The EXPERT-XL Lateral Spine BMD Acquisition and Analysis software is used with the EXPERT-XL bone densitometer system. This software feature estimates bone mineral density (BMD) of the lumbar spine vertebrae in the lateral view. This BMD value can then be compared to a reference population at the sole discretion of the physician.

Device Description

The EXPERT-XL Lateral Spine BMD Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density (BMD), in g/cm2, of the lumbar spine vertebrae in the lateral view provided for the EXPERT-XL Bone Densitometer with a reference population for comparative purposes.

AI/ML Overview

This device, the EXPERT-XL Lateral Spine BMD Acquisition and Analysis Software, is an accessory for the EXPERT-XL Bone Densitometer. It is designed to estimate Bone Mineral Density (BMD) of the lumbar spine in the lateral view.

Here's an analysis of the provided information regarding its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
In vitro Correlation with known phantoms (BMD)	High correlation (r = 0.99) with BMD on known phantoms.
In vitro Precision	Equivalent to the AP spine when analyzed with a region-of-interest (ROI) of the same dimension.
In vivo Short Term Precision (CV)	3.0 to 3.5%; acknowledged as higher than AP spine BMD due to smaller ROIs and lower bone density, but considered "acceptable for the small ROI".
Radiation Exposure (skin entrance)	120 mrem; acknowledged as higher than for the AP view but necessary and remains low compared to the maximum permissible dose.
Female Reference Population (BMD changes with age)	Relatively constant BMD for ages 20-49. BMD decreases after age 50 at a rate of 0.008 g/cm² per year (approximately 1% per year). This is a descriptive characteristic rather than a strict performance metric, indicating the software's ability to provide age-stratified data.
Substantial Equivalence	The device is deemed substantially equivalent to the EXPERT-XL standard anterior (AP) spine projection. This is the overarching acceptance criterion for 510(k) clearance.

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not explicitly state the sample size used for the in vitro and in vivo precision and correlation tests.
Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.

3. Number of Experts for Ground Truth and Qualifications

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The "known phantoms" for in vitro testing would inherently have an established ground truth, but the in vivo data's ground truth establishment method is not detailed.

4. Adjudication Method

The document does not describe any adjudication method.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the provided text. The submission focuses on device performance metrics rather than human reader improvement with AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was implicitly done. The "reported device performance" noted in the table above refers to the algorithmic performance of the software itself in measuring BMD. This includes in vitro correlation and precision, as well as in vivo precision, without explicit mention of human interpretation influencing these results.

7. Type of Ground Truth Used

For in vitro testing: "Known phantoms" imply a precisely measured or known BMD value, serving as an objective ground truth.
For in vivo testing: The ground truth for the "average short term precision (CV) in vivo" is based on repeat measurements on human subjects. This is a measure of reproducibility, where the "ground truth" for a given subject at a given time is essentially the value obtained by the device itself, and the precision metric assesses the variability around this. It does not explicitly state an independent "gold standard" for the absolute BMD values in vivo.

8. Sample Size for the Training Set

The document does not specify a training set sample size. It's likely that the software's algorithms were developed and refined (trained) using a dataset, but this information is not provided.

9. How Ground Truth for the Training Set Was Established

The document does not specify how the ground truth for any training set was established. Given the nature of a bone densitometer, training would likely involve a combination of phantom data (with known BMD) and clinical data where BMD might be established through various means (e.g., other densitometry methods, or clinically accepted values). However, this is not detailed here.

Summary

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FEB 1 3 1998

K97443M

313 W. BELTLINE HIGHWAY

MADISON, WI 53713

(608) 274-2663

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 10.0

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:	November 21, 1997
Device/Trade Name:	EXPERT-XL Lateral Spine BMD Acquisition and AnalysisSoftware
Common Name:	Bone Densitometer
Classification Name:	Bone Densitometer21CFR 892.1170
Predicate Device:	EXPERT-XL Bone Mineral Densitometer,standard AP spine site, 510(k) K945526

DESCRIPTION OF THE DEVICE: 10.1

10.2 SUMMARY OF TECHNICAL CHARACTERISTICS

The EXPERT-XL Lateral Spine BMD software acquires images of the lumbar spine in the lateral view; the acquisition takes 16 seconds. The results in vitro correlate highly (r =0.99) with BMD on known phantoms, and the precision in vitro is equivalent to the AP spine when

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analyzed with a region-of-interest (ROI) of the same dimension. The average short term precision (CV) in vivo is 3.0 to 3.5%; this is higher than that of the AP spine BMD due to smaller ROI's and lower bone density. The female reference population has relatively constant BMD for age 20-49, but BMD decreases after age 50 at a rate of of 0.008g/cm2 per year (~1% per year).

The radiation exposure (skin entrance) of 120 mrem is higher than that for the AP view but is necessary due to the increased thickness in the lateral view. The exposure remains low compared to the maximum permissible dose.

CONCLUSION 10.3

The EXPERT-XL Lateral Spine BMD Acquisition and Analysis software option is substantially equivalent to the EXPERT-XL standard anterior (AP) spine projection. The BMD results in vitro show excellent precision and a high correlation to the AP spine. The precision results in vivo are acceptable for the small ROI. The female reference population is relatively constant at the younger age groups with a decline starting after age 50.

No new safety and effectiveness questions are raised with the EXPERT-XL Lateral Spine BMD Acquisition and Analysis software accessory.

Hennifer Birch

Signed

Signed

Kenneth D. Buroker Printed Name

Director, Regulatory Affairs Title

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 1998

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

Re:

K974437 Expert-XL Lateral Spine BMD Acquistion and Analysis Software Dated: November 21, 1997 Received: November 24, 1997 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, whice, 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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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 marked 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 virg 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/cdrh/dsmamajn.html!", ...........................................................................................

Sincerely yours,

h. William Yu.

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

Enclosure

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INDICATION FOR USE FORM 3.0

Page 1 of 1

. 501(k) Number (if known) _____________________________________________________________________________________________________________________________________________________
EXPERT-XL Lateral Spine BMD Acquisition and Analysis Software • Device name:
. Indications For Use:

The EXPERT-XL User's Guide and Technical Manual 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."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K974437
Prescription Use (Per 21 CRF 801.109)	OR	Over-the-Counter Use (Optional Format 1-2-96)

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.