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510(k) Data Aggregation
(21 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 Shimadzu FLUOROspeed is a universal X-ray RF system offering radiographic, fluoroscopic, and angiographic modes. As compared to our recently cleared system the SONIALVISION G4, (K190373) the positions of the tube head and the digital x-ray receptor panel have been swapped. This was done to respond to customer demand. This configuration is identical to products offered by Siemens (K173639) and GE Healthcare (K081091). The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat panel detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.
The provided text is a 510(k) summary for the SHIMADZU Corporation's FLUOROspeed device. It indicates that clinical testing was not performed to demonstrate substantial equivalence. Therefore, there is no information available regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment related to clinical studies.
The submission relies on non-clinical testing and compliance with recognized standards to establish substantial equivalence to predicate devices. The "acceptance criteria" in this context are adherence to these specific standards and the predicate device's characteristics.
Here's a breakdown of the specific points based on the provided document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are essentially the performance and safety requirements outlined in the listed IEC and EN standards, and the device's characteristics being "SAME" as the predicate device (SONIALVISION G4 K190373) for most specifications.
| Acceptance Criteria (Predicate Characteristics & Standard Compliance) | Reported Device Performance (FLUOROspeed) |
|---|---|
| Indications for Use: | |
| Fluoroscopy/radiography diagnosis in hospital. | SAME |
| Operated by qualified personnel. | SAME |
| Total patient population. | SAME |
| NOT for Mammography screening. | SAME |
| NOT for interventional procedure. | SAME |
| Used for radiographic, fluoroscopic, angiographic, pediatric exams. | SAME |
| Stored images for re-monitoring, image processing, storing to | SAME |
| optical media, sending to DICOM server. | |
| Exception: Tomosynthesis option (for SONIALVISION G4) | NOT possible due to fixed position of the tubehead. (This is a difference from the predicate, but the device is cleared without Tomosynthesis, making its indications for use similar to other non-Tomosynthesis predicates). |
| Physical Configuration: | The primary difference is the swapped positions of the tube head and digital x-ray receptor panel. This is compared to products offered by Siemens (K173639) and GE Healthcare (K081091) as well, implying these configurations are acceptable. |
| Digital X-Ray Receptor Panel | |
| Manufacturer: Canon Medical Equipment Group | SAME |
| Model: Canon AS-10, CXDI-401RF (SFD-1717BF) | SAME |
| Size: 43 x 43 CM | SAME |
| Pixel Size: 160 μm | SAME |
| Number of Pixels: 2,688 x 2,688 | SAME |
| Acquisition Modes (Binning): Up to 3 fps (1x1), Up to 15 fps (1x1), | SAME |
| Up to 30 fps (2x2) | |
| DQE @ 1 µGy in 0 lp/mm, RQA5: 0.75 | SAME |
| Spatial Resolution [MTF@2cycle/mm, RQA5]: 0.28 | SAME |
| A/D Conversion: 16 Bit | SAME |
| Digital Radiography Unit: DR-300 | SAME |
| Rad/Fluoro Characteristics: | |
| Generator: 80 kW | SAME (80 kW) |
| Collimator: Type R-300 | SAME |
| Ceiling Tube Support: CH-200 | SAME |
| Radiography: | |
| Tube Voltage: 40 to 150 kV | SAME (40 to 150 kV) |
| Tube Current: 10 to 800 mA | SAME (10 to 800 mA) |
| mAs: 0.5 to 800 mAs | SAME (0.5 to 800 mAs) |
| Time: 0.001 to 10 sec | SAME (0.001 to 10 sec) |
| Fluoroscopy: | |
| Tube Voltage: 50 to 125 kV | SAME (50 to 125 kV) |
| Tube Current: Max. 20 mA | SAME (Max. 20 mA) |
| Time: Total 99 min 59 sec, continuous 10 min | SAME (Total 99 min 59 sec, continuous 10 min) |
| Pulsed Fluoroscopy: Max. 30 fps, grid-controlled | SAME (Max. 30 fps, grid-controlled) |
| Compliance with recognized standards: | The device was found to comply with: IEC 60601-1:2005+A1:2012, IEC 60601-1-3:2008+A1, IEC 60601-1-6:2010+A1, IEC/EN 60601-2-28:2010, IEC 60601-2-54:2009+A1, IEC 62304:2006, IEC 62366:2007+A1, EN 60601-1-2:2015/IEC 60601-1-2:2014. It is also certified to comply with the US Radiation Safety Performance Standard. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set. The evaluation was based on non-clinical testing and comparison to predicate device specifications.
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. No clinical test set requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set.
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. No clinical effectiveness study involving human readers or AI assistance was performed. This device is an X-ray system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an X-ray system, not an algorithm, and no standalone algorithmic performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical ground truth was established as no clinical studies were conducted. The "ground truth" for this submission is established by the specifications and performance of the legally marketed predicate device and compliance with international safety and performance standards.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is a medical imaging device, not an AI/ML diagnostic algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or its ground truth establishment.
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