(135 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on adding reference values, not AI/ML processing.
No
The device provides reference values for spine morphometry, which are used at the physician's discretion. It does not directly treat or diagnose a disease or condition, but rather aids in the interpretation of patient data. Therefore, it is not a therapeutic device.
Yes
The device is described as "EXPERT Spine Morphometry Software" which processes data to provide "reference values of spine morphometry" for comparison, which are then "used at the discretion of the physician." This functionality, providing data for a physician to interpret for clinical use, indicates a diagnostic purpose. The predicate devices also include a "Bone Densitometer," further suggesting a diagnostic application.
Yes
The device is described as "EXPERT Spine Morphometry Software" and the description focuses solely on the addition of reference values to this software. There is no mention of any associated hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software provides reference values for spine morphometry and that the results are used at the discretion of the physician. This indicates the software is a tool to aid in the interpretation of patient data, not a test performed on biological samples to diagnose or monitor a condition.
- Device Description: The description focuses on adding reference values to existing software for spine morphometry. This aligns with a software tool for analysis, not an in vitro test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), which is a defining characteristic of IVD devices. The input is likely imaging data (though not explicitly stated, the anatomical site and morphometry suggest this).
- Predicate Devices: The predicate devices listed are "EXPERT Spine Morphometry" and "DPX Bone Densitometer, Reference Values." These are devices related to imaging analysis and bone density measurement, not IVD tests.
In summary, the device is a software tool that provides reference data to assist physicians in interpreting spine morphometry measurements, likely derived from imaging. This falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Not Found
Product codes
892.1170
Device Description
Reference values of spine morphometry have been added to the EXPERT Spine Morphometry Software. The addition of reference values does not change the intended use of the EXPERT Spine Morphometry Software. The reference value comparison results are used at the discretion of the physician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine
Indicated Patient Age Range
Not Found
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)
Data from seven studies and over 3500 subjects have been used to provide normalized reference data for spine morphometry.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EXPERT Spine Morphometry, 510(k) K950611, DPX Bone Densitometer, Reference Values, 510(k) K890121
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
Image /page/0/Picture/0 description: The image shows the word "LUNAR" in large, bold, black letters. The font is sans-serif and appears to be slightly condensed. The letters are closely spaced, creating a solid block of text. The background is plain white, providing a strong contrast with the black letters.
K 961007
313 W. BELTLINE HIGHWAY
MADISON, WI 53713
(608) 274-2663
JUL 2 5 1996
8.0 510(K) SUMMARY
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(C).
| Re: | 510(k) Pre-market Notification |
|---|---|
| Contact Person: | Gary Syring |
| LUNAR Corporation | |
| 313 West Beltline Highway | |
| Madison, WI 53713 | |
| Phone: | (608) 274-2663 |
| Fax: | (608) 274-0853 |
| Date: | March 8, 1996 |
| Device Name: | EXPERT® Spine Morphometry Reference Values |
| Common Name: | Spine Morphometry Reference Values |
| Trade Name: | EXPERT® Spine Morphometry Reference Values |
| Classification Name: | 21 CFR 892.1170, Bone Densitometer |
| Predicate Device: | EXPERT Spine Morphometry, 510(k) K950611 |
| DPX Bone Densitometer, Reference Values | |
| 510(k) K890121 |
8.1 DESCRIPTION OF THE DEVICE:
Reference values of spine morphometry have been added to the EXPERT Spine Morphometry Software. The addition of reference values does not change the intended use of the EXPERT Spine Morphometry Software. The reference value comparison results are used at the discretion of the physician.
1
DISCUSSION OF PERFORMANCE DATA SUBMITTED IN SUPPORT OF 8.2 THE SAFETY AND EFFICACY CLAIMS FOR THE DEVICE:
Data from seven studies and over 3500 subjects have been used to provide normalized reference data for spine morphometry.
CONCLUSIONS DRAWN FROM DATA: 8.3
The addition of spine morphometry reference values does not raise any new questions of safety or effectiveness. The reference data is used at the discretion of the physician.
Tory Ayring
Signed
Gary Syring Printed Name
Director, Regulatory Affairs
Title
Summary of Safety and Effectiveness, Page 2 of 2