(69 days)
The MammoPath can be used with Mammotest® (K861692). Mammotest is a breast biopsy system manufactured by Fischer Imaging, Inc., a dedicated Mammographic device for stereotactically - guided needle biopsy of the breast. Mammotest allows the operator to visualize suspicious breast lesions under Mammographic X-Ray and to guide various tissue acquisition devices to the lesion for tissue harvesting. The Mammopath would then be used for digital imaging of the harvested specimen to provide rapid verification that the correct tissue has been excised during biopsy.
The MammoPath can also be used as a stand-alone unit (without Fischer's Mammotest) and would be used to verify correct tissue sampling any given harvested specimen.
Doing the verification directly in the same room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit number of patient recalls.
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This document is a 510(k) clearance letter from the FDA for a device called "Mammopath™". It acknowledges the company's intent to market the device and determines it substantially equivalent to legally marketed predicate devices. However, the letter does not contain any information about acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based only on the provided text. The document is solely a regulatory clearance and does not include the detailed technical or clinical study data.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.