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The GE Lunar enCORE software used on the GE Lunar bone densitometer total body scan estimates the Resting Metabolic Rate (RMR) in the male or female population age 18 and older. The data can be displayed in user-defined statistical formats and trends.

The GE Lunar enCORE software used on the GE Lunar bone densitometer total body scan estimates the Relative Skeletal Muscle Index (RSMI) in the male or female population age 18 and older. The data can be displayed in user-defined statistical formats and trends.

The MirrorImage function in the enCORE software used on the GF. Lunar DXA bone densitometers can be used to estimate the total body composition and bone mineral density (BMD) when regions of the body are outside of the scan window by using scanned data from the corresponding region(s) on the opposite half of the body.

enCORE is the software is used by the series of GE Lunar DXA bone densitometers. Release 14 of the enCORE software (enCORE 14 or enCORE 14.xx) includes some feature enhancements. The software will calculate Resting Metabolic Rate (RMR) and Resting Skeletal Muscle Index (RSMI) using existing scan data. The calculations of RMR and RSMI do not require any changes to the bone densitometer nor does it require additional scanning or radiation exposure beyond the Total Body scans.

Additionally, the enCORE software can utilize a MirrorImage function, which estimates Body Composition values using scanned data from the opposite side of the body if the patient does not fit entirely within the scan window.

The GE Lunar DXA bone densitometers measure the bone mineral density (BMD), lean and fat tissue mass and calculate 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 provided 510(k) summary for K113286 does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it states that "The subject of this premarket submission, the GE Lunar DXA Bone Densitometers, did not require clinical studies to support substantial equivalence."

The submission focuses on establishing substantial equivalence to a predicate device (Body Composition Software Option for GE Lunar DEXA Bone Densitometers, K071570) based on the following:

• Same fundamental scientific technology.
• No changes to the scan performed for RMR, RSMI, or MirrorImage functions; they utilize existing scan data.
• Quality assurance measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing).

Therefore, specific information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, or standalone performance studies is largely not applicable or not provided in this document.

However, based on the information provided, here's a structured response indicating what is and is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided. The submission states that clinical studies were not required to support substantial equivalence. The "performance" described relates to the calculation of RMR, RSMI, and MirrorImage functionality using existing scan data, rather than specific quantitative performance metrics against acceptance criteria.

2. Sample size used for the test set and the data provenance

Not applicable. No clinical or performance test set, in the traditional sense, is described as having been used to evaluate the device against specific performance criteria. The functions utilize "existing scan data" but no study leveraging a specific test set is detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication is described.

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. No MRMC study was conducted or described, as this submission did not involve AI assistance for human readers. The device calculates metrics (RMR, RSMI) or estimates values (MirrorImage) from existing DXA scan data.

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

Not explicitly described as a standalone performance study with quantitative results. The submission implies the algorithm's performance is inherently tied to the validated performance of the underlying DXA system and existing Body Composition software, as it uses the same "fundamental scientific technology" and "existing scan data." The document states "It is concluded that the added features do not impact safety and effectiveness of the enCORE software or the GE Lunar DXA Bone Densitometers in comparison to the predicate device," which is a statement of equivalence rather than standalone performance against a defined ground truth.

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

Not applicable. No explicit ground truth for a new performance claim is described. The device leverages calculations based on existing DXA scan data, which implies reliance on the established accuracy and precision of the DXA measurements themselves from the predicate device.

8. The sample size for the training set

Not specified. No training set for an AI/machine learning model is mentioned, as the focus is on calculations and estimations from existing DXA data rather than a new AI-driven diagnostic or interpretative model.

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

Not applicable. No training set ground truth establishment is described.

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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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