(115 days)
The InfiMed i one 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 i2M 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 i TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.
The InfiMed i-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 i?™ 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 ism 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, Trixell Pixium RF4343), computer, monitor, and the digital imaging system.
The provided text describes the Infimed Nexus DRF Digital X-ray Imaging System and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, a dedicated study proving device performance against those criteria, or the methodology typically associated with such studies (sample sizes, expert qualifications, adjudication, MRMC studies, ground truth details, training set information).
The document mentions "Validation Protocols" and "predetermined test methods and corresponding acceptance criteria" in its Non-clinical Tests Discussion, and states that "all release criteria have been met." It also refers to a "Clinical Data submitted is consistent with FDA guidance document... for Solid State X-ray Imaging Devices." However, it does not provide the actual acceptance criteria, the specific results against them, or the details of the clinical study itself.
Therefore, I cannot fully answer your request for specific details regarding acceptance criteria and the study proving the device meets them, as that information is not present in the provided text.
Based on the available information, here's what can be extracted and what information is missing:
Information Not Found in the Provided Document:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective) for any test data.
- Number of experts used to establish ground truth for the test set.
- Qualifications of those experts.
- Adjudication method for the test set.
- Results of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including effect size.
- Results of a standalone (algorithm-only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for either training or testing.
- Sample size for the training set.
- How ground truth for the training set was established.
Information Extracted (Limited):
The document broadly states that:
- "Validation 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 i-TM Digital Xray Imaging System is as safe and effective as the predicate device."
- "Clinical Data submitted is consistent with FDA guidance document 'Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices'."
Essentially, the document confirms that non-clinical and clinical tests were performed, and acceptance criteria were met, but it does not specify what those criteria were or the detailed methodology and results of the studies. These details would typically be found in the actual validation protocols and study reports referenced, but they are not included in this 510(k) summary.
§ 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.