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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. It is not used for mammography

The MOZART Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens both in two-dimensional and three-dimensional 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. It has been clinically proven for the following: Provides more anatomical information than single planar 2-D imaging alone. The subject x-ray cabinet system Kubtec Mozart Xpert 42 is not intended for mammography. Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of inters (ROI). To produce these slices 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. Tomosynthesis provides visualization of human anatomy by Removing overlying anatomical structures, which could otherwise obscure a structure of interest by superimposition in a two dimensional presentation, and Producing a number of slice images throughout the entire volume of the anatomy. 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. To support the Tomosynthesis application, the predicate device, MOZART (XPERT42), has a low-voltage screw drive linear actuator installed in the enclosed head of the cabinet with the same 50 kVp monoblock Xray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and an Amorphous Selenium detector mounted stationary in the bottom of the cabinet x-ray unit.

This document describes a 510(k) premarket notification for the KUBTEC MOZART (XPERT42) system, a cabinet x-ray system for imaging excised specimens. The 510(k) submission seeks to demonstrate substantial equivalence to a previously cleared device (K183624, also KUBTEC MOZART (XPERT42)) despite a change in detector technology. This is a notification for a device change rather than a new AI/CAD system. Therefore, much of the requested information regarding AI study design (like ground truth establishment, training sets, multi-reader multi-case studies, and specific performance metrics like F1-score or AUC) is not applicable or explicitly stated in this type of submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (a medical imaging system with a component change), "acceptance criteria" primarily relate to safety, effectiveness, and substantial equivalence to a predicate device. Performance is generally demonstrated by showing that the new component (Amorphous Selenium detector) is comparable or improved in relevant technical specifications compared to the old component (CMOS detector), without adversely affecting the overall device's stated indications for use.

2. Sample size used for the test set and the data provenance

The document does not describe a clinical study in the traditional sense with a "test set" of patient data. This is a 510(k) for a device modification, relying on technical comparison and a claim of substantial equivalence to a predicate device. Therefore, there is no mention of a specific test set formed from clinical images or data provenance in this context. The evaluation is based on technical specifications and conformance to standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As noted above, this submission focuses on device modification and substantial equivalence based on technical specifications and safety standards, not on a clinical performance study using expert-derived ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set and thus no adjudication method described.

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. This device is not an AI/CAD system used to assist human readers, nor is an MRMC study described. It is a specimen imaging system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm-only device. It is a hardware imaging system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. As explained, the submission is about a detector change in an x-ray system, not about the diagnostic accuracy of the images produced using a specific ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable. There is no training set for an AI/ML algorithm.

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