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

Device Description

The Aria X-ray Bone Densitometer is designed to be a value product version of the predicate device, the Prodigy (K982267 and K161682). Like its predicate Prodigy device, the proposed Aria device is composed of a scanner and a computer that runs the software. The scanner comprises the x-ray source and detector, the patient scan table, the mechanical drive system, and the lowest level portions of the control system. The scanner is in communication with the computer, which is a standard PC. The computer runs the enCORE software, and thus controls the scanner, acquires scan data from the scanner, stores and analyzes the data, and interacts with the human operator.

Aria X-ray Bone Densitometer functions with the same software as the one that is FDA cleared under GE Lunar DXA Bone Densitometers with enCORE version 17 (K161682).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study conducted for the Aria device, based on the provided text:

Based on the provided information, the Aria device is an X-ray Bone Densitometer. The study presented is a bench testing to demonstrate precision and accuracy, not a clinical study involving human subjects or AI algorithms. As such, several requested items like "Multi-reader multi-case (MRMC) comparative effectiveness study" and "Human reader improve with AI vs without AI assistance" are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Measure	Acceptance Criteria	Reported Device Performance
Precision	<= 1.0%	Met (demonstrated in results)
Accuracy (r)	> 0.95	Met (demonstrated in results)

2. Sample Size and Data Provenance for the Test Set

Sample Size: The text mentions "a wide range of phantoms" for precision and accuracy tests, and "a set of phantoms with different BMD and tissue composition properties." However, specific numerical sample sizes for these phantom sets are not provided.
Data Provenance: The tests were conducted during "product development" as "bench testing." The data provenance is from phantom measurements, not human participants. No country of origin is explicitly stated for the phantom data, but it's implied to be internal testing by GE Healthcare (USA). The study is retrospective in the sense that it's based on controlled phantom measurements rather than prospective patient recruitment.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for the test set was established using phantoms with known bone mineral density (BMD) and tissue composition properties, not by human experts. The accuracy was verified by showing an "excellent correlation to previously released Prodigy product," implying a comparison to an established device's performance.

4. Adjudication Method for the Test Set

Not applicable. Since the ground truth was phantom-based and not expert-driven, there was no adjudication method involving multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The presented study is a bench test, and the device is a bone densitometer, not an AI-assisted diagnostic tool for human interpretation. Therefore, there's no "effect size of how much human readers improve with AI vs without AI assistance" to report.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The precision and accuracy bench testing evaluates the algorithm's (and the overall device's) ability to accurately and precisely estimate bone density from phantom measurements without human intervention in the measurement process. The results "demonstrate that Aria can accurately and precisely estimate bone density."

7. Type of Ground Truth Used

The ground truth used was phantom-based with established, known values for bone mineral density (BMD) and tissue composition properties. These values were validated against the performance of the predicate Prodigy product.

8. Sample Size for the Training Set

Not explicitly stated and likely not applicable in the traditional sense for a machine learning model. The Aria device is presented as a "value product version" using the "same software as the one that is FDA cleared under GE Lunar DXA Bone Densitometers with enCORE version 17 (K161682)." This suggests that the core algorithms might have been developed and "trained" (if applicable for this type of system) with data associated with the enCORE software, but the document does not provide details on a specific training set size for Aria's development.

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

Not explicitly stated and likely not applicable in the traditional sense for a machine learning model. Given that the Aria uses the same software (enCORE v17) as its predicate, the ground truth for any underlying algorithm "training" would have been established during the development of that software. Typically for bone densitometry, this involves:
- Phantom studies: Similar to the testing described, using phantoms with known physical properties.
- Clinical studies: Correlating device measurements against other established methods or clinical outcomes, although this document states clinical studies were "not required" for Aria's substantial equivalence.

Summary

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GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC % Nicole Landreville, Eng, RAC, FRAPS Regulatory Affairs Manager 3030 Ohmeda Drive MADISON WI 53718

Re: K180782

Trade/Device Name: Aria Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: KGI Dated: March 21, 2018 Received: March 26, 2018

Dear Ms. Landreville:

We have reviewed vour 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 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.

April 20, 2018

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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone

(1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'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)

K180782

Device Name Aria

Indications for Use (Describe)

X-ray Bone Densitometer designed to estimate the bone mineral density of patients when medically indicated by their physicians.

· Provides an estimate of bone mineral density at various anatomical sites (Spine, Femur, Forearm). These values can then be compared to an adult reference population at the sole discretion of the physician.
Provides an assessment of relative risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO).
· Provides an assessment of 10-year fracture risk using WHO FRAX model.
Provides a standardized bone density report using data from the densitometer and physician-generated assessments

based on the patient's demographics, which can assist the physician in communicating scan results to the patient and the patient's referring physician.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

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

Aria

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510(k) Summary

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

Date Submitted:	21-Mar-2018
Submitter:	GE HealthcareGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.3030 Ohmeda DriveMadison, WI, USA 53707
Primary ContactPerson:	Nicole Landreville, Eng, RAC, FRAPSRegulatory Affairs ManagerGE HealthcareGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.Telephone: (289) 208-2365Email: Nicole.landreville@ge.com
Secondary ContactPerson:	Diane UriellRegulatory Affairs DirectorGE HealthcareTelephone: (262) 290-8212Email: Diane.Uriell@ge.com
Device Trade Name:	Aria
Common/UsualName:	X-Ray Bone Densitometer
Classification Names:Product Code:	Regulation Name: Bone DensitometerRegulation: 21 CFR 892.1170Classification: Class IIProduct Codes: KGI
Predicate Device:	Prodigy (K982267 and K161682)
Regulation Name:	Bone Densitometer
Regulation:	21 CFR 892.1170
Classification:	Class II
Product Codes:	KGI
Device Description:	The Aria X-ray Bone Densitometer is designed to be a value product version of the predicate device, the Prodigy (K982267 and K161682). Like its predicate Prodigy device, the proposed Aria device is composed of a scanner and a computer that runs the software. The scanner comprises the x-ray source and detector, the patient scan table, the mechanical drive system, and the lowest level portions of the control system. The scanner is in communication with the computer, which is a standard PC. The computer runs the enCORE software, and thus controls the scanner, acquires scan data from the scanner, stores and analyzes the data, and interacts with the human operator.Aria X-ray Bone Densitometer functions with the same software as the one that is FDA cleared under GE Lunar DXA Bone Densitometers with enCORE version 17 (K161682).
Intended Use:	The bone densitometer is designed to estimate the bone mineral density of patients when medically indicated by their physicians.
Indications for Use:	X-ray Bone Densitometer designed to estimate the bone mineral density of patients when medically indicated by their physicians.Provides an estimate of bone mineral density at various anatomical sites (Spine, Femur, Forearm). These values can then be compared to an adult reference population at the sole discretion of the physician. Provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO). Provides an assessment of 10-year fracture risk using WHO FRAX model. Provides a standardized bone density report using data from the densitometer and physician-generated assessments based on the patient's demographics, which can assist the physician in communicating scan results to the patient and the patient's referring physician.
Technology:	Aria employs the same fundamental scientific technology, thesame mechanism of action and working principle as the predicatedevice Prodigy (K982267).
	The proposed device and the predicate device have the samestructural composition with minor differences. They are bothcomposed of 3 main components:1. Scanner:a. Scanner Table: The proposed device and thepredicate device share a similar designarchitecture and similar manufacturing processes.The scanners differ slightly in physical sizes (whencomparing the Prodigy compact with Ariascanner). Both support the same maximum patientweight.b. Detector: Identical sensor type with differentnumber of elements.c. X-Ray generator: Identical tube voltage and K-edge filter with different max current output.2. Computer: The same computer model is used for Aria andits predicate device.3. Software : The proposed device and the predicate deviceare controlled by the same enCORE software (K161682).Some high-end features are not activated when installedon an Aria system (ex.: features related with bodycomposition and metabolic health).Aria's intended use is a sub-set of Prodigy's intended use in that itprovides an estimate of the bone mineral density.
	Aria's indications for use are a sub-set of the predicate Prodigydevice indications for use.
	The additional IFUs on Prodigy relate with metabolic health andadvanced BMD features do not apply to the proposed device.
	These differences do not significantly affect safety and/oreffectiveness.
Determination ofSubstantialEquivalence:	Summary of Non-Clinical Tests:
	The Aria X-ray Bone Densitometer and its applications comply withvoluntary standards.
	• ES60601-1 Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance;• IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: GeneralRequirements for Basic Safety and Essential Performance –Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.

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GE Healthcare

510(k) Premarket Notification Submission Aria

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510(k) Premarket Notification Submission Aria

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IEC 60601-2-28 Medical Electrical Equipment - Part 2-28: ● Determination of Particular Requirements For The Basic Safety And Essential Substantial Performance Of X-Ray Tube Assemblies For Medical Diagnosis; Equivalence: (Cont.) IEC 60601-1-3 Medical Elec. Equipment – Part 1-3: General . Requirements for Safety. Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment: IEC 60601-1-8 Medical Electrical Equipment - Part 1-8: General . Requirements For Basic Safety And Essential Performance -Collateral Standard: General Requirements. Tests And Guidance For Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems; IEC 60601-1-6 Medical electrical equipment - Part 1-6: General ● requirements for safety - Collateral Standard: Usability; IEC 62366 Medical devices - Application of usability . engineering to medical Devices; AAMI / ANSI / ISO 10993-1 Biological Evaluation Of Medical . Devices - Part 1: Evaluation And Testing Within A Risk Management Process; AAMI / ANSI / ISO 10993-5 Biological Evaluation Of Medical ● Devices - Part 5: Tests For In Vitro Cytotoxicity: AAMI / ANSI / IEC 62304 Medical Device Software - Software ● Life Cvcle Processes: ISO 14971 - Medical Devices - Application Of Risk Management ● To Medical Devices; ISO 15223-1 Medical Devices - Symbols To Be Used With ● Medical Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements; ● PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) set. (Radiology); The following quality assurance measures were applied to the development of the system: ■ Risk Analysis ■ Requirements Reviews I Design Reviews ■ Testing on unit level (Module verification) ■ Integration testing . Performance testing (Verification) ■ Safety testing (Verification) 트 Simulated use testing (Validation)

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510(k) Premarket Notification Submission Aria

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Determination ofSubstantialEquivalence: (Cont.)	Risks were reviewed and mitigated with design controls andlabeling. The mitigations were verified and validated as a part ofthe design verification and validation testing that has beenexecuted with acceptable results.The testing/documentation we provided for Aria were completedaccording to the following FDA guidance documents:Usability: Applying Human Factors And Usability EngineeringTo Medical Devices - Guidance For Industry And Food And DrugAdministration Staff. Document Issued On: February 3, 2016. Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices, issued May 11, 2005. Guidance for Off-the-Shelf Software Use in Medical Devices,September 1999. General Principles of Software Validation; Final Guidance forIndustry and FDA Staff, January 2002. Guidance for Industry - Cybersecurity for Networked MedicalDevices Containing Off-the Shelf (OTS) Software, January 2005. Guidance for Content of Premarket Submissions forManagement of Cybersecurity in Medical Devices, issued onOctober 2, 2014. FDA Guidance on Electromagnetic Compatibility (EMC) ofElectrically-Powered Medical Devices issued on July 11, 2016.
	In addition, Aria X-Ray bone densitometer was designed to meetthe applicable federal performance standards listed within 21 CFRSubchapter J as follows:21 CFR 1010 - Performance Standards for Electronic Products:General 21 CFR 1020.30 – Diagnostic X-Ray Systems and Their MajorComponents 21 CFR 1040.10 - Laser Products
	Summary of Clinical Tests:The proposed Aria device intended use / indications for use are asubset of the predicate Prodigy device intended use / indicationsfor use.The subject of this premarket submission, Aria, did not requireclinical studies to support substantial equivalence.
Determination ofSubstantialEquivalence: (Cont.)	Bench Testing: Precision and AccuracyDuring product development, precision and accuracy tests areperformed over a wide range of phantoms to cover the variation inhuman subjects. Repeat measurements on a phantom areperformed to verify precision using standard statistical analysis ofthe data. Similarly, a set of phantoms with different BMD andtissue composition properties is measured to verify accuracy byshowing an excellent correlation to previously released Prodigyproduct. The method used consist of verifying BMD precision andaccuracy for various scan sites by measuring phantom set andcalculate mean, standard deviation, %CV, and correlation toexpected values to ensure clinical performance requirements aremet. The acceptance criteria used are as follows for all sites (APSpine BMD, Femur BMD and Forearm BMD):Precision <=1.0% Accuracy r>0.95 The results of the bench testing provided in the submissiondemonstrate that Aria can accurately and precisely estimate bonedensity.Design verification and validation testing was performed toconfirm that the safety and effectiveness of the device has notbeen affected. The test plans and results have been executed withacceptable results.
Conclusion:	The proposed Aria device intended use / indications for use are asubset of the predicate Prodigy device intended use / indicationsfor use.The differences in the hardware do not result in any new potentialsafety risks.Aria has the same technological characteristics, and performs aswell as the predicate Prodigy device currently legally marketed onthe US market.After analyzing design verification and validation testing it is theconclusion of GE Healthcare that Aria is as safe, as effective, andits performance is substantially equivalent to the predicate Prodigydevice.

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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.