(29 days)
The InfiMed i5TM 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 i5TM 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 i5TM 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 i5TM 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 i5TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.
The InfiMed i5TM 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 i5TM 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 modified InfiMed i5TM 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, Toshiba FDX 4343R, DRTECH FLAATZ 560), computer, monitor, and the digital imaging system.
This document is a 510(k) premarket notification for the InfiMed i5TM Digital X-ray Imaging System (with FLAATZ 560). It asserts substantial equivalence to a predicate device (InfiStitch for i5TM, K101833) and does not contain detailed acceptance criteria and performance data for a standalone or comparative effectiveness study.
Here's what can be extracted and what is explicitly not available based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The text states: "Validation was completed in accordance with the Validation Protocols included with this submission. Protocols were 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 modified i5TM Digital X-ray Imaging System is as safe and effective as the predicate device." However, the specific acceptance criteria and the quantitative or qualitative results of the device performance against those criteria are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided. The document makes a general statement about "Clinical Data submitted" being consistent with FDA guidance, but does not specify the sample size, provenance, or whether the data was retrospective or 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. The document does not describe the establishment of a ground truth with experts. Since this is a 510(k) submission primarily focused on substantial equivalence to a predicate device rather than a de novo clinical trial, such detailed expert review might not have been a primary component of the submission described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. As no details about expert review or ground truth establishment are given, adjudication methods are also absent.
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:
This information is not provided. The document describes the device as a "high resolution digital imaging system" and mentions "Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques," but it does not present itself as an AI-assisted diagnostic tool for which an MRMC study demonstrating improvement with AI would be conducted. The focus is on replacing conventional film techniques or existing digital systems and achieving equivalent or better image quality than the predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not explicitly stated or detailed. The document refers to "Validation Protocols" and "release criteria" being met, suggesting some form of internal testing. However, it does not delineate specific standalone performance metrics for an algorithm without human intervention, especially not in the context of diagnostic accuracy. The device is described as an "imaging system" where an "operator" acquires, displays, and processes images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided. The document refers to "Clinical Data" but does not specify how the ground truth for that data (if any was used for specific performance evaluation) was established.
8. The sample size for the training set:
This information is not provided. The document does not describe the use of a "training set" in the context of machine learning model development. The "Image processing algorithms" mentioned are likely traditional image processing techniques rather than contemporary machine learning algorithms that require large training sets.
9. How the ground truth for the training set was established:
This information is not provided, as there is no mention of a training set or its ground truth.
§ 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.