and lean body mass) of infants between 1 and 8 kg.	The device is described as designed for this purpose, but specific performance metrics (e.g., accuracy, precision) against a defined gold standard are not provided.
Not intended for use with infants requiring life support.	This is an intended use exclusion, not a performance criterion.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified in the provided text.
Data provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. The document does not describe a study involving expert-established ground truth for the device's performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. The document does not describe a study involving expert adjudication.

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. The PEA POD is a medical device for body composition analysis, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

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

The device is a standalone system for measuring body composition. The text implies a standalone performance (system-only) by stating it "satisfies functional performance requirements safely and accurately." However, no specific details of such a study are provided, nor is an algorithm explicitly distinguished from the overall device operation for "standalone" testing in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly specified. The document refers to "verification testing" and "functional performance requirements" but does not detail the nature of the ground truth used (e.g., comparison against a gold standard method, phantom studies, etc.). Given it's a body composition analyzer, potential ground truths could involve known-composition phantoms or comparison against other accepted body composition measurement methods (though this is not detailed).

8. The sample size for the training set

Not applicable. The document does not describe a machine learning or AI algorithm that would typically have a separate training set. The "several algorithms derived from scientific research" mentioned in the device description are likely established mathematical models, not deep learning models requiring a specific training dataset in the same vein.

9. How the ground truth for the training set was established

Not applicable, as there's no mention of a training set for an AI algorithm.

Summary

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MAR - 1. 2004

K032610
page 1 of 2

Section 6 – 510(k) Summary

SUBMITTER INFORMATION

Company Name:

Establishment Registration Number:

Company Address:

Company Phone:

Company Facsimile:

Contact Person:

Life Measurement, Inc.

3003873943

1850 Bates Avenue Concord, CA 94520

(925) 676-6002

(925) 676-6005

Michael Sullivan Vice President of Operations

DEVICE IDENTIFICATION

Device Trade Name:	- Modified Sonamet Body Composition AnalyzerNote : The trade name for the original Sonamet BodyComposition analyzer is currently the “BOD POD”. Themodified version will be referred to as the “PEA POD -Infant Body Composition System” when it is introduced intothe market.
Device Generic Name:	Body Composition Analyzer
Device Classification:	Classification code: 21 CFR 870.2770Code MNW
Classification Panel	Cardiovascular

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K032610
page 2 of 2

IDENTIFICATION OF PREDICATE DEVICES

The modified Sonamet Body Composition System is substantially equivalent to the following devices, which have received FDA clearance:

Device Name	Manufacturer	K Number
Sonamet BodyComposition Analyzer	Life Measurement,Inc.	K924972
EM-SCAN HP-2Pediatric BodyComposition Analyzer	EM-SCAN, Inc.	K902042

The intended use and technological characteristics of the modified Sonamet Body Composition System are the same as the above predicate devices. Modifications for the pediatric use indication do not raise additional questions regarding safety and efficacy,

DEVICE DESCRIPTION

INTENDED USE

CONCLUSIONS DRAWN FROM STUDIES

The results of verification testing demonstrate that the PEA POD Body Composition Analyzer is substantially equivalent to the predicate devices. Test results indicate that the device satisfies functional performance requirements safely and accurately when used as indicated.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

MAR - 1. 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Life Measurement, Inc. c/o Dr. Sheila Pickering 2081 Longden Circle LOS ALTOS CA 94024

Re: K032610

Trade/Device Name: Modified Sonamet Body Composition Analyzer (PEA POD) Regulation Number: 21 CFR $870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 78 MNW Dated: January 5, 2004 Received: January 9, 2004

Dear Dr. Pickering:

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) I ins leter will anow you to begin maining of substantial equivalence of your device to a legally premarket notheadon: "The PPP intenty since of the more 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 If you desire specific advice to: your 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 Additionally, 10. questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general by releveloc to promance nonities under the Act may be obtained from the Division of Strail mornation on your responsibility on the 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, Abdoninal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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ATTACHMENT 14

FDA Submission Cover Sheet

510(k) Number: K032610

Device Name: Modified Sonamet Body Composition Analyzer

Indication For Use:

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

Concurrence Of CDRH, Office Of Device Evaluation (ODE)

Prescription Use

OR Over-The-Counter Use

(Per 21CFR

Nancy C. Broadon

(Division Sign-Off Division of Reproductive. Abde and Radiological Devices 510(k) Number.

143

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.