(97 days)
IVA scans are intended for the visualization or quantitative assessment of vertebral bone deformities. IVA also allows the visualization of abdominal aortic calcification, and, if present, clinical correlation may be advised since abdominal aortic calcification may be associated with cardiovascular disease.
IVA (MXA -II) software option for the X-Ray bone densitometers.
The provided text is a 510(k) summary for the IVA (MXA-II) software option for X-Ray bone densitometers. It focuses on a modified indication for use, specifically for the visualization of abdominal aortic calcification in addition to vertebral bone deformities. However, it explicitly states that no changes were made to the software's operation or performance specifications for this modification. Therefore, the document does not contain information about acceptance criteria or a study proving that the device meets those criteria for the detection of abdominal aortic calcification, as it relies on the predicate device's established performance for a new indication without altering the core functionality.
The document emphasizes substantial equivalence to predicate devices (Hologic Vertebral Morphometry Software Option and Hologic Vertebral Morphometry Software II Option, and general use x-ray systems like the Toshiba KXO-80G x-ray generator). This suggests that previous studies conducted for the predicate devices likely established their performance for vertebral morphometry, which the IVA (MXA-II) software inherits.
Therefore, based solely on the provided text, I cannot complete the requested information regarding acceptance criteria and a study demonstrating the device meets those criteria for the new indication of abdominal aortic calcification visualization. The document explicitly states: "No changes to the manner in which the MXA or MXA-II software operates will be made for the modification to the intended use, nor will any changes be made in the device's performance specifications."
To fully answer your request for this specific modification, additional documentation detailing the validation of the new indication (abdominal aortic calcification visualization) would be required.
However, I can extract the general information presented in the 510(k) summary:
- Device Trade Name: IVA (MXA -II) software option for the X-Ray bone densitometers.
- Device Common Name: X-Ray Bone Densitometer
- Intended Use: IVA scans are intended for the visualization or quantitative assessment of vertebral bone deformities. IVA also allows the visualization of abdominal aortic calcification, and, if present, clinical correlation may be advised since abdominal aortic calcification may be associated with cardiovascular disease.
- Predicates: Hologic Vertebral Morphometry Software Option (K941362), Hologic Vertebral Morphometry Software II Option (K992775), General use x-ray systems (e.g., Toshiba KXO-80G x-ray generator; K945668).
Without a study specifically evaluating the IVA (MXA-II) software against acceptance criteria for abdominal aortic calcification visualization, I cannot provide the requested details.
§ 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.