(88 days)
The Wireless/Wired 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 wherever conventional film/screen or CR systems may be used. The FDR D-EVO is not intended for mammography, fluoroscopy, tomography, and angiography applications.
The proposed device, DR-ID600 w/DR-ID611SE is a modified version of our currentlycleared predicate device, Wired FDR D-EVO flat panel detector system (DR-ID600 w/DR-ID601SE), K103596. The predicate device includes the 14x17" fat panel detector model DR-ID601SE using GOS (Gadolinium Oxysulfide) scintillator whereas the proposed device introduces the 14x17" flat panel detector model DR-ID611SE using a different scintillator material, Csl (Cesium lodide). FUJIFILM's unique Irradiated Side Sampling (ISS) design delivering high image quality, and wireless communication specifications remains unchanged in the proposed device. The proposed DR-ID600 w/DR-ID611SE is a portable digital detector system that acquires and digitizes x-ray exposures from standard radiographic systems, which is the same as our legally marketed predicate device, DR-ID600 w/DR-ID601SE. The proposed device 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. All of which are also the same as our legally marketed predicate device.
The provided text describes a 510(k) premarket notification for a medical device, the Fujifilm Wireless/Wired FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE). The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Diagnostic capability of images | All images from the proposed device were deemed of diagnostic capability by three board-certified radiologists. |
| Equivalence or superiority to predicate device images | Consensus results of three radiologists show the proposed device images were diagnostically equivalent or better than the cleared predicate device's images by 93.3%. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for test set: 30 image pairs.
- Data provenance: Not explicitly stated. The submission is from Fujifilm Medical Systems U.S.A., Inc., suggesting the study was likely conducted or overseen in the USA. It is a retrospective comparison of images, as it compares images already acquired by two different detector types.
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)
- Number of experts: Three.
- Qualifications of experts: Board-certified radiologists. Specific experience level beyond board certification is not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication method: The text states "the consensus results of the three radiologists." This implies a form of consensus-based adjudication, but the exact mechanism (e.g., simple majority, all three agreement) is not specified.
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
- MRMC study: Yes, a reader study was performed. It involved multiple readers (three radiologists) reviewing multiple cases (30 image pairs) comparatively.
- Effect size of human readers improving with AI vs without AI assistance: This study did not involve AI assistance. It was a comparison between two different types of flat panel detectors (CsI vs. GOS scintillator material), evaluating the diagnostic capability of the images produced by each. Therefore, an effect size related to AI improvement is not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone study: No. This study evaluated images produced by a medical device (an X-ray detector system) as interpreted by human radiologists. It does not describe an algorithm performing tasks without human input.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Expert consensus. The diagnostic capability was established by the agreement of three board-certified radiologists.
8. The sample size for the training set
- Sample size for training set: Not applicable/not mentioned. This device is an X-ray detector, not an AI/machine learning algorithm requiring a separate training set. The study concerns the quality of images produced by the detector itself.
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 training set for an AI algorithm.
§ 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.