(24 days)
The equipment is intended to be used for the fluoroscopy/radiography diagnosis in hospital. The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications. The equipment is used for total patient population. The equipment is NOT intended to be used for Mammography screening. The equipment is NOT intended to be used for interventional procedure. The equipment is used for radiographic, fluoroscopic, angiographic and pediatric examinations. Stored images in the equipment can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server. The Tomosynthesis option for the SONIALVISION G4 is intended to generate tomographic images of human anatomy including chest or extremities. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is not intended for mammographic applications
The Shimadzu SONIALVISION G4 is a universal X-ray RF system offering radiographic, fluoroscopic, angiographic and tomosynthesis techniques. Tomosynthesis technique is enabled by additional software option to the digital radiography system of the SONIALVISION G4. The Shimadzu SONIALVISION G4 is floor mounted table, and the system can be configured with Digital Radiography System, X-ray High Voltage Generator, Collimator and X-ray Tube. The purpose of this submission is to introduce an additional compatible digital x-ray receptor panel. This panel is manufactured by Canon. The panel was cleared by FDA for fluoroscopic use in K171194.
The provided document is a 510(k) summary for the Shimadzu SONIALVISION G4, an image-intensified fluoroscopic x-ray system. The submission is to introduce an additional compatible digital x-ray receptor panel (Canon AS-10, CXDI-401RF) to the existing SONIALVISION G4 system.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" but rather presents a comparison of the technical characteristics of the modified device with the predicate device to demonstrate substantial equivalence. The implication is that if the modified device's performance is equivalent or better than the predicate, it meets the unstated acceptance criteria for safety and effectiveness.
| Characteristic | Predicate Device (K142341, SONIALVISION G4) | Modified Device (SONIALVISION G4 with Canon panel) | Acceptance Criteria (Implied) | Reported Performance (Modified Device) |
|---|---|---|---|---|
| Indications for Use | Same as Modified Device | Same as Predicate Device | Equivalent to Predicate | Exactly the same |
| Manufacturer (Panel) | Varian Medical Systems | Varian Medical Systems OR Canon Medical Equipment Group | Equivalent performance/safety to predicate | Canon Medical Equipment Group compatible |
| Model (Panel) | PaxScan™ 4343CB, SDF-1717AF | PaxScan™ 4343CB, SDF-1717AF OR Canon AS-10, CXDI-401RF | Equivalent performance/safety to predicate | Canon AS-10, CXDI-401RF compatible |
| Size (Panel) | 43 x 43 CM | SAME | Equivalent to Predicate | Same |
| Pixel Size | 139μm | 160 μm | Equivalent clinical utility | 160 μm |
| Number of Pixels | 3072 x 3072 | 2,688 x 2,688 | Equivalent clinical utility | 2,688 x 2,688 |
| Acquisition (fps, 1x1) | Up to 3 fps (1x1) | Up to 3 fps (1x1) | Equivalent to Predicate | Up to 3 fps (1x1) |
| Acquisition (fps, 1x1 or 2x2) | Up to 15 fps (1x1 or 2x2) | Up to 15 fps (1x1) | Equivalent to Predicate | Up to 15 fps (1x1) |
| Acquisition (fps, 2x2) | Up to 30 fps (2x2) | Up to 30 fps (2x2) | Equivalent to Predicate | Up to 30 fps (2x2) |
| Spatial Resolution [MTF@2cycle/mm, RQA5] | 0.28 | 0.28 Same performance | Equivalent or better | 0.28 Same performance |
| Modes (Binning) [DQE @ 1 µGy in 0 lp/mm, RQA5] | 0.75 Slightly better | 0.70 Equivalent performance | Equivalent or better | 0.70 Equivalent performance |
| A/D Conversion | 16 Bit | 16 Bit | Equivalent to Predicate | 16 Bit |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The submission does not describe a test set of clinical images or patient data to evaluate the device's diagnostic performance in a clinical setting.
- Data Provenance: Not applicable. The study relies on non-clinical (bench) testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. No clinical test set requiring expert ground truth was used.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. No clinical test set requiring adjudication was used.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an x-ray system, not an AI-powered diagnostic tool requiring human reader assistance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable in the context of an AI algorithm. The device itself is an imaging system. The comparison focuses on the technical specifications of the new X-ray detector panel to demonstrate its equivalence (or non-inferiority) to the predicate panel. The "standalone" performance here refers to the physical and imaging characteristics of the detector itself, which were evaluated by Canon (the manufacturer of the new panel) as referenced in K171194.
7. The type of ground truth used:
- Type of Ground Truth: The ground truth for this submission is based on non-clinical (bench) testing standards and technical specifications that define image quality and system performance for X-ray systems. The comparison is made against the established performance parameters of the predicate device and relevant industry standards.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This submission is for an X-ray imaging system with a new detector panel, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. There is no training set mentioned or implied in this submission, as it's not an AI/ML device.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.