(107 days)
This device is a Computed Radiography System and intended for use in producing digital X-Ray images for general radiography purposes. It comprises of scanner, cassette with reusable phosphor storage plate (IP) and workstation software. It scans X-Ray exposed image plate and produces X-Ray image in digital form. Then, digital image is transferred to workstation for further processing and routing. This device is intended to be operated in a radiological environment by qualified staff. This device is not intended for the acquisition of mammographic image data.
The FireCR Spark is Computed Radiography System which produces the X-ray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (IP) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate. X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collect and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.
Here's an analysis of the provided text regarding the acceptance criteria and study for the FireCR Spark Computed Radiography Scanner:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device K102619) | Reported Device Performance (FireCR Spark) |
|---|---|
| Spatial Resolution: 3.71 lp/mm @ 100μm | Spatial Resolution: 3.7 lp/mm @ 100μm |
| DQE: 23.5% @ 0.5 lp/mm | DQE: 25% @ 0.5 lp/mm |
| MTF: 79% @ 0.5 lp/mm | MTF: 80% @ 0.5 lp/mm |
| Image Matrix (35cm x 43cm @ 100μm): 3500 x 4300 | Image Matrix (35cm x 43cm @ 100μm): 3500 x 4300 |
| Image Matrix (35cm x 43cm @ 200μm): 1750 x 2150 | Image Matrix (35cm x 43cm @ 200μm): 1750 x 2150 |
| Image Matrix (25cm x 30cm @ 100μm): 2500 x 3000 | Image Matrix (24cm x 30cm @ 100μm): 2400 x 3000 (slight difference) |
| Image Matrix (25cm x 30cm @ 200μm): 1250 x 1500 | Image Matrix (24cm x 30cm @ 200μm): 1200 x 1500 (slight difference) |
| Common new panel size: N/A (Pred. device does not have this size) | Image Matrix (18cm x 24cm @ 100μm): 1800 x 2400 (new size) |
| Common new panel size: N/A (Pred. device does not have this size) | Image Matrix (18cm x 24cm @ 200μm): 900 x 1200 (new size) |
| Dynamic Range: 16 bit | Dynamic Range: 16 bit |
| Defect Compensation: By Calibration | Defect Compensation: By Calibration |
Acceptance Criteria for Clinical Study: Implicitly, the FireCR Spark was accepted if its image quality was considered "equivalent" to the predicate device by radiologists.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "Clinical considerations" and "Clinical Study" but doesn't quantify the number of cases or images used.
- Data Provenance: Not explicitly stated. The submission is from a Korean company (3D Imaging & Simulations Corp., Daejeon, Korea), so the data could be from Korea, but this is not confirmed. It is also not specified whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated. The document refers to "radiologists" (plural), indicating more than one, but no specific number is given.
- Qualifications of Experts: Only stated as "radiologists." No detail on their experience (e.g., years of experience, subspecialty) is provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The text only says, "The rating was considered equivalent by radiologists." This suggests a consensus or comparison, but the specific method (e.g., 2+1, 3+1) is not detailed.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study: The document implies a comparison between the FireCR Spark and the predicate device by radiologists ("As a result of Clinical Study, FireCR Spark is considered that Image quality is equivalent to the Predicate Device"). However, it does not explicitly describe a formal MRMC comparative effectiveness study designed to quantify improvement with AI assistance. This device is a Computed Radiography Scanner, not an AI-powered diagnostic tool, so the concept of "human readers improve with AI vs without AI assistance" does not directly apply here. The study focused on demonstrating equivalence in image quality to a predicate device.
- Effect Size of Human Readers Improvement with AI: Not applicable, as this is not an AI-assisted diagnostic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, non-clinical performance data (DQE, MTF, Spatial Resolution, Image Matrix, Dynamic Range, Defect Compensation) were reported for the device itself against the predicate. This is a standalone technical performance evaluation. The clinical study, though involving radiologists, served to confirm the image quality equivalence produced by the algorithm/device for human interpretation, rather than evaluating human-in-the-loop performance.
7. Type of Ground Truth Used
- Type of Ground Truth: For the technical performance metrics (DQE, MTF, Spatial Resolution, etc.), the ground truth is established by physical measurements and engineering specifications.
- For the clinical study, the ground truth was expert consensus/opinion from radiologists regarding image quality equivalence to the predicate device. It does not mention pathology or outcomes data.
8. Sample Size for the Training Set
- Sample Size for Training Set: The document does not mention a "training set" in the context of an AI/ML algorithm. This device is a Computed Radiography Scanner, and its performance is based on its physical and functional characteristics, not on a machine learning algorithm trained on data. Therefore, this question is not directly applicable to the information provided.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a machine learning training set.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.