(84 days)
The Leg'Map software is intended for use to combine a series of digital images acquired by diagnostic radiography during a table translation into a single image, such as combining a series of images of the arteries of the lower leg acquired during bolus chasing. Leg'Map provides the convenience of viewing a single image rather than several images. Also, the Leg'Map digital image meets the preference of those who want an image similar to that of the long cut film (30cm x 120cm) previously used when performing this procedure.
This optional software is run after image acquisition is completed to provide automatic pasting of multiple images acquired in bolus chasing into a single image. It has no affect on the image acquisition system. Leg'Map process its imager from strips extracted from original images and registered with correlation measurements.
The provided text describes a 510(k) summary for a medical device called Leg'Map, a software program designed to combine multiple digital X-ray images of the lower leg into a single, seamless image. However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about any performance metrics, ground truth establishment, or sample sizes for testing or training.
The document focuses on:
- Identification of the product: Leg'Map software by GE Medical Systems -Europe.
- Indications for Use: To combine a series of digital images acquired during diagnostic radiography into a single image, especially for arteries of the lower leg during bolus chasing, providing convenience and a similar view to traditional long cut films.
- Device Description: Optional software that processes images after acquisition, pasting strips from original images and registering them using correlation measurements.
- Conclusions: GE Medical Systems believes Leg'Map is safe, and potential hazards (wrongly pasted images) are controlled by a risk management plan, including hazard analysis, software development process, and external evaluation by different hospitals.
Therefore, I cannot populate the requested table or provide answers to the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as this information is not present in the provided text.
The document is a regulatory submission for 510(k) clearance, which primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's intended use and safety measures, rather than detailing specific performance studies with quantitative metrics.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.