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510(k) Data Aggregation
(186 days)
NuVasive, LessRay™ (K123226)
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.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| DAP calculation accuracy | Within ±35% of measured DAP values. (For DAP reported by ControlRad™ Trace Model 8) | DAP calculations of the ControlRad™ Trace Model 8 were within ±35% of measured DAP values. (Matches predicate device's overall accuracy of ±40%) |
| DAP Reduction | At least 50% reduction 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 FOV. | The ControlRad™ Trace Model 8 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 Accuracy | Within ±35% of measured DAP Reduction values. | DAP Reduction calculations of the ControlRad™ Trace Model 8 were within ±35% of measured DAP Reduction values. |
| ControlRad Trace Filter Attenuation | To evaluate the attenuation level of the filters. (Specific quantitative criteria not explicitly stated, but the device description mentions typical reduction of 61% to 97%) | Test was performed to evaluate the attenuation level. (Implied to meet expectations based on overall statement: "performed and functioned as intended and observations were as expected.") |
| Comparative Image Quality Inside the ROI | Image quality within the ROI is at least the same as the OEC 9800/OEC 9800 Plus alone. | Image quality of the OEC 9800/OEC 9800 Plus with installed ControlRad Trace Model 8 within the ROI is of at least with the same image quality compared to the image quality of the OEC 9800/OEC 9800 Plus alone. |
| Comparative Image Quality Outside the ROI | The filtered image quality outside the ROI provides peripheral image context. (Specific quantitative criteria not explicitly stated regarding perceptual quality, but rather functional context.) | Test was performed to evaluate the filtered image quality outside the ROI and the ability of the filtered image outside the ROI to provide image context. (Implied to meet expectations based on overall statement: "performed and functioned as intended and observations were as expected.") |
| Image Quality Clinical Simulations | To evaluate image quality inside and outside the ROI and the ability of the filtered image outside the ROI to provide image context. (Reaffirms functional purpose of peripheral image context) | Test 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. (Implied to meet expectations based on overall statement: "performed and functioned as intended and observations were as expected.") |
| Touch-In-Gloves Bench Test | Touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape. | The ControlRad Trace Tablet's touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape. |
| Wireless Technology and Cybersecurity | Compliance with FDA Guidance documents titled "Radio Frequency Wireless Technology in Medical Devices" and "Postmarket Management of Cyber Security in Medical Devices". | The evaluation confirmed compliance with the requirements set forth in the specified FDA Guidance documents. |
| Impact on Air Kerma Test | (Not explicitly stated quantitative acceptance criteria, but generally implied to show the impact is safe and within expected parameters or within acceptable limits). | Test was performed to evaluate the impact on actual Air Kerma (AKR). (Implied to meet expectations based on overall statement: "performed and functioned as intended and observations were as expected.") |
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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