(27 days)
The DSM as part of a standard x-ray mammography unit is part of a stereotactic lesion localization system that has the application of localizing, and then giving a physician the capability of performing fine needle aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Digital Spot Mammography System (DSM)". This document does not contain the specific details required to answer your request about acceptance criteria, study design, and performance metrics.
The letter confirms that the device has been found substantially equivalent to predicate devices and can be marketed. It lists the device name, regulation number, product code, and indications for use. However, it does not include:
- Acceptance criteria and reported device performance: This information would typically be in the 510(k) submission itself, which is not provided here.
- Sample sizes, data provenance: Not present in this letter.
- Number and qualifications of experts: Not present.
- Adjudication method: Not present.
- Multi-reader multi-case (MRMC) comparative effectiveness study details: This letter does not mention or describe such a study.
- Standalone performance: Not detailed here.
- Type of ground truth: Not specified.
- Training set sample size and ground truth establishment for training set: Not included.
To answer your questions, I would need access to the actual 510(k) summary or the full submission documentation for K100692, which contains the detailed study information. The provided document is merely the FDA's decision letter.
§ 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.