(168 days)
No
The summary describes calculations based on published definitions and measurements, not AI/ML algorithms. There is no mention of AI, ML, or related concepts like training or test sets for such models.
No.
The device is a diagnostic tool that measures parameters for assessing bone density and body composition, and provides calculations for conditions like Atypical Femur Fracture and Sarcopenia. It does not actively treat or intervene in a disease or condition.
Yes
The device provides measurements, quantifies focal thickening, displays a beaking index, and calculates sarcopenia values based on published definitions, which are all used by healthcare professionals for the management of sarcopenia and assessment of Atypical Femur Fractures. These functions aid in the identification or assessment of a disease or condition.
No
The device description explicitly states that the system is composed of a scanner and a computer, and the software runs on specific GE Lunar DXA Bone Densitometers, which are hardware devices. The software controls the scanner, acquires data from the scanner, and interacts with the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The GE Lunar DXA Bone Densitometers with enCORE software analyze images obtained through Dual-energy X-ray Absorptiometry (DXA). This is an imaging technique that measures bone mineral density and body composition directly within the body, not by testing samples taken from the body.
- Intended Use: The intended use describes the analysis of femur images and the calculation of values based on measured appendicular lean mass and patient data. This analysis is performed on data acquired from the patient's body, not on in vitro samples.
Therefore, the device falls under the category of medical imaging devices and associated software for analysis, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the GE Lunar DXA Bone Densitometers remains the same.
The proposed device: “GE Lunar DXA Bone Densitometers with enCORE version 17 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.
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.
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.
Product codes
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.
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 Sarcopenia
• European Working Group on Sarcopenia in Older People
• Asian Working Group for Sarcopenia
• The Foundation for the National Institutes of Health Biomarkers Consortium Sarcopenia Project
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray transmission measurements
Anatomical Site
Femur, Regional and Whole Body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Values Displayed for AFF: Cortical thickness (beaking index)
Values Displayed for Sarcopenia: 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 Sarcopenia Project, AWGS - Asian Working Group for Sarcopenia, EWGSOP - European Working Group on Sarcopenia in Older People, IWGS - International Working Group on Sarcopenia
Predicate Device(s)
K071570, K113286, K072664, K011917, K130277
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
1
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
2
Indications for Use
510(k) Number (if known) K161682
Device Name
GE Lunar DXA Bone Densitometers with enCORE version 17
Indications for Use (Describe)
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.
| 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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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 Care |
| Diagnostics, LLC.) | |
| 3030 Ohmeda Drive | |
| P.O. Box 7550 | |
| Madison, WI, USA 53707 | |
| Primary Contact | |
| Person: | Nicole Landreville, Eng, RAC |
| Regulatory Affairs Program Manager | |
| GE Healthcare (GE Medical Systems Ultrasound & Primary Care | |
| Diagnostics, LLC.) | |
| Telephone: (289) 208-2365 | |
| Email: Nicole.landreville@ge.com | |
| Secondary Contact | |
| Person: | Diane Uriell |
| Regulatory Affairs Director | |
| GE Healthcare (GE Medical Systems Ultrasound & Primary Care | |
| Diagnostics, LLC) | |
| Telephone: (262) 290-8212 | |
| Email: Diane.Uriell@ge.com | |
| Device Trade Name: | GE Lunar DXA Bone Densitometers with enCORE version 17 |
| Common/Usual | |
| Name: | 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 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. |
| Device Description
(Cont.): | Sarcopenia references: |
| | 1. Fielding RA, Vellas B, Evans WJ, et.al, Sarcopenia: An
Undiagnosed Condition in Older Adults. Current Consensus
Definition: Prevalence, Etiology, and Consequences. J Am Med Dir
Assoc. 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 the
European Working Group on Sarcopenia in Older People. Age
Ageing. 2010;39:412-423. |
| | 3. Chen LK, Liu LK, Woo J,et.al. Sarcopenia in Asia: consensus report
of 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 Sarcopenia
Project: Rationale, Study Description, Conference
Recommendations, and Final Estimates. J Gerontol A Biol Sci
Med Sci 2014 May;69(5):547-558 |
| Intended Use: | The intended use of the GE Lunar DXA Bone Densitometers remains
the same. |
| | The proposed device: “GE Lunar DXA Bone Densitometers with
enCORE version 17 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. |
| Indications for Use: | 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. |
| | 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. |
| Manufacturing Sites: | Site 1: GE Medical Systems Monterrey Mexico, S.A.DE C.V.
Calle Espana #300, Parque Industrial Huinala
Apodaca, Nuevo Leon, C.P.66645, Mexico
Site 2: GE Medical Systems Information Technologies
8200 West Tower Avenue
Milwaukee, WI, 53223, USA
Site 3: GE MEDICAL SYSTEMS CHINA CO., LTD.
no. 19 changjiang road
national hi-tech dev. Zone
Wuxi, CHINA 214028 |
| Comparison of the
technological
characteristics: | GE Lunar DXA Bone Densitometers with enCORE version 17 employ
the same fundamental scientific technology as its predicate devices
with the addition of 2 new software features as well as additional
cybersecurity enhancements:
-
The optional feature for Atypical Femur Fracture (AFF) 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. See
Table A – AFF Feature Comparison Table with Predicates GE
Lunar, Hologic and Proposed device. -
The optional feature for Sarcopenia provides a calculated
sarcopenia classification using one of four definitions
published by sarcopenia leading clinical working groups. The
physician can compare individual values against clinical
thresholds for assessing sarcopenia. See Table B –
Sarcopenia Feature Comparison Table with Predicate GE
Lunar and Proposed device. -
The enCORE version 17 software incorporates latest
Microsoft security patches and other security
enhancements. |
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Table A – AFF Feature Comparison Table with Predicates GE Lunar, Hologic and Proposed device
| Specification | Predicate Device #1
GE Lunar DXA Bone
Densitometers
- AHA - Advanced Hip
Assessment (K072664) - HAL - Hip Axis Length
(K011917) | Predicate Device #2
Hologic Bone Densitometers - Single Energy (SE) Femur
Exams (K130277) | Proposed
GE Lunar DXA Bone
Densitometers with
enCORE version 17 - AFF Atypical Femur
Fracture | Discussion of Differences |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology | Dual-energy X-ray
Absorptiometry (DXA) | Single-energy image | Dual-energy X-ray
Absorptiometry (DXA) | Equivalent. enCORE Version 17 AFF
image is extending existing GE Lunar
DXA femur scans to image distal
shaft. |
| Exam Site | Proximal Femur | Proximal Femur and distal
shaft | Proximal Femur and
distal shaft | Identical to Hologic (K130277) |
| Values Displayed | HAL and sub-region
lengths, angles, ratios,
buckling ratio, section
modulus (Z), cortical
thickness, cross-
sectional area (CSA) and
cross-sectional moment
of inertia (CSMI). | None | Cortical thickness
(beaking index) | Equivalent.
enCORE Version 17 AFF feature
measures cortical width for larger
femoral scan area compared to
Advanced Hip Assessment (AHA). |
| Method of Deformity
Assessment | Quantitative | Visual | Visual and Quantitative | Equivalent.
enCORE Version 17 combines a visual
assessment with quantitative
measurements of cortical width. |
| Specification | Predicate Device #1a
GE Lunar DXA Bone
Densitometers - Total Body composition
(K071570) | Predicate Device #1b
GE Lunar DXA Bone
Densitometers - RSMI Relative Skeletal Muscle
Index (K113286) | Proposed
GE Lunar DXA Bone Densitometers with
enCORE version 17
Sarcopenia calculator | Discussion of
Differences |
| Technology | Dual-energy X-ray
Absorptiometry (DXA) | Dual-energy X-ray
Absorptiometry (DXA) | Dual-energy X-ray
Absorptiometry (DXA) | Identical |
| Anatomical
Sites | Regional and Whole
Body | Regional and Whole
Body | Regional and Whole
Body | Identical |
| Values
Displayed | 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 Sarcopenia
Project:
● AWGS - Asian Working Group for
Sarcopenia
● EWGSOP - European Working Group
on Sarcopenia in Older People
● IWGS - International Working Group
on Sarcopenia | Equivalent.
The Total Body
composition
measurements for
lean mass for arms
and legs (K071570)
were used to
calculate Relative
Skeletal Muscle Index
(K113286). enCORE
Version 17 now
calculates four similar
values based on
newly published
definitions. |
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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 of
Substantial
| Equivalence: (Cont.) | Summary of Clinical Tests: |
|---|---|
| The subject of this premarket submission, GE Lunar DXA Bone | |
| Densitometers with enCORE version 17, 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. | |
| Conclusion: | The GE Lunar DXA Bone Densitometers with enCORE version 17 |
| expands its previously cleared features and indications for use but | |
| does not result in any new potential safety risks. |
The GE Lunar DXA Bone Densitometers with enCORE version 17
have the same technological characteristics, and performs as well
as the predicate devices currently on the market.
Based on the information supplied in this submission, it is the
conclusion of GE Healthcare that the GE Lunar DXA Bone
Densitometers with enCORE version 17 is substantially equivalent
to other marketed devices with similar indications for use and
meeting the same standards. |