(161 days)
The Insight Agile DRF is intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device provides fluoroscopic imaging and is used for guidance and visualization during routine fluoroscopic and image-guided procedures. The device is to be used in professional healthcare facilities, in a variety of image-guided procedures such as feeding tube and catheter insertion on pediatric patients and neonates (birth to one month). This device is not indicated for large/obese patients or interventional use. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (Rx Only)
The Insight Agile DRF Digital Imaging System is a modification of Insight Enhanced DRF, a previously cleared (K200396) fluoroscopic imaging chain employing a flatpanel digital detector (Vieworks 1212G) to replace the image intensifier and video camera on GE R&F systems (P500, Legacy and Advantx). This system has now been modified in the following manner: 1) the digital interface board (DIB) that provides communications with the GE systems has been replaced with a software program that utilizes virtual serial ports. 2) Another software program has been added to allow the system to communicate with and control a Source-Ray x-ray generator. The generator interface provides for Automatic Brightness Stabilization (ABS) control and optional manual control through a graphical user interface on the Insight Aqile image acquisition screen. 3) A second dynamic flat-panel detector (Rayence 1212FCA, K202722) has been integrated to provide an alternate digital detector. 4) the software risk assessment has been changed from minor to moderate. 5) the Indications for Use has been changed to that of the predicate device.
With these modifications, Insight Agile DRF is a fluoroscopic imaging chain that can acquire, process, and display fluoroscopic images when installed on any suitable positioning system in a fixed room, on a mobile or portable stand. Another purpose of this application is to expand the indications for use.
The Insight Agile DRF is an X-ray system, and the provided text does not define acceptance criteria typical for AI/ML-driven diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, it focuses on bench testing and qualitative expert assessment for its substantial equivalence to a predicate device.
However, based on the provided text, I can extract information related to the device's performance, testing, and evaluation:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Image Quality (clinically acceptable and comparable to predicate) | A radiologist found the imaging Engineering images to be of high quality, high resolution, and clinically acceptable for the intended use and fully comparable to the OEC (9800 and 9900) mobile c arms. |
| Imaging Performance (substantial equivalence to predicate) | Bench testing demonstrated substantial equivalence to the predicate device (MobileRay Pulse SE Digital Imaging System, K191503) in terms of imaging performance. This included comparing phantom images and doses used to acquire them. |
| Compliance with Regulatory Standards | The system complies with IEC 60601-1-3, IEC60601-2-54 and 21 CFR 1020.32.Passed all electrical, mechanical, and radiation safety testing.EMC and Electrical Safety performance for the Rayence digital receptor panel had previously been submitted to FDA in K202722. |
| Software Validation | Software has been written and validated according to the FDA Software Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. |
| Cybersecurity | Cybersecurity concerns have been addressed in accordance with: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff (October 2, 2014). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The text mentions a "series of fluoroscopic patient exam images" evaluated by a radiologist. However, a specific number for this series is not provided.
- Data Provenance: The provenance of the patient exam images is not explicitly stated (e.g., country of origin, retrospective or prospective). It is likely from a clinical setting where the OEC mobile c-arms are used for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One radiologist was used.
- Qualifications: The text identifies the expert simply as "A radiologist." No further details on their years of experience or sub-specialty are provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The text describes a single radiologist's evaluation. There is no mention of an adjudication method involving multiple experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The study described is a qualitative assessment by a single radiologist comparing fluoroscopic images from the subject device to predicate devices (OEC 9800 and 9900). There is no AI assistance mentioned, and therefore, no effect size of human readers improving with AI vs without AI assistance is reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device described is an X-ray imaging system, not an AI/ML algorithm. The evaluation focuses on the image quality and performance of the hardware and integrated software. Therefore, the concept of a "standalone (algorithm only)" performance does not directly apply in this context. The bench testing and phantom image comparisons represent the device's inherent imaging capabilities.
7. The type of ground truth used:
- For the image quality assessment, the "ground truth" was the expert opinion/consensus of a single radiologist, who deemed the images "clinically acceptable for the intended use and fully comparable" to existing systems. For bench testing, the ground truth was based on established technical standards and predicate device performance (e.g., image quality characteristics from phantom images).
8. The sample size for the training set:
- The provided text does not describe an AI/ML training set. Therefore, there is no information on a training set sample size.
9. How the ground truth for the training set was established:
- As there is no mention of a training set for an AI/ML component, this information is not applicable and not provided in the text.
§ 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.