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The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.

The Cios Select can operate in three different modes, Digital Radiography, and Pulsed Fluoroscopy which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

The Cios Select (VA21C) with Flat Panel Detector Mobile X-ray System is designed for the surgical environment. The Cios Select FD (VA21) is a modification of the Cios Select (VA21) Flat Panel originally cleared under Premarket Notification K210309 on March 5, 2021.

The Cios Select consists of two major units:

The Siemens Healthineers Cios Select mobile fluoroscopy C-arm system is an X-ray imaging system consisting of two mobile units: a mobile acquisition unit and a monitor cart as the image display station.

The mobile acquisition unit is comprised of the X-ray control, the C-arm which supports the single-tank high-frequency generator/X-ray tube assembly, the flat panel detector, and user controls.

The monitor cart connects to the acquisition unit by a cable. It integrates the TFT flat panel displays, Digital Imaging Processing System, user controls, and image storage devices (USB).

The provided text is a 510(k) summary for the Siemens Cios Select (VA21C) with Flat Panel Detector. It describes modifications made to an existing device (Cios Select (VA21) Flat Panel, cleared under K210309) and argues for its substantial equivalence to the predicate device.

Crucially, this document focuses on demonstrating substantial equivalence of a modified medical device to its predicate, rather than providing a detailed study proving the de novo performance of a new device against specific acceptance criteria for a clinical task (e.g., detecting a disease).

The "acceptance criteria" discussed in this document refer to adherence to regulatory standards, successful completion of non-clinical bench testing, software verification and validation, and human factors validation, all geared towards demonstrating that the modified device is as safe and effective as the original, and performs as expected.

Therefore, many of the requested points regarding clinical study design, expert ground truth, MRMC studies, and training set details are not applicable or not explicitly provided in this type of regulatory submission because the demonstrated equivalence is primarily based on engineering and performance testing, not direct clinical efficacy studies for a new diagnostic or therapeutic capability.

Here's a breakdown based on the provided text, addressing the points as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a "Special 510(k)" for modifications, the "acceptance criteria" are primarily related to conforming to recognized standards and ensuring the modifications do not introduce new safety or effectiveness concerns, rather than specific clinical performance metrics. The "reported device performance" is framed in terms of successful completion of tests demonstrating compliance and functional equivalence to the predicate.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in terms of clinical images or patient data. The testing described is primarily engineering bench testing, software verification/validation, and human factors validation.
• Data Provenance: Not applicable in the context of clinical images/patient data for performance evaluation. Testing was conducted internally by Siemens Healthcare GmbH Corporate Testing Laboratory and through internal product development processes. It is not mentioned whether the human factors validation included users from specific countries.

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

• Not Applicable. This submission does not involve assessment against a "ground truth" for a specific diagnostic task or clinical condition, as it's a submission for modifications to an existing X-ray system, not a new AI-based diagnostic algorithm.

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

• Not Applicable. No adjudication method is mentioned as there's no diagnostic ground truth being established by experts.

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 conducted as this is an X-ray imaging system, not an AI-assisted diagnostic tool for interpretation.

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

• Not Applicable. This is an X-ray imaging system, not an AI algorithm.

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

• Ground truth in this context refers to the specifications and requirements the device is designed to meet, as well as adherence to recognized industry standards for medical device safety and performance. No disease-specific "ground truth" derived from expert consensus, pathology, or outcomes data is relevant for this type of submission.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device that requires a training set of data.

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

• Not Applicable. As above, no training set or associated ground truth is relevant.

In summary: The K223410 510(k) submission for the Cios Select (VA21C) with Flat Panel Detector focuses on demonstrating that minor modifications (software update, new collimator, new PC hardware) to an already cleared X-ray system do not raise new safety or effectiveness concerns and maintain substantial equivalence to its predicate. The "study" referenced in the document is a compilation of engineering bench tests, software verification and validation activities, and human factors validation, all ensuring compliance with regulatory standards and functional performance of the device's hardware and software components. It does not involve a clinical efficacy study or AI performance evaluation.

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The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.

The Cios Select can operate in four different modes, Digital Radiography, Fluoroscopy and Cassette exposure which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Theis 510(k) submission, Cios Select (VA21C) with Imagine Intensifier is a Mobile Carm X-ray System, which is a modification of the Cios Select (VA21) Image Intensifier originally cleared under Premarket Notification K210307 on March 04, 2021.

The Cios Select consists of two major units:

One is the acquisition unit with the C-arm and movable base containing the generator, power unit, system control, and tube housing assembly on one side of the C-arm and the image intensifier on the opposite side.

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 provided text describes a 510(k) premarket notification for a medical device called "Cios Select (VA21) Image Intensifier." This is a special 510(k) submission, meaning it concerns minor modifications to an already cleared predicate device (K210307). As such, the focus of the documentation is on demonstrating that the modified device remains substantially equivalent to the predicate, rather than proving novel performance.

Therefore, the document does not contain a typical "study" proving the device meets acceptance criteria in the sense of a clinical trial or performance study against specific, quantified metrics with a defined ground truth and expert review. Instead, the "acceptance criteria" are implied by compliance with safety and performance standards for an image-intensified fluoroscopic x-ray system, and the "study" is a series of verification and validation (V&V) tests to confirm that the modifications do not introduce new safety or effectiveness issues.

Based on the provided information, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a special 510(k) for modifications, the "acceptance criteria" are primarily related to maintaining safety and performance equivalence to the predicate device and adhering to recognized standards. Specific quantitative performance metrics are not explicitly listed in a table format for the device's image quality or diagnostic accuracy in this submission narrative.

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

• Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of diagnostic performance involving patient data. The "tests" mentioned are non-clinical (bench testing, verification, and validation).
• Data Provenance: The study described is primarily non-clinical validation and verification. There is no indication of patient data being used for the performance evaluation in this specific 510(k) submission, as it relates to system modifications and demonstrating substantial equivalence. The predicate device's prior clearance would have relied on such data. Since clinical testing was deemed "not necessary" for this special 510(k), no patient data (retrospective or prospective, or country of origin) is specified for the current submission's performance evaluation.

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

• Not applicable as this submission describes non-clinical testing for substantial equivalence, not a diagnostic performance study requiring expert ground truth for patient data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

• Not applicable for the same reason as above.

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:

• No, an MRMC study was not performed. This device is an image intensifier system (mobile C-arm X-ray), not an AI-based diagnostic algorithm that assists human readers.

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

• No, this is a medical imaging hardware system with integrated software, not a standalone AI algorithm. The performance evaluation focuses on the safety and functionality of the modified system.

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

• For the non-clinical tests described, the "ground truth" is defined by established engineering specifications, performance standards (e.g., IEC, AAMI, CFR), and functional requirements rather than medical ground truth like pathology or expert consensus on clinical cases. The tests verify that the device performs according to these engineering and regulatory specifications.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI model that underwent a separate and distinct training phase using a specific dataset. The "software" updates mentioned are for system control and image processing, not for a trainable machine learning model.

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

• Not applicable for the same reason as above.

Ask a specific question about this device

The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.

The Cios Select can operate in three different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

The Cios Select (VA21) Mobile X-ray System is designed for the surgical environment. The Cios Select (VA21) is a modification of the Cios Select originally cleared under Premarket Notification K181767 on August 17, 2018.

The Cios Select consists of two major units:

The Siemens Healthineers Cios Select mobile fluoroscopy C-arm system is an X-ray imaging system consisting of two mobile units: a mobile acquisition unit and a monitor cart as the image display station.

The mobile acquisition unit is comprised of the X-ray control, the C-arm which supports the single-tank high-frequency generator/X-ray tube assembly, the flat panel detector, and user controls.

The monitor cart connects to the acquisition unit by a cable. It integrates the TFT flat panel displays, Digital Imaging Processing System, user controls and image storage devices (DVD, USB).

The provided text describes a 510(k) submission for the Cios Select (VA21) Flat Panel X-ray system, which is a modification of an existing device. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or "new" device performance metrics directly applicable to AI/ML systems or diagnostic accuracy studies.

Therefore, the document does not contain the level of detail typically found in studies designed to prove a device meets specific acceptance criteria for diagnostic performance, especially concerning AI/ML algorithms where terms like "ground truth," "expert consensus," "sample size for training/test sets," and "MRMC studies" are paramount.

The modifications described in this 510(k) are mainly related to:

• Upgraded software (VA21) with new optional features (Cios OpenApps, Target pointer)
• New optional laser aimers (tube side and flat detector side)
• Enhanced cybersecurity

The acceptance criteria and study conducted are primarily focused on verifying that these modifications do not introduce new safety or effectiveness concerns and that the device continues to meet established performance and regulatory standards, particularly for safety and electromagnetic compatibility (EMC). It's a "Special 510(k)," indicating minor changes to a cleared device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, standalone performance) are not explicitly detailed in the provided K210309 submission as it is not a submission for a new AI/ML diagnostic algorithm requiring such clinical performance validation.

Here's an attempt to extract and interpret the information based on the provided text:

Acceptance Criteria and Device Performance for Siemens Cios Select (VA21)

As this is a 510(k) submission for modifications to an existing X-ray system, the "acceptance criteria" are primarily related to general safety, effectiveness, and continued compliance with established standards for medical devices and X-ray systems, rather than accuracy metrics for a specific diagnostic task typically seen with AI/ML algorithms. The study conducted is mainly focused on verification and validation of the modifications to ensure they do not alter the substantial equivalence of the device.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) (modifications to an existing device, not a new diagnostic AI), the acceptance criteria are based on compliance with general medical device standards and the assessment that changes do not introduce new safety or effectiveness concerns.

• 21 CFR 1020.30 (Diagnostic X-Ray Systems), 1020.31 (Radiographic), 1020.32 (Fluoroscopic), 1040.10 (Laser products).
• AAMI ANSI ES60601-1:2005/(R)2012 (Electrical Safety)
• IEC 60601-1-2:2014 (EMC)
• IEC 60601-1-3:2013, IEC 60601-2-28:2017, IEC 60601-2-43:2017, IEC 60601-2-54:2009/A1:2015 (X-ray system specific safety)
• ISO 14971:2007 (Risk Management)
  "Electrical safety and EMC testing were conducted... The system complies with the IEC 60601-1, IEC 60601-2-43 and IEC 60601-2-54 standards for safety and the IEC 60601-1-2 standard for EMC." |
  | Software Functionality & Performance (for VA21 upgrade & new features) | "The system software was upgraded to support new software features (1-3)."
  "Upgraded software VA21 with Cios Open Apps and Target Pointer. There are no technological differences in these features and the functionality of these features have not changed except for better visualization of moving k-wires. These features are the exact same features cleared in the Secondary Predicate Device Cios Flow (VA30) K1203504. Software Testing was conducted per Software Guidance."
  "The performance data demonstrates continued conformance with special controls for medical devices containing software."
  "Non-clinical tests were conducted on the Subject Device Cios Select software version VA21 during product development."
  "The testing results support that all the software specifications have met the acceptance criteria."
  "Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence."
  "All testable requirements... have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process."
  "The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the test plans." |
  | New Hardware Components (Laser Aimer functionality) | "Same: The green laser aimers on the side of the tube and flat detector is the same exact laser aimer cleared in the Secondary Predicate Device Cios Spin (VA30) K181550." (Implies functional equivalence and safety verification). |
  | Cybersecurity | "Enhanced Cybersecurity."
  "Same: Cybersecurity features are the same features cleared in Cios Select VA20 (K181767)."
  Siemens "conforms to the cybersecurity requirement... Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010." |
  | Human Factors/Usability | "The Cios Select software (VA21) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process."
  "The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer report and feedback form." |
  | Substantial Equivalence (Overall - no new safety/effectiveness concerns introduced by modifications) | "The Cios Select does not introduce any new potential safety risks and is substantially equivalent, and performs as well as the predicate devices."
  "Results of all conducted testing and clinical assessments were found acceptable and do not raise any new issues of safety or effectiveness." |

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

The document does not specify a "sample size" in the context of clinical images for a diagnostic test set. The testing described is primarily engineering bench testing, software verification/validation, and compliance with performance standards. These tests are conducted on the device itself and its components.

• Test Set: Not applicable in the context of a clinical image test set for diagnostic accuracy. The "test set" here refers to the device and its updated software/hardware components undergoing various engineering and compliance tests.
• Data Provenance: Not applicable for clinical image data. The product is manufactured by Siemens Shanghai Medical Equipment Ltd. (Shanghai, China) and Siemens Medical Solutions USA, Inc. (Malvern, PA, USA) is the importer/distributor. The testing appears to be internal verification and validation conducted by Siemens. The clinical use tests mentioned might involve feedback from "customer employees" (users) but the origin of any "clinical assessments" or "clinical use tests" data (e.g., country, retrospective/prospective collection) is not specified.

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

This information is not provided. The ground truth for this device's performance is established by engineering specifications, regulatory standards, and functional verification, not by expert clinical interpretation because it is an imaging system, not a diagnostic AI tool that renders interpretations.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human adjudication process for a diagnostic outcome, as the study focuses on the device's functional and safety performance, not its diagnostic accuracy in interpreting images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not performed or reported in this 510(k) submission. This type of study is typically done to evaluate the impact of an AI diagnostic aid on human reader performance, which is not the focus of this submission. The device is an X-ray system, not primarily an AI diagnostic tool.

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

Not applicable. The AI/ML aspects (if any, as "Cios OpenApps" might imply some advanced processing) are described as "optional" software features that are "the exact same features cleared in the Secondary Predicate Device Cios Flow (VA30) K1203504." The submission does not detail standalone performance of any such algorithms, as the primary focus is on the substantial equivalence of the modified X-ray system.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Engineering Requirements Specifications (ERS) and Subsystem Requirements Specifications (SRS): Performance is measured against predefined technical requirements.
• Regulatory Standards: Compliance with established safety (e.g., IEC 60601 series, 21 CFR standards) and quality standards.
• Equivalence to Predicate Devices: The "ground truth" is that the modified device performs comparably to the predicates and does not introduce new safety or effectiveness concerns, demonstrating substantial equivalence.
• Risk Management Hazard Keys: Verification that identified hazards have been mitigated.

There is no mention of "expert consensus," "pathology," or "outcomes data" being used as ground truth for a diagnostic performance evaluation in this document.

8. The Sample Size for the Training Set

Not applicable. The document describes modifications to an X-ray system and its software, not the development of a new AI/ML algorithm that would require a distinct training set. The software updates are "upgraded software" or "same features" as predicate devices, implying a focus on verification rather than new algorithm training data.

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

Not applicable, as no dedicated training set for a new AI/ML algorithm is mentioned.

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The Cios Select is a mobile X-ray system intended for use in Operating room. Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.

The Cios Select can operate in four different modes, Digital Radiography, and Pulsed Fluoroscopy and Cassette exposure which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of a intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

This 510(k) submission, Cios Select (VA21) is a Mobile C-arm X-ray System. The Cios Select (VA21) is a modification of the Cios Select originally cleared under Premarket Notification K153232 on February 10, 2016.

The Cios Select consists of two major units:

One is the acquisition unit with the C-arm and movable base containing the generator, power unit, system control, and tube housing assembly on one side of the C-arm and the image intensifier on the opposite side.

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 provided text is a 510(k) summary for the Cios Select (VA21) Image Intensifier, which describes modifications to an existing mobile X-ray system. The document focuses on demonstrating substantial equivalence to predicate devices through verification and validation of these modifications. It primarily references non-clinical performance testing and compliance with various standards.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of quantitative acceptance criteria and corresponding reported device performance values in the way one might expect for a diagnostic AI device. Instead, it details that the device underwent non-clinical performance testing to ensure compliance with several industry standards and regulations.

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

The document primarily discusses non-clinical performance testing and mentions "Bench test Summaries and System Verification and Validation testing." There is no mention of a "test set" in the context of clinical images or data provenance (country of origin, retrospective/prospective). The evaluations were primarily conducted in a laboratory or manufacturing setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission relies on engineering and regulatory compliance testing rather than clinical expert review of images for ground truth establishment.

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

Not applicable. As noted above, this submission does not involve a test set requiring expert adjudication for ground truth.

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 study was mentioned. The device is an image intensifier system, not an AI-powered diagnostic aid that assists human readers.

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

This refers to an X-ray imaging system, not an algorithm. The "standalone" performance refers to the system's ability to operate according to its specifications and regulatory standards. The documentation indicates that "Performance tests were conducted to test the functionality of Cios Select (VA21) System," implying standalone performance evaluation of the device itself.

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

For the non-clinical testing, the "ground truth" is defined by the technical specifications outlined in the various industry standards (e.g., IEC, AAMI) and regulatory requirements (e.g., 21 CFR sections) to which the device was tested for compliance.

8. The sample size for the training set

Not applicable. The document describes an X-ray imaging device and its software modifications, not a machine learning or AI algorithm that requires a "training set."

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

Not applicable, as no training set for a machine learning algorithm is discussed in the provided text.

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The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. The Cios Select can operate in three different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

The Siemens Healthineers Cios Select mobile fluoroscopy C-arm system is an X-ray imaging system consisting of two mobile units: a mobile acquisition unit and a monitor cart as the image display station. The mobile acquisition unit is comprised of the X-ray control, the C-arm which supports the single-tank high-frequency generator/X-ray tube assembly, the flat panel detector, and user controls. The monitor cart connects to the acquisition unit by a cable. It integrates the TFT flat panel displays, Digital Imaging Processing System, user controls and image storage devices (DVD, USB).

The provided text describes a 510(k) summary for the Siemens Cios Select (VA20) mobile X-ray system. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and non-clinical performance testing. It does not contain information about a study proving the device meets acceptance criteria in the context of clinical performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" discussed relate to passing engineering verification and validation tests against established standards and guidance documents.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria or reported device performance in the format of specific clinical metrics (e.g., sensitivity, specificity, AUC) for the device's diagnostic capabilities. Instead, the "acceptance criteria" are related to compliance with consensus standards, regulatory guidance, and internal software/hardware validation.

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

The document explicitly states that the tests conducted were non-clinical (bench testing, software verification, electrical safety, EMC, etc.). Therefore, there is no "test set" in the sense of patient data, clinical images, or human subject data. The provenance of such data, therefore, is not applicable.

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

Not applicable, as no clinical test set with corresponding ground truth established by experts is mentioned in the non-clinical testing section.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication is mentioned.

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. The submission focuses on the safety and effectiveness of the device as a standalone imaging system, not on its impact on human reader performance or the improvement provided by AI assistance.

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

This submission is for a medical imaging device (C-arm X-ray system) and its associated software and hardware updates. The "standalone" performance described refers to the device itself operating according to its technical specifications and regulatory standards. It is an "algorithm only" in the sense that the software processes images without human intervention, but the device's function is to acquire and display images for human interpretation. The non-clinical testing evaluates this standalone device performance.

7. The Type of Ground Truth Used

For the non-clinical testing performed, the "ground truth" refers to predefined technical specifications, regulatory standards, and expected functional outputs. For example:

• Engineering Requirements Specifications keys: The device's output and behavior are compared against these internal design requirements.
• Voluntary Conformance Standards (e.g., IEC, ISO, NEMA): The device's performance (e.g., electrical safety, EMC, software lifecycle processes, radiation protection) is measured against these established industry standards.
• FDA Guidance Documents: The implementation and testing adhere to these regulatory expectations (e.g., software guidance, wireless guidance, SSXI guidance).
• Hazard Analysis/Risk Management: Identification and mitigation of potential hazards serve as "ground truth" for safety assessments.

8. The Sample Size for the Training Set

No training set (in the context of machine learning or AI algorithm development) is mentioned. The submission describes updates to an existing X-ray device and its software based on traditional engineering development and testing, not AI-driven development.

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

Not applicable, as no training set (for AI) is mentioned in the document.

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The Cios Select is a mobile x-ray system intended for use in Operation room, Traumatology, Endoscopy, Intensive Care Station, Paediatrics, Ambulatory patient care and in Veterinary Medicine. The Clos Select can operate in four different modes, Digital Radiography, Fluoroscopy and Pulsed Fluoroscopy and Cassette exposure which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of intramedullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

This 510(k) submission, Cios Select is a Mobile Fluoroscopic C-arm X-ray System. The Cios Select is a modification of the Siremobil Compact originally cleared under Premarket Notification K963093 on September 3rd, 1996.

The Cios Select consists of two major units:

One is the acquisition unit with the C-arm and movable base containing the generator, power unit, system control, and tube housing assembly on one side of the C-arm and the image intensifier on the opposite side.

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.

Based on the provided text, the acceptance criteria and the study proving the device meets them are described as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with detailed metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) and their corresponding device performance. Instead, it states that "The results of these tests also demonstrate that the Cios Select acceptance criteria are adequate for this intended use."

The general performance criteria are inferred from the non-clinical testing and verification/validation processes:

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

The document does not explicitly state a "test set" in terms of patient data or images with a specific sample size. The testing described is primarily non-clinical, focusing on hardware, software, electrical safety, EMC, and environmental aspects.

• Sample Size: Not applicable in the context of patient data for a "test set" as typically understood for AI/algorithm performance. The "test set" refers to the device itself being tested for its functional, safety, and performance aspects.
• Data Provenance: Not applicable as the testing is non-clinical/device-focused.

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

This information is not provided because the "acceptance criteria" and "test set" relate to the device's technical specifications and safety/performance standards, rather than the diagnostic accuracy of an AI algorithm based on clinical ground truth.

4. Adjudication Method for the Test Set

Not applicable, as the evaluation involves meeting technical specifications and standards, not clinical diagnostic consensus.

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 comparative effectiveness study involving human readers and AI assistance was not done. The device, Cios Select, is described as a mobile x-ray system, not an AI-based diagnostic tool intended to assist human readers. The clearance is for the X-ray system itself, not an AI algorithm.

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

This is not applicable. The Cios Select is an "Image-Intensified Fluoroscopic X-Ray System," which is a hardware device with integrated software. It's not a standalone algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the testing described is primarily defined by:

• Established industry standards: e.g., IEC 60601 series, ISO 14971 (risk management), IEC 62304 (software life cycle), DICOM standards.
• Internal specifications: The device's own design and functional requirements.
• Predicate device characteristics: Substantial equivalence demonstrated against the Siremobil Compact K963093, implying its performance characteristics and safety profile are the "ground truth" reference.

8. The Sample Size for the Training Set

Not applicable. The Cios Select is a conventional X-ray system, not an AI/Machine Learning diagnostic algorithm that requires a "training set" of data.

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

Not applicable, as there is no "training set" for an AI algorithm mentioned in the document.

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