(100 days)
The Omega Medical Imaging, LLC CS-series-FP (SSXI) systems with optional accessory device CA-100S as a modification device to provide an automated Region of interest that reduces exposure to the patient and operator. The system is intended for use in Radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging for General Populations. At no time will the CA-100S be considered as a replacement for the primary collimator shall always be used, in accordance with good medical practice, to define a Region of Interest
This 510(k) submission is for the addition of an optional secondary fast collimator system (Model: CA-100S / FluoroShield™ K182834 cleared 02/18/19). The CA-100S/ FluoroShield™ will be used with the following FDA cleared device: Omega's CS-series-FP ( K100102) which utilizes a Varex 2020 Flat Panel Detector. (Note: the only difference between this submission and the predicate is the size of the FPD. The predicate device utilizes a Varex 3030 Flat Panel Detector)
The-CA-100S/ FluoroShield™ system is composed of a Shutter, a ROI Electronics Unit, an Auto-ROI Processor, two ROI Control Panels and a Monitor.
The CA-100S / FluoroShield™ is a secondary collimator that can only be used in conjunction with the primary collimator. When using the CA-100S / FluoroShield™, the primary collimator shall be used to manually define a region of interest. Once this ROI has been established by the primary collimator, the CA-100S / FluoroShield™ can be used to further reduce the size of the ROI beyond the ROI initially established with the primary collimator.
I am sorry, but based on the provided text, there is no information about specific acceptance criteria and detailed study that proves the device meets those criteria for the CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ mentioned in the document.
The document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's description, function, and safety compliance. While it mentions that "Additional testing for this submission was performed utilizing a DAP meter to demonstrate the dose reduction results utilizing the CA-100S / FluoroShield™ accessory" and "A clinical study was conducted sampling 100 patients as well to demonstrate the dose reduction to patients and staff," it does not provide the specific acceptance criteria for these tests or detailed results in a table format.
Here's what can be extracted regarding some of your questions, but it's not a complete answer to all:
- Study Objective: The clinical study aimed to compare and measure radiation exposure to patients using Dose Area Product (DAP) and scatter radiation to endoscopy personnel using Landauer Luxel personal dosimetry badges.
- Performance Claim (from clinical study conclusion): "When using FluoroShield, unnecessary radiation can be reduced up to 61.8% in patients and 59.4% to the staff."
- Sample size for test set: 100 patients for the clinical study.
- Data provenance: The clinical study was a "prospective study of 100 consecutive patients who underwent fluoroscopy-guided endoscopic procedure." It doesn't specify the country of origin.
- Training set: No information available about a training set. The descriptions of "segmentation model" and "motion detection module" being updated or based on
trained images from the 2020 systemimply a training process, but details on sample size or ground truth establishment for this training are not provided. - Ground truth: For the clinical study, the ground truth appears to be measured radiation exposure (DAP for patients, dosimetry badges for staff).
- Other details: Questions 1 (table of acceptance criteria), 3 (experts), 4 (adjudication), 5 (MRMC study), and 6 (standalone performance) are not addressed in the provided 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.