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

The Siemens Cios Connect mobile fluoroscopy system is an imageintensified fluoroscopic 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 Image Intensifier, and user controls. The monitor cart connects to the acquisition unit by a cable. It integrates the TFT flat panel displays, Digital Image Processing System, user controls and image storage devices (DVD, USB).

Interfaces are provided for optional devices such as external monitors, thermal printers, MP3 players, connections for 2D navigation systems, lithotripters or injectors, as well as wired and wireless DICOM network interfaces.

The provided document is a 510(k) summary for the Siemens Cios Connect, a mobile fluoroscopic X-ray system. It outlines various aspects of the device, its intended use, and comparisons to predicate devices for demonstrating substantial equivalence. However, it does not contain specific acceptance criteria, performance metrics, or details of a study that directly proves the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.

The document focuses on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and compliance with regulatory standards. It mentions "bench testing," "non-clinical testing," "electrical safety and EMC testing," and "software verification and validation testing," indicating that these internal tests were successfully performed against internal acceptance criteria (e.g., meeting engineering requirements, system test plans, industry standards). However, these reports do not provide the detailed performance data or study design that would address the requested information.

Therefore, many of the requested items cannot be directly answered from the provided text.

Here's an attempt to extract what can be found and to explicitly state what is missing:

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

Cannot be fully provided from the text. The document states:

• "All testable requirements in the Engineering Requirements Specifications keys, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys 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."
• "System level validation and regression testing has been performed successfully, demonstrating that the device meets the acceptance criteria as noted in the system test plans."
• "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."

Missing: The specific numerical or qualitative acceptance criteria themselves are not listed, nor are the detailed reported performance results against those criteria. The compliance with standards implies meeting their requirements, but the specifics are not detailed.

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

Cannot be provided from the text. The document describes various "testing" and "validation activities" on "production prototype devices" without specifying sample sizes for any test sets or data provenance. The testing appears to be internal validation rather than a clinical study with patient data.

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)

Cannot be provided from the text. There is no mention of experts establishing ground truth, as the testing described is technical validation of the device's functionality and safety, not a clinical performance assessment against a ground truth.

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

Cannot be provided from the text. No adjudication method 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. The document does not describe any MRMC comparative effectiveness study, nor does it mention AI assistance. The device is an imaging system (fluoroscopic X-ray), not an AI-powered diagnostic tool.

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

Cannot be provided from the text. The document does not describe a standalone algorithm performance study. The device is a hardware imaging system with integrated software.

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

Cannot be provided from the text. There is no mention of ground truth as the testing described relates to the technical specifications and safety of the imaging device itself, not the accuracy of interpretations (which would typically involve ground truth).

8. The sample size for the training set

Cannot be provided from the text. The device is a medical imaging system hardware/software, not an AI/Machine Learning algorithm that typically requires a "training set" in the context of model development. Software verification and validation are mentioned, but this refers to traditional software engineering processes, not ML training.

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

Cannot be provided from the text. As there's no mention of a "training set" in the context of AI/ML, there's no information on how its ground truth was established.

Summary of Available Information on Acceptance Criteria and Studies from the Text:

The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Siemens Cios Connect to legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness.

The document indicates that the device underwent several types of internal and compliance testing:

• Bench Testing: Evaluated performance and functionality of new features, hardware, and software updates. All testable requirements in Engineering Requirements Specifications, Subsystem Requirements Specifications, and Risk Management Hazard keys were successfully verified and traced. Software verification and regression testing met "previously determined acceptance criteria as stated in the test plans."
• Non-Clinical Testing: Validation activities were performed at the "System test level on production prototype devices" by "appropriately trained and knowledgeable test personnel." System level validation and regression testing "demonstrated that the device meets the acceptance criteria as noted in the system test plans."
• Electrical Safety and Electromagnetic Compatibility (EMC): Tested and found compliant with IEC 60601-1, IEC 60601-2-43, IEC 60601-2-54 for safety, and IEC 60601-1-2 for EMC.
• Software Verification and Validation Testing: Conducted in accordance with FDA guidance for "moderate" level of concern software. Design requirements were fulfilled, the system functions as intended, and the device performs as designed.

The "acceptance criteria" and "study" described are primarily internal engineering and regulatory compliance validations against pre-defined specifications and recognized standards, rather than a clinical performance study with detailed statistical outcomes against a defined ground truth on a large patient dataset. The document concludes that these tests confirm the Cios Connect performs as designed and does not raise new safety or effectiveness concerns compared to predicate devices.

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