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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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(29 days)
Ysio Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Ysio Max enables radiographic and tomographic exposures of the whole body and may be used on pediatric, adult and bariatric patients. It can also be used for emergency applications.
Ysio Max is not for mammography examinations.
The Ysio Max is a stationary X-ray system for radiography. The main components are the X-ray generator, the X-ray tube with collimator supported by a ceiling rail system. The Ysio Max comes with SSXIs (Solid State X-ray Imagers) that can be mobile or fixed in the Bucky tray. An image processing and data management system (syngo FLC) completes the radiographic suite.
The purpose of this submission is the upgrade to a new software version VF10 and minor hardware changes. The modified Yisio Max will introduce the following new features:
- The operating system will be MS Windows 10
- New cybersecurity features
- Additional pediatric programs
- Implementing a "Virtual Machine" that supports hospital IT
- The SSXIs have been updated
- The EMC (Electromagnetic Compatibility was tested according to the IEC . 4th edition)
- . The image processing algorithms (Diamond view Plus) will be used for exposures without grid.
The provided text is a 510(k) premarket notification for a medical device called Ysio Max. It focuses on demonstrating substantial equivalence to a predicate device after a software upgrade (VF10) and minor hardware changes.
Based on the provided document, the device (Ysio Max with VF10 software) is a stationary X-ray system, not an AI/ML-powered device for which acceptance criteria typically involve performance metrics like sensitivity, specificity, or AUC.
Therefore, the acceptance criteria and study detailed in the document are primarily related to demonstrating that the updated device maintains the same safety and effectiveness as its predicate device and complies with relevant performance standards, rather than proving a specific diagnostic accuracy or improvement in human reader performance using AI assistance.
Here's a breakdown of the information as it applies to this specific submission, addressing your points where relevant:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implicitly tied to demonstrating continued substantial equivalence to the predicate device and compliance with applicable industry standards and FDA regulations. Performance is reported through comparisons to the predicate and confirmation of adherence to standards.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Maintain same intended use as predicate. | "Ysio Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Ysio Max enables radiographic and tomographic exposures of the whole body and may be used on pediatric, adult and bariatric patients. It can also be used for emergency applications. Ysio Max is not for mammography examinations." (Identical to predicate, "reworded to simplify"). |
| Technological Characteristics | Maintain comparable technological characteristics to predicate. | X-ray Generator: Same (Polydoros 65/80 kW) |
| X-ray tube: Same (OPTITOP 150/40/80/HC-100) | ||
| Collimator: Same (Digital Multileaf Collimator N) | ||
| Air kerma: Same (Kerma X) | ||
| X-ray techniques: Same (Radiography) | ||
| Organ programs: Same functionality (X-ray parameters, Imaging processing parameters). | ||
| Digital Imaging System: Same (Fluorospot Compact aka syngo FLC). | ||
| Image processing: Same (Diamond View Plus, "made user friendly"). | ||
| Detector Performance | Detectors (SSXI) must be similar in performance to predicates and comply with guidance (e.g., DQE, MTF). | Trixell Pixium 4343RCE (MAX static): DQE @ 0.05 lp/mm (2 uGy), 67% (Predicate: 65%); MTF @ 1 lp/mm, 62% (Predicate: 63%). "Difference not significant". |
| Trixell Pixium 3543 EZh (MAX wi-D): DQE @ 1 lp/mm (2 µGy), 51% (Predicate: 50%); MTF @ 1 lp/mm, 63% (Predicate: 61%). "Difference not significant". | ||
| Trixell Pixium 2430 EZ (MAX mini): DQE @ 1 lp/mm (2 µGy), 50% (Predicate: 50%); MTF @ 1 lp/mm, 61% (Predicate: 61%). "Same". | ||
| Software Functionality | Correctly perform as designed, fulfill software requirements, and align with user needs. | "the verification/validation activities successfully confirmed that the software requirements have been fulfilled and that system functionality is consistent with the user needs and intended uses. The VF10 software correctly performs as designed and raises no new questions regarding safety or effectiveness." |
| Cybersecurity | Improved cybersecurity. | "New cybersecurity features" and "Security package based on MS Win 10" (Predicate: MS Win 7). "Improved". |
| Operating System | Update to current OS. | "MS Windows 10" (Predicate: Windows 7). |
| Compliance with Standards | Adherence to relevant IEC, ISO, NEMA, and FDA performance standards. | Compliance confirmed for IEC 60601 series, IEC 62366, ISO 14971, IEC 62304, IEC 61910-1, NEMA PS 3.1 - 3.20 (DICOM), ISO 10993-1. Specifically, IEC 60601-1-2:2007 Edition 4.0 for EMC testing was applied ("Testing according to current IEC test scope"). |
| FDA Performance Standards | Compliance with 21 CFR 1020.30-31. | "Performance testing confirmed that the Ysio Max with VF10 complies with 21 CFR 1020.30-31 Federal Performance Standards for X-Ray equipment." Specific sections are listed. |
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "test set" in the context of an AI/ML algorithm being evaluated on a dataset of patient cases. Instead, the testing is described as verification and validation (V&V) testing of the software and hardware components, and performance measurements of the X-ray detectors against technical specifications. These are engineering and performance tests, not clinical studies on a patient cohort for diagnostic AI.
- Data Provenance: Not applicable in the context of diagnostic data for AI. The testing is internal to the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML diagnostic system requiring expert interpretation as ground truth. The "ground truth" for the device's performance is adherence to engineering specifications and regulatory standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human reader interpretations of medical images that would require adjudication.
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 study was not done. The document explicitly states: "For the subject of this premarket submission, Siemens did not do an evaluation of the clinical image quality as X-ray technology; geometry and SSXI changes are minor." This device is an X-ray system itself, not an AI assistant intended to improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The Ysio Max is a medical imaging device (a stationary X-ray system), not a standalone diagnostic algorithm. Its performance is measured by its ability to generate images and comply with technical and safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is based on engineering specifications, compliance with standardized test methods (e.g., IEC standards for electrical safety, EMC, radiation protection), and measurable physical characteristics of the detectors (DQE, MTF). It's a technical "ground truth" rather than a clinical diagnostic one.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable for the same reason mentioned above.
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