Ten-Year Fracture Risk Option: The Ten-Year Fracture Risk Option for the Norland DXA Bone Densitometeters uses the femoral neck T-Score, along with certain clinical risk factors, to estimate the patient's ten-year risk of a hip fracture and/or a major osteoporotic fracture, based on the FRAX algorithm developed by the World Health Organization (WHO). This information is useful to health care professional as they manage diseases or conditions relating to bone health. This option does not diagnose disease or recommend treatment.

SIRI Table Option: The SIRI Table Option for the Norland DXA Bone Densitometers uses the SIRI UWE % Fat value, and plots it on the industry standard body fat charts. The chart used depends on the patient's gender and age, and it indicates whether the patient is Underfat, Healthy, Overfat, or Obese. These charts are the result of work done by the National Institute of Health (National Heart, Lung, and Blood Institute), who assigned underfat to obese classifications to the BMI value; and by Tanita Corporation, who related BMI to % body fat based on DXA bone densitometry. This option also calculates the patient's Body Mass Index (BMI) based solely on the height and weight data inputted by the operator, as a convenience. This information is useful to health care professional as they manage diseases or conditions relating to or affected by the patient's relative amount of fat tissue. This option does not diagnose disease or recommend treatment.

Device Description

The Ten-Year Fracture Risk Option and the SIRI Table Option for the Norland DXA Bone Densitometers are software options that use presently provided scan results and related industry standards to provide additional information to the medical professional as they diagnose and treat bone related and body fat related diseases and conditions.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the "Ten-Year Fracture Risk and SIRI Table Options for Norland DXA Bone Densitometers," based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Target)	Reported Device Performance (Result)
Ten-Year Fracture Risk Option
Chart Value Accuracy	Chart values in software match FRAX website	"The chart values in the software were compared to the values in the charts on the FRAX website, by a person different from the one who entered the data." "The results correlated well."
Clinical Risk Factor Accuracy	Clinical risk factors and significance in software match FRAX publication	"The clinical risk factors and the low, moderate, and high significance assigned to them, were verified to be the same as the FRAX publication."
Probability Calculation Accuracy	Software-generated 10-year probability of hip fracture and major osteoporotic fracture matches FRAX website for same demographics	"These values were then compared to the values given by the charts on the FRAX website for the same demographics. The results correlated well and a linear regression analysis was carried out on the resulting data."
SIRI Table Option
Proper Chart Inclusion	Correct body fat chart included in the report based on gender and age	"Previously acquired data from 150 patients was used by the new software to generate their bone exam report, to verify the proper chart was included in the report..."
SIRI UWE % Fat Plotting Accuracy	SIRI UWE % Fat value properly plotted on the correct chart	"...and to verify the SIRI UWE % Fat value was properly plotted on the chart."
General
Safety & Effectiveness	No new safety or efficacy questions raised compared to predicate devices	"No new safety or efficacy questions are raised." (for both options, repeatedly stated)
Substantial Equivalence	Substantially equivalent to predicate devices	"Testing confirms the performance... is consistent with the indications for use; and that these options are substantially equivalent to currently marketed devices with respect to safety and efficacy."

Study Details

Sample sizes used for the test set and data provenance:
- Ten-Year Fracture Risk: 150 patients. Data provenance is "Previously acquired data." Specific country of origin is not mentioned, but "Norland customers" are referenced for the broader testing. The data is retrospective as it refers to "previously acquired data."
- SIRI Table Option: 150 patients. Data provenance is "Previously acquired data." Specific country of origin is not mentioned. The data is retrospective.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- No expert "ground truth" establishment is described for the test set. For the Ten-Year Fracture Risk option, the comparison was made against the "charts on the FRAX website" and the "FRAX publication." For the SIRI Table Option, the verification was against the "proper chart" and the "SIRI UWE % Fat value." The comparison for the Ten-Year Fracture Risk chart values was done "by a person different from the one who entered the data," suggesting an internal verification process rather than external expert consensus.
Adjudication method for the test set:
- Adjudication methods like 2+1 or 3+1 are not mentioned. The testing described focuses on direct comparison and verification against established standards (FRAX website/publication, industry-standard body fat charts). For the Ten-Year Fracture Risk chart values, there was a double-check by a different person.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not required for either of these options to establish safety or effectiveness, because they do not cause changes to the scanning or analysis processes. Instead, they just use the values presently generated to produce their results."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance described is standalone. The software options "use presently provided scan results and related industry standards to provide additional information" and "do not affect the technology... No physical changes are required and the scanning and analysis functions are not impacted." The "proper operation of both options with real patient data was tested" which describes the standalone algorithm's output.
The type of ground truth used:
- Ten-Year Fracture Risk: The ground truth used was the World Health Organization (WHO) Fracture Risk Assessment algorithm (FRAX) accessible via its website charts and publication.
- SIRI Table Option: The ground truth used was industry-standard Body Fat Charts developed by Tanita from the work by D. Galligher, and classifications from the National Institute of Health (National Heart, Lung, and Blood Institute) relating BMI to % body fat.
The sample size for the training set:
- The document does not mention a separate "training set" for the device. The device is a software option that applies existing algorithms (FRAX, Tanita/Galligher body fat charts) to pre-existing DXA scan results. Hence, the algorithms themselves would have been developed and "trained" on their respective datasets by WHO/FRAX and Tanita/Galligher/NIH over time, not by Norland for this specific device submission.
How the ground truth for the training set was established:
- As there's no training set for this specific device, the ground truth for the underlying FRAX algorithm and body fat charts was established externally by the World Health Organization (WHO), Tanita Corporation, and the National Institute of Health (National Heart, Lung, and Blood Institute) respectively, based on their research and epidemiological studies. The document does not describe their ground truth establishment methods.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for Norland, a CooperSurgical Company. The word "NORLAND" is written in large, bold, black letters. Below the word "NORLAND" is the text "a CooperSurgical Company".

09132 W(6340 Hackbarth Road / Fort Aikinson, W1-53538 (920) 563-9504 / Fax (920) 563-8626

510(k) Summary

prepared in accordance with 21 CFR Part 807.92(c) April 2009

JUN 29 2009

ું જ

1. Name Ten-Year Fracture Risk and SIRI Table Options for Norland DXA Bone Densitometers
1. Manufacturer Norland, a CooperSurgical Company W6340 Hackbarth Road Fort Atkinson, WI, 53538 Establishment Registration #2124648
1. Owner Cooper Surgical Inc. 95 Corporate Drive Trumbull, CT, 06611 Establishment Registration #1216677
1. Contact Person Mr. Tom Williams VP RA/Business Assurance
1. Trade Name Ten-Year Fracture Risk and SIRI Table Options for Norland DXA Bone Densitometers
1. Common Name Ten-Year Fracture Risk and SIRI Table Options
1. Classification DXA Bone Densitometer, 90 KGI, Class II, Section 892.1170
Predicate Device Comparison 8.

Ten-Year Fracture Risk Option

K080711, Hologic 10-year Fracture Risk Questionnaire Option.

The Norland Ten-Year Fracture Risk Option is substantially equivalent to the Hologic 10-year Fracture Risk Option. Both use the World Health organization (WHO) Fracture Risk Assessment algorithm (FRAX) to estimate the patient's risk of hip fracture and major osteoporotic fracture. No new safety or efficacy questions are raised.

SIRI Table Option

K071570. GE Lunar Body Composition Software Ontion.

K014009 - Tanita Body Composition Analyzer

The Norland SIRI Table Option for the Norland DXA Bone Densitometers is substantially equivalent to the GE Lunar Body Composition Software Option. Both use DXA technology to determine % Body Fat, and both plot this value against the gender and age matched Body Fat Charts to indicate if the patient is Underfat, Healthy, Overfat, or Obese. Further, both use similar technology and have similar intended uses. The SIRI Table Option is also comparable to the

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

510(k) Summary

prepared in accordance with 21 CFR Part 807 92(c) January 2009

Tanita Body Composition Analyzer because it uses the relationship between % body fat and the classifications (Underfat to Obese), that was developed by Tanita and used in their analyzer. No new safety or efficacy questions are raised.

ರು. Device Description

10. Intended Use

The Ten-Year Fracture Risk Option uses the femoral neck T-Score results of the Norland DXA bone densitometer, along with the results of a Clinical Risk Factor questionnaire, to determine the patient's risk of incurring a hip fracture or a major osteoporotic fracture in the next ten years. This information is useful to health care professional as they manage diseases or conditions relating to bone health. This option does not diagnose disease or recommend treatment.

The SIRI Table Option uses the SIRI UWE % Fat results of the Norland DXA bone densitometer to classify the patient as Underfat, Healthy, Overfat, or Obese, based on the industry standard Body. Fat Charts developed by Tanita from the work done by D. Galligher. It also calculates the industry standard BMI based on the patient height and weight information entered by the operator. This information is useful to health care professionals as they manage diseases or conditions relating to or affected by the patient's relative amount of fat tissue. This option does not diagnose disease or recommend treatment.

11. Technological Characteristics

These options do not affect the technology of the Norland bone densitometers. No physical changes are required and the scanning and analysis functions are not impacted. They only require software modifications to add their additional features.

12. Non-Clinical Tests

Ten-Year Fracture Risk:

The chart values in the software were compared to the values in the charts on the FRAX website, by a person different from the one who entered the data. The clinical risk factors and the low, woderate, and high significance assigned to them, were verified to be the same as the FRAX publication.

Previously acquired data from 150 patients was used by the new software to generate their Ten-Year Probability of a hip fracture and of a Major Osteoporotic Fracture. These values were then compared to the values given by the charts on the FRAX website for the same demographics. The results correlated well and a linear regression analysis was carried out on the resulting data.

SIRI Table Option.

Previously acquired data from 150 patients was used by the new software to generate their bone exam report, to verify the proper chart was included in the report, and to verify the SIRK UWE % Fatu value was properly plotted on the chart.

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

・

510(k) Summary

prepared in accordance with 21 CFR Part 807.92(c) January 2009

13. Clinical Tests

Clinical testing was not required for cither of these options to establish safety or effectiveness. because they do not cause changes to the scanning or analysis processes. Instead, they just use the values presently generated to produce their results.

However, proper operation of both options with real patient data was tested, using sets of clinical data available from Norland customers. See bench testing above. However, no subjects were scanned solely to test these new options.

14. Test Conclusions

Testing confirms the performance of the Ten-Year Fracture Risk Option and the SIRI Table Option is consistent with the indications for use; and that these options are substantially equivalent to currently marketed devices with respect to safety and efficacy.

1. Other Pertinent Information (None)

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three stripes representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 29 2009

Mr. Thomas G. Williams VP RA/Business Assurance CooperSurgical, Inc. 95 Corporate Drive TRUMBULL CT 06611

Re: K091325

Trade/Device Name: Ten-Year Fracture Risk and SIRI Table Option for Norland DXA Bone Densitometer

Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: April 30, 2009 Received: May 5, 2009

Dear Mr. Williams:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Drue, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{4}------------------------------------------------

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrls/indr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): KC91325

Ten-Year Fracture Risk and SIRI Table Options for Norland DXA Bone Device Name: Densitometers

Indications for Use: .

Ten-Year Fracture Risk Option

The Ten-Year Fracture Risk Option for the Norland DXA Bone Densitometeters uses the femoral neck T-Score, along with certain clinical risk factors, to estimate the patient's len-year risk of a hip fracture and/or a major osteoporodic fracture, based on the FRAX algorithm developed by the World Health Organization (WHO). This information is useful to health care professional as they manage diseases or conditions relating to bone health. This option does not diagnose disease or recommend treatment.

SIRI Table Option

The SIRI Table Option for the Norland DXA Bone Densitometers uses the SIRI UWE % Fat value, and plots it on the industry standard body fat charts. The chart used depends on the patient's gender and age, and it indicates whether the patient is Underfat, Healthy, Overfat, or Obese. These charts are the result of work done by the National Institute of Health (National Heart, Lung, and Blood Institute), who assigned underfat to obese classifications to the BMI value; and by Tanita Corporation, who related BMI to % body fat based on DXA bone densitometry. This ontion also calculates the patient's Body Mass Index (BMI) based solely on the height and weight data inputted by the operator, as a convenience. This information is useful to health care professional as they manage diseases or conditions relating to or affected by the patient's relative amount of fat tissue. This option does not diagnose disease or recommend treatment.

Prescription Use YES AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use NO (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Center for Devices and Radiological Health / CDRH

Hath Pluma

(Division Sign-Off) Division of Reproductive, Abdominal 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.