(74 days)
The Planmed Sophie and Planmed Sophie Classic are mammographic xray systems, which are intended to be used to produce radiographs of the breast. The devices can be equipped with accessories to fulfil different diagnostic needs.
Planmed Sophie and Sophie Classic Modification MAXVIEW Positioning System
The provided text is a 510(k) premarket notification letter from the FDA regarding a mammographic X-ray system. It does not contain any information about acceptance criteria or a study proving the device meets them. The letter merely states that the FDA has reviewed the notification and determined the device (Planmed Sophie and Sophie Classic Modification MAXVIEW Positioning System) is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document does not contain any of the requested information regarding:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.