FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS by NORLAND CORP.

This fracture risk assessment capability provides information that aids the physician in determining risk of fracture, risk of bone disease, or treatment effectiveness. This fracture risk assessment capability interprets the results of the bone density tests performed by Norland bone densitometers in accordance with methods in general use in the medical community. In general they use the bone densitometer values (usually BMD and T-Score) and patient information (usually gender, age, and ethnic background). The interpretation is based on the World Health Organization's (WHO) criteria relating bone density to risk of fracture and diagnosis of osteoporosis. In general, the WHO criteria means that patients with T-Scores from +1 to -1 are considered to be normal; with T-Scores from -1 to -2.5 are considered to have low bone mass and have an increased risk of fracture; and with T-Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture. This information is presented graphically and as verbiage on the screens and reports.

This fracture risk capability does not require any modifications to the Norland bone densitometers besides adding the fracture risk information to the screens and printouts. In particular, it does not increase the scanning time, patient dose, or scatter radiation.

AI/ML Overview

The provided text is a 510(k) summary for a "Fracture Risk Assessment Capability" for Norland X-Ray Bone Densitometers. This device is an interpretation capability that uses existing bone densitometer values (BMD and T-Score) and patient information (gender, age, ethnic background) to assess fracture risk based on World Health Organization (WHO) criteria.

The document states that the device "does not require any modifications to the Norland bone densitometers besides adding the fracture risk information to the screens and printouts" and "does not increase the scanning time, patient dose, or scatter radiation." It also asserts that "This Norland Fracture Risk Assessment Capability is comparable to fracture risk assessment capabilities in use with other bone densitometers in the industry. No new safety or effectiveness issues are raised."

However, this document does not contain specific acceptance criteria, study details, or performance metrics for the device itself. It focuses on the substantial equivalence argument, stating that the device is comparable to existing predicate devices and does not raise new safety or effectiveness issues. Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor can I detail specific study parameters for this particular device.

The FDA's letter (K980569) confirms that the device is substantially equivalent to a predicate device, meaning it doesn't require new clinical studies to prove safety and effectiveness if it meets the criteria of being essentially the same as a legally marketed device.

Based on the provided text, the following information is available or can be inferred, but many points requested in your prompt are explicitly not available:

Acceptance Criteria and Study Details (Based on available information in the document)

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Safety: No new safety issues raised.	"No new safety or effectiveness issues are raised." The device does not increase scanning time, patient dose, or scatter radiation.
Effectiveness: Comparable to fracture risk assessment capabilities in other bone densitometers.	"This Norland Fracture Risk Assessment Capability is comparable to fracture risk assessment capabilities in use with other bone densitometers in the industry." Interprets results based on WHO criteria (T-Scores).
Functionality: Provides information aiding physicians in determining risk of fracture, risk of bone disease, or treatment effectiveness.	Provides graphical and verbiage presentations of fracture risk interpretation based on bone densitometer values and patient demographics, following WHO criteria.

Explanation: The "acceptance criteria" for this 510(k) submission are primarily based on demonstrating substantial equivalence to a predicate device and confirming that the new capability does not introduce new safety or effectiveness concerns. There are no quantitative performance metrics (e.g., sensitivity, specificity, AUC) detailed in this summary.

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

Not provided. The document states the device interprets existing bone density test results but does not describe any specific test set or clinical study conducted for this 510(k) submission. The argument is based on substantial equivalence, implying that the underlying science of fracture risk assessment based on WHO criteria is already established.

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

Not applicable. No specific test set with ground truth established by experts is described for this submission. The "ground truth" for the interpretation method itself is the established World Health Organization (WHO) criteria for T-Scores and their relation to fracture risk and osteoporosis diagnosis.

4. Adjudication method for the test set:

Not applicable. No specific test set requiring adjudication is described.

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. The provided text does not describe an MRMC study or any study involving human readers' improvement with or without AI assistance. The device is described as an "interpretation capability" that presents information, not as an AI-assisted diagnostic tool for readers.

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

Yes, implicitly. The device itself is an "interpretation capability" that processes bone densitometer values and patient information to generate a fracture risk assessment based on predefined WHO criteria. This operates in a standalone manner to generate its output, which is then presented to a physician. No human interpretation is built into the algorithm's output generation. However, this is not a diagnostic device in itself, but an aid to the physician.

7. The type of ground truth used:

Expert Consensus / Clinical Guidelines: The ground truth for the fracture risk assessment interpretation is based on the World Health Organization's (WHO) criteria for relating bone density (T-Scores) to the risk of fracture and diagnosis of osteoporosis.

8. The sample size for the training set:

Not applicable / Not provided. The device is not described as an AI/ML model that undergoes a "training" phase in the conventional sense. It applies established WHO criteria. The WHO criteria themselves were developed based on extensive medical and scientific research, but that's foundational knowledge, not a training set for this specific device.

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

Not applicable. As described above, there's no "training set" in the context of an AI/ML algorithm. The underlying "ground truth" (WHO criteria) was established through scientific consensus and epidemiological studies in the medical community.

Summary

{0}------------------------------------------------

February 1998

Fracture Risk Assessment 510(k) - Supplement 1

JUN 12 1998

510k Summary

as required by 807.92(c) for

Fracture Risk Assessment Capability

for Norland X-Ray Bone Densitometers

Prepared February 1998

Norland Medical Systems, Inc. Submitted by: W6340 Hackbarth Road Fort Atkinson, WI 53538 Reg. # 2124648 Contact Person: Mr. Terry Schwalenberg Director Regulatory Affairs 920-563-8456 x229 Fracture Risk Assessment Capability for Norland X-Ray Bone Device Trade Name: Densitometers Common Name: Fracture risk assessment for bone densitometers Classification: Bone densitometer. (21 CFR 892.1170), product code 90KGI: Class II Fracture Risk Assessment for pDEXATM Bone Densitometer (K973104) Predicate Devices: Norland Medical Systems, Inc., Fort Atkinson, WI Fracture Risk Assessment for the Norland-Cameron Model 178 Bone Mineral Analyzer, which is a pre-amendment device. Description of This fracture risk assessment capability provides information that aids the Device: physician in determining risk of fracture, risk of bone disease, or treatment effectiveness. This fracture risk assessment capability interprets the results of the bone density tests performed by Norland bone densitometers in accordance with methods in general use in the medical community. In general they use the bone densitometer values (usually BMD and T-Score) and patient information (usually gender, age, and ethnic background). The interpretation is based on the World Health Organization's (WHO) criteria relating bone density to risk of fracture and diagnosis of osteoporosis. In general, the WHO criteria means that patients with T-Scores from +1 to -1 are considered to be normal; with T-Scores from -1 to -2.5 are considered to have low bone mass and have an increased risk of fracture; and with T-Scores below -2.5 are considered to be osteoporotic

{1}------------------------------------------------

and have a high risk of fracture. This information is presented graphically and as verbiage on the screens and reports.

This Norland Fracture Risk Assessment Capability is comparable to Safety and Effectiveness: fracture risk assessment capabilities in use with other bone densitometers in the industry. No new safety or effectiveness issues are raised.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping heads suggesting a sense of community and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the department's role and national scope.

JUN | 7 1998

Terry Schwalenberg Director Regulatory Affairs Norland Systems, Inc. W6340 Hackbarth Road Fort Atkinson, WI 53538

Re:

K980569

Fracture risk capabililty for the Norland Bone Densitometer: Models XR Series, pDEXA Series, Apollo Series, XCT Series and SXA Series Dated: April 16, 1998 Received: April 20, 1998 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI

Dear Mr. Schwalenberg:

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 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 Aporoval), 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 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Kilian Yin

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

Enclosure

{3}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(K) Number (if known):

Device Name: Fracture Risk Assessment Capability for Norland X-Ray Bone Densitometers.

Indications For Use:

The bone density estimates from Norland X-Ray Bone Densitometers can be used as an aid to the physician in determining risk of fracture.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Prescription Use
OR
Over-The-Counter-Use
(Per 21 CFR 810.109)

David A. Byrom

Page 1-4

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number

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.