(174 days)
The MOZART® Supra® Specimen Tomosynthesis System is a cabinet X-ray system that is used to provide 2-dimensional and 3-dimensional tomographic digital X-ray images of harvested specimens from various anatomical regions.
The MOZART SUPRA (XPERT84) 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.
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
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- 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 SUPRA (XPERT84), K200756, 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 an Amorphous Selenium detector mounted stationary in the bottom of the cabinet xray unit
- Producing a number of slice images throughout the entire volume of the anatomy
The Kubtec MOZART SUPRA (XPERT 84) Radiography System is a Cabinet X-ray System for generating 2D and 3D tomographic digital X-ray images of harvested specimens.
Here's an analysis of the acceptance criteria and study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance | Study Proving Performance |
|---|---|---|---|
| Safety Standards | Compliance with various IEC, ISO, and CFR standards. | Successfully tested to IEC 61010-1 and EMC Directive 2004/108/EC. Design controls and risk management maintained per ISO 13485:2016, 21 CFR Part 820, and 21 CFR 1020.40. | Internal and external safety testing by INTERTEK |
| Radiation Safety | Less than 0.1 mR/hr at 5 cm from any exterior surface at maximum kV. | Less than 0.1 mR/hr at 5 cm from any exterior surface at maximum kV. | Not explicitly detailed, but stated as a specification. |
| Image Resolution (Detector) | Not explicitly defined as acceptance criteria, but resolution is a key performance metric. | Resolution: 85μm for proposed AXS-1824V2 & AXS-2430V2 detectors. | Verification via imaging of line-pair gauges and phantoms. |
| DQE at 1 Lp/mm (Detector) | Not explicitly defined as acceptance criteria. | >50% for AXS-1824V2, >70% for AXS-2430V2. | Verified through performance testing (presumably by Analogic, the detector manufacturer, and then confirmed by Kubtec). |
| MTF at 1 Lp/mm (Detector) | Not explicitly defined as acceptance criteria. | >90% for AXS-1824V2, >95% for AXS-2430V2. | Verified through performance testing (presumably by Analogic, the detector manufacturer, and then confirmed by Kubtec). |
| Bit Depth (Detector) | Not explicitly defined as acceptance criteria. | 16 bits for AXS-1824V2 & AXS-2430V2. | Verified through performance testing. |
| Software Functionality | DICOM Store, Print, and Modality Worklist functionalities. | DIGICOM Software supports DICOM Store, Print, and Modality Worklist. | Internal validation and verification. |
| Overall Performance Equivalence | As safe and effective as the predicate devices. | Performance verified and cleared via 510(k) K193166 when incorporated into the Siemens MAMMOMAT Revelation. | Claims proven internally and validated/verified via imaging of line-pair gauges and phantoms. Clinically validated through reads by a board-certified radiologist. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document only mentions "excised breast biopsies" for clinical validation and "line-pair gauges and phantoms" for internal validation. No specific number of cases or images for the test set is provided.
- Data Provenance: The data provenance for the clinical validation is "reads of excised breast biopsies by a board certified radiologist." This implies retrospective processing of existing biopsies, but does not specify the country of origin. The data for line-pair gauges and phantoms would be generated during internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: "A board certified radiologist" (singular) is mentioned for the clinical validation.
- Qualifications: "board certified radiologist." No specific years of experience are provided.
4. Adjudication Method for the Test Set
- Given that only a single board-certified radiologist is mentioned for clinical validation, there is no adjudication method described beyond the single expert's assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The document describes a substantial equivalence submission, which typically focuses on demonstrating that the new device performs as well as, or is equivalent to, legally marketed predicate devices, rather than comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document describes a radiographic system that produces images, not an AI algorithm for image interpretation. Therefore, the concept of a "standalone" AI algorithm performance is not applicable in this context. The device's performance relates to the quality of the images it produces. The software (DIGICOM) primarily handles image processing and DICOM functionalities, not autonomous diagnostic interpretation.
7. The Type of Ground Truth Used
- For clinical validation reported, the ground truth was established by an expert assessment ("reads of excised breast biopsies by a board certified radiologist").
- For technical performance validation (resolution, DQE, MTF), the ground truth relies on physical measurement standards using "line-pair gauges and phantoms."
8. The Sample Size for the Training Set
- The document does not describe a "training set" in the context of an AI algorithm learning from data. The device is a radiographic system, and its software (DIGICOM) is for image handling and processing, not for AI-driven image analysis that requires a training set.
9. How the Ground Truth for the Training Set was Established
- As there is no mention of a training set for an AI algorithm (see point 8), this question is 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.