(176 days)
The MOZART(XPERT42) is a Cabinet x-ray system that is used to provide two dimensional and three dimensional tomographic digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.
The MOZART Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimensional and threedimensional tomosynthesis views.
- 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.
Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of inters (ROI). To produce these multiple projection radiographic images are acquired in rapid succession as the X-ray tube sweeps and rotates across the ROI. Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices.
To support the Tomosynthesis application, the predicate device, XPERT 40, has a low-voltage screw drive linear actuator installed in the enclosed head of the cabinet with the same 50 kVp monoblock X-ray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and the same CMOS detector mounted stationary in the bottom of the cabinet x-ray unit.
To support the Tomosynthesis application, the proposed device, MOZART, utilizes the predicate device, XPERT 40, having the addition of a low-voltage screw-drive linear actuator installed in the enclosed head of the cabinet, which ensures operator safety, with the same 50 kVp monoblock X-ray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and the same CMOS detector mounted stationary in the bottom of the same shielded cabinet x-ray unit with proprietary software installed into an off the shelf personal computer, Microsoft Windows 7 Operating System, and a 2 megapixel or greater portrait type monitor.
The workstation on the MOZART utilizes a more powerful GPU to facilitate the handling of the collected projection data. It utilizes a method of dynamically reconstructing 3D tomographic images from a set of projections images. This includes loading the set of projection images into memory, selecting a region of interest, applying any necessary preprocessing, selecting a reconstruction method reconstructing an image according to said reconstruction method to produce a 3D tomographic image focusing on said region of interest, performing any post reconstruction processing on the 3D tomographic image and rendering said 3D tomographic image on a display. US Patent US 8,233,690 B2 displaying the complete algorithm and process is included.
The provided text describes a 510(k) premarket notification for the KUBTEC MOZART (XPERT42) system, which is a cabinet x-ray system for imaging excised specimens. However, the document does not contain a detailed study proving the device meets specific acceptance criteria through a clinical or comparative effectiveness study as would typically be described for an AI/CADe device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Kubtec XPERT 40) based on similar technology, materials, safety, effectiveness features, and design.
The core of the "proof" for this device lies in its demonstrated substantial equivalence to a predicate device rather than an independent performance study against set criteria. The new device, MOZART, has technological differences primarily related to the addition of a mechanism to move the x-ray source linearly and proprietary software to compile multiple images into 1mm slices and a 2-D image (tomosynthesis application).
Therefore, I cannot provide a table of acceptance criteria and reported device performance from a dedicated study, nor can I answer questions related to sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies, as these types of studies are not detailed in the provided text in the context of proving device performance against specific metrics.
Here's what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the MOZART system itself, nor does it report such performance. The primary "acceptance" is that the device is substantially equivalent to its predicate.
However, a comparison of technical specifications between the MOZART (XPERT42) and the predicate XPERT 40 is provided, which serves as a basis for demonstrating equivalence in performance characteristics.
| Feature / Criteria | Predicate (XPERT 40) | MOZART (XPERT42) |
|---|---|---|
| Tube Potential | 10-50kV | 10-50kV |
| Focal Spot | 200 KR |
The "reported device performance" in this context is that the MOZART system, with its added technological features for tomosynthesis, is considered as safe and effective as the predicate device (XPERT 40) for its stated indications for use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical performance study with a test set of patient or specimen images is described in the provided document. The 510(k) relies on technical specifications, safety testing (e.g., electrical, radiation control), and the established safety and effectiveness of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical performance study with a test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The MOZART system is a specimen radiography system, not stated to be an AI/CADe device that assists human readers in diagnostics of patient images. Its "proprietary software" is for compiling images and reconstruction of tomosynthesis slices, not for AI-assisted image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable, as there is no mention of a machine learning model requiring a training set for diagnostic performance. The "proprietary software" mentioned is for image reconstruction, not for AI diagnosis.
9. How the ground truth for the training set was established
Not applicable.
§ 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.