(337 days)
The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The FDR Visionary Suite enables radiographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The FDR Visionary Suite uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes.
The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition.
The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/ trained professionals.
The device is not intended for mammographic applications.
The FDR Visionary Suite is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The device can be used in a wide range of applications of digital radiography. The device consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support, collimator and digital radiography system. The system can be configured with radiographic table and/or radiographic stand as well.
Optionally, the device is also used to perform tomosynthesis radiography by two different reconstruction modes, e.g. Filtered Back-Projection (FBP) mode and Shift-and-Add (SA) mode. SA reconstructed images are intended to be used alongside FBP reconstructed images and not for stand-alone diagnostic purpose.
This document pertains to the FDR Visionary Suite, a stationary X-ray system. The acceptance criteria and the study proving the device meets these criteria are primarily based on non-clinical performance testing and substantial equivalence to predicate devices, rather than a clinical study with detailed performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Aspect | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Image Acquisition & Processing | Functionality and image quality comparable to predicate devices (K093427, K121499, K101686, K122454) for general radiography and tomosynthesis, including options for image stitching and dual-energy subtraction. | Non-clinical performance bench tests and image quality evaluations were conducted to demonstrate substantial equivalence of image processing techniques. This included phantom tests with various anatomical body phantoms. Specifically, for Dual Energy Subtraction, an additional test assured distinction of lesions overlying bones to calcification/tubercle shade. For metal artifact reduction in tomosynthesis, the FBP mode of the new device showed a "same level of metal artifact reduction capability as the mode with artifact reduction of its predicate device." |
| Tomosynthesis Specifics | Shot Interval: 200msec; Exposure number: Max 60; Angulation: Table Max 60 deg, Wall Stand Max 40 deg; Slice Interval: Min 1mm; Pixel Size: 150um; Processing: FUJIFILM Tomosynthesis processing (DR-ID 300CL/900CL) with PPU. | The new device matches these specifications, using FUJIFILM Tomosynthesis processing (DR-ID 900CL) with Pre-Processing Unit (PPU). Optional FBP and Shift-and-Add (SA) modes are available, with SA images intended for use alongside FBP, not for stand-alone diagnostic purposes. |
| Electromagnetic Compatibility | Conformity with IEC60601-1-2. | In conformity with IEC60601-1-2 (difference in edition, but deemed not to affect safety/effectiveness). |
| Materials & Biocompatibility | Conformity with IEC10993-1. | All materials and components conform to IEC10993-1 and are in clinical use by other commercial products. Difference from predicate device deemed not to affect safety/effectiveness. |
| Sterility | Not sterilized. | Not sterilized (same as predicate). |
| Electrical, Mechanical, Chemical, Thermal Safety | Substantial equivalence to predicate by conformed standards. | Substantially equivalent by their conformed standards. |
| Software Verification & Validation | Adherence to FDA guidance for medical device software and cybersecurity. Assurance of safety and effectiveness despite software processing differences. | Software Risk Analysis and Verification and Validation testing were conducted per FDA guidance. "Based on our risk analysis of software, the difference does not affect its safety and effectiveness." |
| Radiation Safety | Conformity with CFR and IEC60601-1-3. | Substantially equivalent by conformities of CFR and IEC60601-1-3. |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify a numerical sample size for the test set. It mentions "phantom tests using several different anatomical body phantoms."
- Data Provenance: Not explicitly stated, but given the manufacturer (SHIMADZU CORPORATION, Japan) and the predicate devices being from FUJIFILM CORPORATION, Japan, it is highly likely the phantom tests and image quality evaluations were conducted in a controlled, non-clinical laboratory setting, likely in Japan. This was a retrospective evaluation against existing predicate device performance, not a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- The document does not specify the number of experts or their qualifications for establishing ground truth for the test set.
- Given that the testing involved "phantom tests" and "image quality evaluation," the ground truth would likely be established based on known characteristics of the phantoms and objective image quality metrics, potentially interpreted by imaging scientists or engineers rather than clinical experts.
4. Adjudication Method for the Test Set
- The document does not specify any adjudication method for the test set. As the testing appears to be non-clinical (phantom-based), a formal adjudication process involving multiple human readers for diagnostic interpretation would not typically be required or relevant in the same manner as a clinical study.
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
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The result of non-clinical bench testing demonstrates substantial equivalence to the predicate devices. Therefore, it is our understanding that clinical testing is not required in this case."
- Consequently, there is no reported effect size of human reader improvement with or without AI assistance, as this type of study was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, standalone performance testing was implicitly performed as part of the "non-clinical performance bench test and image quality evaluate substantial equivalence of image processing technique to each predicate device". These tests assess the device's image acquisition and processing capabilities independent of human interpretation for diagnostic purposes, focusing on technical image quality metrics and functional equivalence to the predicate. The "metal artifact reduction function of tomosynthesis option" testing is an example of an algorithm-only performance assessment.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical performance testing, the ground truth was based on known characteristics of anatomical phantoms and objective image quality metrics. For example, in metal artifact reduction, the ground truth would be the known presence and characteristics of metal in the phantom and objective metrics of how well the artifact is reduced. For "distinction of lesion overlying bones," the ground truth would be the known presence/absence and characteristics of these features in the phantom.
8. The Sample Size for the Training Set
- The document does not provide information regarding a "training set" or its sample size. This is because the submission primarily focuses on demonstrating substantial equivalence to physically existing predicate devices through engineering and quality testing, rather than an AI/machine learning model that typically requires a large training dataset. The "software processing methods" mentioned are likely traditional image processing algorithms, not deep learning models.
9. How the Ground Truth for the Training Set was Established
- As no training set is described, this information is not applicable and not provided in the document.
§ 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.