The EXPERT-XL Orthopedic Hip Acquisition and Analysis Software is used with the EXPERT-XL Bone Mineral Densitometry system. This new software feature allows for estimation of periprosthetic BMD of an orthopedic hip implant in sub-regions called Gruen zones. These zones are a typical radiographic labeling technique for orthopedic hip implants.

Device Description

The Orthopedic Hip Acquisition and Analysis Software is an accessory software option for the EXPERT-XL Bone Densitometer that allows estimation of Bone Mineral Density BMD (in g/cm2) of periprosthetic bone adjacent to an orthopedic hip implant.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the EXPERT-XL Orthopedic Hip Acquisition and Analysis Software:

Note: The provided document is a 510(k) summary and FDA clearance letter, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results with detailed acceptance criteria and standalone performance metrics. Therefore, some of the requested information, particularly regarding specific performance acceptance criteria, expert adjudication, MRMC studies, and detailed ground truth methodology, is not explicitly present in this type of regulatory submission.

Acceptance Criteria and Study for EXPERT-XL Orthopedic Hip Acquisition and Analysis Software

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Correlation with Predicate Device	High correlation (r ≥ X) with DPX series	r = 0.97
Precision (In Vivo CV)	≤ 3% for all sites (comparable to DPX series)	3% or under for all sites
Scan Time	Not explicitly stated as acceptance criteria, but a functional attribute.	12 seconds
Entrance Radiation Exposure	Low compared to maximum permissible dose and conventional radiographs.	53 mrem
Safety Concerns	No new safety concerns posed compared to predicate.	"No new safety or efficacy concerns."
Efficacy Concerns	No new efficacy concerns posed compared to predicate.	"No new safety or efficacy concerns."
Comparable Results to Predicate	BMD results comparable to DPX series.	"Comparable to the DPX results."

Explanation: The acceptance criteria for this 510(k) submission are primarily based on demonstrating substantial equivalence to the predicate device (K914404 Orthopedic Software for Lunar DPX Series densitometers). This means the new device should perform similarly or better than the predicate without raising new safety or efficacy concerns. The "reported device performance" are the metrics provided to support this claim of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated in the provided document. The correlation (r=0.97) and precision (CV) values are given, implying a test was performed, but the number of subjects or scans is not specified.
Data Provenance: Not explicitly stated. Given the company (Lunar Corporation) is located in Madison, WI, USA, it is highly probable the data was collected in the USA, but this is an inference. It's also not specified if the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

Explanation: For a 510(k) submission focused on substantial equivalence for a bone densitometry device, the "ground truth" for BMD measurements is typically established through direct measurement by the device itself or by comparison to another validated device (the predicate). Expert consensus or pathologist review is less common for establishing the primary ground truth in this specific application, as the output is a quantitative measure (BMD). The comparison is to another device's measurements.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not mentioned. The study likely involved direct comparison of quantitative BMD output rather than subjective interpretation requiring adjudication among multiple readers.

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

MRMC Study: No, an MRMC comparative effectiveness study is not described or indicated for this device. The device provides a quantitative measurement (BMD) and is not intended for subjective interpretation by human readers. Therefore, an "improvement with AI vs. without AI assistance" effect size is not relevant in this context.

6. Standalone Performance Study (Algorithm Only)

Standalone Study: Yes, the described performance metrics (correlation r=0.97, precision CV=3%) are indicative of a standalone performance study. The device's software (algorithm) produces these quantitative results, and they are compared to those of the predicate device. There is no mention of a human-in-the-loop component in the evaluation of these specific metrics.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth appears to be the results obtained from the predicate device, the Lunar DPX series densitometers. The study establishes a high correlation between the EXPERT-XL Orthopedic Hip software results and the DPX series results. For precision, the in vivo CV is compared to that shown on DPX series densitometers.

8. Sample Size for the Training Set

Training Set Sample Size: Not mentioned. 510(k) summaries generally do not detail the development or training process for the algorithm unless it's critical to establishing substantial equivalence for a novel aspect.

9. How Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not mentioned. As with the test set, it's highly probable that if any training was involved in the software development, it would have been based on BMD measurements from established, validated bone densitometry systems, likely including the predicate device or similar systems. Given the nature of a 510(k) in 1997, sophisticated AI/ML training paradigms as understood today might not have been applicable, or if they were, the details are not required in this summary.

Summary

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Image /page/0/Picture/0 description: The image shows the word "LUNAR" in large, bold, black letters. The letters are slightly distressed, giving them a textured appearance. The background is white, providing a strong contrast that makes the word stand out.

K972517

313 W. BELTLINE HIGHWAY

MADISON, WI 53713

(608) 274-2663

NOV 1 8 1997

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. Buroker
	LUNAR Corporation
	313 West Beltline Highway
	Madison, WI 53713
Phone:	(608) 288-6460
Fax:	(608) 274-0853
Date:	July 3, 1997
Device/Trade Name:	EXPERT-XL Orthopedic Hip Acquisition and AnalysisSoftware
Common Name:	Bone Densitometer
Classification Name:	Bone Densitometer21CFR 892.1170
Predicate Device:	K914404 Orthopedic Software for Lunar DPX Seriesdensitometers

DESCRIPTION OF THE DEVICE: 10.1

SUMMARY OF TECHNICAL CHARACTERISTICS 10.2

Scans of the orthopedic hip region take 12 seconds. The EXPERT-XL Orthopedic Hip software results correlate highly (r =0.97) with DPX series, which already fras 510(k) clearance. Also, the average short term precision (CV) in vivo is 3% or under for all sites, which is comparable to that shown on DPX series densitometers. The entrance radiation exposure to the skin of 53 mrem is higher than that for DPX series densitometers but remains low compared to the maximum permissible dose and to conventional radiographs of the region.

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CONCLUSION 10.3

The BMD results for the EXPERT-XL Orthopedic Hip Acquisition and Analysis and software option are comparable to the DPX results and have similar precision. No new afety and software option are comparable to the DI X results and have stample provisition and Analysis software accessory.

Humphrey D. Buck
Signed

Kenneth D. Buroker Printed Name

Director, Regulatory Affairs Title

1 3

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

18 1997 NOV

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

Re:

K972517

Expert-XL Orthopedic Hip Acquisition and Analysis Software Dated: October 7, 1997 Received: October 15, 1997 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI

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 the intens 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 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 (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 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 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 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,

Lillian Yin, Ph.D.

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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3.0 INDICATIONS FOR USE FORM

501(k) Number (if known): .
Device name: EXPERT-XL Orthopedic Hip Acquisition and Analysis Software .
Indications For Use: .

The EXPERT-XL Orthopedic Hip Acquisition and Analysis Software requires a 12 seconds with an entrance radiation exposure to the skin of 53 mrem. This software posses no new safety or efficacy concerns.

The use on the EXPERT-XL Orthopedic Hip Acquisition and Analysis Software is restricted to prescription only. The User's Guide for the 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."

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)

510(k) Number

Over-the-Counter Use

(Optional Format 1-2-96)

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Vimind le. Segum

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

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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.