(252 days)
The iCR3600M CR Mammography Feature together with iCR3600M CR Mammography Cassette comprise a device which, when used in conjunction with an iCRco 3600 CR System and a mammographic x-ray machine, generates digital mammographic images. The device is intended to be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by an MQSA qualified physician using either hardcopy film or softcopy display at a workstation.
The iCR3600M CR Mammography Feature together with iCR3600M CR Mammography Cassette comprise a device which, when used in conjunction with an iCRco 3600 CR System and a mammographic x-ray machine, generates digital mammographic images.
The provided text does not contain detailed information about acceptance criteria and the study that proves the device meets the acceptance criteria. It is a 510(k) premarket notification letter from the FDA regarding the iCRco 3600M full-field digital mammography system, stating that the device is substantially equivalent to legally marketed predicate devices.
The letter mentions that the device generates digital mammographic images and is intended for screening and diagnosis of breast cancer, for use in the same clinical applications as traditional screen-film based mammographic systems, and that images can be interpreted by an MQSA qualified physician. However, it does not provide the specific performance metrics (like sensitivity, specificity, or accuracy) that would serve as acceptance criteria, nor does it detail a study that proves the device meets such criteria.
Therefore, I cannot extract the requested information from the provided text for the following points:
- A table of acceptance criteria and the reported device performance: Not available.
- Sample sized used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not available.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
The document is primarily a regulatory approval notice, not a clinical study report.
§ 892.1715 Full-field digital mammography system.
(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.