(22 days)
The InfiMed i5m 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 i5m 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 i2m 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 i-714 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 if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.
The InfiMed i m 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 i-1 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 platforms.
The modified InfiMed if me 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), computer, monitor, and the digital i maging system. The InfiStitch for i-m Digital X-ray Imaging System is an option which allows the operator to generate sequential radiographic images and electronically jointhum to create a single electronic image. This feature will be available for any InfiMed customer utilizing the i-The Digital X-ray Imaging System DR application on any flat parel detector.
The provided document is a 510(k) summary for the InfiMed InfiStitch for i5 Digital X-ray Imaging System. It describes the device, its intended use, and states that validation was completed with predetermined test methods and acceptance criteria. However, it does not provide a detailed breakdown of specific acceptance criteria or the study results that demonstrate the device meets those criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. Many of the requested details about the study are also not explicitly stated.
Based on the provided text, here's what can be extracted and what remains unknown regarding the acceptance criteria and the study:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document. The document mentions "predetermined test methods and corresponding acceptance criteria" were used for validation, and "all release criteria have been met." However, it does not specify what those criteria are (e.g., specific quantitative metrics for image quality, resolution, stitching accuracy).
- Reported Device Performance: The document generally states that the modified device "delivers equivalent or better image quality as the predicate device" and is "as safe and effective as the predicate device." It does not provide specific performance metrics or data.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. The document only mentions "Non-clinical Tests Discussion" and "Clinical Tests Discussion."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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 mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a digital X-ray imaging system with a stitching function, not an AI-assisted diagnostic tool in the sense of providing automated readings or decision support that would typically involve a detailed MRMC study to show reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that the device (including the InfiStitch algorithm) was tested, but it does not specify whether a standalone algorithm-only performance assessment was conducted separately from the overall system performance. The "InfiStitch" feature is an "option which allows the operator to generate sequential radiographic images and electronically join them to create a single electronic image," suggesting it's part of the operator's workflow rather than a fully autonomous diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given it's an imaging system, ground truth would likely relate to image quality assessment criteria (e.g., spatial resolution, contrast-to-noise ratio, geometric accuracy for stitching), but the specific methods are not detailed.
8. The sample size for the training set:
- The document does not mention a "training set." This type of device (digital X-ray imaging system with stitching function) typically undergoes verification and validation through engineering tests, phantom studies, and possibly human factors evaluations rather than machine learning training/testing paradigms with distinct training and test sets.
9. How the ground truth for the training set was established:
- Not applicable, as no training set is mentioned in the context of this device's validation.
In summary, the document states that validation was performed and that the device meets its release criteria, implying acceptance criteria were met. However, it does not provide the specific details of these criteria or the results of the studies in a manner that allows for the completion of the requested table and answers to most of the specific questions. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance metrics against pre-defined acceptance criteria for a novel algorithm.
§ 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.