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The Bunkerhill BMD Algorithm is a post-processing AI-powered software intended for adults 30 years and above to assess estimated DXA-measured average areal bone mineral density of spinal bones from existing CT scans and outputs a flag for low bone density below a pre-specified threshold. It is not intended to replace DXA or any other tests dedicated to BMD measurement. Bunkerhill BMD is an opportunistic AI-powered tool that enables:(1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure

The Bunkerhill BMD application is a software only medical device (SaMD) that includes deep- learning-based computer vision and post-processing algorithms that estimates the bone mineral density from previously obtained computed tomography (CT) images. The results from Bunkerhill BMD are not intended to be used as the primary input for clinical decision making, but rather are intended to provide information that may assist the clinician to identify 'findings of interest' within existing imaging studies.

TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO's FRAX® Fracture Risk Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old. TBS provides information independent of BMD value: it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers...). The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time. Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not disease or recommend treatment regimens. Only the health care professional can make these judgments.

TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X-ray absorptiometry (DXA) and other clinical risk factors for osteoporosis and fragility fracture. It calculates a score (Trabecular Bone Score - TBS) derived from the texture of the DXA image of the anterior-posterior (AP) lumbar spine and has been shown to be related to bone microarchitecture. The method analyzes X-ray based images acquired by DXA imaging systems and produces the TBS based on the computation of an Adapted Experimental Variogram (modified fractal-like approach). This variogram is used to measure the degree of spatial variation between pairs of data points in a spatial dimension of a region of a digital image. The absolute TBS values for the same equivalent tissue thickness vary slightly between GE and Hologic systems. Additionally, within each system, variability in TBS values can be observed across different scan modes. To address these differences, corrections are applied that are both device-specific and mode-specific. For instance, TBS is corrected differently for GE and Hologic systems to account for inherent differences in tissue thickness assessment. Furthermore, corrections are also tailored separately for each scan mode within the same system, ensuring that TBS measurements remain consistent and reliable regardless of the scan mode used. These device-specific and mode-specific corrections are necessitated by differences in the dynamic range of tissue thickness measurements between GE and Hologic devices. The variations arise due to differences in the methodologies used to assess tissue thickness. To harmonize these discrepancies and ensure measurement accuracy, correction fits derived from ex-vivo data are applied individually to each device and scan mode. This approach ensures the accuracy and consistency of TBS measurements across all configurations. The device is intended to be used for bone health assessment in medical facilities employing one or more DXA system(s) to which the subject device is connected. These facilities are usually hospitals, clinics, healthcare centers, radiology practices and medical imaging centers. The software is designed to be used by qualified clinical professionals (including physicians, radiologists and DXA technicians) and the physicians are solely responsible for making all final patient management decisions.

VirtuOst uses data from computed tomography scans to estimate bone mineral density, bone strength, and a load-to-strength ratio. This information can be used by a physician to assess fracture risk, identify osteoporosis, and monitor therapy. For pediatric patients, VirtuOst provides these estimates without any classifications and should be used only when the benefit of obtaining these estimates outweighs the risk of radiation.

VirtuOst is a software-only medical device that analyzes data in computed tomography (CT) scans to measure bone mineral density (BMD), bone strength, and a load-to-strength ratio at the proximal femur and vertebral body. BMD is measured from both a 2D projection (in g/cm2) and a volumetric scan reconstruction (in mg/cm³) of the CT scan. VirtuOst measurements can be used by a physician to identify osteoporosis, assess fracture risk, and monitor therapy. The VirtuOst analysis is performed on previously physician-acquired image data and is unrelated to acquisition equipment and clinical workstations.

3D-SHAPER uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z, Buckling Ratio, cortical sBMD, trabecular vBMD and integral vBMD. 3D-SHAPER is indicated to be used by qualified medical professionals to assist healthcare professionals in the bone health evaluation & changes, and cannot fully substitute their clinical judgement.

3D-SHAPER is a software reconstructing in 3D, the shape and bone mineral density from 2D DXA images. The software incorporates a DXA-based 3D reconstruction and measures the distribution of bone mineral mass at specific cross sections of the hip. It provides physicians with estimates of the structural properties of the hip, such as densities or geometrical parameters. The software is not suitable for use with paediatric patients or for subjects with hip prosthesis such as total hip replacement prosthesis, hip resurfacing prosthesis or an osteosynthesis system, since the software has not been tested against these conditions. 3D-SHAPER is indicated to be used by qualified medical professionals to assist healthcare professionals in the bone health evaluation & changes, and cannot fully substitute their clinical judgement. The 3D-SHAPER® measurements include: Cortical surface Bone Mineral Density (Cortical sBMD, mg/cm2) Trabecular volumetric Bone Mineral Density (Trabecular vBMD, mg/cm³) Integral volumetric Bone Mineral Density (Integral vBMD, mg/cm³), the integral compartment being the union of the cortical and trabecular compartments. Hip structural measurements: Cross-Sectional Area (CSA, in cm²), Cross-Sectional Moment of Inertia (CSMI, in cm4), section modulus (Z, in cm3) and buckling Ratio (BR). Cortical sBMD, trabecular VBMD and integral vBMD are calculated at the total femur. CSA, CSMI, Z and BR are calculated in cross-sections at the neck, intertrochanteric region and lower shaft.

The Automated Bone Mineral Density Software Module (ABMD) is a post-processing AI-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. ABMD is not intended to replace DXA or any other tests dedicated to BMD measurement. It is solely designed for measuring BMD in existing CT scans ordered for reasons other than BMD measurement. In summary, ABMD is an opportunistic AI-powered tool that enables: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure.

The Automated Bone Mineral Density (ABMD) Software is a software module that estimates bone mineral density in the vertebral bones by averaging Hounsfield Units (HU) in the trabecular area. ABMD Software is a post-processing software that works on existing CT scans. ABMD Software measurements are to be reviewed by radiologists and should be used by healthcare providers in conjunction with clinical evaluation.

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.

X-ray Bone Densitometer designed to estimate the bone mineral density of patients when medically indicated by their physicians. - Provides an estimate of bone mineral density at various anatomical sites (Spine, Femur, Forearm). These values can then be compared to an adult reference population at the sole discretion of the physician. - Provides an assessment of relative risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO). - Provides an assessment of 10-year fracture risk using WHO FRAX model. - Provides a standardized bone density report using data from the densitometer and physician-generated assessments based on the patient's demographics, which can assist the physician in communicating scan results to the patient and the patient's referring physician.

The Aria X-ray Bone Densitometer is designed to be a value product version of the predicate device, the Prodigy (K982267 and K161682). Like its predicate Prodigy device, the proposed Aria device is composed of a scanner and a computer that runs the software. 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. Aria X-ray Bone Densitometer functions with the same software as the one that is FDA cleared under GE Lunar DXA Bone Densitometers with enCORE version 17 (K161682).

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.

TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO's FRAX® Fracture Risk Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old. TBS provides information independent of BMD value: it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers . . . ). The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time. Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not disease, or recommend treatment regimens. Only the health care professional can make these judgments.

TBS iNsight is a software provided for use as a complement to to both DXA analysis and clinical examination. It computes the AP spine DXA examination file and calculates the Trabecular Bone Score (TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. It provides as an option an assessment of 10-year fracture risk, based on the WHO's FRAX® Tool, after adjustment for the TBS. The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time.

The QCT Pro Asynchronous Calibration Module is intended to provide an alternative method for calibrating QCT data sets that are intended for analysis with QCT Pro Spine and Hip application modules. Installation of the QCT Pro Asynchronous Calibration Module does not alter the clinical indications for use of the QCT Pro Spine and Hip application modules. It does, however, provide an additional means of obtaining calibration data that does not require the simultaneous scanning of a patient with a CT calibration standard as is required when using the QCT Pro Spine and Hip application modules without the installation of the QCT Pro Asynchronous Calibration Module. Thus the QCT Pro Asynchronous Calibration Module facilitates: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans of the anatomical regions where estimating bone density is prescribed, and (3) assessment of bone density without a phantom as an independent measurement procedure.

The QCT Pro Asynchronous Calibration Module is intended to extend the capabilities of QCT Pro bone mineral densitometer products (K894854. K002113. K030330) currently marketed by Mindways to the measurement of bone mineral content (BMC) and bone mineral density (BMD) from patient-specific CT images acquired without the simultaneous use of a CT calibration phantom. The QCT Pro bone mineral densitometer products distributed with or supplemented with the QCT Pro Asynchronous Calibration Module will be marketed under the name QCT Pro CliniQCT or more simply CliniQCT. Mineral calibration with the asynchronous calibration method is obtained from phantom measurements acquired on the same CT scanner, operated in a substantially similar mode used to acquire a patient CT scan. The phantom measurements used for calibration purposes may be acquired before or after a patient CT scan to which they are to be applied. The asynchronous calibration mode facilitates: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans of the anatomical regions where estimating bone density is prescribed, and (3) assessment of bone density without a phantom as an independent measurement procedure. Retrospective bone density analysis provides bone density information without exposing a patient to additional ionizing radiation while combining CT studies results in an overall reduction in patient exposure to ionizing radiation relative to the expected radiation dose associated with performing the studies separately.