(81 days)
Not Found
No
The summary describes standard bone densitometry software and does not mention any AI or ML techniques.
No
This software-only device estimates bone mineral density for diagnostic purposes, and does not directly provide or control therapy.
Yes
The device estimates bone mineral density (BMD) of the lumbar spine vertebrae, which can then be compared to a reference population at the discretion of a physician. This information aids in diagnosis or monitoring of bone health.
No
The device is described as "accessory software option for estimation of Bone Mineral Density (BMD)... provided for the EXPERT-XL Bone Densitometer". This indicates it is software that functions with a specific hardware device (the bone densitometer), not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The EXPERT-XL Lateral Spine BMD Acquisition and Analysis software works with a bone densitometer system to estimate bone mineral density in vivo (within the living body) using imaging technology. It does not analyze samples taken from the body.
- Input: The input is data from a bone densitometer, not a biological sample.
- Output: The output is an estimated BMD value, not a result from a test performed on a biological sample.
Therefore, this device falls under the category of medical imaging software used for diagnostic purposes, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EXPERT-XL Lateral Spine BMD Acquisition and Analysis software is used with the EXPERT-XL bone densitometer system. This software feature estimates bone mineral density (BMD) of the lumbar spine vertebrae in the lateral view. This BMD value can then be compared to a reference population at the sole discretion of the physician.
Product codes (comma separated list FDA assigned to the subject device)
90 KGI
Device Description
The EXPERT-XL Lateral Spine BMD Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density (BMD), in g/cm2, of the lumbar spine vertebrae in the lateral view provided for the EXPERT-XL Bone Densitometer with a reference population for comparative purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine vertebrae in the lateral view
Indicated Patient Age Range
The female reference population has relatively constant BMD for age 20-49, but BMD decreases after age 50 at a rate of of 0.008g/cm2 per year (~1% per year).
Intended User / Care Setting
by or on the order of a physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The EXPERT-XL Lateral Spine BMD software acquires images of the lumbar spine in the lateral view; the acquisition takes 16 seconds. The results in vitro correlate highly (r =0.99) with BMD on known phantoms, and the precision in vitro is equivalent to the AP spine when analyzed with a region-of-interest (ROI) of the same dimension. The average short term precision (CV) in vivo is 3.0 to 3.5%; this is higher than that of the AP spine BMD due to smaller ROI's and lower bone density.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation (r =0.99), precision (CV) in vivo is 3.0 to 3.5%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
FEB 1 3 1998
K97443M
313 W. BELTLINE HIGHWAY
MADISON, WI 53713
(608) 274-2663
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: | November 21, 1997 |
| Device/Trade Name: | EXPERT-XL Lateral Spine BMD Acquisition and Analysis
Software |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer
21CFR 892.1170 |
| Predicate Device: | EXPERT-XL Bone Mineral Densitometer,
standard AP spine site, 510(k) K945526 |
DESCRIPTION OF THE DEVICE: 10.1
The EXPERT-XL Lateral Spine BMD Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density (BMD), in g/cm2, of the lumbar spine vertebrae in the lateral view provided for the EXPERT-XL Bone Densitometer with a reference population for comparative purposes.
10.2 SUMMARY OF TECHNICAL CHARACTERISTICS
The EXPERT-XL Lateral Spine BMD software acquires images of the lumbar spine in the lateral view; the acquisition takes 16 seconds. The results in vitro correlate highly (r =0.99) with BMD on known phantoms, and the precision in vitro is equivalent to the AP spine when
1
analyzed with a region-of-interest (ROI) of the same dimension. The average short term precision (CV) in vivo is 3.0 to 3.5%; this is higher than that of the AP spine BMD due to smaller ROI's and lower bone density. The female reference population has relatively constant BMD for age 20-49, but BMD decreases after age 50 at a rate of of 0.008g/cm2 per year (~1% per year).
The radiation exposure (skin entrance) of 120 mrem is higher than that for the AP view but is necessary due to the increased thickness in the lateral view. The exposure remains low compared to the maximum permissible dose.
CONCLUSION 10.3
The EXPERT-XL Lateral Spine BMD Acquisition and Analysis software option is substantially equivalent to the EXPERT-XL standard anterior (AP) spine projection. The BMD results in vitro show excellent precision and a high correlation to the AP spine. The precision results in vivo are acceptable for the small ROI. The female reference population is relatively constant at the younger age groups with a decline starting after age 50.
No new safety and effectiveness questions are raised with the EXPERT-XL Lateral Spine BMD Acquisition and Analysis software accessory.
Hennifer Birch
Signed
Signed
Kenneth D. Buroker Printed Name
Director, Regulatory Affairs Title
2
Image /page/2/Picture/17 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, depicted in a minimalist, abstract design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 1998
Kenneth D. Buroker Director, Regulatory Affairs Lunar Corporation 313 West Beltline Highway Madison, WI 53713
Re:
K974437 Expert-XL Lateral Spine BMD Acquistion and Analysis Software Dated: November 21, 1997 Received: November 24, 1997 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI
Dear Mr. Buroker:
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, whice, 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 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 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 virg 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/dsmamajn.html!", ...........................................................................................
Sincerely yours,
h. William Yu.
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
3
INDICATION FOR USE FORM 3.0
Page 1 of 1
- . 501(k) Number (if known) _____________________________________________________________________________________________________________________________________________________
- EXPERT-XL Lateral Spine BMD Acquisition and Analysis Software • Device name:
- . Indications For Use:
The EXPERT-XL Lateral Spine BMD Acquisition and Analysis software is used with the EXPERT-XL bone densitometer system. This software feature estimates bone mineral density (BMD) of the lumbar spine vertebrae in the lateral view. This BMD value can then be compared to a reference population at the sole discretion of the physician.
The EXPERT-XL User's Guide and Technical Manual 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) | ||
|---|---|---|
| (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | ||
| 510(k) Number | K974437 | |
| Prescription Use (Per 21 CRF 801.109) | OR | Over-the-Counter Use (Optional Format 1-2-96) |