The Fracture Risk option is used with the LUNAR DPX Series of bone densitometer systems. This option 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). Physician and patient information is provided to indicate that although bone density is the single most important factor in the assessment of fracture risk and the diagnosis of osteoporosis, the physician should also consider other factors.

The use of the Fracture Risk option for DPX Series is restricted to prescription use only.

Device Description

The Fracture Risk Option for DPX Series Bone Densitometers provides fracture risk assessment based on patient's bone mineral density T-score.

The Fracture Risk option for DPX Series is a software accessory to aid the physician in assessing fracture risk from the results of a DPX Series bone density examination. The Fracture Risk Assessment Feature does not cause any changes to the scan parameters used in the examination, and it does not affect the results produced.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or an analytical study with performance metrics in the format requested.

Here's an analysis of what is available based on the provided text, and what is missing:

What is present in the document:

This is a 510(k) Pre-market Notification for the "Fracture Risk option for DPX Series Bone Densitometers."
The device is a software accessory that provides fracture risk assessment based on a patient's bone mineral density T-score.
It does not involve a comparative effectiveness study with human readers or standalone algorithm performance. Instead, it relies on substantiating equivalency to a predicate device.
The ground truth for the device's assessment is stated to be "the categories of fracture risk defined by the World Health Organization (WHO)" using the patient's T-score value. This indicates a reliance on established medical guidelines rather than a new empirical study for establishing fracture risk.
The submission document is a summary of safety and effectiveness, and the FDA's clearance letter. It concludes that "No new safety and effectiveness questions are raised" because the device is substantially equivalent to a pre-amendment device (Norland-Cameron Model 178 Bone Mineral Analyzer).

Missing Information (not found in the provided text):

A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, accuracy, precision). The document states no new safety or efficacy concerns and relies on substantial equivalence.
Sample size used for the test set.
Data provenance (country of origin, retrospective/prospective).
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Information on a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
Information on standalone (algorithm-only) performance.
Sample size for the training set.
How ground truth for the training set was established (beyond reliance on WHO guidelines for T-score interpretation).

Summary of available information:

Table of acceptance criteria and reported device performance: Not applicable in the context of this 510(k) submission, as it focuses on substantial equivalence rather than new performance claims from an analytical study. The "performance" is implicitly tied to compliance with WHO guidelines for T-score interpretation.
Sample size used for the test set and data provenance: No test set is described. The device leverages existing interpretations of T-scores based on WHO guidelines.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as reliance is on WHO-defined categories of fracture risk, not a specific expert interpretation for a test set.
Adjudication method for the test set: Not applicable.
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 study was mentioned or performed as part of this submission. The device is a software accessory providing information based on existing measurements.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No specific standalone performance study is described. The device's function is to apply established WHO criteria to T-scores, which are generated by the bone densitometer.
The type of ground truth used: World Health Organization (WHO) definitions and categories of fracture risk based on T-score values. This is a form of established clinical guideline or consensus.
The sample size for the training set: Not applicable. This device is not described as using a machine learning model that requires a training set. It applies a rule-based algorithm (T-score to WHO fracture risk category).
How the ground truth for the training set was established: Not applicable, for the same reason as above.

In essence, this device's regulatory review focused on its classification and the absence of new safety or efficacy concerns given its function as a software accessory applying established medical guidelines to existing data (bone density T-scores). It was determined to be "substantially equivalent" to a predicate device, meaning it did not require novel performance studies against specific acceptance criteria for a new clinical claim.

Summary

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K983271

MADISON, WI 53713 313 W. BELTLINE HIGHWAY

(608) 274-2663

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 9.0

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).

Contact Person:	Kenneth D. BurokerLUNAR Corporation313 West Beltline HighwayMadison, WI 53713
Phone:	(608) 288-6460
Fax:	(608) 274-0853
Date:	September 15, 1998
Device/Trade Name:	Fracture Risk option for DPX Series Bone Densitometers
Common Name:	Bone Densitometer
Classification Name:	Bone Densitometer21CFR 892.1170
Predicate Device:	Norland-Cameron Model 178 Bone Mineral Analyzer (pre amendment)

DESCRIPTION OF THE DEVICE: 9.1

The Fracture Risk Option for DPX Series Bone Densitometers provides fracture risk assessment based on patient's bone mineral density T-score.

9.2 SUMMARY OF TECHNICAL CHARACTERISTICS

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9.3 CONCLUSION

The Fracture Risk option for the DPX series bone densitometers is substantially equivalent to the Norland-Cameron Model 178 Bone Mineral Analyzer, a pre-amendment device that was used to aid the physician in determining fracture risk. No new safety and effectiveness questions are raised with the Fracture Risk option for DPX Series bone densitometers.

Signed

Kenneth D. Buroker Name

Director, Regulatory Affairs Title

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the central design.

Re:

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1998

Kenneth D. Buroker Director, Regulatory Affairs Lunar Corporation 313 West Beltline Highway Madison, WI 53713

K983271

Fracture Risk Assessment Option for DPX Series Bone Densitometer Dated: September 15, 1998 Received: September 17, 1998 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI

Dear Mr. Buroker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisious 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr/dsmardsmamain.html".

Sincerely yours,

William Yip

Lillian Yin, Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE FORM 3.0

510(k) Number (if known) _ 1983271 .
Device Name: Fracture Risk option for DPX Series Bone Densitometers .
. Indications for use:

The use of the Fracture Risk option for DPX Series is restricted to prescription use only. The operator's manual for the DPX system contains the following statement:

"United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."

The Fracture Risk option for DPX Series poses no new safety or efficacy concerns.

PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Urnid A. Seppman

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological D

510(k) Number K983271

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.