(167 days)
The InfiMed i5 TM Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i TM Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i5 TM Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.
For the DR application, the InfiMed i5 TM Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
For the RF/DSA application, the InfiMed i5 TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.
The InfiMed i5 TM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i5 TM Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.
The InfiMed i5 TM Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A), computer, monitor, and the digital imaging system.
The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics. Instead, it offers a 510(k) summary for the InfiMed i5™ Digital X-ray Imaging System, focusing on its substantial equivalence to predicate devices.
However, based on the non-clinical tests discussion, we can infer the general approach to validation.
Here's an analysis of the provided information relative to your request:
1. A table of acceptance criteria and the reported device performance
The document mentions: "Validation was completed in accordance with the Validation Protocol included with this submission. This protocol was designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met and the i5™ Digital X-ray Imaging System is as safe and effective as the predicate devices."
However, no specific acceptance criteria or reported device performance metrics are provided in the text for inclusion in a table. The conclusion only states that all release criteria were met.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states "Non-clinical Tests Discussion: Validation was completed..." and "Clinical Data submitted is consistent with FDA guidance document...". However, it does not specify the sample size for any test set or provide details about data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 mention an MRMC comparative effectiveness study or any details about AI assistance. The system is described as a "digital imaging system intended to replace conventional film techniques, or existing digital systems." It focuses on image acquisition, display, processing, and distribution.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document does not explicitly state that a standalone algorithm-only performance study was conducted. The system is presented as an integrated digital X-ray imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. The general statement is that "Clinical Data submitted is consistent with FDA guidance document..." but it doesn't detail how ground truth was established for that data.
8. The sample size for the training set
The document does not mention a training set or its sample size, as it describes a digital imaging system rather than a machine learning model that would typically require a training set.
9. How the ground truth for the training set was established
As no training set is mentioned, this information is not applicable/provided.
§ 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.