(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.
§ 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.