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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.

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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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.

Detailed Study Information (Based on the provided text):

1. 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).

2. 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.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No clinical test set.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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