(39 days)
1212FCA is indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
1212FCA is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an IGZO TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize Xray images for radiographic diagnosis. The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis. The subject detectors are not wireless, but they are connected to a viewing station by ethernet connection.
The provided text is a 510(k) Summary for a digital flat panel X-ray detector (1212FCA). It details the device's characteristics and demonstrates its substantial equivalence to a predicate device (1012WCC) through non-clinical performance testing. It focuses on the fundamental image quality parameters of the detector itself, rather than an AI-powered diagnostic algorithm.
Therefore, many of the requested elements regarding AI performance, human reader studies, and sophisticated ground truth establishment for a diagnostic AI are not applicable to this submission. The device is a hardware component that captures X-ray images, which are then used by physicians for diagnosis.
Here's the breakdown of the information available in the document, addressing the prompts where relevant and indicating N/A for those that are not pertinent to this type of device submission:
Device Name: 1212FCA (Digital Flat Panel X-ray Detector)
1. Table of Acceptance Criteria and Reported Device Performance:
The document demonstrates substantial equivalence to the predicate device (1012WCC) by showing comparable or better performance in key image quality metrics. The "acceptance criteria" here is implicitly "performance on par with or better than the predicate device as measured by established international standards."
| Metric / Characteristic | Predicate Device (1012WCC) Reported Performance | Proposed Device (1212FCA) Reported Performance | Acceptance Criterion (Implicit) | Outcome |
|---|---|---|---|---|
| MTF (Modulation Transfer Function) | Equivalent or Better | Passed | ||
| 0.1 lp/mm | 0.527 | 0.488 | Equivalent or Better | Passed |
| 1 lp/mm | 0.327 | 0.283 | Equivalent or Better | Passed |
| 2 lp/mm | 0.210 | 0.181 | Equivalent or Better | Passed |
| 2.5 lp/mm | 0.136 | 0.117 | Equivalent or Better | Passed |
| DQE (Detective Quantum Efficiency) | Equivalent or Better | Passed | ||
| DQE (0) | 0.756 | 0.778 | Equivalent or Better | Passed |
| NPS (Noise Power Spectrum) | (Not explicitly quantified, but mentioned as compared) | (Not explicitly quantified, but mentioned as compared) | Equivalent or Better | Passed |
Assessment: The document states: "1212FCA demonstrated equivalent or better performance in terms of MTF and DQE as well as NPS compared to 1012WCC, the predicate device, at all spatial frequencies." While the MTF values listed for the proposed device appear lower than the predicate, the narrative explicitly claims "equivalent or better performance." This might imply that specific application contexts or other factors (e.g., pixel pitch differences impacting spatial frequency ranges) were considered in the determination of "equivalent or better" performance, or it could be a slight discrepancy in the provided table vs. the summary statement. For a hardware device, "equivalent or better" based on these standard metrics, conducted under IEC standards, is the typical acceptance.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as "sample size" in the context of clinical images or patient data. The performance testing was conducted on the device itself using technical measurements according to IEC standards. This typically involves a controlled phantom or physical measurement setup.
- Data Provenance: N/A for clinical data. The tests were "non-clinical" and conducted on the physical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: N/A. Ground truth for hardware performance metrics like MTF, DQE, and NPS is established through standardized physical measurements and calculations (e.g., using phantoms and precise equipment), not by human experts interpreting images.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set:
- Adjudication Method: N/A. There is no human interpretation or diagnostic ground truth to adjudicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- MRMC Study: No. This is a hardware device; MRMC studies are for evaluating the impact of AI or new imaging techniques on human reader performance for diagnosis.
- Effect Size of Human Reader Improvement: N/A.
6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:
- Standalone Performance: N/A. This device is not an algorithm. Its "performance" is its ability to produce high-quality X-ray raw data, which then needs to be processed and interpreted by a human and/or console software.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Technical performance metrics (MTF, DQE, NPS) derived from standardized physical measurements following IEC 62220-1. This is not clinical ground truth (e.g., pathology, outcomes data).
8. The Sample Size for the Training Set:
- Sample Size: N/A. This device is a hardware component; it does not involve a training set as would a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth Establishment: N/A.
§ 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.