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The software's intended use is to assist diagnosis of chest pathology by minimizing anatomical distractions such as the ribs and clavicle in chest x-ray images.

The Bone Suppression Software is a software component for use on diagnostic x-ray systems utilizing digital radiography (DR) or computed radiography (CR) technology. The software option suppresses bone anatomy in order to enhance visualization of chest pathology in a companion image that is delivered in addition to the original diagnostic image.

Here's a breakdown of the acceptance criteria and study information for the Bone Suppression Software, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria for the Bone Suppression Software's performance. It states that "Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as the predicate device." However, the specific metrics or thresholds for these criteria are not detailed.

Therefore, this section focuses on the qualitative claims made and the reported outcome.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the provided text. The document mentions "Clinical testing was conducted," but does not give a number of cases.
• Data Provenance: Not specified. It's unclear what country the data came from or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document only mentions "Clinical testing was conducted to evaluate the acceptability of the companion images for assisting diagnosis." It implies that qualified professionals reviewed the images, but their specific roles or experience levels are not detailed.

4. Adjudication Method for the Test Set

• Not specified. The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating the clinical images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: The document does not explicitly state that an MRMC comparative effectiveness study was done comparing human readers with and without AI assistance (bone suppression).
• Effect Size: Not provided. Since an MRMC study is not confirmed, no effect size is discussed. The study's focus was on the "acceptability of the companion images for assisting diagnosis" and demonstrating equivalence to a predicate.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• The document describes the "Bone Suppression Software" as a "software component" that "suppresses bone anatomy in order to enhance visualization of chest pathology in a companion image that is delivered in addition to the original diagnostic image." This heavily implies that the software provides a processed image for human interpretation, rather than a standalone diagnostic output. While the algorithm performs its function independently, the "clinical testing" mentioned focuses on the acceptability of the companion images for assisting diagnosis, indicating an evaluation of the output intended for human review, not a standalone diagnostic performance evaluation against ground truth.

7. The Type of Ground Truth Used

• The document implies that the ground truth for evaluation was based on the "acceptability of the companion images for assisting diagnosis" by clinical review. However, the specific type of ground truth (e.g., pathology, clinical follow-up, expert consensus on disease presence) against which the diagnostic enhancement was measured is not explicitly stated. It appears the ground truth was primarily related to the acceptability and utility of the suppressed images for assisting diagnosis rather than independently verifying the presence or absence of specific pathologies with a definitive gold standard.

8. The Sample Size for the Training Set

• Not specified. The document does not provide any information about the training data or its sample size.

9. How the Ground Truth for the Training Set Was Established

• Not specified. As no information on the training set or its ground truth is provided, the establishment method is unknown.

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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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