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The ControlRad® Select Model Z with the Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z 's region of interest (ROI) as compared to Artis zee non-collimated image area. 1 The ControlRad Select Model Z semi-transparent filter should not be used in lieu of the Artis zee's collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.

Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, bv image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions.

1 Relative to open Field of View (FOV), the ControlRad Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the edge size of the full FOV.

The ControlRad® Select Model Z is a set of components mounted on the Artis zee system and cannot be used independent of the Artis zee system.

The ControlRad® Select Model Z consists of a ControlRad® filter mounted onto the Siemens Medical Artis zee (K181407) C-arm. The ControlRad® filter is installed semipermanently (i.e., the filter may be removed to return the C-arm to its original condition) to aid in reducing both patient and clinicians' radiation exposure while providing fluoroscopic imaging of the patient during diagnostic, surgical and interventional procedures.

The ControlRad® Filter is an optional component installed on the Siemens Artis zee's collimator to further reduce radiation emissions. The ControlRad® Select Model Z is only compatible with the 30 x 40 detector and associated collimator. Use of this system on other sizes is prohibited.

The additional radiation reduction provided by the ControlRad® Filter will be outside the clinician-selected ROI and within the un-collimated region/image FOV.

The main components of the ControlRad® Select Model Z which are used with the Artis zee are:

• ControlRad® Tablet .
• ControlRad® Filter .
• ControlRad® Hardware ●
• ControlRad® Software and Firmware Modules .
• . ControlRad® Communication Interface

The ControlRad® Select Model Z is a system used to assist trained clinicians which is used to provide X-ray images when the clinician performs a medical procedure while reducing the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad® Select Model Z's region of interest (ROI) as compared to the Artis zee non-collimated image area. The ControlRad® Select Model Z can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.

ControlRad® Select Model Z contains a titanium filter. Two filter sizes are available with nominal thicknesses of 2.5mm or 3.0 mm, both of which are partially transparent to X-ray radiation.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., number of images, number of patients). However, it lists various tests conducted, including:

• Software Verification: v3.0.5 software.
• Impact, Accuracy, and Reduction tests related to Air Kerma and Dose Area Product (DAP): These are quantitative measurements performed on the device.
• Image quality evaluation via clinical simulations: This suggests a test set related to clinical scenarios.

The data provenance is implied to be prospective testing conducted by ControlRad, Inc. during product development. The tests are focused on the device's functional performance and adherence to standards rather than analysis of patient data from a specific origin. There is no mention of country of origin for the data or whether it was retrospective.

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

The document does not mention the use of experts to establish a "ground truth" for a specific test set, as this is not a diagnostic AI device requiring expert interpretation for label generation. The tests performed are primarily engineering and performance verification tests against established technical specifications and regulatory standards.

For "Image quality evaluation via clinical simulations," while the document indicates that the image quality outside the ROI was validated as "clinically relevant," it does not specify the number or qualifications of experts involved in this validation.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the studies are largely technical performance verifications against predefined criteria and standards, not studies requiring adjudication of diagnostic interpretations.

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 comparative effectiveness study involving human readers and AI assistance was not done. The ControlRad® Select Model Z is a system that modifies the fluoroscopic image acquisition to reduce radiation, not a diagnostic AI that assists human readers in interpreting images. Its primary benefit is radiation dose reduction while maintaining image quality within the ROI and providing contextual information outside it.

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

Yes, in essence, the majority of the performance verification tests listed were effectively "standalone" tests of the device's technical and physical performance metrics without human interpretation in the loop. These include:

• Air Kerma and DAP accuracy and reduction tests.
• Software verification.
• Mechanical and electrical requirement verifications.
• Filter attenuation, leakage radiation, and stray radiation evaluations.

The "Comparative image quality inside the ROI" and "Comparative image quality outside the ROI" also evaluate the output of the system (images) directly against defined quality criteria.

7. The Type of Ground Truth Used:

The "ground truth" for the various performance tests is based on established technical specifications, regulatory standards, and physical measurements. For example:

• Dose Area Product (DAP) Accuracy: Based on standards like IEC 60601-2-43 and 21 CFR 1020.32, with an acceptance criterion of ±35%.
• Radiation Modulation/Reduction: Based on the device's design specification (e.g., reduces at least 85% of DAP at 65 kVp under certain ROI conditions; typically reduces radiation outside the aperture by 44% to 98%).
• Image Quality: Verified against the image quality of the Artis zee system alone within the ROI, and characterized for clinical relevance outside the ROI. These would involve objective image quality metrics.
• Safety Standards: Adherence to standards like ISO 14971, IEC 60601 series, and FDA 21 CFR 1020.30-32.

8. The Sample Size for the Training Set:

This information is not provided in the document. The ControlRad® Select Model Z is a hardware and software system for X-ray modulation, not a machine learning model developed with a distinct "training set" in the context of diagnostic AI. While it uses software and firmware, the document describes performance testing rather than machine learning model validation based on a training set.

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

This information is not applicable as a distinct training set (in the context of machine learning for diagnostic inference) and its ground truth establishment are not described for this device. The software and firmware within the device control the physical mechanisms (filters, etc.) and process images based on pre-defined algorithms and physical principles, rather than learning from a labeled training set in the typical AI sense.

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The ControlRad™ Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to OEC® 9900 Elite non-collimated image area. 1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite's collimators, as they block the most radiation, but can help physicians balance dose visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

1 Relative to open Field of View (FOV), the ControlRad Trace Model 9 reduces at least 50% of the Dose Area Product at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.

The ControlRad™ Trace Model 9 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface all installed on the OEC 9900 Elite. The ControlRad™ Trace Model 9 is a system used to assist trained clinicians which is used to provide X-ray images when the clinician performs a medical procedure while reducing the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to the OEC 9900 Elite non-collimated image area. The ControlRad™ Trace Model 9 can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.

Here's a breakdown of the acceptance criteria and study information for the ControlRad™ Trace Model 9, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes various performance tests conducted by ControlRad to demonstrate the safety and effectiveness of the ControlRad™ Trace Model 9. However, it does not detail specific study methodologies with the level of granularity requested for some fields (e.g., exact sample sizes for test sets, data provenance, ground truth establishment for training data, MRMC studies). The tests described are primarily bench tests and clinical simulations rather than large-scale clinical trials with human readers.

Here's what can be extracted:

• Sample size used for the test set and the data provenance: Not explicitly stated for each test. The studies appear to be retrospective in the sense that they are engineering performance tests and simulations rather than prospective patient studies. The data provenance is implied to be from testing conducted by ControlRad, Inc.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. For image quality evaluations, the text mentions "clinically simulated image" and "ability of the filtered image outside the ROI to provide image context to the ROI", implying expert review, but the number and qualifications are not specified.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated.
• 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 involving human readers and AI assistance is described. The image quality tests are comparative to the OEC 9900 Elite alone, not comparing human performance with and without the device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The described tests are largely standalone performance evaluations of the device's capabilities (e.g., DAP reduction accuracy, attenuation, filter motion). The "Image Quality Clinical Simulations" also assessed algorithm performance in generating the filtered image and its ability to provide context.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc):
  • For DAP measurements: Measured DAP values (using a dosimeter or similar equipment)
  • For image quality: Likely expert visual assessment against the baseline OEC 9900 Elite images. The term "clinically simulated image" suggests a controlled environment for evaluation.
  • For touchscreen and filter motion: Functional verification against expected operational behavior.
• The sample size for the training set: Not applicable and not mentioned. This device is an X-ray system enhancement with a filter and image processing, not a machine learning model that requires a "training set" in the conventional sense for image interpretation. The device's software is based on algorithms that modify X-ray output and image display.
• How the ground truth for the training set was established: Not applicable, as there's no mention of a traditional machine learning training set.

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The ControlRad™ Trace Model 8, when used with OEC® 9800/OEC® 9800 Plus, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to the OEC® 9800/OEC® 9800 Plus non-collimated image area. The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9800/OEC® 9800 Plus' collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cholangiography, endoscopic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

The ControlRad™ Trace Model 8 is an accessory to the cleared OEC 9800/OEC 9800 Plus system. The ControlRad™ Trace Model 8 accessory installed in the OEC 9800/OEC 9800 Plus is a system used to assist trained clinicians. The system is used to provide X-ray images when the clinician performs a medical procedure while reducing the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to the OEC 9800/OEC 9800 Plus non-collimated image area. The ControlRad™ Trace Model 8 can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.

The ControlRad™ Trace Model 8 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface.

The ControlRad™ Trace Model 8 is an accessory to the OEC 9800/OEC 9800 Plus fluoroscopic systems, designed to reduce patient and clinician radiation exposure outside a selected Region of Interest (ROI) while maintaining imaging capability.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes several performance tests. The table below lists the acceptance criteria and the reported performance as described.

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

The provided summary does not specify the sample sizes for any of the performance tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the data). The tests appear to be conducted as laboratory/bench tests or simulated clinical scenarios rather than involving patient data from a specific geography.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth, particularly concerning image quality assessments. It mentions "trained clinicians" but does not detail their involvement in ground truth establishment for the performance tests.

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

The document does not specify any adjudication method for the test set results, particularly for subjective assessments like image quality.

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:

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The evaluation focused on the device's performance in terms of radiation reduction and image quality, not on human reader improvement with or without AI assistance. The ControlRad Trace Model 8 is not presented as an AI-assisted diagnostic tool but rather a radiation modulation accessory.

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

The device is an accessory to a fluoroscopic system and involves a "clinician-selected ROI." Therefore, its operation inherently involves a "human-in-the-loop." The performance tests evaluate the device's technical capabilities (e.g., DAP reduction, image quality within/outside ROI, calculation accuracy, filter attenuation), which could be considered "standalone" in evaluating the physical and computational aspects of the device itself, but its intended use is always with a human operator. The document does not describe a purely algorithm-only performance evaluation separate from its integration with the OEC system and clinician interaction.

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

For quantitative measures like DAP and DAP reduction, the "ground truth" was established by measured physical values using appropriate dosimetry equipment. For image quality assessments, it implicitly relies on a comparison to the image quality of the OEC 9800/OEC 9800 Plus alone, suggesting a comparative visual assessment as the basis for "ground truth" for image quality, presumably against a predetermined standard or the predicate device's baseline. There is no mention of expert consensus, pathology, or outcomes data specific to establishing ground truth for these performance tests.

8. The sample size for the training set:

The document does not mention a training set in the context of machine learning or AI models. The ControlRad™ Trace Model 8 is described as an accessory with hardware, software, and firmware modules that control a physical filter and perform image processing based on a user-selected ROI. It does not appear to involve a learning algorithm that would require a distinct training set in the typical AI/ML sense.

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

As no training set is described or implied for an AI/ML model, this information is not applicable based on the provided document. The device's operation is based on pre-programmed logic and physical principles rather than learned patterns.

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