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.

Device Description

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.

AI/ML Overview

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.

Feature	Acceptance Criteria (Implied / Demonstrated)	Reported Device Performance
AFF Software	Equivalence to Predicate Devices: 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: 1. Technology: Dual-energy X-ray Absorptiometry (DXA) for proposed device must be identical to GE Lunar DXA predicates for Total Body composition and RSMI. 2. Anatomical Sites: Must be identical (Regional and Whole Body) to GE Lunar DXA predicates. 3. 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

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.
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.
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.
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.
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."
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.
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.
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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 2, 2016

GE Healthcare (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC) % Ms. Nicole Landreville Regulatory Affairs Program Manager 3030 Ohmeda Drive MADISON WI 53718

Re: K161682

Trade/Device Name: GE Lunar DXA Bone Densitometers with enCORE version 17 Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: KGI Dated: October 31, 2016 Received: November 1, 2016

Dear Ms. Landreville:

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. 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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161682

Device Name

GE Lunar DXA Bone Densitometers with enCORE version 17

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Section 5: 510(k) Summary

GE Lunar DXA Bone Densitometers with enCORE version 17

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510(k) Summary

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

Date:	15-Jun-2016
Submitter:	GE Healthcare (GE Medical Systems Ultrasound & Primary CareDiagnostics, LLC.)3030 Ohmeda DriveP.O. Box 7550Madison, WI, USA 53707
Primary ContactPerson:	Nicole Landreville, Eng, RACRegulatory Affairs Program ManagerGE Healthcare (GE Medical Systems Ultrasound & Primary CareDiagnostics, LLC.)Telephone: (289) 208-2365Email: Nicole.landreville@ge.com
Secondary ContactPerson:	Diane UriellRegulatory Affairs DirectorGE Healthcare (GE Medical Systems Ultrasound & Primary CareDiagnostics, LLC)Telephone: (262) 290-8212Email: Diane.Uriell@ge.com
Device Trade Name:	GE Lunar DXA Bone Densitometers with enCORE version 17
Common/UsualName:	X-Ray Bone Densitometer
Classification Names:	Bone Densitometer (21CFR 892.1170)
Predicate Devices:	1. Lunar DXA Bone Densitometers with enCORE software:Total Body Composition (K071570 – Product Code: KGI) RSMI - Relative Skeletal Muscle Index (K113286- Product Code: KGI) AHA - Advanced Hip Assessment (K072664 – Product Code: KGI) HAL- Hip Axis Length (K011917 – Product Code: KGI) 2. Hologic Bone Densitometers Single Energy (SE) Femur Exams (K130277 – Product Code: KGI).
Device Description:	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.
Device Description(Cont.):	GE Lunar DXA Bone Densitometers with enCORE software weremodified to include 2 new software features as well as additionalcybersecurity enhancements:A- The software will now expand upon its previously cleared HipAxis Length (K011917) & AHA - Advanced Hip Assessment(K072664) by the addition of an optional feature for AtypicalFemur Fracture (AFF): AFFs are stress or insufficiency fracturesthat occur in the subtrochanteric or diaphyseal regions of thefemur and may be associated with long term bisphosphonateuse. The new AFF feature brings minor changes to theanatomical sites to extend the DXA femur scan to include thedistal femur shaft, measure the lateral and medial cortex widthand quantify focal thickening of the lateral cortex along thefemoral shaft. The beaking index can be displayed and trendedacross serial scans. The new AFF indication for use is equivalentto the Hologic Single Energy (SE) Femur Exams (K130277).
	B- The software will now expand upon its previously cleared TotalBody Composition (K071570) and RSMI - Relative Skeletal MuscleIndex (K113286) by the addition of an optional feature forSarcopenia calculation: Sarcopenia is a gradual loss of musclemass and strength associated with aging and is a factor in theoccurrence of frailty, falls, and fractures. Sarcopenia definitionshave 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 HealthBiomarkers Consortium Sarcopenia Project4
	All definitions include DXA appendicular lean mass (ALM), a valuemeasured from DXA total body scans, in combination with othermeasurements of muscle strength and physical performance(e.g. grip strength and gait speed). The new sarcopenia softwarefeature allows the user to select one of the four definitions,extend the total body user interface so user can input musclestrength and physical performance data along with DXA ALM,and compare individual values against clinical thresholds forassessing sarcopenia.The Sarcopenia feature provides a calculated sarcopeniaclassification using one of the four definitions above.
	C- The enCORE version 17 software incorporates latest Microsoftsecurity patches and other security enhancements.
Device Description(Cont.):	Sarcopenia references:
	1. Fielding RA, Vellas B, Evans WJ, et.al, Sarcopenia: AnUndiagnosed Condition in Older Adults. Current ConsensusDefinition: Prevalence, Etiology, and Consequences. J Am Med DirAssoc. 2011 May ; 12(4): 249–256.
	2. Cruz-Jentoft AJ, Baeyens JP, Bauer JM, et al. Sarcopenia:European consensus on definition and diagnosis: report of theEuropean Working Group on Sarcopenia in Older People. AgeAgeing. 2010;39:412-423.
	3. Chen LK, Liu LK, Woo J,et.al. Sarcopenia in Asia: consensus reportof the Asian Working Group for Sarcopenia. J Am Med Dir Assoc.2014 Feb;15(2):95-101
	4. Studenski SA1, Peters KW, Alley DE,et.al. The FNIH SarcopeniaProject: Rationale, Study Description, ConferenceRecommendations, and Final Estimates. J Gerontol A Biol SciMed Sci 2014 May;69(5):547-558
Intended Use:	The intended use of the GE Lunar DXA Bone Densitometers remainsthe same.
	The proposed device: “GE Lunar DXA Bone Densitometers withenCORE version 17 software” is intended for medical purposes tomeasure bone density, bone mineral content, and fat and lean tissuecontent by x-ray transmission measurements through the bone andadjacent tissues.
Indications for Use:	Optional Atypical Femur Fracture (AFF) software uses Femur imagesto visualize focal reaction or thickening along the lateral cortex ofthe femoral shaft which may be accompanied by a transverseradiolucent line. This software provides measurements of the lateraland medial cortex width and quantifies focal thickening of the lateralcortex along the femoral shaft. The beaking index can be displayedand trended across serial scans.
	Optional sarcopenia software calculates values based on publisheddefinitions and thresholds using measured appendicular lean massin combination with patient demographics and entered values ofmuscle strength and physical performance. These values may beuseful to health care professionals in their management ofsarcopenia.
Manufacturing Sites:	Site 1: GE Medical Systems Monterrey Mexico, S.A.DE C.V.Calle Espana #300, Parque Industrial HuinalaApodaca, Nuevo Leon, C.P.66645, MexicoSite 2: GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI, 53223, USASite 3: GE MEDICAL SYSTEMS CHINA CO., LTD.no. 19 changjiang roadnational hi-tech dev. ZoneWuxi, CHINA 214028
Comparison of thetechnologicalcharacteristics:	GE Lunar DXA Bone Densitometers with enCORE version 17 employthe same fundamental scientific technology as its predicate deviceswith the addition of 2 new software features as well as additionalcybersecurity enhancements:1. The optional feature for Atypical Femur Fracture (AFF) bringsminor changes to the anatomical sites to extend the DXAfemur scan to include the distal femur shaft, measure thelateral and medial cortex width and quantify focal thickeningof the lateral cortex along the femoral shaft. The beakingindex can be displayed and trended across serial scans. SeeTable A – AFF Feature Comparison Table with Predicates GELunar, Hologic and Proposed device.2. The optional feature for Sarcopenia provides a calculatedsarcopenia classification using one of four definitionspublished by sarcopenia leading clinical working groups. Thephysician can compare individual values against clinicalthresholds for assessing sarcopenia. See Table B –Sarcopenia Feature Comparison Table with Predicate GELunar and Proposed device.3. The enCORE version 17 software incorporates latestMicrosoft security patches and other securityenhancements.

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Table A – AFF Feature Comparison Table with Predicates GE Lunar, Hologic and Proposed device

Specification	Predicate Device #1GE Lunar DXA BoneDensitometers- AHA - Advanced HipAssessment (K072664)- HAL - Hip Axis Length(K011917)	Predicate Device #2Hologic Bone Densitometers- Single Energy (SE) FemurExams (K130277)	ProposedGE Lunar DXA BoneDensitometers withenCORE version 17- AFF Atypical FemurFracture	Discussion of Differences
Technology	Dual-energy X-rayAbsorptiometry (DXA)	Single-energy image	Dual-energy X-rayAbsorptiometry (DXA)	Equivalent. enCORE Version 17 AFFimage is extending existing GE LunarDXA femur scans to image distalshaft.
Exam Site	Proximal Femur	Proximal Femur and distalshaft	Proximal Femur anddistal shaft	Identical to Hologic (K130277)
Values Displayed	HAL and sub-regionlengths, angles, ratios,buckling ratio, sectionmodulus (Z), corticalthickness, cross-sectional area (CSA) andcross-sectional momentof inertia (CSMI).	None	Cortical thickness(beaking index)	Equivalent.enCORE Version 17 AFF featuremeasures cortical width for largerfemoral scan area compared toAdvanced Hip Assessment (AHA).
Method of DeformityAssessment	Quantitative	Visual	Visual and Quantitative	Equivalent.enCORE Version 17 combines a visualassessment with quantitativemeasurements of cortical width.
Specification	Predicate Device #1aGE Lunar DXA BoneDensitometers- Total Body composition(K071570)	Predicate Device #1bGE Lunar DXA BoneDensitometers- RSMI Relative Skeletal MuscleIndex (K113286)	ProposedGE Lunar DXA Bone Densitometers withenCORE version 17Sarcopenia calculator	Discussion ofDifferences
Technology	Dual-energy X-rayAbsorptiometry (DXA)	Dual-energy X-rayAbsorptiometry (DXA)	Dual-energy X-rayAbsorptiometry (DXA)	Identical
AnatomicalSites	Regional and WholeBody	Regional and WholeBody	Regional and WholeBody	Identical
ValuesDisplayed	Bone Mineral Density (BMD)● Lean and Fat Tissue mass● Bone Mineral Content● (BMC)● Area● Soft Tissue Mass● Regional Soft Tissue Mass● Total Soft Tissue Mass● Fat Free Mass● Regional/Total Soft Tissue● Mass Ratios● %Fat● Region %fat● Total Body %fat	Bone Mineral Density (BMD)● Lean and Fat Tissue mass● Bone Mineral Content● (BMC)● Area● Soft Tissue Mass● Regional Soft Tissue Mass● Total Soft Tissue Mass● Fat Free Mass● Regional/Total Soft Tissue● Mass Ratios● %Fat● Region %fat	Bone Mineral Density (BMD)● Lean and Fat Tissue mass● Bone Mineral Content (BMC)● Area● Soft Tissue Mass● Regional Soft Tissue Mass● Total Soft Tissue Mass● Fat Free Mass● Regional/Total Soft Tissue Mass Ratios● %Fat● Region %fat● Total Body %fat● RSMI – Relative Skeletal Muscle Index● FNIH - Foundation for the National● Institutes of Health SarcopeniaProject:● AWGS - Asian Working Group forSarcopenia● EWGSOP - European Working Groupon Sarcopenia in Older People● IWGS - International Working Groupon Sarcopenia	Equivalent.The Total Bodycompositionmeasurements forlean mass for armsand legs (K071570)were used tocalculate RelativeSkeletal Muscle Index(K113286). enCOREVersion 17 nowcalculates four similarvalues based onnewly publisheddefinitions.

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Table B – Sarcopenia Feature Comparison Table with Predicate GE Lunar and Proposed device

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Determination of Summary of Non-Clinical Tests: Substantial The GE Lunar DXA Bone Densitometers with enCORE version 17 Equivalence: and its applications comply with voluntary standards. The following quality assurance measures were applied to the development of the system: 트 Risk Analysis 트 Requirements Reviews I Design Reviews ■ Testing on unit level (Module verification) I Integration testing (System verification) I Performance testing (Verification) I Safety testing (Verification) 트 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 the AFF and Sarcopenia calculator optional software features added two new Indications for Use. These software changes were tested successfully and as described in supporting evidence: · Summary of the verification and validation testing performed on the enCORE software version 17. Test results confirmed that the design outputs met the design input requirements. · Summary of the non-clinical evaluation of the "AFF" software option and the non-clinical evaluation of the optional sarcopenia calculator software. These bench testing results confirmed the substantial equivalence in terms of safety and effectiveness to the predicate devices. There is no change to the diseases or conditions expected to be diagnosed, treated, prevented, cured or mitigated. There is no change to the patient population.

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Determination ofSubstantialEquivalence: (Cont.)	Summary of Clinical Tests:
The subject of this premarket submission, GE Lunar DXA BoneDensitometers with enCORE version 17, did not require clinicalstudies to support substantial equivalence.	A clinical literature search was performed and provided to supportthe additional optional software features calculations andassociated indications for use.
Conclusion:	The GE Lunar DXA Bone Densitometers with enCORE version 17expands its previously cleared features and indications for use butdoes not result in any new potential safety risks.The GE Lunar DXA Bone Densitometers with enCORE version 17have the same technological characteristics, and performs as wellas the predicate devices currently on the market.Based on the information supplied in this submission, it is theconclusion of GE Healthcare that the GE Lunar DXA BoneDensitometers with enCORE version 17 is substantially equivalentto other marketed devices with similar indications for use andmeeting the same standards.

Determination ofSubstantialEquivalence: (Cont.)

Summary of Clinical Tests:

The subject of this premarket submission, GE Lunar DXA BoneDensitometers with enCORE version 17, did not require clinicalstudies to support substantial equivalence.

A clinical literature search was performed and provided to supportthe additional optional software features calculations andassociated indications for use.

Conclusion:

The GE Lunar DXA Bone Densitometers with enCORE version 17expands its previously cleared features and indications for use butdoes not result in any new potential safety risks.The GE Lunar DXA Bone Densitometers with enCORE version 17have the same technological characteristics, and performs as wellas the predicate devices currently on the market.Based on the information supplied in this submission, it is theconclusion of GE Healthcare that the GE Lunar DXA BoneDensitometers with enCORE version 17 is substantially equivalentto other marketed devices with similar indications for use andmeeting the same standards.

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.