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.

Device Description

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.

AI/ML Overview

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:

Feature/Study	Acceptance Criteria (Implied from text)	Reported Device Performance
DXAVision and Adult TBLH (Bone & Body Composition)	Differences in DXA results for neck-to-knees scans and total body measurements should be slightly larger but similar to precision studies in literature.	Differences are "slightly larger but similar to the results of precision studies of duplicate scans reported in the literature for both iDXA and Prodigy."
Integrated TBS iNsight (TBS and FRAX adjusted for TBS)	Results should be comparable between the integrated TBS and the previously cleared standalone TBS iNsight application.	"demonstrates that TBS and FRAX adjusted for TBS results are comparable between results calculated with the TBS integrated into enCORE 18 software and previously cleared TBS iNsight application."
CoreScan VAT/SAT (Visceral and Subcutaneous Adipose Tissue)	VAT/SAT results should be precise and accurate.	"demonstrate[s] that the VAT/SAT results for the updated CoreScan software option are precise and accurate."
Small Body Composition ROIs (Bone and Body Composition of Arms/Legs)	Accuracy of bone and body composition for upper and lower arms and legs should be confirmed.	"confirm the accuracy of bone and body composition of the upper and lower arms and legs."
Advanced Analytics	The feature should incorporate results of previously cleared features into user-defined equations and not affect safety or effectiveness.	"incorporates results of previously cleared features into user defined equations and does not affect the safety or effectiveness of the system."
Software Verification and Validation	Software should meet design specification requirements.	"confirmed that the software met the design specification requirements."

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.

Summary

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GE Medical Systems Ultrasound & Primary Care Diagnostics LLC % Ms. Martha Kamrow Regulatory Affairs Leader 3030 Ohmeda Drive MADISON WI 53718

Re: K191112

Trade/Device Name: GEHC DXA Bone Densitometers with enCORE version 18 Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: Class II Product Code: KGI Dated: August 16, 2019 Received: August 19, 2019

Dear Ms. Kamrow:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

September 19, 2019

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K191112 Device Name

GEHC DXA Bone Densitometers with enCORE version 18

Indications for Use (Describe)

A) Provides an estimate of bone mineral density at various anatomical sites (Spine, Femur, Total Body, and Forearm). These values can then be compared to an adult reference population at the sole discretion of the physician.
B) Provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO).
C) Provides an assessment of 10-year fracture risk using WHO FRAX model.
D) Provides a standardized bone density report using data from the densitometer and physiciangenerated assessments based on the patient's demographics, which can assist the physician in communicating scan results to the patient's referring physician. Optional Hand BMD software estimates the BMD at the hand.
E) Optional Hand BMD software estimates the BMD at the hand.
F) Optional Dual-Energy Vertebral Assessment software provides an x-ray image of the spine for qualitative visual assessment in order to identify vertebral deformations and estimate vertebral heights (morphometry).
G) Optional Orthopedic software estimates periprosthetic BMD of an orthopedic hip or knee implant (pre- and post-surgery).

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Indications for Use

510(k) Number (if known)

K191112

Device Name

GEHC DXA Bone Densitometers with enCORE version 18

Indications for Use (Describe)

H) Optional Complete Pediatric software option measures bone mineral content (BMC), bone mineral density (BMD) and body composition (lean body mass and fat mass) in patients from birth to 20 years of age. The software provides a comparison of measured variables obtained by dual energy x-ray absorptiometry to a database of reference values for patients 5-19 years of age. These data can be used for comparative purposes at the sole discretion of the physician. The software does not provide a reference population for comparative purposes for patients younger than 5 years of age.
I) Optional Body Composition software measures the regional and whole body bone mineral density (BMD), lean and fat tissue mass, and calculates other derivative values which can be displayed in user-defined statistical formats and trends and compared to reference populations at the sole discretion of the healthcare professional. Some of the diseases/conditions for which body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/HIV, and cystic fibrosis.
J) The Mirrorlmage function used on the GE 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 bodv.
K) Optional CoreScan software estimates the Visceral Adipose Tissue (VAT) content and the Subcutaneous Adipose Tissue (SAT) content within the android region in a male or female population between the ages of 18 and 90 with a BMI between 18.5 and 40, excluding pregnant women. The content that is estimated is the VAT Volume, VAT Area, SAT Mass, SAT Volume, and SAT Area. The values can be displayed in user-defined statistical formats and trends. Some of the diseases/conditions for which VAT estimation can be useful include hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, metabolic syndrome, and some cancers that are correlated to adipose tissue inflammation.
L) Optional total body composition software 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.
M) Optional total body composition software 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.
N) Optional Advanced Hip Assessment (AHA) software provides a measurement of hip axis length (HAL) and a mean value of HAL for Caucasian and Asian females on femur images. It also calculates hip geometry values used to evaluate the structural properties of the hip.

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Indications for Use

K191112

Device Name

GEHC DXA Bone Densitometers with enCORE version 18

Indications for Use (Describe)

O) 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 lateral cortex along the femoral shaft. The beaking index can be displayed and trended across serial scans.
P) 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.
Q) Optional DXAVision software feature provides a complete bone and body composition assessment in one optimized exam including BMD with TBS, Fracture Risk, Adiposity/Metabolic status, and Sarcopenia status.
R) 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 diagnose disease or recommend treatment regimens. Only the health care professional can make these judgments.

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510(k) Summary

K191112

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	16-Aug-2019
Submitter:	GE Healthcare (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.)3030 Ohmeda DriveP.O. Box 7550Madison, WI, USA 53707
Primary ContactPerson:	Martha KamrowRegulatory Affairs LeaderGE Healthcare (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.)Telephone: (262) 548-2673Email: Martha.Kamrow@ge.com
Secondary ContactPerson:	Nicole Landreville, P.Eng, RAC, FRAPSRegulatory Affairs ManagerGE Healthcare (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC)Telephone: (289) 208-2365Email: Nicole.Landreville@ge.com
Device Trade Name:	GEHC DXA Bone Densitometers with enCORE version 18
Common/UsualName:	X-Ray Bone Densitometer
Classification Names:Product Code:	Bone Densitometer (21CFR 892.1170)KGI
Predicate Device(s):	1. Lunar DXA Bone Densitometers with enCORE software:• GEHC DXA Bone Densitometer with enCORE version 17 (K161682)2. MediMaps Group's TBS Insight• TBS Insight (K152299)
Device Description:	The changes proposed in this Premarket Notification will be used with the existingGEHC DXA Bone Densitometers, which utilize the enCORE software.

The GEHC DXA Bone Densitometers are marketed under the following names:
Prodigy originally cleared under K982267.o
o Lunar iDXA originally cleared under K052581.
Device Identification/Characteristics/Description:
GEHC DXA Bone Densitometers are composed of a scanner and a computer. Thescanner comprises the x-ray source and detector, the patient scan table, themechanical drive system, and the lowest level portions of the control system. Thescanner is in communication with the computer, which is a standard PC. Thecomputer runs the enCORE software, and thus controls the scanner, acquires scandata from the scanner, stores and analyzes the data, and interacts with the humanoperator.
GEHC DXA Bone Densitometers are used healthcare facilities and hospitals tomeasure bone mineral density (BMD) and body composition (%fat, fat mass, leanmass) using a technique called Dual-energy X-ray Absorptiometry or DXA. DXAmeasures the attenuation of x-rays of two different energy levels after they passthrough the body of a subject. As bone, fat tissue, and lean tissue absorb thedifferent energy x-rays at different rates, the relative attenuation of each x-rayenergy is measured and used to calculate the composition of each pixel.
Key Performance Specifications/Characteristics of the Device:
The existing GEHC DXA Bone Densitometers with enCORE software features weremodified:
a)DXAVision software feature provides a complete bone and bodycomposition assessment in one optimized exam including BMD with TBS,Fracture Risk, Adiposity/Metabolic status, and Sarcopenia status.DXAVision combines multiple measurements (Spine, DualFemur, TotalBody) in one exam, simplifying workflow. Options to exclude the head andlower legs from the Total Body measurement are available to improvepatient throughput while still capturing the core body composition results.Total results are estimated from the area measured (neck to knees) soexisting reference data can continue to be used. Bone and compositionresults are available in a single, comprehensive, patient-focused report.DXAVision body composition estimates of Total Body %fat is comparableto our previously cleared feature: Spine/Femur Estimated Total Body %fat(K071570).
Integrated TBS iNsight. TBSI iNsight is a software provided for use as ab)complement to both the DXA analysis and clinical examination. Itcomputes a Trabecular Bone Score (TBS) from the antero-posterior spineDXA examination file that is compared to those of the age-matchedcontrols. The TBS is derived from the texture of the DXA image and hasbeen shown to be related to bone microarchitecture. enCORE version 18software integrates the cleared TBS iNsight application (K152299) into theDXA software to provide a more streamlined workflow for the user.

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c)	CoreScan software feature adds reporting of Visceral Adipose Tissue (VAT)area and Subcutaneous Adipose Tissue (SAT) volume, mass, and area tothe existing VAT volume and mass. Area is calculated by dividing thevolume by the height of the region. The size of the subcutaneous fat layeris estimated and subtracted from fat in the abdominal region to estimatevisceral fat using geometric modeling. There is no change in the algorithmfrom that was cleared with enCORE v13.6 software (K103730) however theSAT results are now reported in addition to VAT. Both VAT and SAT datacan be trended to see how the fat distribution in a person changes overtime.
d)	Total Body Less Head (TBLH) for Adults feature provides BMD and bodycomposition results for a total body scan excluding the head. An option toexclude scanning the head is available to reduce scan time and allowscanning of taller subjects that might not otherwise fit in the san window.Total results are estimated so existing reference data can continue to beused. TBLH body composition estimates of Total Body %fat is comparableto our previously cleared feature: Spine/Femur Estimated Total Body %fat(K071570).
e)	Smaller body composition ROIs feature provides additional regional bone,fat, and lean results for the upper and lower arms and legs. This feature issubstantially equivalent to previously cleared GEHC body compositionsoftware option for GE Lunar DEXA Bone Densitometers (K071570).
f)	Advanced Analytics software feature allows the user to create customequations using existing data already available from their DXA system, setuser-defined classification thresholds based on these equations, andestablish actionable patient goals based on evaluation of the results.
g)	Additional security features provide compatibility with the US Departmentof Defense Risk Management Framework (RMF) including FIPS 140-2encryption, TLS for DICOM, IPv6 protocol, and audit trails.
	The addition of these new enCORE v18 software features expands the Indicationsfor Use with the following statements:
a)	Optional DXAVision software feature provides a complete bone and bodycomposition assessment in one optimized exam including BMD with TBS,Fracture Risk, Adiposity/Metabolic status, and Sarcopenia status.
b)	TBS iNsight is a software provided for use as a complement to both DXAanalysis and clinical examination. It computes the antero-posterior spineDXA examination file and calculates a score (Trabecular Bone Score - TBS)that is compared to those of the age-matched controls. The TBS is derivedfrom the texture of the DXA image and has been shown to be related tobone microarchitecture. TBS iNsight provides as an option an assessmentof 10-year fracture risk. It provides an estimate of 10-year probability ofhip fracture and 10-year probability of a major osteoporotic fracture.

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	(clinical spine, forearm, hip or shoulder fracture). This estimate is basedon the WHO's FRAX® Fracture Risk Assessment Tool, after adjustment forthe TBS. The tool has been validated for Caucasian and Asian men andpost-menopausal women between 40 and 90 years old. TBS provides
	information independent of BMD value; it is used as a complement to thedata obtained from the DXA analysis and the clinical examination
	(questioning by the clinician about patient history, bioassay of boneresorption markers). The results can be used by a physician inconjunction with other clinical risk factors as an aid in the diagnosis ofosteoporosis and other medical conditions leading to altered trabecularbone microarchitecture, and ultimately in the assessment of fracture risk.The TBS score can assist the health care professional in monitoring theeffect of treatments on patients across time. Overall fracture risk willdepend on many additional factors that should be considered beforemaking diagnostic or therapeutic recommendations. The software doesnot diagnose disease or recommend treatment regimens. Only the healthcare professional can make these judgments.
	Optional CoreScan software estimates the Visceral Adipose Tissue (VAT)C)content and the Subcutaneous Adipose Tissue (SAT) content within theandroid region in a male or female population between the ages of 18and 90 with a BMI between 18.5 and 40, excluding pregnant women. Thecontent that is estimated is the VAT Mass, VAT Volume, VAT Area, SATMass, SAT Volume, and SAT Area. The values can be displayed in user-defined statistical formats and trends. Some of the diseases/conditionsfor which VAT estimation can be useful include hypertension, impairedfasting glucose, impaired glucose tolerance, diabetes mellitus,dyslipidemia, metabolic syndrome, and some cancers that are correlatedto adipose tissue inflammation.
	The enCORE v18 software incorporates latest Microsoft security patches and othersecurity enhancements.
	Material Used:
	There were no changes made to the material used in the fabrication of●Lunar iDXA and Prodigy X-Ray Bone Densitometers.
Intended Use:	The intended use of the GE Lunar DXA Bone Densitometers remains the same.The proposed device: GE Lunar DXA Bone Densitometers with the enCORE version18 software is intended for medical purposes to measure bone density, bonemineral content, and fat and lean tissue content by x-ray transmissionmeasurements through the bone and adjacent tissues.
Indications for Use:	Provides an estimate of bone mineral density at various anatomical sitesA)(Spine, Femur, Total Body, and Forearm). These values can then be

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	compared to an adult reference population at the sole discretion of thephysician.
B)	Provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the WorldHealth Organization (WHO).
C)	Provides an assessment of 10-year fracture risk using WHO FRAX model.
D)	Provides a standardized bone density report using data from thedensitometer and physician-generated assessments based on the patient'sdemographics, which can assist the physician in communicating scanresults to the patient and the patient's referring physician.
E)	Optional Hand BMD software estimates the BMD at the hand.
F)	Optional Dual-Energy Vertebral Assessment software provides an x-rayimage of the spine for qualitative visual assessment in order to identifyvertebral deformations and estimate vertebral heights (morphometry).
G)	Optional Orthopedic software estimates periprosthetic BMD of anorthopedic hip or knee implant (pre- and post-surgery).
H)	Optional Complete Pediatric software option measures bone mineralcontent (BMC), bone mineral density (BMD) and body composition (leanbody mass and fat mass) in patients from birth to 20 years of age. Thesoftware provides a comparison of measured variables obtained by dualenergy x-ray absorptiometry to a database of reference values for patients5-19 years of age. These data can be used for comparative purposes at thesole discretion of the physician. The software does not provide a referencepopulation for comparative purposes for patients younger than 5 years ofage.
I)	Optional Body Composition software measures the regional and wholebody bone mineral density (BMD), lean and fat tissue mass, and calculatesother derivative values which can be displayed in user-defined statisticalformats and trends and compared to reference populations at the solediscretion of the healthcare professional. Some of the diseases/conditionsfor which body composition values are useful include chronic renal failure,anorexia nervosa, obesity, AIDS/HIV, and cystic fibrosis.
J)	The MirrorImage function used on the GE Lunar DXA bone densitometerscan be used to estimate the total body composition and bone mineraldensity (BMD) when regions of the body are outside of the scan windowby using scanned data from the corresponding region(s) on the oppositehalf of the body.
K)	Optional CoreScan software estimates the Visceral Adipose Tissue (VAT)content and the Subcutaneous Adipose Tissue (SAT) content within theandroid region in a male or female population between the ages of 18 and90 with a BMI between 18.5 and 40, excluding pregnant women. Thecontent that is estimated is the VAT Mass, VAT Volume, VAT Area, SATMass, SAT Volume, and SAT Area. The values can be displayed in user-

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		defined statistical formats and trends. Some of the diseases/conditions forwhich VAT estimation can be useful include hypertension, impaired fastingglucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia,metabolic syndrome, and some cancers that are correlated to adiposetissue inflammation.
	L)	Optional total body composition software estimates the Resting MetabolicRate (RMR) in the male or female population age 18 and older. The datacan be displayed in user-defined statistical formats and trends.
	M)	Optional total body composition software estimates the Relative SkeletalMuscle Index (RSMI) in the male or female population age 18 and older.The data can be displayed in user-defined statistical formats and trends.
	N)	Optional Advanced Hip Assessment (AHA) software provides ameasurement of hip axis length (HAL) and a mean value of HAL forCaucasian and Asian females on femur images. It also calculates hipgeometry values used to evaluate the structural properties of the hip.
	O)	Optional Atypical Femur Fracture (AFF) software uses femur images tovisualize focal reaction or thickening along the lateral cortex of the femoralshaft which may be accompanied by a transverse radiolucent line. Thissoftware provides measurements of the lateral and medial cortex widthand quantifies focal thickening of the lateral cortex along the femoralshaft. The beaking index can be displayed and trended across serial scans.
	P)	Optional sarcopenia software calculates values based on publisheddefinitions and thresholds using measured appendicular lean mass incombination with patient demographics and entered values of musclestrength and physical performance. These values may be useful to healthcare professionals in their management of sarcopenia.
	Q)	Optional DXAVision software feature provides a complete bone and bodycomposition assessment in one optimized exam including BMD with TBS,Fracture Risk, Adiposity/Metabolic status, and Sarcopenia status.
	R)	TBS iNsight is a software provided for use as a complement to both DXAanalysis and clinical examination. It computes the antero-posterior spineDXA examination file and calculates a score (Trabecular Bone Score - TBS)that is compared to those of the age-matched controls. The TBS is derivedfrom the texture of the DXA image and has been shown to be related tobone microarchitecture.
		TBS iNsight provides as an option an assessment of 10-year fracture risk. Itprovides an estimate of 10-year probability of hip fracture and 10-yearprobability of a major osteoporotic fracture (clinical spine, forearm, hip orshoulder fracture). This estimate is based on the WHO's FRAX® FractureRisk Assessment Tool, after adjustment for the TBS. The tool has beenvalidated for Caucasian and Asian men and post-menopausal womenbetween 40 and 90 years old.

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	TBS provides information independent of BMD value; it is used as acomplement to the data obtained from the DXA analysis and the clinicalexamination (questioning by the clinician about patient history, bioassay ofbone resorption markers...). The results can be used by a physician inconjunction with other clinical risk factors as an aid in the diagnosis ofosteoporosis and other medical conditions leading to altered trabecularbone microarchitecture, and ultimately in the assessment of fracture risk.The TBS score can assist the health care professional in monitoring theeffect of treatments on patients across time. Overall fracture risk willdepend on many additional factors that should be considered beforemaking diagnostic or therapeutic recommendations. The software doesnot diagnose disease or recommend treatment regimens. Only the healthcare professional can make these judgments.
Manufacturing Site:	GE Medical Systems Monterrey Mexico, S.A.DE C.V.Calle Espana #300, Parque Industrial HuinalaApodaca, Nuevo Leon, C.P.66645, Mexico
Technology:	GE DXA Bone Densitometers (Lunar iDXA and Prodigy) with the enCORE version 18employs the same fundamental scientific technology as its predicate device GELunar DXA Bone Densitometers with enCORE software v17.
Determination ofSubstantialEquivalence:	Summary of Non-Clinical Tests:The GE Lunar DXA Bone Densitometers with the enCORE version 18 and itsapplications comply with voluntary standards. The following quality assurancemeasures were applied to the development of the system:Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation) There is no change to the system hardware.Although these changes do not impact the intended use of the system, adding TBSiNsight, Optional CoreScan and Optional DXAVision software features added newIndications for Use. These software changes were tested successful:

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• Software verification and validation testing results performed on the
enCORE software version 18 confirmed that the software met the design
specification requirements.

• Bench Performance testing results performed on the DXAVision, Adult
TBLH, Integrated TBS iNsight, CoreScan VAT/SAT, Smaller BC ROIs, and
Advanced Analytics software options confirmed that the design outputs
met the design input requirements.

DXAVision and Adult TBLH – We conclude that the differences in DXA●
results for DXAVision for neck-to-knees scans and for Adult TBLH total
body measurements of bone and body composition in a heterogenous
sample of men and women with a diverse range of age, BMI, BMD, and
body fat are slightly larger but similar to the results of precision studies
of duplicate scans reported in the literature for both iDXA and Prodigy.

Integrated TBS's bench testing using internal engineering DXA data●
sets demonstrates that TBS and FRAX adjusted for TBS results are
comparable between results calculated with the TBS integrated into
enCORE 18 software and previously cleared TBS iNsight application.

CoreScan's bench testing used an anthropomorphic phantom to●
demonstrate the VAT/SAT results for the updated CoreScan software
option are precise and accurate.
The new Small Body Composition ROI verification results confirm the●
accuracy of bone and body composition of the upper and lower arms
and legs.

●The new Advanced Analytics software option incorporates results of
previously cleared features into user defined equations and does not
affect the safety or effectiveness of the system.

Therefore, GE Healthcare concludes that GEHC DXA Bone Densitometers with
enCORE version 18 is as safe and as effective as the Predicate devices for its
intended use.

There is no change to the diseases or conditions expected to be diagnosed,
treated, prevented, cured or mitigated. There is also no change to the patient
population.

Summary of Clinical Tests:
Although the subject of this premarket submission, GEHC DXA Bone Densitometers
with the enCORE version 18, did not require clinical studies to support substantial
equivalence, a clinical literature search was performed and provided to support
the additional optional software features calculations and associated indications
for use.

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Conclusion:	The GEHC DXA Bone Densitometers with enCORE version 18 expands its previouslycleared features and indications for use but does not result in any new potentialsafety risks. The GEHC DXA Bone Densitometers have the same technologicalcharacteristics and performs as well as the predicate devices currently on themarket.
	Based on: conformance to standards; development under GE Healthcare's qualitymanagement system and design controls; successful verification/validation testingand additional bench performance testing. GE Healthcare believes that the GEHCDXA Bone Densitometers with enCORE version 18 is substantially equivalent to itspredicate device GE Lunar DXA Bone Densitometers with enCORE version 17(K161682). The TBS feature is substantially equivalent to its predicate deviceMediMaps Group's TBS Insight (K152299).
	Therefore, GE Healthcare concludes that GEHC DXA Bone Densitometers withenCORE version 18 is as safe and as effective as the Predicate devices for itsintended use.

Conclusion:

The GEHC DXA Bone Densitometers with enCORE version 18 expands its previouslycleared features and indications for use but does not result in any new potentialsafety risks. The GEHC DXA Bone Densitometers have the same technologicalcharacteristics and performs as well as the predicate devices currently on themarket.

Based on: conformance to standards; development under GE Healthcare's qualitymanagement system and design controls; successful verification/validation testingand additional bench performance testing. GE Healthcare believes that the GEHCDXA Bone Densitometers with enCORE version 18 is substantially equivalent to itspredicate device GE Lunar DXA Bone Densitometers with enCORE version 17(K161682). The TBS feature is substantially equivalent to its predicate deviceMediMaps Group's TBS Insight (K152299).

Therefore, GE Healthcare concludes that GEHC DXA Bone Densitometers withenCORE version 18 is as safe and as effective as the Predicate devices for itsintended use.

Regulation Number and Section

§ 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.