(87 days)
K/DEN number: Not Found
Not Found
No
The device description focuses on providing pre-calculated reference data from a published study (NHANES) and comparing patient results to this static data. There is no mention of algorithms that learn or adapt from data.
No
The device is a software option for X-Ray Bone Densitometers used for comparing a subject's bone mineral density to reference data. It is for diagnostic purposes, not for treating a condition.
Yes
The device produces "deviation 'scores'" (Z-score and T-score) quantifying the difference between a patient's estimated Bone Mineral Density (BMD) and reference data, which are values used in the diagnosis of conditions like osteoporosis.
Yes
The device is described as a "Software Option" that provides reference data to be used with existing hardware (Hologic QDR Series X-Ray Bone Densitometers). It does not appear to include any new hardware components or modifications to the existing hardware.
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: This device is a software option for an X-ray bone densitometer. It uses X-ray imaging to measure bone mineral density in vivo (within the living body) and then compares these measurements to reference data.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It analyzes data derived from an imaging procedure performed on the body.
Therefore, because the device operates on data obtained from an in vivo imaging technique rather than analyzing in vitro biological samples, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the NHANES Reference Data Software Option for Hologic QDR Series X-Ray Bone Densitometers is to allow comparisons of a subject's estimated proximal femur (hip) Bone Mineral Density (BMD, in g/cm²) to reference data for sex and ethnicity matched controls. Published results from the NHANES study (A.C. Looker, et al., Osteoporosis International Vol. 5, pg 389- 409, 1995), including male and female proximal femur reference values for African American, Mexican American, and caucasian American subjects are included in this software option.
Product codes
Not Found
Device Description
The NHANES Reference Data Software Option for Hologic QDR Series X-Ray Bone Densitometers provides proximal femur (hip) reference data for male and female Caucasian American, African American, and Mexican American subjects. The new reference data is used in conjunction with previously existing software on QDR Series densitometers, which allows comparisons of patient results to sex, ethnicity, and age matched reference values. The NHANES Reference Data Software Option provides 1) reference data for male and female African American and Mexican American subjects which was previously not available, and 2) the newest, most up to date male and female caucasian American reference data, while maintaining previous Hologic hip reference data and still allowing clinicians to generate and use local reference data.
The reference values contained in this software option were obtained from published results (A.C. Looker, et al., Osteoporosis International Vol. 5, pg 389- 409, 1995) of the National Health and Nutrition Education Survey III ("NHANES III") study, in which 7116 total subjects have been enrolled. Published reference values are stratified by sex, ethnicity, age (from 20 to 80 years), and analysis region (results are tabulated for the Neck, Trochanteric, Intertrochanteric, Ward's, and Total regions of the hip). Standard existing QDR densitometer software was designed to stratify reference values in exactly the same manner, and thus the published results are directly transferable to the Hologic QDR software.
Patient results for each analysis region can be compared to reference values both graphically and quantitatively. Graphical plots of the age dependent reference Bone Mineral Density (BMD) values corresponding to the sex and ethnicity of the patient are generated, with a marker placed at the position corresponding to the estimated patient BMD and age. Deviation "scores" are computed, quantifying (in population standard deviation units) the difference between the patient's estimated BMD and the mean value for either age matched (Z-score) or young adult (T-score) reference data. In addition, the patient BMD is expressed in percent of the age matched mean and in percent of the young adult mean.
The NHANES caucasian American female reference data differs slightly from the original Hologic data, due to differences in study design (inclusion/exclusion criteria, number of subjects, geographic region and methods of subject recruitment, etc.) and the unavoidable variability between different reference data sets obtained even under the EXACT same conditions. Thus both the Hologic reference data and the NHANES data are equally valid, and the physician may determine which data most accurately reflects the local population. Alternatively the software allows the physician to define and use unique local reference values of their choice.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
proximal femur (hip)
Indicated Patient Age Range
from 20 to 80 years
Intended User / Care Setting
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hologic QDR Series X-Ray Bone Densitometers with Reference Data
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 222 1996
510(k) Summary of Safety and Effectiveness:
NHANES Reference Data Software Option for QDR Series X-Ray Bone Densitometers
| Submitter: | Hologic, Inc. |
|---|---|
| Submitter Address: | 590 Lincoln Street |
| Waltham, MA 02154 | |
| Contact Person: | Nandini Murthy, Regulatory Scientist |
| Phone Number: | (617) 890-2300 |
| Fax Number: | (617) 890-8031 |
| Date Prepared: | August 23, 1996 |
| Device Trade Name: | NHANES Reference Data Software Option for Hologic QDR Series X- |
| Ray Bone Densitometers | |
| Device Common Name: | Reference Data for Bone Mineral Densitometer |
| Device Classification Name: | Reference Data for Bone Mineral Densitometer |
| Predicate Devices: | Hologic QDR Series X-Ray Bone Densitometers with Reference Data |
| Device Description: | The NHANES Reference Data Software Option for Hologic QDR Series X-Ray |
| Bone Densitometers provides proximal femur (hip) reference data for male and | |
| female Caucasian American, African American, and Mexican American | |
| subjects. The new reference data is used in conjunction with previously existing | |
| software on QDR Series densitometers, which allows comparisons of patient | |
| results to sex, ethnicity, and age matched reference values. The NHANES | |
| Reference Data Software Option provides 1) reference data for male and female | |
| African American and Mexican American subjects which was previously not | |
| available, and 2) the newest, most up to date male and female caucasian | |
| American reference data, while maintaining previous Hologic hip reference data | |
| and still allowing clinicians to generate and use local reference data. |
The reference values contained in this software option were obtained from
published results (A.C. Looker, et al., Osteoporosis International Vol. 5, pg 389-
409, 1995) of the National Health and Nutrition Education Survey III
("NHANES III") study, in which 7116 total subjects have been enrolled.
Published reference values are stratified by sex, ethnicity, age (from 20 to 80
years), and analysis region (results are tabulated for the Neck, Trochanteric,
Intertrochanteric, Ward's, and Total regions of the hip). Standard existing QDR
densitometer software was designed to stratify reference values in exactly the
1
=
same manner, and thus the published results are directly transferable to the Hologic QDR software.
| | Patient results for each analysis region can be compared to reference values both
graphically and quantitatively. Graphical plots of the age dependent reference
Bone Mineral Density (BMD) values corresponding to the sex and ethnicity of
the patient are generated, with a marker placed at the position corresponding to
the estimated patient BMD and age. Deviation "scores" are computed,
quantifying (in population standard deviation units) the difference between the
patient's estimated BMD and the mean value for either age matched (Z-score) or
young adult (T-score) reference data. In addition, the patient BMD is expressed
in percent of the age matched mean and in percent of the young adult mean. |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The NHANES caucasian American female reference data differs slightly from
the original Hologic data, due to differences in study design (inclusion/exclusion
criteria, number of subjects, geographic region and methods of subject
recruitment, etc.) and the unavoidable variability between different reference
data sets obtained even under the EXACT same conditions. Thus both the
Hologic reference data and the NHANES data are equally valid, and the
physician may determine which data most accurately reflects the local
population. Alternatively the software allows the physician to define and use
unique local reference values of their choice. |
| Intended Use: | The intended use of the NHANES Reference Data Software Option for Hologic
QDR Series X-Ray Bone Densitometers is to allow comparisons of a subject's
estimated proximal femur (hip) Bone Mineral Density (BMD, in g/cm²) to
reference data for sex and ethnicity matched controls. Published results from the
NHANES study (A.C. Looker, et al., Osteoporosis International Vol. 5, pg 389-
409, 1995), including male and female proximal femur reference values for
African American, Mexican American, and caucasian American subjects are
included in this software option. |
| Device Technological
Characteristics and
Comparison to
Predicate Device: | Except for the new reference data itself, there are no differences between the
NHANES Reference Data Software Option and the previous reference data
software and capabilities included in the standard Hologic QDR software. |
| Conclusion: | The NHANES Reference Data Software Option provides a means for the user to
compare proximal femur BMD results to reference data for male and female
African American and Mexican American subjects, which was previously not
available, and provides an additional option for male and female caucasian
American reference data. For caucasian American subjects, this software option
gives the physician the ability to compare results to standard Hologic reference
data, the most recent NHANES reference data (acquired under a different study
design), or, as for any subject, to unique user defined local reference data.
Patient results are compared graphically and quantitatively to reference values in
order to assist the physician in interpretation. |