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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® Select Model Z with Siemens Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z's region of interest (ROI) as compared to Artis zee noncollimated image area. 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, rotational angiography, multipurpose angography and whole body radiographic/fluoroscopic procedures as well as procedures next to the for i.e. patient extremities.

Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by 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.

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. 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 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, urthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

The ControlRad® Trace Model 8, when used with OEC® 9800 Plus, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures 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.

ControlRad® Select Model Z Device Description:
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. It consists of a ControlRad filter mounted onto the Siemens Medical Artis zee (K181407) C-arm. The ControlRad filter is installed semi-permanently 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 20x20 detector and associated collimator. 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 are ControlRad Tablet, ControlRad Filter, ControlRad Hardware, ControlRad Software and Firmware Modules, and ControlRad Communication Interface. ControlRad® Select Model Z contains a titanium filter (2.5mm or 3mm nominal thickness). The system allows physicians to select a customizable region of interest (ROI) using a ControlRad dedicated screen Tablet. The proprietary technology then adjusts semi-tranium filters to deliver the designed high-quality image.

ControlRad® Trace Model 9 Device Description:
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 components are installed semi-permanently in the cleared GE Healthcare Surgery's OEC® 9900 Elite (K122234) and operate in parallel to the GE Healthcare Surgery's OEC® 9900 Elite. The CR Trace Filter is installed on top of the GE Healthcare Surgery's OEC® 9900 Elite's collimator. The CR Trace Filter is a semi-transparent filter which reduces the X-ray radiation outside the clinician-selected ROI.

ControlRad® Trace Model 8 Device Description:
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 consists of the following main components: ControlRad ("CR") Trace Tablet, CR Trace Filter, CR Hardware, CR Software and Firmware Modules and CR Communication Interface. The ControlRad® Trace Model 8 components are installed semi-permanently on the cleared GE Healthcare Surgery's OEC® 9800 Plus (K132027) and operate in parallel to the GE Healthcare Surgery's OEC® 9800 Plus. The CR Trace Filter is installed on top of the GE Healthcare Surgery's OEC® 9800 Plus's collimator. The CR Trace Filter is a semi-transparent filter which reduces the X-ray radiation outside the clinician-selected ROI.

The provided FDA 510(k) summary (K211782) describes three devices: ControlRad® Select Model Z, ControlRad® Trace Model 9, and ControlRad® Trace Model 8. The summary indicates that these are "Bundled Special 510(K) submissions" or "Catch-Up" 510(k)s, suggesting that for each device, the current submission refers to minor changes to a previously cleared predicate device of the same name. Therefore, the performance data presented is primarily to demonstrate that the minor changes do not raise new questions of safety and effectiveness, and that the device remains at least as safe and effective as its predicate.

Here's a breakdown of the acceptance criteria and study information provided for each device, based on the input text:

ControlRad® Select Model Z

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Indications for Use: Provide fluoroscopic imaging while reducing patient and clinician radiation exposure (Dose Area Product) outside the ROI compared to Artis zee non-collimated image area.

Specific Claim: Reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length smaller than 1/5 the edge size of the full FOV. | The device's indications for use are the same as the predicate. The device "is able to reduce DAP as noted in the indications for use" (Dose Area Product (DAP) Reduction test). |
| Impact of Air Kerma: ControlRad® components integrated with Artis zee system do not significantly increase Air Kerma when compared to Artis zee alone. | "Verification that the ControlRad® components on the reference system do not significantly increase Air Kerma... was met." (Impact of Air Kerma test). |
| Air Kerma and Air Kerma Rate (AK/AKR) Accuracy: AK and AKR of the subject system (ControlRad® + Artis zee) is ±35% of Artis zee alone, per 21 CFR 1020.32. | "Verification that the AK and AKR of the subject system... is ±35%... was met." (Air Kerma and Air Kerma Rate Accuracy test). |
| Radiation Dose Structure Report (RDSR) AK Accuracy: Cumulative AKR as referenced in the RDSR of the subject system (ControlRad® + Artis zee) is ±35% of Artis zee alone. | "Verification that the cumulative AKR as referenced in the RDSR of the subject system... is ±35%... was met." (Radiation Dose Structure Report (RDSR) AK Accuracy test). |
| Reference Air Kerma Warning Functionality: Not impacted by ControlRad® components. | "Verification that the Reference Air Kerma Warning Functionality is not impacted... was met." (Reference Air Kerma Warning Functionality test). |
| Dose Area Product (DAP) Accuracy: DAP measurements of the subject system (ControlRad® + Artis zee) is ±35% of Artis zee system per IEC 60601-2-43. | "Demonstrate the DAP measurements of the subject system... is ±35%... was met." (Dose Area Product (DAP) Accuracy test). |
| Filter Attenuation: X-ray radiation attenuation by ControlRad® components shows 44% to 98% attenuation outside the ROI. | "Demonstrate the x-ray radiation attenuation by the addition of the ControlRad® components on the reference system show a 44 to 98% attenuation outside the ROI was met." (Filter Attenuation Testing). |
| Leakage Radiation Evaluation: No adverse impact of ControlRad® components on reference device leakage radiation. | Evaluation performed; outcome not explicitly stated as a percentage or specific value, but "Results of all conducted testing was found acceptable". |
| Stray Radiation Evaluation: No adverse impact of ControlRad® components on reference device stray radiation. | Evaluation performed; outcome not explicitly stated as a percentage or specific value, but "Results of all conducted testing was found acceptable". |
| Recovery Management: As required by IEC 60601-2-43, section 201.4.101. | "Verification that recovery management of ControlRad® Select Model Z as required by IEC 60601-2-43, section 201.4.101 was met." (Recovery Management test). |
| Mechanical Impact on Filter Cover: Impact to filter/collimator cover does not create unacceptable risk per IEC 60601-1 requirements. | "Verification that impact to the filter / collimator cover does not create unacceptable risk per IEC 60601-1 requirements was met." (Mechanical Impact on Filter Cover test). |
| Collision Sensor Functionality Evaluation: Maintained when using ControlRad® filter/collimator covers. | "Verification that the collision sensor functionality is maintained when using the ControlRad® filter / collimator covers was met." (Collision Sensor Functionality Evaluation test). |
| Focal Spot to Patient Distance: Implementation per IEC 60601-2-54, section 203.9 requirements. | "Verification that the focal spot to skin distance implementation per IEC 60601-2-54, section 203.9 requirements was met." (Focal spot to patient distance test). |
| Tensile Strength Evaluation: Additional mass from Select Model Z filter does not create unacceptable risk from tensile strength per IEC 60601-1 requirements. | "Verification that additional mass from the Select Model Z filter does not create unacceptable risk from tensile strength per IEC 60601-1 requirements was met." (Tensile Strength Evaluation test). |
| Filter Motion Reliability Testing: Durability of mechanical filter assembly verified within a random motion stress test. | "Verification that the durability of the mechanical filter assembly in frame of a random motion stress test was met." (Filter Motion Reliability Testing). |
| Comparative image quality inside the ROI: At least the same image quality as the Siemens Artis zee alone. | "Verifies that image quality inside the ROI is at least the same quality as the image that would be gathered with the Artis zee alone was met." (Comparative image quality inside the ROI test). |
| Comparative image quality outside the ROI: Quantify the level of image quality degradation. | "Quantify the level of image quality degradation outside the region of interest as a result of the CR filter blades was met." (Comparative image quality outside the ROI test). |
| Image quality evaluation via clinical simulations: Image quality outside the ROI is clinically relevant following degradation due to use of ControlRad filters. | "To validate that the image quality outside the ROI in clinically relevant following degradation due to use of the ControlRad filters was met." (Image quality evaluation via clinical simulations test). |
| DAP Chamber Change Justification: Justify the change in DAP chamber. | Justification performed; outcome not explicitly detailed, but "Results of all conducted testing was found acceptable". |
| Touch-In-Glove Bench Test: Sensitivity of ControlRad® tablet with sterile radiation reducing gloves. | "To verify the sensitivity of the ControlRad® tablet when using sterile radiation reducing gloves was met." (Touch-In-Glove Bench Test). |
| Wireless Devices and Cybersecurity Evaluation: Compliance with FDA Guidance documents: "Radio Frequency Wireless Technology in Medical Devices" and "Postmarket Management of Cyber Security in Medical Devices." Process of preventing unauthorized access, modifications, misuse, denial of use, or unauthorized use of information. | Evaluation performed; "ControlRad® conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use...". |

2. Sample size for test set and data provenance: The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than providing detailed clinical study reports. The performance data section describes types of tests conducted (e.g., Impact of Air Kerma, DAP Accuracy, Comparative Image Quality) and generic statements about "verification" that criteria were met. It does not provide specific sample sizes (e.g., number of images, patients, or instances) for any of these tests, nor does it specify the country of origin or whether the data was retrospective or prospective. It only states that "Nonclinical tests were conducted on ControlRad® Select Model Z during product development," implying bench testing rather than clinical data.

3. Number of experts and qualifications: Not specified. The document mentions "clinically relevant" for image quality, but doesn't detail external expert review or qualifications for establishing ground truth on the test set.

4. Adjudication method for test set: Not specified.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not explicitly mentioned or detailed. The term "Comparative image quality inside/outside the ROI" indicates a comparison to the Artis zee alone, but no details on human readers, effect sizes, or AI assistance are provided. The device described appears to be a hardware/software add-on that reduces radiation while maintaining image quality or providing contextual information, not primarily an AI algorithm for diagnosis.

6. Standalone (algorithm-only) performance: The device is described as an accessory that works with existing fluoroscopic X-ray systems (Siemens Artis zee, OEC 9900 Elite, OEC 9800 Plus) to reduce radiation dose in specific areas while maintaining or providing contextual image quality. Its performance is always in conjunction with the base imaging system; therefore, a purely "standalone" algorithm-only performance is not applicable in the context of this device. The testing focuses on the integrated system's performance.

7. Type of ground truth used: Based on the descriptions of "performance tests," "verification," and "evaluation" against specific metrics (e.g., DAP accuracy, AKR accuracy, image quality compared to the base system), the ground truth appears to be based on physical phantom measurements, quantitative dosimetry, and technical performance metrics as opposed to clinical outcomes or expert consensus on disease presence. For "Comparative image quality," the baseline performance of the unmodified Artis zee system served as a reference. Clinical simulations were mentioned for image quality evaluation, but further details about how "ground truth" was established within those simulations are not provided.

8. Sample size for training set: Not applicable and not mentioned. This device is an accessory that modifies X-ray output and image processing to reduce dose; it is not presented as a machine learning/AI diagnostic system that would typically require a training set of patient data with ground truth labels.

9. How ground truth for training set was established: Not applicable, as no training set for an AI/ML algorithm is described. The software components relate to controlling the filter and image processing, not to learning from data.

ControlRad® Trace Model 9

The information for ControlRad® Trace Model 9 is very similar in structure and detail to the Select Model Z.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Indications for Use: Reduce patients and clinicians' radiation exposure (DAP) outside the ROI compared to OEC® 9900 Elite non-collimated image area.

Specific Claim: Reduces at least 50% of the DAP at 50 kVp and ROI with width and length smaller than 1/3 the diameter of the full FOV. | The device's indications for use are the same as the predicate. The device "reduces at least 50% of the DAP at 50kVp and ROI with width and length are smaller than 1/3 the diameter of the full FOV" (DAP Reduction Accuracy Test). |
| Impact on Air Kerma: Evaluate impact on Air Kerma Rate (AKR) of GE Healthcare Surgery's OEC 9900 Elite. | "Impact on Air Kerma Test was performed in order to evaluate the impact... In all performance tests... performed and functioned as intended and observations were as expected." |
| DAP calculation accuracy: DAP calculations within ±35% of measured DAP values. | "Dose-Area-Product (DAP) calculation accuracy test was performed to demonstrate that DAP calculations... are within ±35% of measured DAP values was met." |
| DAP Reduction Accuracy: DAP Reduction calculations within ±35% of measured DAP Reduction values. | "Dose-Area-Product (DAP) Reduction Accuracy Test was performed to demonstrate that DAP Reduction calculations... are within ±35% of the DAP Reduction values was met." |
| ControlRad® Trace Filter Attenuation: Evaluate attenuation level of the filters. | "ControlRad® Trace Filter Attenuation Test was performed to evaluate the attenuation level... In all performance tests... performed and functioned as intended and observations were as expected." |
| Comparative Image Quality inside the ROI: Image quality within ROI is at least the same as OEC 9900 Elite alone. | "Comparative Image Quality inside the ROI Test was performed to demonstrate that the image quality... within the ROI is of at least the same image quality compared to the image quality of the OEC 9900 Elite alone was met." |
| Comparative Image Quality outside the ROI: Evaluate filtered image quality outside the ROI. | "Comparative Image Quality outside the ROI Test was performed in order to evaluate the filtered image quality outside the ROI... In all performance tests... performed and functioned as intended and observations were as expected." |
| Image Quality Clinical Simulations: Evaluate image quality inside/outside ROI and ability of filtered image outside ROI to provide image context to the ROI. | "Image Quality Clinical Simulations was preformed to evaluate the image quality inside and outside the ROI and the ability of the filtered image outside the ROI to provide image context to the ROI... was met." |
| Touch-In-Gloves Bench Test: Tablet touchscreen operates as intended with sterile radiation protective gloves and touchscreen drape. | "Touch-In-Gloves Bench Test was performed in order to demonstrate that the CR Trace Tablet's touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape was met." |
| Wireless Technology and Cybersecurity Evaluation: Compliance with FDA Guidance documents and process for preventing unauthorized access, modifications, misuse, denial of use, or unauthorized use of information. | "Wireless Technology and Cybersecurity Evaluation was performed in order to evaluate the ControlRad® Trace Model 9's compliance... ControlRad conforms to the cybersecurity requirementing a process of preventing unauthorized access..." |

2. Sample size for test set and data provenance: No specific sample sizes, country of origin, or whether data was retrospective/prospective are mentioned. "Non-clinical tests were conducted... during product development."

3. Number of experts and qualifications: Not specified.

4. Adjudication method for test set: Not specified.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not explicitly mentioned or detailed.

6. Standalone (algorithm-only) performance: Not applicable. Performance is integrated with the OEC 9900 Elite system.

7. Type of ground truth used: Based on the descriptions, ground truth appears to be based on physical phantom measurements, quantitative dosimetry, and technical performance metrics compared to the unmodified OEC 9900 Elite system. "Image Quality Clinical Simulations" are mentioned, but details on how ground truth was established within are not provided.

8. Sample size for training set: Not applicable and not mentioned.

9. How ground truth for training set was established: Not applicable.

ControlRad® Trace Model 8

The information for ControlRad® Trace Model 8 is also very similar in structure and detail to the other models.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Indications for Use: Reduce patients and clinicians' radiation exposure (DAP) outside the ROI compared to OEC® 9800/9800 Plus non-collimated image area.

Specific Claim: Reduces at least 50% of the DAP at 50 kVp and ROI with width and length smaller than 1/3 the diameter of the full FOV. | The device's indications for use are the same as the predicate. The device "reduces at least 50% of the DAP at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV" (DAP Reduction Test). |
| Impact on Air Kerma: Evaluate impact on Air Kerma Rate (AKR) of GE Healthcare Surgery's OEC 9800 Plus. | "Impact on Air Kerma Test was performed in order to evaluate the impact... In all performance tests... performed and functioned as intended and observations were as expected." |
| DAP calculation accuracy: DAP calculations within ±35% of measured DAP values. | "DAP calculation accuracy test was performed to demonstrate that DAP calculations... are within ±35% of measured DAP values was met." |
| DAP Reduction Accuracy: DAP Reduction calculations within ±35% of measured DAP Reduction values. | "DAP Reduction Accuracy Test was performed to demonstrate that DAP Reduction calculations... are within ±35% of measured DAP Reduction values was met." |
| ControlRad® Trace Filter Attenuation: Evaluate attenuation level of the filters. | "ControlRad® Trace Filter Attenuation Test was performed to evaluate the attenuation level... In all performance tests... performed and functioned as intended and observations were as expected." |
| Comparative Image Quality Inside the ROI: Image quality within ROI is at least the same as OEC 9800 Plus alone. | "Comparative Image Quality Inside the ROI Test was performed to demonstrate that the image quality... within the ROI is at least with the same image quality compared to the image quality of the GE Healthcare Surgery's OEC 9800 Plus alone was met." |
| Comparative Image Quality Outside the ROI: Evaluate filtered image quality outside the ROI. | "Comparative Image Quality Outside the ROI Test was performed in order to evaluate the filtered image quality outside the ROI... In all performance tests... performed and functioned as intended and observations were as expected." |
| Image Quality Clinical Simulations: Evaluate image quality inside/outside ROI and ability of filtered image outside ROI to provide image context to the ROI. | "Image Quality Clinical Simulations was performed to evaluate the image quality inside and outside the ROI and the ability of the filtered image outside the ROI to provide image context to the ROI... was met." |
| Touch-In-Gloves Bench Test: Tablet touchscreen operates as intended with sterile radiation protective gloves and touchscreen drape. | "Touch-In-Gloves Bench Test was performed in order to demonstrate that the CR Trace Tablet's touchscreen operates as intended when using sterile radiation protective qloves and touchscreen drape was met." |
| Wireless Technology and Cybersecurity Evaluation: Compliance with FDA Guidance documents and process for preventing unauthorized access, modifications, misuse, denial of use, or unauthorized use of information. | "Wireless Technology and Cybersecurity Evaluation was performed in order to evaluate the ControlRad® Trace Model 8's compliance... ControlRad® conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access..." |

2. Sample size for test set and data provenance: No specific sample sizes, country of origin, or whether data was retrospective/prospective are mentioned. "Non-clinical tests were conducted... during product development."

3. Number of experts and qualifications: Not specified.

4. Adjudication method for test set: Not specified.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not explicitly mentioned or detailed.

6. Standalone (algorithm-only) performance: Not applicable. Performance is integrated with the OEC 9800 Plus system.

7. Type of ground truth used: Based on the descriptions, ground truth appears to be based on physical phantom measurements, quantitative dosimetry, and technical performance metrics compared to the unmodified OEC 9800 Plus system. "Image Quality Clinical Simulations" are mentioned, but details on how ground truth was established within are not provided.

8. Sample size for training set: Not applicable and not mentioned.

9. How ground truth for training set was established: Not applicable.

In summary, the 510(k) relies on a conformance approach for these "catch-up" submissions, demonstrating that minor changes to previously cleared devices do not negatively impact safety and effectiveness. The studies described are primarily technical and bench-top validations of the components and system performance against pre-defined engineering and regulatory standards and against the baseline performance of the unmodified C-arm systems. They do not involve extensive human-in-the-loop studies or clinical trials with large patient cohorts to establish nuanced clinical effectiveness or comparative diagnostic accuracy.

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The ControlRad® Select Model Z with Siemens 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, 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 quided surgery by Xray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions.

1Relative 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. ControlRad® hereby submits this Traditional 510(k) to request clearance to market the ControlRad® Select Model Z with SW version V1.0.0.7.1 and a dose reduction claim: 85% of the Dose Area Product (DAP) at 65 kVp with width and length that are smaller than 1/5 the edge size of the full Field Of View (FOV).

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 20x20 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 reqion 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 3mm, both of which are partially transparent to X-ray radiation.

Based on the user selection of the Artis zee collimator the ControlRad Filter region of interest (ROI) the radiation will be reduced. The X-ray beam inside the ROI is not impacted by the ControlRad Filters. All radiation outside the ROI and inside the Artis zee collimated area will be filtered. This 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® Select Model Z allows physicians to select a customizable region of interest (ROI) using a ControlRad dedicated screen Tablet. The proprietary technology then adjusts semi-transparent titanium filters to deliver the designed high-quality image. This allows the Artis zee to generate an image in the selected physician's ROI while providing a lower radiation dose to the periphery. The result is a reduction in the overall radiation dose and exposure to the patient and the healthcare team while providing the physician the contextual information needed outside the ROI.

The workflow is therefore supported with lower radiation than with conventional imaging settings.

The ControlRad Filter is designed to always include the center of the FOV in the ROI. Therefore, when selecting an ROI by the user, the actual ROI might be expanded to include the center of the FOV.

The ControlRad® Select Model Z is a product that can be mounted only on the following configurations of the Artis zee: floor, ceiling, and bi-plane systems.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the ControlRad® Select Model Z:

Acceptance Criteria and Device Performance

The provided document details various performance tests conducted to demonstrate the device's safety and effectiveness. The acceptance criteria are implicit in the "Verification" or "Accuracy" statements, and the "Reported Device Performance" is the stated outcome of these tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes (e.g., number of images, patients, or test runs) for each specific test mentioned in the "Performance Data" section. It primarily relies on bench testing, system validation testing, and simulated clinical use tests.

• Data Provenance: The studies appear to be non-clinical bench and system validation tests conducted by the manufacturer, rather than studies involving human subjects in a real-world clinical setting. The "clinical simulations" suggest a controlled environment. There is no information regarding the country of origin of data in terms of patient data, as no patient data appears to have been formally collected for this 510(k) submission. These are engineering and performance validation tests.

3. Number of Experts and Qualifications for Ground Truth

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

• For "Comparative image quality inside the ROI" and "Image quality evaluation via clinical simulations," it states that these validate the image quality, implying expert assessment. However, the specific number and qualifications of these "experts" (e.g., radiologists) are not provided.
• The overall evaluation is based on meeting technical performance standards and demonstrating substantial equivalence to a predicate device, which primarily involves engineering validation rather than human interpretation assessment of image quality.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. Given that the studies are primarily technical performance validations (bench and system tests, not reader studies), such adjudication methods would typically not be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The submission focuses on demonstrating substantial equivalence through technical performance tests and comparing the device's technical specifications to a predicate device. The goal is to show the device functions as intended and safely, not to quantify improvement in human reader performance with AI assistance.

6. Standalone (Algorithm Only) Performance

The device is an add-on component to an existing fluoroscopic x-ray system (Siemens Artis zee). It is described as a "set of components mounted on the Artis zee system and cannot be used independent of the Artis zee system." Therefore, a standalone performance study in the sense of an "algorithm only without human-in-the-loop" would not be applicable as the device itself is a physical and integrated system component, not just a software algorithm for interpretation. Its function is to modify the X-ray field and subsequent image processing, which inherently involves human operation and interaction with the Artis zee system.

7. Type of Ground Truth Used

The ground truth used for these tests is primarily engineering specifications and established performance standards (e.g., 21 CFR 1020.32, IEC 60601 series).

• For radiation dose metrics, the ground truth is derived from quantitative measurements verifying compliance with specified tolerances (e.g., ±35% accuracy for AK, AKR, DAP).
• For image quality, the ground truth for "inside the ROI" is the image quality of the predicate Artis zee system alone. For "outside the ROI," it's about validating that the degraded image quality remains "clinically relevant" through "clinical simulations," suggesting a qualitative assessment against a clinical utility standard.
• For mechanical, electrical, and software aspects, the ground truth is conformance to relevant international standards (ISO, IEC) and FDA guidance documents.

8. Sample Size for the Training Set

The document does not mention a "training set" or "training data" in the conventional sense associated with machine learning or AI models. This device primarily involves hardware modifications and associated software that controls the physical filter and image processing. It is not an AI algorithm that learns from a dataset like an image classification model.

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

As no training set is discussed or implied to be part of the device's development or validation process (as it's not a machine learning model), this question is not applicable.

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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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ControlRad Sterile Cover is a single use sterile equipment cover intended for use by professionals in a sterile clinical setting to cover the ControlRad Trace Tablet and create a sterile barrier between the rest of the sterile field to prevent contamination during various procedures.

The ControlRad Sterile Cover is a terminally sterilized device intended to cover the ControlRad tablet in order to operate a ControlRad tablet in a sterile environment.

The provided text describes the regulatory clearance for the "ControlRad Sterile Cover," a surgical drape accessory. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with non-clinical testing results.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a "Sterile Cover," which is a physical device (a surgical drape accessory). It is not an AI/ML-driven device or a diagnostic device, therefore, many of the typical acceptance criteria and study designs associated with AI/ML or diagnostic performance (like MRMC studies, expert ground truth establishment for diagnostic accuracy, standalone algorithm performance, training set details) are not applicable to this type of medical device. The "performance" here refers to the physical and functional integrity of the sterile cover.

1. Table of Acceptance Criteria and Reported Device Performance

Specifics Not Applicable or Not Provided for This Device Type:

Given that this is a physical medical device (sterile cover) and not an AI/ML diagnostic or treatment planning system, several items in the prompt are not applicable to the type of data and studies required for its clearance.

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

  • The document does not explicitly state the sample sizes for each non-clinical test. These tests are typically conducted on a representative sample of the manufactured device.
  • Data provenance is not specified in terms of country of origin or retrospective/prospective, as this applies more to clinical data or imaging datasets, which are not relevant here.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like a sterile cover is established through objective physical, chemical, and biological testing as per international standards (e.g., ASTM, ISO). There are no human "experts" establishing diagnostic ground truth in this context.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations of data (e.g., image reads by radiologists), which is not part of the testing for this device.

• 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: Not applicable. This type of study is for evaluating the impact of AI on human diagnostic performance, which is irrelevant for a sterile cover.

• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from the established and validated methodologies of the referenced ASTM and ISO standards for physical properties, barrier integrity, sterility, and biocompatibility.

• 8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.

• 9. How the ground truth for the training set was established: Not applicable.

In summary, the "study" proving the device meets acceptance criteria is a series of non-clinical laboratory tests performed according to recognized international and national standards (ASTM, ISO). The acceptance criteria are objective, quantifiable thresholds or observations (e.g., no penetration, specific strength values, sterility assurance level) that the device must meet to demonstrate its safety and effectiveness as a sterile barrier.

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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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