(105 days)
The WirelessMired FDR D-EVO 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 pediatric and neonatal exams wherever conventional film /screen or CR systems may be used. The FDR D-EVQ is not intended for mammography, fluoroscopy, tomography, and angiography applications.
Fujifilm's FDR D-EVO Flat Panel Detector System (DR-ID600) is a portable digital detector system that acquires and digitizes x-ray exposures from standard radiographic systems. It is designed to be used in any environment that would typically use a radiographic cassette. It can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid exams.
The FDR D-EVO FPD system is currently indicated for general projection radiographic applications and offers two different detector types in terms of scintillator materials (gadolinium oxysulfide (GOS) and cesium iodide (Csl)). The new submission is being submitted for the same FDR D-EVO FPD system to seek the clearance of the pediatric indication for use.
Here's a breakdown of the acceptance criteria and study information for the Fujifilm FDR D-EVO Flat Panel Detector System (DR-ID600), based on the provided text:
Acceptance Criteria and Device Performance
The provided document (a 510(k) summary) doesn't explicitly list specific quantitative "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, or image quality metrics with thresholds). Instead, it states the device conforms to voluntary standards and provides acceptable diagnostic capability and image quality at reasonably low dose levels for pediatric use. The "reported device performance" is qualitative and based on expert evaluation.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Conformance to voluntary standards | Conforms to IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4, UL60601-1, and DICOM. The standardized dose index (Exposure Index (EI) and Deviation Index (DI)) comply with IEC 62494-1. Flat panel detector characteristics described per FDA Guidance for 510(k)'s for Solid State X-ray Imaging Devices (1999) fundamentally remain unchanged. |
| Acceptable diagnostic capability for pediatric use | Evaluation by a pediatric radiologist concluded that, when used with Fujifilm's recommended exposure conditions, the FDR D-EVO FPD system (both GOS-based and CsI-based panels) can provide acceptable diagnostic capability for pediatric patients. |
| Acceptable image quality at reasonably low dose for pediatric use | Evaluation by a pediatric radiologist concluded that, when used with Fujifilm's recommended exposure conditions, the FDR D-EVO FPD system (both GOS-based and CsI-based panels) can provide acceptable image quality at reasonably low dose levels typically used for pediatric use. The results of this image quality evaluation and dose assessment are explicitly stated to be provided in the submission. |
Study Details
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Sample size used for the test set and data provenance:
- Test Set Sample Size: The document states that images were acquired "using phantoms that mimicked the pediatric subgroups." It does not provide a specific numerical sample size (e.g., number of phantom images or specific phantom types) for this test set.
- Data Provenance: The data was generated through laboratory testing using phantoms. The country of origin is not explicitly stated, but the submission is from FUJIFILM Medical Systems U.S.A., Inc. This was a prospective study as it involved acquiring new images for the evaluation.
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Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of Experts: Singular: "a pediatric radiologist."
- Qualifications: "with experience in evaluating patient images and images of pediatric phantoms."
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Adjudication method for the test set:
- The document mentions evaluation by "a pediatric radiologist," implying no multi-reader adjudication method (e.g., 2+1 or 3+1). It appears to be a single-reader evaluation.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- No. The document describes an image quality evaluation by a single pediatric radiologist using phantoms. It does not mention an MRMC study or a comparison of human readers with vs. without AI assistance. The device itself is a flat panel detector, not an AI-assisted diagnostic tool in the sense of providing algorithmic interpretations for comparison with human readers.
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If a standalone study (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not directly applicable in the typical sense for this type of device. The FDR D-EVO is a hardware component (a flat panel detector) that acquires images, not an algorithm that interprets them. The "performance" being evaluated here is the image quality and diagnostic capability derived from the detector's output, which is then assessed by a human expert. The study essentially is a standalone evaluation of the device's capability to produce images suitable for diagnostic interpretation across pediatric subgroups.
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The type of ground truth used:
- The ground truth was established through expert consensus/evaluation by a pediatric radiologist evaluating images from phantoms designed to mimic pediatric subgroups. The phantoms themselves provide a known "truth" (e.g., structures, densities) which the radiologist assesses in the acquired images for diagnostic capability and image quality.
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The sample size for the training set:
- The document does not mention a training set. This device is a digital X-ray detector, and its primary function is image acquisition, not complex image analysis or AI interpretation that would typically require a training set in the context of machine learning. The focus of the submission is on hardware performance and image output suitability.
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How the ground truth for the training set was established:
- Not applicable, as no training set is mentioned or implied for this device's function.
§ 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.