EXPERT-XL® Total Body Acquisition and Analysis Software is used with the EXPERT-XL® bone densitometer system. This software acquires and estimates BMD, Lean Tissue Mass, and Fat Tissue Mass for the Total Body and sub-regions.

The use of the EXPERT-XL® Total Body Acquisition and Analysis Software is restricted to prescription use only.

Device Description

The EXPERT-XL Total Body Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density (BMD in g/cm), Lean Tissue Mass (g), and Fat Tissue Mass (g) for the Total Body and sub-regions.

AI/ML Overview

The provided document describes the EXPERT-XL Total Body Acquisition and Analysis Software, an accessory option for estimating Bone Mineral Density (BMD), Lean Tissue Mass, and Fat Tissue Mass for the Total Body and sub-regions.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The core acceptance criteria for the EXPERT-XL Total Body Acquisition and Analysis Software are based on its correlation and precision compared to the predicate DPX series products.

Acceptance Criteria (Predicate DPX Series Performance)	Reported Device Performance (EXPERT-XL Software)
High correlation for Total Body BMD estimations	Highly correlated (r=0.97) with DPX series
High correlation for Lean and Fat Tissue Mass estimations	Highly correlated (r=0.95) with DPX series
Short term precision (%CV) for BMD	0.4% (comparable to DPX series)
Short term precision (%CV) for Lean Tissue Mass	3.1% (comparable to DPX series)
Short term precision (%CV) for Fat Tissue Mass	4.8% (comparable to DPX series)
Acceptable radiation exposure	5 mrem (higher than DPX series, but still low compared to maximum permissible dose)

Conclusion from document: The results are "Comparable to the DPX results with similar precision." And "No new safety and effectiveness concerns."

Study Information

The document does not detail a formal clinical study with a defined test set, ground truth, or expert involvement as might be expected for contemporary device submissions. Instead, it relies on a comparative study against a predicate device to establish substantial equivalence.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify a sample size for a test set. The evaluation is described in terms of "Scans of the Total Body on the EXPERT-XL densitometer" and comparison to "corresponding regions estimated with the DPX series of products." This suggests an internal validation against the predicate device's known performance.
- Data provenance (country of origin, retrospective/prospective) is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. The ground truth, in this context, is the performance of the legally marketed predicate device (DPX series). There's no mention of independent experts establishing a new "ground truth."
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There's no mention of an adjudication process as there isn't an independent "ground truth" establishment by multiple readers.
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 done. This device is an accessory software for a bone densitometer, performing quantitative measurements, not a diagnostic aid for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is effectively a standalone performance evaluation. The software directly calculates BMD, Lean Tissue Mass, and Fat Tissue Mass. Its performance is evaluated by comparing its output (correlation and precision) directly to the output of the predicate device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is the performance of the legally marketed predicate device (Lunar DPX series). The EXPERT-XL software's outputs (BMD, lean, fat mass) were compared for correlation and precision against the equivalent outputs from the DPX series. This is a comparison against an established, cleared technology rather than a biological "ground truth" like pathology.
The sample size for the training set:
- The document does not mention a training set. This submission is for an accessory software that calculates established metrics, likely using known algorithms. It doesn't appear to involve machine learning that would require a distinct "training set."
How the ground truth for the training set was established:
- Not applicable, as no training set is mentioned or implied.

Summary

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OCT - 3 1997

K965226

313 W. BELTLINE HIGHWAY

MADISON, WI 53713

(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. Buroker
	LUNAR Corporation
	313 West Beltline Highway
	Madison, WI 53713
Phone:	(608) 288-6460
Fax:	(608) 274-0853
Date:	December 20, 1996
Device/Trade Name:	EXPERT-XL Total Body Acquisition and AnalysisSoftware
Common Name:	Bone Densitometer
Classification Name:	Bone Densitometer
	21CFR 892.1170
Predicate Device:	K88 4625B Total Body Software for Lunar DPX Series
	K93 5454 Tissue Quantitation for DPX Series

DESCRIPTION OF THE DEVICE: 9.1

SUMMARY OF TECHNICAL CHARACTERISTICS 9.2

Scans of the Total Body on the EXPERT-XL densitometer take approximately 3 minutes. The Total Body BMD estimations correlate highly (r=0.97) with corresponding regions estimated with the DPX series of products which already has 510(k) clearance. The Lean and Fat Tissue Mass estimations also correlate highly (r=0.95). The average short term precision (%CV) is 0.4% for BMD, 3.1 % for lean tissue mass, and 4.8% for fat tissue mass which is also comparable to that shown on the DPX series. The radiation exposure of 5 mrem is higher than that for the DPX series densitometers but remains low compared to the maximum permissible dose for the total body.

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CONCLUSION 9.3

The results from the EXPERT-XL Total Body Acquisition and Analysis Software are The results from the EAT ENT ALL Foto Foto similar precision. No new safety and effectiveness Comparable to the DI A results RPPERT-XL Total Body software accessory.

Kunsell Bunk
Signed

Kenneth D. Buroker Name :

Director, Regulatory Affairs .j Title

Summary of Safety, Effectiveness Page 2 of 2

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name encircling a stylized image of three human profiles facing right. The profiles are stacked on top of each other, with the top profile being the most complete and the bottom profile being the least complete. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 1997

Richard B. Mazess, Ph.D. President Lunar Corporation 313 W. Beltine Highway Madison, WI 53713

Re:

Expert-XL Total Body Acquisition and Analysis Software Dated: July 16, 1997 Received: July 17, 1997 Regulatory class: II 21 CFR 892.1170/Procode: 90 KPS

Dear Dr. Mazess:

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 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, 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 and prohibitions against misbranding and adulteration.

K965226

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 (OS) 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/dsmamain.html".

Sincerely yours,

W. 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

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INDICATION FOR USE FORM 3.0

Page 1 of 1

510(k) Number (if known) K965226

Device Name: EXPERT-XL Total Body Acquisition and Analysis Software

Indications for use:

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The use of the EXPERT-XL® Total Body Acquisition and Analysis Software is restricted to prescription use only. The operator's manual for the EXPERT-XL 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 EXPERT-XL Total Body Acquisition and Analysis software requires a 3 minute exposure, with an exposure dose of 3 mrem. This software option is substantially equivalent to the DPX Total Body software and 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)

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

510(k) Number	K965226
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OR
Over-the-Counter Use(Optional Format 1-2-96)

CONFIDENTIAL

Prescription Use (Per 21 CRF 801.109)

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.