Search Results
Found 1 results
510(k) Data Aggregation
(230 days)
The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems are intended for use in radiographic/fluoroscopic application including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems incorporates a solid-state flat-panel detector (FPD) as an option to the cleared Omega Medical Imaging, Inc. CS-series fluoroscopy systems (K070834) in lieu of an image intensifier/CCD based imaging detector. The CS-series fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted C-am and a patient table. The dual plane systems incorporate a ceiling suspended C-arm. The image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The caplured digital image is processed by the acquisition system which includes image processing, viewing functions, local storage, and DICOM compatibility.
The Omega Medical Imaging, Inc. CS-series-FP (SSXI) fluoroscopy system aims to provide imaging performance comparable to existing fluoroscopy systems by incorporating a solid-state flat-panel detector (FPD).
1. A table of acceptance criteria and the reported device performance:
The document provides detailed technical specifications for the CS-series-FP (SSXI) system, which serve as its performance criteria. The device is reported to meet these specifications directly by listing them as characteristics of the system.
| Acceptance Criteria (Technical Specifications of CS-series-FP) | Reported Device Performance |
|---|---|
| 1. Flat Panel Detector | |
| 1.1 Receptor Type: Amorphous Silicon | Amorphous Silicon |
| 1.2 Conversion Screen: Cesium Iodide | Cesium Iodide |
| 1.3 Pixel Area - Active: 19.8 cm X 19.8 cm | 19.8 cm X 19.8 cm |
| 1.4 Pixel Matrix - Active: 1024 X 1024 | 1024 X 1024 |
| 1.5 Pixel Pitch: 194 $\mu$m | 194 $\mu$m |
| 1.6 Limiting Resolution: 2.58 lp/mm | 2.58 lp/mm |
| 1.7 MTF, X-ray: $\geq$ 35% @ 1.30 lp/mm | $\geq$ 35% @ 1.30 lp/mm |
| 1.8 Energy Range: 40 - 150 kV | 40 - 150 kV |
| 1.9 Fill Factor: 70% | 70% |
| 1.10 Dynamic Range: 72 dB | 72 dB |
| 1.11 Contrast Ratio: Large Area (120mm): < 0.8%, Small Area (10mm): < 7% | Large Area (120mm): < 0.8%, Small Area (10mm): < 7% |
| 1.12 A/D Conversion: 14-bits | 14-bits |
| 2. Acquisition | |
| 2.1 Modes: Pulsed Fluoro, Spot, & Cine | Pulsed Fluoro, Spot, & Cine |
| 2.2 Pulsed Fluoro Rates: 3.75, 7.5, and 15 pps | 3.75, 7.5, and 15 pps |
| 2.3 Spot Rates: Single & 2 fps | Single & 2 fps |
| 2.4 Cine Rates: 15 & 30 fps | 15 & 30 fps |
| 2.5 Polarity: Positive & Negative | Positive & Negative |
| 2.6 Edge Enhancement: 5 level | 5 level |
| 2.7 Noise Reduction: 6 level with motion correction | 6 level with motion correction |
| 2.8 Last Image Hold: Yes | Yes |
| 2.9 Fluoro Loops: Yes | Yes |
| 2.10 Horizontal & Vertical Flip: Yes | Yes |
| 3. Acquisition Workstation | |
| 3.1 Workstation Model: MX-200-OMI | MX-200-OMI |
| 3.2 Monitor, size: 2 X 18.1 inch, Medical Grade, high contrast monochrome | 2 X 18.1 inch, Medical Grade, high contrast monochrome |
| 3.3 Grey Levels: (not specified, implied to be appropriate for 14-bit A/D) | (not specified directly, assumed adequate) |
| 3.4 Review (Fluoro Loops/Cine): Forward, Reverse, Pause, and Speed | Forward, Reverse, Pause, and Speed |
| 3.5 Window/Level Adjust: Yes | Yes |
| 3.6 Annotation: Yes | Yes |
| 3.7 Image Invert: Yes | Yes |
| 3.8 Horizontal & Vertical Flip: Yes | Yes |
| 3.9 Zoom & Roam: Yes (2X) | Yes (2X) |
| 3.10 Image Storage: Minimum: 117,000 images | Minimum: 117,000 images |
| 3.11 Networking Capabilities: Ethernet 10/100 | Ethernet 10/100 |
| 3.12 DICOM Store: Yes | Yes |
| 3.13 DICOM Print: Yes | Yes |
| (and other GUI/monitor identifiers and functions as listed in the document) | (all listed functions are stated as being present) |
The document presents these as inherent features and specifications of the device rather than a comparison to a set of pre-defined acceptance criteria with explicit "pass/fail" reporting for each. The overall claim of substantial equivalence implies that these specifications are acceptable for its intended use and comparable to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The provided document does not describe a clinical study with a test set of patient data. Instead, it focuses on the engineering and performance specifications of the device itself and its components. The "Non-Clinical Performance" section mentions "detailed data comparing performance with the existing Omega Medical Imaging, Inc. CS-series systems utilizing an image-intensifier/CCD based image acquisition system. Also included is detailed specifications and performance of the Varian PaxScan 2020 flat-panel detector." This indicates technical performance testing (e.g., image quality metrics, hardware functionality) rather than a study on clinical images.
Therefore, information on sample size, data provenance, or retrospective/prospective nature of a clinical test set is not available in this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set requiring expert ground truth establishment is described. The performance data presented relates to technical specifications of the imaging system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring adjudication is described.
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 MRMC comparative effectiveness study is described in this document. The device is a fluoroscopy system, not an AI-powered diagnostic tool. The submission focuses on device equivalence to predicate systems for performing standard fluoroscopic procedures.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as this is a medical imaging acquisition system, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as there is no clinical test set requiring ground truth. The "ground truth" for the device's performance is its adherence to technical specifications and safety standards, which are evaluated through engineering tests and comparisons to known performance of predicate devices and components (like the Varian PaxScan FPD).
8. The sample size for the training set:
Not applicable, as this device submission is for a medical imaging hardware system, not an AI or deep learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as no training set is relevant to this device submission.
Ask a specific question about this device
Page 1 of 1