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The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include, but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures. The patient population may include pediatric patients.

The Cios Flow is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include, but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.

The Cios Alpha and Cios Flow (VA31A) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Alpha and Cios Flow provide comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components:

a) The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The C-arm can be angulated in both planes and lifted vertically, shifted to the side, and moved forward/backward by an operator.

b) The second unit is the image display station with a movable trolley for the image processing and storage system, image display, and documentation. Both units are connected with a cable.

The main unit is connected to the main power outlet, and the trolley is connected to a data network.

The following modifications were made to the predicate device Cios Alpha and Cios Flow. Siemens Medical Solutions USA, Inc. submits this Bundled Traditional 510k to request clearance for Subject Devices Cios Alpha and Cios Flow (VA31A) for the following device modifications made to the Predicates Device Cios Alpha and Cios Flow (VA30).

This 510k submission, Subject Devices "Cios Alpha" and "Cios Flow" with software version VA31A, will support the following categories of modifications made to the Subject Devices in comparison to the Predicate Devices:

1. Software updated from VA30 to VA31A to support the following software features: A. Updated InstantLink with Extended NXS Interface
2. Updated Collimator
3. New optional flat detector Trixell Pixium 3131SOD with IGZO (Indium Gallium Zinc Oxide) technology
4. Updated FLC imaging system with new PC hardware Updated the High Performance Graphic Card on the Apphost PC
5. Updated Eaton UPS 5P 850i G2 as successor of UPS 5P 850i due to obsolescense
6. The Cios Alpha is also known as "Cios Alpha.neo" The Cios Flow is also known as Cios Flow.neo

The provided 510(k) clearance letter details modifications to an existing fluoroscopic X-ray system, Cios Alpha and Cios Flow, specifically focusing on software updates and hardware changes (e.g., a new flat detector).

However, the provided text does not contain explicit acceptance criteria tables for performance metrics (such as image quality, diagnostic accuracy, sensitivity, specificity, or AUC) or the results of a statistically powered, pre-specified study proving the device meets these criteria in a comparative effectiveness setting (e.g., MRMC study).

The document primarily focuses on bench testing, software validation, and compliance with recognized standards to demonstrate the substantial equivalence of the modified device to its predicate. It states that "All test results met all acceptance criteria" for software modifications and that a "Clinical Cadaver Report" was conducted to assess the non-inferiority of a new flat panel detector's subjective image quality. This suggests acceptance criteria were established internally for these tests, but they are not detailed in the provided document.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics for clinical effectiveness are not present in this 510(k) clearance letter summary. The document's purpose is to justify substantial equivalence based on safety, hardware/software changes, and compliance with standards, rather than proving enhanced clinical effectiveness through a comparative study.

Here's an attempt to answer based on the available information, noting what is not provided:

Acceptance Criteria and Device Performance

No explicit quantitative acceptance criteria table for clinical performance (e.g., diagnostic accuracy metrics like sensitivity, specificity, AUC) is provided in the document. The document discusses "acceptance criteria" in the context of:

• Software Validation: "The testing results show that all the software specifications have met the acceptance criteria." (Page 14)
• Non-clinical Testing: "All test results met all acceptance criteria." (Page 10)
• Clinical Cadaver Report (Subjective Image Quality): The IGZO detector was considered "non-inferior (equal or better) concerning the subjective image quality for four anatomical regions that have been investigated in the ortho-trauma setting." (Page 14) This implies a qualitative acceptance criterion of non-inferiority for subjective image quality, but no numerical thresholds are given.

Since no specific performance metrics with numerical acceptance criteria are provided for clinical use, a table demonstrating reported device performance against such criteria cannot be created from this text. The document refers broadly to testing results meeting "acceptance criteria" but does not define them publicly.

Study Details Proving Device Meets Acceptance Criteria

The primary "study" mentioned for clinical relevance is a Clinical Cadaver Report.

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Not specified for the Clinical Cadaver Report.
   • Data Provenance: The study was a "Clinical Cadaver Report." This implies an experimental, non-human, pre-clinical study. The country of origin is not specified but given the manufacturing site in Germany, it's possible the testing was conducted there or at Siemens facilities elsewhere. It is inherently prospective as it's a pre-market development activity.

2. Number of Experts and Qualifications:

   • Number of Experts: Not specified.
   • Qualifications: Not specified.

3. Adjudication Method:

   • Adjudication Method: Not specified. Given it was a "subjective image quality" assessment, it would likely involve multiple readers, but the method (e.g., 2+1, 3+1) is not disclosed.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Was an MRMC study done? The document does not indicate that a formal MRMC comparative effectiveness study was done to show human readers improve with AI vs. without AI assistance. The "Clinical Cadaver Report" focused on the subjective image quality of the new detector, not human performance with AI. The device described primarily appears to be an imaging system, not an AI-assisted diagnostic tool that would typically undergo MRMC studies for improved human interpretation.

5. Standalone Performance:

   • Was a standalone (algorithm only without human-in-the-loop performance) done? Not explicitly stated in the context of clinical performance. The "software functional, verification, and System validation testing" (Page 11) and "software validation data" (Page 14) refer to the algorithm's internal performance against specifications, not its standalone diagnostic accuracy on clinical images.

6. Type of Ground Truth Used:

   • Ground Truth for Clinical Cadaver Report: In the context of "subjective image quality," the "ground truth" would be the consensus assessment of the evaluating experts regarding the quality of the images generated by the new IGZO detector compared to the a-Si detector. It is not pathology or outcomes data.

7. Training Set (if applicable for AI/Software components):

   • Sample Size for Training Set: The document does not mention an AI component that would require a distinct "training set" in the common understanding of machine learning. The "software" referred to is control software for the X-ray system, not a diagnostic AI algorithm.

8. Ground Truth for Training Set:

   • How ground truth was established for training set: Not applicable, as there's no indication of machine learning model training. The software modifications are described as updates to system control, interfaces, and hardware support.

In summary: The provided 510(k) clearance letter demonstrates that the modified Cios Alpha and Cios Flow systems meet regulatory requirements for substantial equivalence, primarily through non-clinical testing, compliance with safety standards, and software validation against internal acceptance criteria. A "Clinical Cadaver Report" assessed the subjective image quality of a new detector, finding it non-inferior. However, the document does not contain the specific details of clinical performance acceptance criteria, sample sizes for such studies, or a multi-reader comparative effectiveness study as would be seen for AI-enabled diagnostic tools.

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The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastrointestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.

The Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Alpha provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components:
a) The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and be lifted vertically, shifted to the side and move forward/backward by an operator.
b) The second unit is the image display station with a moveable trolley for the image processing and storage system, image display and documentation. Both units are connected to each other with a cable.
The main unit is connected to the main power outlet and the trolley is connected to a data network.

The Siemens Cios Alpha (VA30) is a mobile X-ray system. This submission describes modifications to the predicate device software.

Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for each software modification with corresponding device performance metrics. Instead, it states that "The Cios Alpha software (VA30) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process." and "The testing results support that all the software specifications have met the acceptance criteria."

The modifications are primarily software enhancements aimed at improving user interaction and safety features. The "reported device performance" is qualitative, asserting that the modified features function as intended and are comparable to or improved from the predicate devices.

2. Sample size used for the test set and the data provenance (country of origin of the data, retrospective or prospective)

The document does not specify the sample size for any test set or the data provenance (country, retrospective/prospective). It mentions "verification and validation testing" and "clinical use tests with customer report and feedback form" but provides no details on these.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number or qualifications of experts used to establish ground truth for any test set.

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

The document does not mention any specific adjudication method for the 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

No MRMC comparative effectiveness study is mentioned in the provided text, nor is any AI component or human reader improvement with AI assistance discussed. The device is an X-ray system with software modifications, not an AI-powered diagnostic tool for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is an X-ray system, not a standalone algorithm. The "software modifications" refer to direct user interface and system control features, not an independent algorithm for diagnostic interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not explicitly state the type of ground truth used. However, given the nature of the software modifications (Target Pointer, Interactive User Touch Control, Dose Regulation Indicator, Sound Radiation Delay, Product Software Security), the ground truth for their effectiveness would likely be based on functional testing, compliance with specifications, and user feedback/system behavior validation, rather than medical ground truth like pathology or outcomes data. The Human Factor Usability Validation suggests user feedback played a role.

8. The sample size for the training set

This is not applicable since the modifications are for a medical device's operating software, not for an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

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The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro- intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.

The Cios Alpha mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Alpha provides comprehensive image acquisition modes. The system consists of two major components:
a) The C-arm with an X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and lifted vertically, shifted to the side and moved forward/backward by an operator.
b) The second component is the image display station with a moveable trolley that holds the image processing and storage system, and the image display. Both components are connected to each other with a cable.

Here's an analysis of the acceptance criteria and study information provided in the document for the Cios Alpha (VA30) device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for quantitative performance metrics in a pass/fail format. Instead, it presents a comparison of the Subject Device's (Cios Alpha (VA30)) performance to its Predicate (Cios Alpha (VA10)) and Reference Devices for Solid State X-Ray Imaging (SSXI) specifications. The implication is that comparable or better performance is the acceptance criterion for the SSXI metrics.

Additional Acceptance Criteria (General):

• Compliance with voluntary standards (Table 3), FDA Guidance Documents (Table 4).
• Software verification and validation meeting acceptance criteria.
• Risk analysis completed and hazards mitigated.
• Human Factors Usability Validation showing addressing human factors and successful clinical use tests.
• Cybersecurity requirements met.

Study Proving Device Meets Acceptance Criteria:

The document describes several non-clinical performance tests and analyses to demonstrate that the Cios Alpha (VA30) meets the acceptance criteria, primarily for substantial equivalence to its predicate devices.

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

• Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of patient data or number of images for evaluating the SSXI metrics. The performance evaluation seems to be based on engineering bench testing of device capabilities rather than a separate clinical image set.
• Data Provenance: The data provenance for the SSXI metrics and other performance tests is non-clinical bench testing. The document states: "Performance tests were conduct[ed] to test the functionality of the Cios Alpha (VA30)." It also mentions "Additional engineering bench testing was performed including: the non-clinical testing identified in the guidance for submission of 510(k) s for Solid State X-Ray Imaging Devices (SSXI); demonstration of system performance; and an imaging performance evaluation."
  • The "clinical images are not required" statement further confirms the non-clinical nature of the specific SSXI evaluation.
  • The Human Factor Usability Validation mentions "clinical use tests with customer report and feedback form," which implies some level of prospective, real-world (or simulated real-world) interaction, but specific sample sizes are not provided.
  • The origin of the data is Siemens Healthcare GmbH Corporate Testing Laboratory and internal verification/validation processes.

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

• The document does not describe the use of experts to establish ground truth for a test set in the traditional sense of image interpretation for diagnostic accuracy. The testing primarily focuses on technical specifications of the imaging system itself.
• For the Human Factors Usability Validation, "customer report and feedback form" are mentioned, implying input from users (healthcare professionals), but no specific number or detailed qualifications are provided.

4. Adjudication Method for the Test Set

• Given that the primary performance evaluation described is non-clinical bench testing of engineering specifications (SSXI metrics), an adjudication method for a test set based on expert consensus would not be applicable or mentioned. The "ground truth" for these metrics is objectively measured device performance.

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 MRMC comparative effectiveness study is mentioned. This submission is for an imaging system (C-arm X-ray system), not an AI-powered diagnostic algorithm that assists human readers. While it includes "new software functions" like "Target Pointer," which "enables the automatic detection of K-wires and displays the trajectory," the document does not present a study evaluating the impact of this feature on human reader performance or diagnostic accuracy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• The document evaluates the Cios Alpha as an imaging system, not a standalone AI algorithm. While it contains new software features, the performance metrics discussed (e.g., DQE, MTF) are system-level imaging characteristics. The "Target Pointer" feature performs automatic detection, but its standalone performance (e.g., accuracy of K-wire detection) is not detailed in the provided text. The overall context is regulatory clearance for hardware and software modifications of an existing medical device, not a new AI-enabled diagnostic device undergoing standalone performance evaluation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the SSXI performance metrics (DQE, Dynamic Range, MTF, etc.), the "ground truth" is based on objective physical measurements and technical standards. These are inherent properties of the imaging system's detector and processing.
• For software functions, "ground truth" is established through detailed software testing to confirm they "worked as intended" according to specifications and requirements.
• For Human Factors, ground truth would relate to usability and safety observations and feedback during "clinical use tests."

8. The Sample Size for the Training Set

• The document does not mention a training set sample size. This is expected as the submission primarily concerns an imaging system rather than a machine learning algorithm requiring a distinct training phase with annotated data. Although new software features are present, the submission focuses on their validation as part of the overall device.

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

• Since no training set is discussed, the method for establishing its ground truth is also not applicable in this document.

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The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.

The Cios Alpha is a mobile fluoroscopy system designed for the surgical environment. The Cios Alpha provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components:
a) The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and be lifted vertically, shifted to the side and moved forward/backward by an operator.
b) The monitor trolley providing image processing, review and patient data entry. The monitor trolley may contain an optional hardcopy (paper) printer and navigational equipment as well.

The Siemens Cios Alpha is a mobile fluoroscopic X-ray system that undergone non-clinical and clinical testing to demonstrate its performance and substantial equivalence to a predicate device, the ARCADIS Avantic.

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, quantitative acceptance criteria for image quality beyond general "Good" or "Very good" ratings. However, it does compare technological characteristics.

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

• Sample Size: More than 70 patients were examined during the clinical evaluation (customer use test).
• Data Provenance: The data was generated during a "customer use test" in a clinical environment. The country of origin is not explicitly stated, but Siemens Medical Systems, Inc. is based in Malvern, PA, USA, and the manufacturing site is in Kemnath, Germany. Given this is a 510(k) submission to the FDA, it is highly likely that at least some, if not all, of the clinical evaluation was conducted in the USA or in a manner compliant with US regulatory requirements. The data is prospective, as it was a specific evaluation conducted for 8 weeks in a clinical environment.

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

The document states: "It was the investigators opinion that in this test phase the new Cios Alpha provided an even better, more detailed image quality as compared to the ARCADIS Avantic (predicate device)."

• Number of Experts: The document refers to "investigators" (plural) but does not specify an exact number.
• Qualifications of Experts: The qualifications of the "investigators" are not explicitly stated, but it is implied they are healthcare professionals who are experienced in evaluating medical imaging devices in a clinical setting ("customer use test," "clinical environment").

4. Adjudication Method for the Test Set:

The document describes the assessment as "the investigator's opinion." This suggests a qualitative assessment by the clinical investigators, rather than a formal, multi-reader adjudication process (e.g., 2+1 or 3+1). It does not mention blinding or independent review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:

No, a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The clinical evaluation was a customer use test where investigators provided an opinion on image quality compared to the predicate, but it does not detail a structured study comparing human reader performance with and without AI assistance or with the new device versus the predicate in a statistically rigorous MRMC design.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The Cios Alpha is an imaging device, not an AI algorithm. Therefore, the concept of a "standalone" algorithm performance as typically applied to AI/CAD devices is not relevant here. The device's performance is based on its ability to produce images. The non-clinical tests involved compliance with various IEC/ISO standards and X-Ray performance tests, which evaluate the device itself.

7. The Type of Ground Truth Used:

For the clinical evaluation, the "ground truth" for image quality was based on the subjective expert opinion/consensus of the clinical investigators. The document mentions the "investigators opinion" regarding image quality being "even better, more detailed" compared to the predicate. This is a qualitative assessment rather than a definitive objective measure like pathology or clinical outcomes.

8. The Sample Size for the Training Set:

The Cios Alpha is a fluoroscopic X-ray system, not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. The document describes its development as being "based on the ARCADIS Avantic and the experience Siemens has with more than 30 years with predicate mobile fluoroscopy C-arms (SIREMOBILE series)." This refers to product development experience and engineering, not a data-driven training set for an AI model.

9. How the Ground Truth for the Training Set was Established:

As the Cios Alpha is not an AI/ML algorithm requiring a training set, the concept of establishing ground truth for a training set is not applicable to this submission. The device's design and performance are a result of engineering principles, compliance with standards, and experience with prior generations of fluoroscopy systems.

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