(13 days)
No
The summary describes standard bone densitometry software and does not mention any AI or ML techniques. The performance studies focus on correlation and precision, typical metrics for this type of device, and there is no mention of training or test sets for AI/ML models.
No
The device is described as software for the estimation of Bone Mineral Density (BMD), which is a diagnostic tool, not a therapeutic one. It analyzes data to provide information about the patient's condition, but it does not treat or cure any disease.
Yes
The device is described as software for "estimation of Bone Mineral Density BMD (in g/cm3)," which is a measurement used in the diagnosis of conditions like osteoporosis.
No
The device is described as an "accessory software option" for a "Bone Densitometer," which is a hardware device. The software's function is to process data acquired by the densitometer. Therefore, it is 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 devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is used to measure Bone Mineral Density (BMD) directly on the human body (forearm and/or hand) using a bone densitometer. This is an in vivo measurement, not an in vitro measurement.
The description clearly states it's an accessory software for a bone densitometer used for acquisition and analysis of BMD from the forearm and/or hand region. This process involves scanning the patient directly, not analyzing a sample taken from the patient.
N/A
Intended Use / Indications for Use
Not Found
Product codes
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Device Description
The EXPERT-XL Hand and/or Forearm Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density BMD (in g/cm3) of the forearm and/or hand region provided for by the EXPERT-XL Bone Densitometer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
forearm and/or hand region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
Scans of the forearm or hand region take about 10 seconds. The EXPERT-XL Forearm and Hand software results correlate highly (r = 0.96) with the corresponding regions measured on the DPX series, which already has 510(k) clearance. Also, the average short term precision (CV) in vivo is 2% or under for all sites, which is comparable to that shown on DPX series densitometers. The radiation exposure of 12 mrem is higher than that for DPX series densitometers but remains low compared to the maximum permissible dose to the extremities.
Key Metrics
Not Found
Predicate Device(s)
K915535 Forearm Software for Lunar DPX Series, K953032 Hand Software for Lunar DPX Series
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV - 8 1996
Image /page/0/Picture/1 description: The image shows the word "LUNAR" in a bold, sans-serif font. The letters are large and closely spaced, creating a solid block of text. The word is in black against a white background, providing a high contrast that makes it easily readable.
MADISON, WI 53713
(608) 274-2663
10.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
313 W. BELTLINE HIGHWAY
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: | October 23, 1996 |
| Device/Trade Name: | EXPERT-XL Forearm and Hand Acquisition and Analysis
Software |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer
21CFR 892.1170 |
| Predicate Device: | K915535 Forearm Software for Lunar DPX Series
K953032 Hand Software for Lunar DPX Series |
10.1 DESCRIPTION OF THE DEVICE:
The EXPERT-XL Hand and/or Forearm Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density BMD (in g/cm3) of the forearm and/or hand region provided for by the EXPERT-XL Bone Densitometer.
10.2 SUMMARY OF TECHNICAL CHARACTERISTICS
Scans of the forearm or hand region take about 10 seconds. The EXPERT-XL Forearm and Hand software results correlate highly (r = 0.96) with the corresponding regions measured on the DPX series, which already has 510(k) clearance. Also, the average short term precision (CV) in vivo is 2% or under for all sites, which is comparable to that shown on DPX series densitometers. The radiation exposure of 12 mrem is higher than that for DPX series densitometers but remains low compared to the maximum permissible dose to the extremities.
21
1
10.3 CONCLUSION
The BMD results for the EXPERT-XL forearm/hand software option are comparable to the DPX results and have similar precision. No new safety and effectiveness questions are raised with the EXPERT-XL forearm and hand software accessory.
Signed
Kenneth D. Buroker Printed Name ....
Director, Regulatory Affairs Title