The GE Lunar Body Composition Software option (body composition) used on GE Lunar DEXA bone densitometer scans measures the regional and whole body bone mineral density (BMD), lean and fat tissue mass and calculates derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI). The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional.

These body composition values are useful to health care professionals in their management of diseases/conditions where the disease/condition itself, or its treatment, can affect the relative amounts of patient fat and lean tissue. The GE Lunar Body Composition Software option does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases/conditions for which body composition values are useful include nutritional disorders, overweight, obesity, weight management, eating disorders, anorexia nervosa, wasting syndrome, sarcopenia , gastrointestinal disorders, Crohn's disease, celiac disease, gastrectomy, hepatobiliary disorders, cirrhosis, gallstones, renal disorders, chronic renal failure, hemodialysis, organ transplantation, endocrinological disorders, hypopituitarism, acromegaly, Cushing's syndrome, growth hormone deficiency, bone disorders, osteoporosis, Paget's disease, osteopetrosis, pulmonary diseases, cystic fibrosis, chronic pulmonary obstructive disease (COPD), cardiovascular disease, corticosteroids therapy, hormone therapy, total parenteral nutrition (TPN), diabetes, AIDS(HIV. sympathetic dystrophy syndrome, amiotrophic lateral sclerosis, tetraplegy, Duchenn's muscular dystrophy, spinal cord injury complication. DEXA body composition is a useful alternative to hydrostatic weighing, skin fold measurements and bio-impedance estimates.

Device Description

The Body Composition Software Option for GE Lunar DEXA Bone Densitometers measures the bone mineral density (BMD), lean and fat tissue mass and calculates derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI). The values can be displayed in user-defined statistical formats and trends with color image mapping and compared to reference populations at the sole discretion of the health care professional. The software does not require any changes to the bone densitometer nor does it require additional scanning or radiation exposure beyond the bone density scans.

AI/ML Overview

The provided submission for K071570, "GE Lunar Body Composition Software," does not detail specific acceptance criteria or a dedicated study proving the device meets them in the way modern AI/ML device submissions typically do.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics, intended use, and safety/effectiveness features. The documentation indicates that no clinical tests were required for safety or effectiveness for this particular device.

However, I can extract the information provided about the non-clinical tests and the general claims made about the device's performance.

Here's an analysis based on the provided text, structured to address your points, acknowledging the absence of some requested details due to the nature of this particular 510(k) summary from 2007:

Acceptance Criteria and Device Performance (Based on available information)

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission is from 2007 and for a software option integrated with existing hardware, specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, or precision targets) are not explicitly stated in the public summary. The primary "acceptance criteria" here is "substantial equivalence" to predicate devices, supported by non-clinical testing.

Metric/Criterion	Acceptance Criteria (Implied)	Reported Device Performance
Accuracy	Within design specifications (for various body composition metrics)	"In vitro precision and accuracy values were computed through a series of tests on phantoms and were within design specifications."
Precision	Within design specifications (for various body composition metrics)	"In vitro precision and accuracy values were computed through a series of tests on phantoms and were within design specifications."
Safety	Conforms to applicable medical device safety standards	"The device has been evaluated for electrical and mechanical safety, and has been found to conform with applicable medical device safety standards."
Effectiveness	Comparable to predicate devices	"Comparable in key safety and effectiveness features... similar intended uses as the predicate devices." (No separate clinical effectiveness trials were deemed necessary due to substantial equivalence).
Technological Characteristics	Same/similar to predicate devices	"It has the same technological characteristics, is comparable in key safety and effectiveness features, it utilizes similar design, construction, and has similar intended uses as the predicate devices."

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

Sample Size for Test Set: Not explicitly stated as "test set" in the context of a clinical study. The non-clinical tests were performed "on phantoms." The number and type of phantoms are not specified.
Data Provenance: The testing was "in vitro" using phantoms. No human (patient) data is mentioned for testing.

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

This information is not provided as the evaluation was based on in vitro phantom testing, not clinical data requiring expert review for ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation was based on in vitro phantom testing and "design specifications," not clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not performed and was not required. The submission explicitly states: "No clinical tests were required to establish safety or effectiveness." The basis for clearance was substantial equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The performance was evaluated in a standalone (algorithm only) manner through "in vitro precision and accuracy values... computed through a series of tests on phantoms." This was a technical verification of the software's ability to measure and calculate body composition metrics against known phantom values, rather than a clinical performance study.

7. The Type of Ground Truth Used

For the non-clinical tests, the ground truth was based on the known properties of the phantoms used for in vitro testing, which represent ideal or controlled measurements.

8. The Sample Size for the Training Set

This information is not provided. The document describes a software option for existing DEXA bone densitometers rather than a de novo AI/ML algorithm that typically requires a distinct training set. The software likely implements established algorithms for calculating body composition from DEXA scans.

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

This information is not provided and is likely not applicable in the sense of a modern ML training data "ground truth." The software likely uses established physical models and algorithms for converting DEXA measurements into body composition values, rather than being "trained" on a dataset with external ground truth labels.

Summary Rationale for Clearance:

The central argument for this 510(k) submission is that the "GE Lunar Body Composition Software Option" is substantially equivalent to legally marketed predicate devices (specifically, the "Body Composition Software Option for Norland DEXA Bone Densitometers" and the "GE Lunar Prodigy Total Body Software option").

The basis for this conclusion includes:

Comparable Intended Use: Measures regional and whole-body BMD, lean, and fat tissue mass, and calculates derivative values for diagnostic support.
Similar Technological Characteristics: Utilizes similar design, construction, methods for calculation.
Non-Clinical Testing: In vitro precision and accuracy on phantoms were "within design specifications."
Safety: Evaluated for electrical and mechanical safety and found to conform to applicable medical device safety standards.
Quality Systems: The manufacturer's design and development process conforms with 21 CFR 820 and ISO 13485 quality systems.

Due to the device being a software option for an already cleared imaging modality, and its substantial similarity to existing devices, clinical trials were not deemed necessary by the FDA.

Summary

{0}------------------------------------------------

K071570

510{k} Premarket Notification E Medical Systems Lunar - GE Lunar Body Composition Software March 12th, 2007

JUN 2 7 2007

Attachment B 510 (k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

GE Healthcare

Section a):

1. Submitter:	GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC division ofGeneral Electric CompanyGE Medical Systems Lunar (business name)726 Heartland TrailMadison, WI 53717
Contact Person:	James P. RaskobSafety and Regulatory Engineering ManagerTelephone: 608-826-7425; Fax: 608-299-2132

March 12th, 2007 Date Prepared: 2. Device Name: GE Lunar Body Composition Software Option

Bone Densitometer, 21 CFR 892,1170. 90-KGI
1. Marketed Device: Body Composition Software Option for Norland DEXA Bone Densitometers K973459 currently in commercial distribution.
1. Device Description: The Body Composition Software Option for GE Lunar DEXA Bone Densitometers measures the bone mineral density (BMD), lean and fat tissue mass and calculates derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI). The values can be displayed in user-defined statistical formats and trends with color image mapping and compared to reference populations at the sole discretion of the health care professional. The software does not require any changes to the bone densitometer nor does it require additional scanning or radiation exposure beyond the bone density scans.

Indications for Use:

Device Name: Body Composition Software Option for GE Lunar DEXA Bone Densitometers

{1}------------------------------------------------

510(k) Premarket Notification GE Medical Systems Lunar - GE Lunar Body Composition Software March 12th, 2007

useful include nutritional disorders, overweight, obesity, weight management, eating disorders, anorexia nervosa, wasting syndrome, sarcopenia , gastrointestinal disorders, Crohn's disease, celiac disease, gastrectomy, hepatobiliary disorders, cirrhosis, gallstones, renal disorders, chronic renal failure, hemodialysis, organ transplantation, endocrinological disorders, hypopituitarism, acromegaly, Cushing's syndrome, growth hormone deficiency, bone disorders, osteoporosis, Paget's disease, osteopetrosis, pulmonary diseases, cystic fibrosis, chronic pulmonary obstructive disease (COPD), cardiovascular disease, corticosteroids therapy, hormone therapy, total parenteral nutrition (TPN), diabetes, AIDS(HIV. sympathetic dystrophy syndrome, amiotrophic lateral sclerosis, tetraplegy, Duchenne's muscular dystrophy, spinal cord injury complication. DEXA body composition is a useful alternative to hydrostatic weighing, skin fold measurements and bio-impedance estimates.

1. Comparison with Predicate Device: The Body Composition Software Option for GE Lunar DEXA Bone Densitometers is of a comparable type and substantially equivalent to the Body Composition Software Option for Norland DEXA Bone Densitometers and the GE Lunar Prodigy Total Body Software option. It has the same technological characteristics, is comparable in key safety and effectiveness features, it utilizes similar design, construction, and mas similar intended uses as the predicate devices.

Section b):

1. Non-clinical Tests: The device has been evaluated for electrical and mechanical safety, and has been found to conform with applicable medical device safety standards. In vitro precision and accuracy values were computed through a series of tests on phantoms and were within design specifications.

Clinical Tests: No clinical tests were required to establish safety or effectiveness.
Conclusion: Intended uses and other key features are consistent with previously cleared bone densitometer body composition software. The design and development process of the manufacturer conforms with 21 CFR 820 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance was verified through independent evaluation with ongoing factory surveillance. The Body Composition Software Option for GE Lunar DEXA Bone Densitometers is substantially equivalent to currently marketed devices with respect to safety and effectiveness.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN 27 2007

GE Medical Systems Lunar % Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K071570

Trade/Device Name: Body Composition Software Option for GE Lunar DEXA Bone Densitometers Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: June 7, 2007 Received: June 8, 2007

Dear Mr. Kogoma:

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/2/Picture/9 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. There are four stars at the bottom of the logo.

Prototing and Promoting Public Hadth

{3}------------------------------------------------

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.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Chogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

K071570

Attachment E

510 (k) Indications for Use

510(k) Number (if known):

Device Name: Body Composition Software Option for GE Lunar DEXA Bone Densitometers

The GE Lunar Body Composition Software option (body composition) used on GE Lunar DEXA bone densitometer measures the regional and whole body bone mineral density (BMD), lean and fat tissue mass and calculates derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI). The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional.

Prescription Use XXX (Part 21 CFR 801 Subpart D)

Over-The-Counter
(21 CFR 801)

Over The Counter Use (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)

AND/OR

Helenteeur

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Regulation Number and Section

§ 892.1170 Bone densitometer.

(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.