(85 days)
Not Found
No
The summary describes a device that estimates bone mineral density based on correlation with calcium hydroxyapatite pellets and in vivo precision studies. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on correlation and precision, not metrics like AUC, sensitivity, or specificity often used to evaluate AI/ML models.
No
The device provides an estimation of Bone Mineral Density (BMD) which is a diagnostic measurement, not a therapeutic intervention.
Yes
Explanation: The device provides an estimation of Bone Mineral Density (BMD), which is a measurement used in the diagnosis of conditions like osteoporosis. The "Summary of Performance Studies" indicates in vivo precision, suggesting its use in a clinical setting to assess patients.
No
The device description states it provides an estimation of Bone Mineral Density (BMD) for the forearm and heel. While the summary doesn't explicitly mention hardware, the nature of BMD measurement typically involves a physical device (like a DEXA scanner or similar technology) to acquire the data needed for the estimation. The performance studies also mention in vitro and in vivo testing, which strongly suggests a hardware component is involved in data acquisition. The predicate devices listed (Osteon Osteoanalyzer and Norland pDEXA) are also hardware-based BMD measurement devices.
Based on the provided information, it is unlikely that the PIXI Bone device is an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Description: The PIXI Bone device estimates Bone Mineral Density (BMD) for the forearm and heel. This is a measurement taken directly from the patient's body, not from a sample taken from the body.
- Anatomical Site: The device operates on the forearm and heel, which are parts of the living body.
- Lack of Mention of Samples: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in the description.
- Performance Studies: The performance studies describe in vitro (using pellets) and in vivo (on living subjects) precision, which aligns with a device that interacts directly with the body.
Therefore, the PIXI Bone device appears to be a diagnostic imaging device or a bone densitometry device that measures a physical characteristic of the body directly, rather than an IVD that analyzes biological samples.
N/A
Intended Use / Indications for Use
Not Found
Product codes
892.1170
Device Description
The PIXI Bone provides an estimation of Bone Mineral Density (BMD in g/cm2) for the regions of the forearm and heel (os calcis).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forearm and heel (os calcis)
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
Not Found
Summary of Performance Studies
The PIXI® Bone Densitometer requires a 5 second exposure, with a total exposure dose of 20 mrem. The radiation exposure of 20 mrem is higher than that for the predicate devices but remains low compared to the maximum permissible dose for extremities. The BMD estimations correlate highly (r= 0.998 ) with the actual density of calcium hydroxyapatite pellets. The average short term precision (%CV) in vitro was 0.68 %. The average short term precision (%CV) in vivo is 1.5% for forearm BMD, and 1.97 % for Os Calcis BMD. These values are comparable to those shown on previously cleared devices.
Key Metrics
BMD estimations correlate highly (r= 0.998 ) with the actual density of calcium hydroxyapatite pellets. The average short term precision (%CV) in vitro was 0.68 %. The average short term precision (%CV) in vivo is 1.5% for forearm BMD, and 1.97 % for Os Calcis BMD.
Predicate Device(s)
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 a blocky, slightly rounded style. The letters are closely spaced, creating a solid, impactful visual. The background is plain white, which makes the word stand out.
APR 1 6 1997
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: | January 17, 1997 |
| Device/Trade Name: | PIXI Bone Densitometer |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer
21CFR 892.1170 |
| Predicate Device: | Osteon Osteoanalyzer
510 (k) K891582
Norland pDEXA |
DESCRIPTION OF THE DEVICE: 10.1
The PIXI Bone provides an estimation of Bone Mineral Density (BMD in g/cm2) for the regions of the forearm and heel (os calcis).
SUMMARY OF TECHNICAL CHARACTERISTICS 10.2
The PIXI® Bone Densitometer requires a 5 second exposure, with a total exposure dose of 20 mrem. The radiation exposure of 20 mrem is higher than that for the predicate devices but remains low compared to the maximum permissible dose for extremities. The BMD estimations correlate highly (r= 0.998 ) with the actual density of calcium hydroxyapatite pellets. The average short term precision (%CV) in vitro was 0.68 %. The average short term precision (%CV) in vivo is 1.5% for forearm BMD, and 1.97 % for Os Calcis BMD. These values are comparable to those shown on previously cleared devices.
1
CONCLUSION 10.3
The results from the PIXI bone densitometer are comparable to previously registered devices which demonstrate similar precision. No new safety and effectiveness questions are raised with the PIXI Bone Densitometer
Signed Kenneth D. Buroker ___________________________________________________________________________________________________________________________________________________________ Printed Name Director, Regulatory Affairs ... . . . . Title ,144
Summary of Safety, Effectiveness Page 2 of 2
..