(93 days)
The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including; skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography.
The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
The Ysio Max Radiography X-ray system is designed as a modular system with components such as ceiling suspension with X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless and fixed integrated detectors, that may be combined into different configurations to meet specific customer needs.
The Ysio Max components may be used together with fluoroscopy tables (i.e. Luminos Agile or Luminos dRF) to facilitate radiographic examinations on such tables, when not needed for fluoroscopy.
The Ysio Max Radiography X-ray system is based on the currently available predicate Ysio.
Here's an analysis of the acceptance criteria and study information for the Siemens Ysio Max device, based on the provided text.
Based on the provided 510(k) summary for the Siemens Ysio Max, no clinical studies were performed or are described for this submission. The submission states: "Clinical testing was not applicable as Ysio Max has no new or changed Indications for Use nor any new clinical applications were introduced with the modified system."
The submission focuses on demonstrating substantial equivalence to its predicate device (Ysio) based on technological characteristics and non-clinical performance testing.
Therefore, many of the requested categories related to clinical study design and ground truth are not applicable in this specific regulatory submission.
Acceptance Criteria and Reported Device Performance
Since this submission is based on substantial equivalence and non-clinical testing, the "acceptance criteria" here refer to conformance with recognized standards and successful non-clinical verification and validation. There isn't a direct table of clinical performance metrics like sensitivity/specificity.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| 1. Conformance to Recognized Performance Standards | Siemens claims conformance in signed Statements of Conformance to recognized performance standards (details of specific standards not explicitly listed but would include electrical, mechanical, and safety standards like IEC). |
| 2. Software Performance | Non-clinical tests (integration and functional) were conducted on the software during product development. The Risk Analysis was completed and risk control implemented. Testing results support that all software specifications have met the acceptance criteria. |
| 3. Verification and Validation of Device | Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence. |
| 4. EMC/Electrical Safety | Evaluated according to IEC Standards. Conformance to Voluntary Standards covering Electrical and Mechanical Safety. The identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate device Ysio in terms of safety and effectiveness. |
| 5. Quality Assurance Measures Applied | Risk Analysis, Requirement Specification Reviews, Design Reviews, Integration testing (System verification). |
| 6. Safety in Use & Error Handling | Instructions for use are included, and information enables safe and effective operation. Several safety features (visual/audible warnings) are incorporated. The system is continually monitored; if an error occurs, functions are blocked, and an error message is displayed. Operators are healthcare professionals familiar with X-ray examinations. Adherence to recognized and established industry practices, and all equipment is subject to final performance testing. |
Detailed Study Information (Based on the provided text):
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. No clinical test set. The non-clinical tests relate to software, electrical, and mechanical functionality, rather than diagnostic performance on a patient dataset.
- Data Provenance: Not applicable for a clinical test set. Non-clinical testing would have been performed by Siemens internally in Germany (manufacturing site) and/or the US (importer/distributor).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There's no clinical test set for which ground truth would need to be established by experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set.
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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 MRMC comparative effectiveness study was performed or described. The submission is for an X-ray system, not an AI-assisted diagnostic tool in the sense of image interpretation. While the device mentions "AIM (Artificial Intelligence Mapping) feature" for movement, this relates to system control and workflow, not diagnostic image interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of diagnostic AI. The software testing mentioned is for system control and functionality.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No clinical ground truth was established for this submission. For non-clinical tests, "ground truth" would correspond to expected operational parameters and correct functionality based on engineering specifications and recognized standards.
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The sample size for the training set:
- Not applicable. There's no mention of a training set for an AI-based diagnostic algorithm. If the "AIM (Artificial Intelligence Mapping)" feature involved machine learning, details of its training set are not provided in this 510(k) summary.
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How the ground truth for the training set was established:
- Not applicable. No training set for diagnostic AI is described.
Summary of Device Modifications and Justification for No Clinical Testing:
The Ysio Max is presented as substantially equivalent to the predicate Ysio. The key changes are:
- New detector generation (Trixell) offering different sizes.
- New system control software with "Free Axis Simultaneous Travel (FAST)" and "AIM (Artificial Intelligence Mapping)" for improved workflow in positioning.
- Option to process images with Riverain ClearRead (formerly SoftView), which itself has a separate 510(k) clearance (K092363). This was an existing option for the predicate.
- Ergonomic mechanical improvements (new handgrips).
The justification for not conducting clinical testing is explicitly stated as: "Clinical testing was not applicable as Ysio Max has no new or changed Indications for Use nor any new clinical applications were introduced with the modified system." This means the device continues to perform its intended function (radiographic and tomographic exposures) as the predicate, and the modifications are considered not to affect its safety and effectiveness in a way that would necessitate new clinical evidence.
§ 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.