The FRAX™ 10-Year Fracture Risk software option is an accessory to currently marketed GE Lunar bone densitometer devices, which are intended to estimate the bone mineral density and body composition (lean and fat tissue mass) of patients when medically indicated by their physicians. This software option is intended to provide an assessment of 10-year fracture risk. The option 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 patient's age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence of several risk factors and is computed using the FRAX™ Fracture Risk Assessment Tool endorsed by the World Health Organization (WHO). The tool has been validated for men and post-menopausal women between 40 and 90 years old. The output is provided in a separate screen display and report that can be viewed or printed or exported to an optional physician report generator tool. The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the assessment of fracture risk.

Device Description

This software option is intended to provide an assessment of 10-year fracture risk. The option 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 patient's age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence or absence of several risk factors and is computed using the FRAX™ Fracture Risk Assessment Tool endorsed by the World Health Organization (WHO). The tool has been validated for men and post-menopausal women between 40 and 90 years old. The output is provided in a separate screen display and report that can be viewed or printed or exported to an optional physician report generator tool.

AI/ML Overview

This response is based on the provided text. The document does not explicitly state acceptance criteria in a quantitative manner, nor does it provide a direct "device performance" in terms of clinical outcomes that are independently measured against such criteria. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and conformance to published data and the WHO FRAX algorithm.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Consistency with WHO FRAX Algorithm Output	Outputs from the GE Lunar FRAX™ 10-year Fracture Risk Software were consistent with the independent outputs published that utilized the WHO 10-year fracture probability algorithm for specific age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence of several clinical risk factors.
Substantial Equivalence to Predicate Devices	The GE Lunar FRAX™ 10-year Fracture Risk Software Option is of a comparable type and substantially equivalent to the Fracture Risk for DPX bone densitometers and Fracture Risk from BMD using Hologic QDR x-ray Bone Densitometers. It has the same technological characteristics, is comparable in key safety and effectiveness features, it utilizes similar design, construction, and materials, and has similar intended uses as the predicate devices.
Conformance to Design Specifications and Industry Standards	The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. The design and development process conforms with 21 CFR 820 and ISO 13485 quality systems.
Clinical Validation (FRAX Model)	The FRAX™ tool has been validated for men and post-menopausal women between 40 and 90 years old through extensive published literature describing its development and clinical validation.

2. Sample size used for the test set and the data provenance:

Test Set (for software output consistency): The document states "Design verification tests of the software option were performed using a series of test cases from published data." No specific sample size for these test cases is provided, nor are details on the country of origin or whether the data was retrospective or prospective. It implies the use of existing, published examples of FRAX calculations.
Validation Cohorts (for FRAX model itself):
- Sample Size: 230,486 subjects.
- Follow-up: 1,208,528 patient years of follow-up.
- Data Provenance: "Eleven independent, population-based cohorts that did not participate in the model synthesis." The earlier description of the model development mentioned "centers in North America, Europe, Asia, and Australia," so it's reasonable to infer a similar, broad geographic distribution for the validation cohorts. The data is described as "follow up data from nine prospective, population-based cohorts" for model development, and implies the validation data is also prospective given the "patient years of follow-up."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided for the software’s design verification test cases. The "ground truth" for these tests was the "independent outputs published that utilized the WHO 10-year fracture probability algorithm." This implies that the algorithm itself, as published by the WHO, served as the reference standard, rather than a panel of experts specifically forming a ground truth for this device's test set.

For the FRAX model's overall development and validation, experts presumably developed and endorsed the WHO FRAX algorithm, but the document does not specify their number or qualifications as part of this device's testing.

4. Adjudication method for the test set:

This information is not provided. The software performance was verified by checking consistency with "independent outputs published," which suggests a direct comparison method rather than an adjudication process involving human experts for the software itself.

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 was performed or cited for this specific device. The device is an algorithm that provides a risk score, not an AI to assist human readers in image interpretation. No human-in-the-loop performance improvement data is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, in essence. The primary "test" performed for this device was a non-clinical evaluation comparing its algorithm's outputs to "independent outputs published that utilized the WHO 10-year fracture probability algorithm." This is a standalone performance assessment of the algorithm's consistency with the established WHO FRAX standard.

7. The type of ground truth used:

For the device's software verification: The ground truth was the published outputs of the WHO 10-year fracture probability algorithm.
For the underlying FRAX model's validation: The ground truth was observed fracture events (hip fractures and other osteoporotic fractures) recorded during "person years of follow-up" in large, population-based cohorts.

8. The sample size for the training set:

For the FRAX model development: The model was "developed from baseline and follow up data from nine prospective, population-based cohorts... consisting of 46,340 people and 189,852 person years of follow-up." This represents the core "training" data for the FRAX algorithm itself.
For the GE Lunar device's software: No specific "training set" for the software is mentioned, as it implements an existing, published algorithm (FRAX).

9. How the ground truth for the training set was established:

For the FRAX model development:
- Clinical Risk Factors: "Appropriate clinical risk factors for fracture were determined from eleven large cohort studies."
- Outcome Data: The ground truth was the occurrence of actual fracture events (hip fractures and other osteoporotic fractures) observed during the "189,852 person years of follow-up." These events were "reported," implying clinical diagnosis and documentation.
- The data was "generally randomly selected and analyzed according to accepted epidemiological practices" and "published in peer-reviewed journals," suggesting rigorous methodology for establishing these outcomes.

Summary

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K082317

SEP 2 6 2008

Attachment A 510 (k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

Image /page/0/Picture/3 description: This document contains information about the GE Lunar FRAX 10-year fracture risk software option. It includes the submitter's information, which is GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC, located in Madison, WI. The contact person is James P. Raskob, and the date prepared is August 12, 2008. The device is a bone densitometer, and marketed devices include fracture risk assessments for DPX bone densitometers K983271 and Hologic QDR x-ray Bone Densitometers K983028.

composition (lean and fat tissue mass) of patients when medically indicated by their physicians.

The results can be used by a physician in coniunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the assessment of fracture risk.

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510(k) Premarket Notification GE Medical Systems Lunar - FRAX™ 10-year Fracture Risk software option August 12, 2008

1. Comparison with Predicate Device: The GE Lunar FRAX™ 10-year Fracture Risk Software Option for GE Lunar DXA Bone Densitometers is of a comparable type and substantially equivalent to the Fracture Risk for DPX bone densitometers and Fracture Risk from BMD using Hologic QDR x-ray Bone Densitometers. It has the same technological characteristics, is comparable in key safety and effectiveness features, it utilizes similar design, construction, and materials, and has similar intended uses as the predicate devices.

Section b):

1. Non-clinical Tests: The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. Design verification tests of the software option were performed using a series of test cases from published data. These tests confirmed outputs from the GE Lunar FRAX™ 10-year Fracture Risk Software were consistent with the independent outputs published that utilized the WHO 10-year fracture probability algorithm for specific age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence of several clinical risk factors.
Clinical Tests: No new clinical studies were required to establish safety or effectiveness of the new 2. software option. Published literature describing the development and clinical validation of the FRAX™ WHO Fracture Risk Assessment Tool were provided.

The FRAX™ model is based on a large collection of data. Appropriate clinical risk factors for fracture were determined from eleven large cohort studies. The FRAX™ model was then developed from baseline and follow up data from nine prospective, population-based cohorts, including centers in North America, Europe, Asia, and Australia, consisting of 46,340 people and 189,852 person years of follow-up, during which 850 hip fractures and 3318 other osteoporotic fractures were reported. Data were generally randomly selected and analyzed according to accepted epidemiological practices. All data were published in peer-reviewed journals.

The performance characteristics determined from the primary cohorts were then validated in eleven independent, population-based cohorts that did not participate in the model synthesis. The validation cohorts consisted of 230,486 subjects representing 1,208,528 patient years of follow-up, during which 3360 hip fractures and 15,183 other osteoporotic fractures occurred.

1. Conclusion: Intended uses and other key features are consistent with previously cleared bone densitometer fracture risk software options. The design and development process of the manufacturer conforms with 21 CFR 820 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance was verified through ongoing internal and applicable medical do noo ouroly ocandards and the GE Lunar FRAX™ 10-year Fracture Risk Software Option for GE Lunar DXA Bone Densitometers is substantially equivalent to currently marketed devices with respect to intended use and safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized graphic of three horizontal lines that resemble a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2008

Mr. James P. Raskob Safety and Regulatory Engineering Manager General Electric Co. GE Medical Systems Lunar 726 Heartland Trail MADISON WI 53717

Re: K082317

Trade/Device Name: FRAX™ 10-Year Fracture Risk Software Option for GE Lunar Bone Densitometers Regulation Number: 21 CFR 892.1170

Regulation Name: Bone Densitometer Regulatory Class: II Product Code: KGI Dated: August 12, 2008 Received: August 13, 2008

Dear Mr. Raskob:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

hoque M. Zhang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification

GE Medical Systems Lunar -- FRAX™ 10-year Fracture Risk software option

Attachment D

510 (k) Indications for Use

510(k) Number (if known): V 08 2,3 17

Device Name: FRAX™ 10-Year Fracture Risk Software Option for GE Lunar Bone Densitometers

This software option is intended to provide an assessment of 10-year fracture risk. The option 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 patient's age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence of several risk County, chiniony, from 110cm, formal nook BMD T Golfe, and the proofito of Group Horsen by the World Health Organization (WHO). The tool has been validated for men and post-menopausal women between 40 and 90 years old. The output is provided in a separate screen display and report that can be viewed or printed or exported to an optional physician report generator tool.

The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the assessment of fracture risk.

Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR

Over The Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Halia Perez

(Division Sign Off)

ductive. Andominal 2

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.