The Fracture Risk Option consists of updated software which adds the fracture risk features to the screens and printed reports for the pDEXA. It also includes a supplement to the pDEXA Operator's Guide which explains how to interpret the pDEXA bone density values to aid in the assessment of fracture risk and the diagnosis of osteoporosis.

AI/ML Overview

The provided document for K973104, "Fracture Risk Assessment Option for the Norland pDEXA™ Bone Densitometer," is a 510(k) summary submitted to the FDA in 1997. This submission focuses on establishing substantial equivalence to a pre-amendment device (Norland-Cameron Model 178 Bone Mineral Analyzer) rather than presenting a performance study with detailed acceptance criteria and reported device performance. As such, many of the requested details about a specific study testing the device against performance criteria are not available in this document.

Here's a breakdown of what can be extracted and what is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not describe specific numerical acceptance criteria or present data from a performance study of the "Fracture Risk Assessment Option." Its primary argument is substantial equivalence to an existing device's intended use and function.

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

Not available. There is no mention of a test set, sample size, or data provenance (country of origin, retrospective/prospective) for evaluating the "Fracture Risk Assessment Option."

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

Not available. Since no specific performance study is detailed, there's no information about experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not available. No test set or adjudication method is described.

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

No. The document does not describe an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a software option for a bone densitometer, and the focus is on its output's relationship to existing diagnostic guidelines, not its impact on human reader performance in an MRMC setting.

6. Standalone Performance Study (Algorithm Only)

Not performed or reported in this document. The submission is for a "Fracture Risk Assessment Option" which is an update to existing software. The focus is on the substantial equivalence of its output (T-Scores and fracture risk categorization based on WHO definitions) to a predicate device's method, not on new standalone performance metrics. The document states: "The Fracture Risk Option provides an assessment of relative fracture risk based on the T-Score value. It presents the World Health Organization's (WHO) definition of osteoporosis and osteopenia; and makes the same diagnostic recommendations originally made by the pre-amendment Model 178." This implies the performance is tied to the established science behind T-Scores and WHO definitions, not a new algorithm requiring a standalone study in this context.

7. Type of Ground Truth Used

The ground truth implicitly used for the "Fracture Risk Assessment Option" is based on:

Expert Consensus and Established Medical Guidelines: Specifically, the World Health Organization's (WHO) definition of osteoporosis and osteopenia, which is based on T-scores (standard deviations below the young adult mean).
Predicate Device's Methodology: The comparison to the "pre-amendment Model 178" implies that its established approach of assessing bone density relative to a reference population and assigning fracture risk based on deviations from the mean served as a form of "ground truth" for equivalence. The "Interpretation of Fracture Index Charts; E. Smith and J. R. Cameron" (Smith-Cameron charts) is referenced as proof for the predicate device's claims.

8. Sample Size for the Training Set

Not available. As a software update applying WHO definitions and T-scores to data from an existing bone densitometer, it is highly unlikely there was a "training set" in the modern machine learning sense. The device's "training" (establishment of reference populations) would have occurred during the development of the original pDEXA™ Bone Densitometer device and the predicate Model 178. The document mentions "reference population (device specific)" for comparison, but not sample sizes for this reference population.

9. How the Ground Truth for the Training Set Was Established

Not available for this specific submission. For the underlying bone densitometry, the "ground truth" for establishing reference populations would typically involve:

Large Cohorts of Healthy Individuals: To establish normal bone mineral density (BMD) values across different age groups and genders.
Clinical Studies and Epidemiological Data: To correlate BMD values with fracture incidence, leading to the establishment of thresholds like the WHO T-score criteria.

The document refers to the "reference population (device specific)" and states that the "Fracture Risk Option" and the Model 178 "both compare this bone density assessment to a reference population in terms of the number of standard deviations the value is below the mean." The ground truth for these reference populations was established through previous scientific and clinical work, much of which predates this 510(k) submission. The exact methods for the specific Norland devices' reference populations are not detailed here beyond mentioning the "Smith-Cameron charts."

Summary

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K973104

JAN 2 9 1998

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS as required by 807.92(c) for

APPENDIX D

Supplement 9/97

FRACTURE RISK ASSESSMENT OPTION

for the Norland pDEXATM Bone Densitometer Prepared 29 September 1997

Norland Corporation SUBMITTED BY: W6340 Hackbarth Road Fort Atkinson, WI 53538

CONTACT: Terry Schwalenberg Director Regulatory Affairs Fax: 920-563-8626 Tel: 920-563-8456

Fracture Risk Assessment Option for the Norland Model pDEXATM Bone TRADE NAME: Densitometer (Fracture Risk Option) Densitometer, Bone (90KGI) (21 CFR 892.1170), Class II CLASSIFICATION: fracture risk assessment for dual energy bone densitometer COMMON NAME:

Fracture Risk Assessment for the Norland-Cameron Model 178 Bone PREDICATE Mineral Analyzer (Model 178); which is a pre-amendment device. DEVICE:

The Fracture Risk Option consists of updated software which adds the DEVICE DESCRIPTION: fracture risk features to the screens and printed reports for the pDEXA. It also includes a supplement to the pDEXA Operator's Guide which explains how to interpret the pDEXA bone density values to aid in the assessment of fracture risk and the diagnosis of osteoporosis.

The Fracture Risk Option provides an assessment of relative fracture risk INTENDED USE: based on the T-Score value. It presents the World Health Organization's (WHO) definition of osteoporosis and osteopenia; and makes the same diagnostic recommendations originally made by the pre-amendment Model 178. It also indicates that although bone density is the single most important factor in the assessment of fracture risk and the diagnosis of osteoporosis, other factors must also be considered by the physician in their diagnosis. Some of these factors are provided and others are referenced.

The Fracture Risk Option is substantially equivalent to the pre-amendment SUBSTANTIAL fracture risk assessment capability of the Model 178, because they both EQUIVALENCE: have the same intended use. They both assess the subject's bone density, then compare it to a reference population (device specific), and then assess fracture risk based on the number of standard deviations below the mean of the reference population. Further, they both claim increasing fracture risk for larger deviations below the mean and provide recommendations to the physician regarding diagnosis and treatment.

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Supplement 9/97

ATTACHMENT E

STATEMENT OF SUBSTANTIAL EQUIVALENCE

The Fracture Risk Assessment Option for the Norland pDEXA Bone Densitometer (Fracture Risk Option) is substantially equivalent to the pre-amendment fracture risk claims of the Norland-Cameron Bone Mineral Analyzer (Model 178) because they both have the same intended use based on the following:

. Both assess bone density of the forearm.
Both compare this bone density assessment to a reference population in terms of the number of . standard deviations the value is below the mean. In both cases this reference population is device specific.
Both assign increasing risk of fracture for larger deviations below the mean. .
Both make the same recommendations to physicians relating to diagnosis and treatment. .
Both state that the physician is responsible for the diagnosis and that the device only provides . useful information to aid the phvsician in his diagnosis.

While there are technological differences between the Fracture Risk Option and the Model 178, they do not impact intended use because it is based on the subject's value relative to a reference population determined for the specific device used. It is the comparison of the subject's value to the reference population in terms of the number of standard deviations from the mean for that reference population, that conveys the intended use. This is the same for the Fracture Risk Option and the Model 178.

The fracture risk claims for the Model 178 are shown in the publication: "Interpretation of Fracture Index Charts; E. Smith and J. R. Cameron"; which was distributed to Norland customers pre-amendment. This publication includes the famous Smith-Cameron charts. See attachment A2.

The main difference between the fracture risk claims of the Fracture Risk Option and the Model 178 is that the Fracture Risk Option determines all three risk regions in terms of voung reference values (T-Score), while the Model 178 used age matched criteria (Z-Score) for part of the separation between the two lower risk regions. This difference is not significant because it does not affect the peri-menopausal, post menopausal, or elderly portions of the chart. In these important regions, thev both are based on T-Score. Also, even in the vounger age region where thev are different, the practical implications are minimal.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 9 1398

Terry Schwalenberg Director Regulatory Affairs Norland Corporation W6340 Hackbarth Road Fort Atkinson, WI 53538

Re:

K973104 Fracture Risk Assessment Option for the Norland Model pDEXA™ Bone Dated: November 21, 1997 Regulatory class: II Received: December 2, 1997 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, 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 misbranion.

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 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/cdrl/dsmamain.html".

Sincerely yours,

h) Tiau Yri

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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ATTACHMENT B

INDICATIONS FOR USE STATEMENT

510(K) Number (if known): K973104

Device Name: Fracture Risk Assessment Option for the Norland Model pDEXA™ Bone Densitometer

The bone density estimates from the Norland pDEXA™ Bone Densitometer can be used as an aid to the physician in determining fracture risk.

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