(154 days)
The Kubtec XPERT 80 is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. It is not used for mammography
The XPERT 80 Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. The exceptionally high magnification capability (up to 5X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 30 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Kubtec DIGICOM Specimen Radiography software. It has been designed to comply with 21 CFR 1020.40.
The provided text is a 510(k) Summary for the Kubtec XPERT 80 Specimen Radiography System. It details the device, its intended use, and its substantial equivalence to predicate devices, but does not contain information about the acceptance criteria or a study proving the device meets those criteria, especially in the context of AI performance or human-in-the-loop studies.
The document discusses:
- Device Description: The XPERT 80 Specimen Radiography System is a Cabinet X-ray System for high-detail radiographic imaging of surgically excised medical specimens.
- Comparison to Predicate Devices: The key difference from the primary predicate (K071233) is the addition of an Amorphous Selenium detector. The document asserts that this new detector's performance has been verified and cleared via 510(k) K193166 as incorporated into the Siemens MAMMOMAT Revelation.
- Standards Compliance: The device successfully completed internal and external safety testing to various IEC, ISO, NEMA, and CFR standards related to medical electrical equipment, software life cycle processes, risk management, and radiation safety.
- Conclusion: The device is considered as safe and effective as the predicate device, with technological differences limited to the detector type, and no new indications for use.
Therefore, I cannot provide the requested information from the given text as it does not describe:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance for such a test.
- Number of experts or their qualifications.
- Adjudication methods.
- MRMC comparative effectiveness study or human-AI improvement effect size.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on demonstrating substantial equivalence based on technical specifications and compliance with safety standards rather than a performance study involving AI or human interpretation of images.
§ 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.