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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.

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.

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.

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.

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