(97 days)
The FDR D-EVO GL flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatic exams wherever conventional film/screen or CR systems may be used. This device is used to capture anatomic regions that are too large for conventional CR/DR format sizes. FDR D-EVO GL is not intended for mammography, fluoroscopy, tomography, and angiography applications.
Fujifilm's FDR D-EVO GL FPD System (DR-ID1300) is a digital detector system that interfaces with, and acquires and digitizes x-ray exposures from, standard radiographic systems. The DR-ID1300 is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults and pediatrics including longlength exams where anatomic regions that are too large for conventional CR/DR format sizes, such as the entire spine or lower extremities, can be captured. The DR-ID1300 employs a new DR detector with a large exposure area size of ~ 17 x 49 inches. The detector can be placed in an appropriate stand for upright exams.
The provided text contains information about the FDR D-EVO GL Flat Panel Detector System (DR-ID1300) and its 510(k) submission. However, it explicitly states:
"Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies."
Therefore, I cannot provide details on acceptance criteria and a study proving the device meets those criteria from a clinical perspective because such a study was not performed. The substantial equivalence was demonstrated through non-clinical studies and comparisons to predicate devices.
The document mentions that the device conforms to voluntary standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, IEC 62494-1, and DICOM) and followed FDA guidance documents for solid-state X-ray imaging devices, software, and cybersecurity. These standards and guidances implicitly define performance requirements, but specific acceptance criteria and detailed performance metrics are not explicitly presented in a table format suitable for your request.
Based on the provided document, here's what can be inferred and what cannot be answered:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided as clinical performance data was not generated. The document only states that "All the major detector characteristics that may affect the image quality are substantially equivalent to the legally marketed DR-ID1201SE detector in K142003." and "The difference in MTF measurements is negligible, and the difference in DQE (Detective Quantum Efficiency) measurement is insignificant." These are comparative statements rather than specific acceptance criteria and reported performance values.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. No clinical test set was used for performance evaluation as no clinical study was performed. Non-clinical bench testing was "conducted to evaluate the long view attributes that are unique to the DR-ID1300 system," but details on sample size or data provenance for these non-clinical tests are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No clinical ground truth was established as no clinical study was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set data was created that would require adjudication.
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. The document explicitly states "No clinical study has been performed." Additionally, this device is a flat panel detector system, not an AI-based diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This is a hardware device (flat panel detector) that captures images, not an algorithm being evaluated for standalone performance. The "non-clinical studies" focused on validating its characteristics against a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No clinical ground truth was established. The "ground truth" for the non-clinical studies would be instrument specifications, physics measurements, and comparisons to the predicate device's measured characteristics.
8. The sample size for the training set:
- Not applicable/Not provided. This device is a flat panel detector system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. See above.
In summary, the provided document describes a 510(k) submission for a new flat panel detector system where substantial equivalence was demonstrated through non-clinical studies and comparisons to predicate devices, rather than through clinical performance data.
§ 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.