(172 days)
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.
§ 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.