(80 days)
The MOZART SUPRA Specimen Tomosynthesis System is a Cabinet x-ray system that is specifically designed to provide high detail radiographic imaging of surgically excised medical specimens from various anatomical regions, i.e. breast, both in 2-dimensional and 3-dimensional tomosynthesis views.
The MOZART SUPRA(XPERT84) Specimen Radiography System is a Cabinet X-ray System specifically designed to provide 3-D high detail radiographic imaging of surgically excised medical specimens utilizing tomosynthesis. The MOZART SUPRA(XPERT84) is a fully self-contained and shielded cabinet system equipped with a 90kVp micro-focus x-ray source and a 10'' x 12" 49.5 micron high resolution CMOS Digital Detector. It is the only cabinet specimen imaging system to utilize 3-D Tomosynthesis technology. Creates images in 1mm digital slices of the specimen, allowing physicians to evaluate the specimen layer by layer.
The provided document is a 510(k) premarket notification for a medical device, the Kubtec MOZART SUPRA (XPERT 84) Radiography System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating performance against specific metrics for AI-powered device functionality.
The document describes a stationary X-ray system designed for high detail radiographic imaging of surgically excised medical specimens, including breast specimens, in both 2D and 3D tomosynthesis views. It highlights the device's capability to provide more anatomical information, precisely identify lesion locations, exclude overlying tissue, and identify surgical margins. There is no mention of an Artificial Intelligence (AI) component within this device or its functionality. The "software" mentioned (KUBTEC DIGICOM) relates to image acquisition and processing, not AI for diagnosis or analysis.
Therefore, many of the requested elements regarding acceptance criteria and study design for an AI-powered device cannot be extracted from this document. The document describes a traditional medical imaging device, not an AI/ML product.
However, I can extract information related to the device's performance based on the general information provided for its intended use as a radiography system.
Here's an attempt to address the request based on the available information, noting the absence of AI-specific details:
Acceptance Criteria and Device Performance (as a Radiography System, NOT AI)
The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards (electrical safety, EMC, software V&V for function, not AI performance). There are no explicit quantitative acceptance criteria (e.g., sensitivity, specificity, AUC) for diagnostic performance laid out in a table, as one would expect for an AI algorithm. The closest to "performance" is the device's technical specifications and the claim that it "produces diagnostic quality images."
Table of Acceptance Criteria and Reported Device Performance (Proxy)
Since this is not an AI device, I will create a table based on the device's technical specifications and claimed imaging capabilities, which implicitly serve as performance indicators for a radiography system, rather than diagnostic accuracy metrics.
| Acceptance Criterion (Implicit/Technical) | Reported Device Performance (Kubtec MOZART SUPRA (XPERT 84)) |
|---|---|
| Imaging Modalities | 2-Dimensional and 3-Dimensional Tomosynthesis views |
| Specimen Type | Surgically excised medical specimens (e.g., breast) |
| X-ray Source Potential | 40-90 kVp |
| Focal Spot Size |
§ 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.