(56 days)
None
No
The summary describes standard bone densitometry software providing estimations based on scans and comparisons to reference populations. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies. The performance studies focus on correlation and precision, which are standard metrics for this type of device.
No.
The software provides an estimate of BMD, fat, and lean tissue mass, which is compared to a reference population. It does not exert any action on the body or treat any condition.
Yes
This device estimates BMD, fat, and lean tissue mass, and the BMD value can be compared to a reference population by a physician. This provides information used for diagnosis or assessment of a medical condition.
No
The device is described as "Software for the Prodigy bone densitometer" and its intended use is "used with the Prodigy bone densitometer system." This indicates it is a component or accessory to a hardware device (the bone densitometer) and 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 Total Body Software works with a bone densitometer system to estimate bone mineral density, fat, and lean tissue mass. This is done by scanning the patient's body directly, not by analyzing a sample taken from the body.
- Input: The input is a bone densitometer scan, which is an imaging modality, not a biological sample.
- Intended Use: The intended use is to provide an estimate of body composition parameters, which are then used by a physician for clinical assessment. This is a direct measurement on the patient, not a test performed on a sample.
Therefore, the device falls under the category of a medical device that performs measurements on the human body, rather than an in vitro diagnostic device that analyzes samples from the body.
N/A
Intended Use / Indications for Use
The Total Body Software is used with the Prodigy bone densitometer system. This software provides an estimate of BMD, fat and lean tissue mass. The BMD value can then be compared to a reference population at the sole discretion of the physician.
Product codes
90 KGI
Device Description
The Total Body Software for the Prodigy bone densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2), lean and fat tissue mass of the total body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
total body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
restricted to prescription use only. The operator's manual for the Prodigy system 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."
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
The BMD estimations in vivo provided by the Prodigy correlate r>0.98 with the DPX. The average BMD, and lean and fat tissue mass values obtained in 46 subjects were very similar to the results obtained on a DPX. The average short-term precision (%CV) in vivo was
§ 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
Image /page/0/Picture/0 description: The image shows the word "LUNAR" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word appears to be a logo or brand name, presented in a simple and impactful way.
Quantitation
313 W. BELTLINE HIGHWAY
MADISON, WI 53713
(608) 274-2663
8 1498
10.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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 9, 1998 |
| Device/Trade Name: | Prodigy Total Body Software |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer
21CFR 892.1170 |
| Predicate Device: | LUNAR DPX Total Body Software
510(k) K884625/B
LUNAR DPX Total Body Tissue Q
Software
510(k) K935454 |
10.1 DESCRIPTION OF THE DEVICE:
The Total Body Software for the Prodigy bone densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2), lean and fat tissue mass of the total body.
10.2 SUMMARY OF TECHNICAL CHARACTERISTICS
The Prodigy Bone Densitometer performs a 5-minute total body scan, with a total skin exposure dose of 0.13 mrem per measurement.
1
The BMD estimations in vivo provided by the Prodigy correlate r>0.98 with the DPX. The average BMD, and lean and fat tissue mass values obtained in 46 subjects were very similar to the results obtained on a DPX. The average short-term precision (%CV) in vivo was "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,
S.(k) Number. K98 3564
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)