(58 days)
Dual-energy Vertebral Assessment View Software is used with the Prodigy bone densitometer. This software provides an x-ray image of the spine for qualitative visual assessment in order to identify vertebral deformations and estimate vertebral heights (morphometry).
The use of the Prodigy Bone Densitometer is restricted to prescription use only. The operator's manual for the Prodigy 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."
The Dual-energy Vertebral Assessment View Software enables imaging of the spine for visual identification of vertebral deformities and estimation of vertebral heights (morphometry). Using this software, the patient is scanned as under the currently distributed product. The Dual-energy Vertebral Assessment View Option adds the ability to visually assess the image for identification of vertebral deformations.
The provided text describes a 510(k) summary for the GE Lunar Prodigy Dual-energy Vertebral Assessment View Software. However, it does not contain specific information about acceptance criteria or a detailed study proving the device meets acceptance criteria.
The document states:
- "The Prodigy Dual-energy Vertebral Assessment View Software is substantially equivalent to currently marketed software. No new safety and effectiveness questions are raised with the Dual-energy Vertebral Assessment View Software application."
This indicates that the submission relies on demonstrating substantial equivalence to predicate devices (GE Lunar Lateral View software 510(k) K000826, LUNAR EXPERT Morphometry Software 510(k) K950611, Hologic Morphometry II option 510(k) K992775), rather than providing a detailed study with specific performance metrics against pre-defined acceptance criteria for the new software feature itself.
Therefore, I cannot provide the requested information from the given text as it is not present. The document focuses on regulatory compliance through substantial equivalence, not on a detailed performance study with acceptance criteria.
§ 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.