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The proposed device: GE Lunar DXA Bone Densitometers with the enCORE version 18 software is intended for medical purposes to measure bone density, bone mineral content, and fat and lean tissue content by x-ray transmission measurements through the bone and adjacent tissues.

The changes proposed in this Premarket Notification will be used with the existing GEHC DXA Bone Densitometers, which utilize the enCORE software.

The GEHC DXA Bone Densitometers are composed of a scanner and a computer. The scanner comprises the x-ray source and detector, the patient scan table, the mechanical drive system, and the lowest level portions of the control system. The scanner is in communication with the computer, which is a standard PC. The computer runs the enCORE software, and thus controls the scanner, acquires scan data from the scanner, stores and analyzes the data, and interacts with the human operator.

GEHC DXA Bone Densitometers are used healthcare facilities and hospitals to measure bone mineral density (BMD) and body composition (%fat, fat mass, lean mass) using a technique called Dual-energy X-ray Absorptiometry or DXA. DXA measures the attenuation of x-rays of two different energy levels after they pass through the body of a subject. As bone, fat tissue, and lean tissue absorb the different energy x-rays at different rates, the relative attenuation of each x-ray energy is measured and used to calculate the composition of each pixel.

The provided text describes the GEHC DXA Bone Densitometers with enCORE version 18. This device is a bone densitometer that measures bone mineral density (BMD) and body composition using Dual-energy X-ray Absorptiometry (DXA). The submission is a 510(k) premarket notification, indicating that the device claims substantial equivalence to existing legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical thresholds for performance. Instead, it describes various software features and states that bench performance testing confirmed that design outputs met design input requirements and that results are "comparable" or "precise and accurate."

Here's an attempt to structure the information into a table based on the provided text, recognizing that precise criteria are often implied rather than explicitly stated with quantifiable targets in this type of summary:

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

• DXAVision/Adult TBLH: The study involved a "heterogeneous sample of men and women with a diverse range of age, BMI, BMD, and body fat." No specific numerical sample size is provided.
• Integrated TBS iNsight: "internal engineering DXA data sets" were used. No specific numerical sample size.
• CoreScan: An "anthropomorphic phantom" was used. This is not human data.
• Small Body Composition ROIs: No specific sample size or provenance is mentioned for the verification results.
• Advanced Analytics: No specific sample size or provenance is mentioned.
• Software Verification and Validation: No specific sample size or provenance is mentioned besides "software verification and validation testing."

The provenance of human data, based on the description, is internal to GE Healthcare ("internal engineering DXA data sets"). It is implied to be retrospective, as it refers to existing data sets.

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

The document does not explicitly mention the number or qualifications of experts used to establish ground truth for any of the described tests. The studies focus on comparing the updated software features to previous cleared versions or literature, or phantom data, rather than independent expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

No adjudication method is mentioned for any of the described tests. The evaluations appear to be based on comparisons to predicate technology, internal software testing, or phantom measurements.

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

No MRMC comparative effectiveness study is mentioned. The device's improvements are focused on streamlined workflow, integration of features, and accuracy/precision of measurements, not on direct human reader improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are primarily standalone algorithmic performance evaluations. For example, the CoreScan bench testing used an anthropomorphic phantom, and the TBS iNsight validation compared algorithmic outputs. The DXAVision and Adult TBLH studies compare algorithm results to literature-reported precision, implying a standalone assessment of the algorithm's measurement precision.

7. The Type of Ground Truth Used

• DXAVision/Adult TBLH: The "ground truth" used for comparison appears to be the precision of "duplicate scans reported in the literature" for existing iDXA and Prodigy devices. This implies a comparison to established performance benchmarks rather than an independently adjudicated 'ground truth' for each case.
• Integrated TBS iNsight: The "ground truth" is the results from the "previously cleared TBS iNsight application."
• CoreScan: The "ground truth" is derived from the known characteristics of an "anthropomorphic phantom."
• Small Body Composition ROIs: "Accuracy of bone and body composition" is confirmed, suggesting comparison to a known standard or previously validated measurements, but the specific nature of this ground truth is not detailed.
• Advanced Analytics: No explicit ground truth is mentioned, as this feature is about user-defined equations using existing data.

8. The Sample Size for the Training Set

The document does not provide details about training sets for any of the software features. This submission is for updates to existing software (enCORE version 18) and integration of previously cleared applications, suggesting development was not based on a new, distinct training phase described in this summary.

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

Since no training set details are provided, the method for establishing ground truth for a training set is not described. The focus of this 510(k) submission is on changes and integrations based on verified algorithms and features, rather than the initial development of a new AI model requiring a training set.

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Optional Atypical Femur Fracture (AFF) software uses Femur images to visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. This software provides measurements of the lateral and medial cortex width and quantifies focal thickening of the femoral shaft. The beaking index can be displayed and trended across serial scans.

Optional sarcopenia software calculates values based on published definitions and thresholds using measured appendicular lean mass in combination with patient demographics and entered values of muscle strength and physical performance. These values may be useful to health care professionals in their management of sarcopenia.

GE Lunar DXA Bone Densitometers with enCORE version 17 are composed of a scanner and a computer. The scanner comprises the x-ray source and detector, the patient scan table, the mechanical drive system, and the lowest level portions of the control system. The scanner is in communication with the computer, which is a standard PC. The computer runs the enCORE software, and thus controls the scanner, acquires scan data from the scanner, stores and analyzes the data, and interacts with the human operator.

The enCORE software runs on the following list of GE Lunar DXA Bone Densitometers:
Lunar Prodigy Series: (Prodigy, Prodigy Compact, Prodigy Pro, Prodigy Pro Compact, Prodigy Primo, Prodigy Primo Compact, Prodigy Advance, Prodigy Advance Compact) Lunar iDXA Series: (iDXA, iDXA Advance, iDXA Pro, iDXA Forma, Lunar iDXA) DPX Series: DPX-NT & DPX-Bravo. The GE Lunar DXA Bone Densitometers with enCORE version 17 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 enCORE software is used on GE Lunar DXA bone densitometers. Release 17 of the enCORE software (enCORE 17 or enCORE 17.xx) includes some feature enhancements.

GE Lunar DXA Bone Densitometers with enCORE software were modified to include 2 new software features as well as additional cybersecurity enhancements:
A- The software will now expand upon its previously cleared Hip Axis Length (K011917) & AHA - Advanced Hip Assessment (K072664) by the addition of an optional feature for Atypical Femur Fracture (AFF): AFFs are stress or insufficiency fractures that occur in the subtrochanteric or diaphyseal regions of the femur and may be associated with long term bisphosphonate use. The new AFF feature brings minor changes to the anatomical sites to extend the DXA femur scan to include the distal femur shaft, measure the lateral and medial cortex width and quantify focal thickening of the lateral cortex along the femoral shaft. The beaking index can be displayed and trended across serial scans. The new AFF indication for use is equivalent to the Hologic Single Energy (SE) Femur Exams (K130277).

B- The software will now expand upon its previously cleared Total Body Composition (K071570) and RSMI - Relative Skeletal Muscle Index (K113286) by the addition of an optional feature for Sarcopenia calculation: Sarcopenia is a gradual loss of muscle mass and strength associated with aging and is a factor in the occurrence of frailty, falls, and fractures. Sarcopenia definitions have been published by four leading clinical working groups:
• International Working Group on Sarcopenia1:
• European Working Group on Sarcopenia in Older People2
• Asian Working Group for Sarcopenia3
• The Foundation for the National Institutes of Health Biomarkers Consortium Sarcopenia Project4

All definitions include DXA appendicular lean mass (ALM), a value measured from DXA total body scans, in combination with other measurements of muscle strength and physical performance (e.g. grip strength and gait speed). The new sarcopenia software feature allows the user to select one of the four definitions, extend the total body user interface so user can input muscle strength and physical performance data along with DXA ALM, and compare individual values against clinical thresholds for assessing sarcopenia.
The Sarcopenia feature provides a calculated sarcopenia classification using one of the four definitions above.

C- The enCORE version 17 software incorporates latest Microsoft security patches and other security enhancements.

Here's a breakdown of the acceptance criteria and study information for the GE Lunar DXA Bone Densitometers with enCORE version 17, based on the provided document.

It's important to note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report. Therefore, some of the requested information (especially regarding detailed study methodology, ground truth establishment, and MRMC studies) is not explicitly provided.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in a pass/fail format for the new Atypical Femur Fracture (AFF) and Sarcopenia features. Instead, it demonstrates equivalence to predicate devices and conformance to published definitions and measurement capabilities.

1. Technology: Dual-energy X-ray Absorptiometry (DXA) for proposed device is equivalent to GE Lunar DXA for AHA/HAL. For imaging distal shaft, it is equivalent to the Hologic predicate using single-energy image.
2. Exam Site: Must extend to Proximal Femur and distal shaft (similar to Hologic predicate).
3. Values Displayed: Quantitative measurements of cortical thickness (beaking index) for the larger femoral scan area, extending beyond previous AHA capabilities.
4. Method of Deformity Assessment: Combines visual assessment with quantitative measurements of cortical width (similar to Hologic's visual).
   Functional: Visualize focal reaction/thickening, measure lateral/medial cortex width, quantify focal thickening, display/trend beaking index. | Technology: Employs Dual-energy X-ray Absorptiometry (DXA), extending existing GE Lunar DXA femur scans to image the distal shaft. This is deemed equivalent to the predicate devices.
   Exam Site: Images both the Proximal Femur and distal shaft, identical to the Hologic predicate (K130277).
   Values Displayed: The enCORE Version 17 AFF feature measures cortical width (beaking index) over a larger femoral scan area compared to the Advanced Hip Assessment (AHA), demonstrating extended capability while remaining equivalent in principle of measurement.
   Method of Deformity Assessment: Combines a visual assessment with quantitative measurements of cortical width, which is considered equivalent to the predicate methods. The software "provides measurements of the lateral and medial cortex width and quantifies focal thickening of the femoral shaft. The beaking index can be displayed and trended across serial scans." |
   | Sarcopenia Software | Equivalence to Predicate Devices:
5. Technology: Dual-energy X-ray Absorptiometry (DXA) for proposed device must be identical to GE Lunar DXA predicates for Total Body composition and RSMI.
6. Anatomical Sites: Must be identical (Regional and Whole Body) to GE Lunar DXA predicates.
7. Values Displayed: Must provide BMD, lean/fat tissue mass, BMC, Area, Soft Tissue Mass (regional/total), Fat Free Mass, Ratios, %Fat (regional/total), RSMI, and new calculated values based on published definitions (FNIH, AWGS, EWGSOP, IWGS).
   Functional: Calculate values based on published definitions and thresholds using measured appendicular lean mass (ALM) in combination with patient demographics and entered values of muscle strength and physical performance. | Technology: Employs Dual-energy X-ray Absorptiometry (DXA), identical to its predicate devices for total body composition and RSMI.
   Anatomical Sites: Measures Regional and Whole Body, identical to its predicate devices.
   Values Displayed: Provides all values from the predicate devices (BMD, lean/fat tissue mass, BMC, etc.) and additionally calculates RSMI, FNIH, AWGS, EWGSOP, and IWGS values, directly incorporating the four published sarcopenia definitions. The software "calculates values based on published definitions and thresholds using measured appendicular lean mass in combination with patient demographics and entered values of muscle strength and physical performance." |
   | General Software Enhancements (including Cybersecurity) | Functional: Incorporate latest Microsoft security patches and other security enhancements. Maintain safety and effectiveness. | The enCORE version 17 software incorporates the latest Microsoft security patches and other security enhancements. No adverse impact on safety or effectiveness was reported. |

Study Information

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify a distinct "test set" sample size for the AFF or Sarcopenia features from a clinical data perspective. It primarily relies on non-clinical evaluation (bench testing) for software verification and validation.
   • Data Provenance: Not explicitly stated for specific test data used. However, the basis for the Sarcopenia calculations is "published definitions and thresholds" from international working groups. For AFF, it extends existing DXA femur scans, implying the use of standard DXA imaging. As no new clinical studies were required, there is no mention of country of origin or retrospective/prospective data collection for a dedicated test set.

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

   • This information is not provided in the document, as no specific clinical test set requiring expert ground truth for adjudication is detailed. The Sarcopenia feature relies on published definitions from various clinical working groups as its "ground truth" for calculations. For AFF, the ground truth for measurement accuracy would likely be established through phantom or simulated data testing, not expert consensus on pathology.

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

   • None explicitly stated, as no clinical test set requiring human adjudication is described.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "The subject of this premarket submission, GE Lunar DXA Bone Densitometers with enCORE version 17, did not require clinical studies to support substantial equivalence." These features are presented as measurement and calculation tools, not as diagnostic AI aids that would improve human reader performance in an MRMC study.

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

   • Yes, in essence. The "non-clinical evaluation" and "bench testing" of the "AFF" software option and the "optional sarcopenia calculator software" represent standalone algorithm testing. The software performs measurements (cortical width) and calculations (sarcopenia classifications) and presents them to the user. The testing confirmed that "the design outputs met the design input requirements" and demonstrated "safety and effectiveness to the predicate devices."

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

   • For AFF (measurements): Implied ground truth from established anatomical measurements, potentially verified through phantom studies or comparison to existing validated measurement techniques. The document mentions "minor changes to the anatomical sites to extend the DXA femur scan," implying reliance on anatomical correctness and quantitative measurement accuracy.
   • For Sarcopenia (calculations): The "ground truth" for the calculations is based on published definitions and thresholds from four leading clinical working groups (International Working Group on Sarcopenia, European Working Group on Sarcopenia in Older People, Asian Working Group for Sarcopenia, and The Foundation for the National Institutes of Health Biomarkers Consortium Sarcopenia Project). The software's performance is validated against these established definitions.

7. The sample size for the training set:

   • Not applicable / not provided. The document describes software enhancements that perform measurements and calculations based on known anatomical structures and published clinical definitions. There is no indication of a machine learning or AI model that required a specific training set of images or data to learn from for these new features. The software's functionality appears to be rule-based or algorithmically determined parameters rather than learned from a training set.

8. How the ground truth for the training set was established:

   • Not applicable / not provided, as there is no mention of a training set for machine learning. The "ground truth" for the software's functionality is its adherence to anatomical principles and published clinical definitions.

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