(103 days)
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
| Acceptance Criteria | Reported Device Performance | Study Proving Performance (from text) |
|---|---|---|
| Reduces at least 50% of the Dose Area Product (DAP) at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full Field of View (FOV). | The ControlRad™ Trace Model 9, when installed on the OEC 9900 Elite, 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: "DAP Reduction Accuracy Test was performed to demonstrate that DAP Reduction calculations of the ControlRad™ Trace Model 9 when installed in GE Healthcare Surgery's OEC 9900 Elite system are within ±35% of the DAP Reduction values." |
| DAP calculations are within ±35% of measured DAP values. | DAP calculations of the ControlRad™ Trace Model 9 when installed in GE Healthcare Surgery's OEC 9900 Elite system are within ±35% of measured DAP values. | Dose-Area-Product (DAP) calculation accuracy test: "Dose-Area-Product (DAP) calculation accuracy test was performed to demonstrate that DAP calculations of the ControlRad™ Trace Model 9 when installed in GE Healthcare Surgery's OEC 9900 Elite system are within ±35% of measured DAP values." |
| Image quality inside the Region of Interest (ROI) is at least the same as the OEC 9900 Elite alone. | The image inside the clinician-selected ROI has at least the same image quality in the ROI as the GE Healthcare Surgery's OEC® 9900 Elite (K122234). | Comparative Image Quality inside the ROI Test: "Comparative Image Quality inside the ROI Test was performed to demonstrate that the image quality of the OEC 9900 Elite with installed ControlRad Trace Model 8 within the ROI is of at least the same image quality compared to the image quality of the OEC 9900 Elite alone." |
| The filtered image quality outside the ROI provides peripheral image context to the ROI. | The image outside the clinician-selected ROI is a lower-dose processed image which provides peripheral image context to the ROI. | Comparative Image Quality outside the ROI Test: "Comparative Image Quality outside the ROI Test was performed in order to evaluate the filtered image quality outside the ROI of the OEC 9900 Elite with installed ControlRad Trace Model 9 in the periphery image outside the ROI compared to the image quality of the OEC 9900 Elite alone." |
| Image Quality Clinical Simulations: "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, of a clinically simulated image obtained by the GE Healthcare Surgery's OEC® 9900 Elite with installed ControlRad™ Trace Model 9." | ||
| The CR Trace Tablet's touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape. | The CR Trace Tablet's touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape. | Touch-In-Gloves Bench Test: "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." |
| Filter motion reliability | Filter motion reliability was tested due to changes in assembly. | Filter motion reliability testing: "Filter motion reliability testing was performed due to changes in assembly of the Trace 9 filter." |
| Compliance with wireless technology and cybersecurity requirements. | The ControlRad™ Trace Model 9's compliance was evaluated. | Wireless Technology and Cybersecurity Evaluation: "Wireless Technology and Cybersecurity Evaluation was performed in order to evaluate the ControlRad™ Trace Model 9's compliance with the requirements set forth in FDA Guidance documents titled 'Radio Frequency Wireless Technology in Medical Devices' and 'Postmarket Management of Cyber Security in Medical Devices'." |
| Compliance with IEC 60601-1 for instability in transport position and from horizontal/vertical forces. | The device was tested to ensure compliance with IEC 60601-1 around instability. | Instability test: "Due to weight changes with the workstation, an instability test was performed to ensure compliance with IEC 60601-1 Instability in transport position and Instability from horizontal and vertical forces clauses." |
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.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.