(134 days)
The EVS 4343 Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications
The EVS 4343 is a wired/wireless flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EVS 4343 differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.
EVS 4343 consists of main components such as SSU, USB Switch Box and other accessories (Tether Interface Cable, Access Point, Hand Switch, Generator Interface Cable, LAN Cable, Interface cable, AC Power Code).
The provided text describes the DRTECH EVS 4343 Digital X-ray detector, which is a wired/wireless flat-panel digital X-ray detector intended for general radiographic diagnosis of human anatomy. It aims to replace film or screen-based radiographic systems in all general-purpose diagnostic procedures, excluding mammography applications.
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
The document doesn't explicitly state "acceptance criteria" as a separate section with specific numerical thresholds for diagnostic equivalence beyond general performance metrics like DQE and MTF. Instead, it focuses on demonstrating substantial equivalence to a predicate device (E-WOO TECHNOLOGY Xmaru1717, K091090) through various comparisons and a clinical study confirming diagnostic capability.
However, we can infer some performance metrics and a general acceptance criterion of "diagnostic equivalence."
| Criterion Type | Specific Metric / Standard | Acceptance Criteria (Predicate Performance - K091090) | Reported Device Performance (EVS 4343) | Status (Relative to Predicate) |
|---|---|---|---|---|
| Non-Clinical Performance | ||||
| DQE (Detective Quantum Efficiency) | at 1.0 lp/mm | 36.2% | 34.7% | Basically Equal/Better (as stated in section 9, though numerically lower here) |
| MTF (Modulation Transfer Function) | at 1.0 lp/mm | 18.8% (extrapolated from "predicate 18.8%") | 64.3% | Better |
| Resolution | - | 3.6 LP/mm | 3.6 LP/mm | Same |
| Clinical Performance | Diagnostic Capability | "Diagnostic capability of images" (Predicate device) | "Images of equivalent diagnostic capability" | Equivalent |
| Regulatory Compliance | AAMI ANSI ES60601-1 | Compliant | Compliant | Met |
| IEC 60601-1-2 | Compliant | Compliant | Met | |
| ISO 14971 | Compliant | Compliant | Met | |
| IEC 62220-1 | Compliant | Compliant | Met | |
| NEMA PS 3.1 - 3.20 (DICOM) | Compliant | Compliant | Met |
Note on DQE and MTF: The document states in Section 9: "The non-clinical performance testing constrains that the main physical values for comparison of X-ray devices like DQE and MTF are basically equal or better than the predicate device ranging 64.3% (predicate 18.8%) for MTF at 1.0lp/mm and 34.7% (predicate 36.2%) for DQE at 1.0lp/mm." While 34.7% is numerically lower than 36.2%, the statement implies it's still considered "basically equal or better" in the context of the overall assessment, or within an acceptable margin.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "a single-blinded concurrence study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices was conducted." This implies cases or images were presented, but the number of cases is not provided.
- Data Provenance: Not specified. It's unclear if the data was collected retrospectively or prospectively, or the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified. The study is described as a "single-blinded concurrence study," which suggests multiple readers participated, but the method for resolving disagreements or establishing expert consensus (e.g., 2+1, 3+1) is not detailed.
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: The document describes a "single-blinded concurrence study" comparing the EVS 4343's images to the predicate device for diagnostic capability. This implies a comparison between devices, likely with multiple readers, fitting parts of an MRMC design in terms of reader involvement. However, it is not a comparative effectiveness study of human readers with AI vs. without AI assistance. The EVS 4343 is a digital X-ray detector, not an AI-powered diagnostic assist tool. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The EVS 4343 is a hardware device (X-ray detector) that produces images for human interpretation, not an algorithm that performs diagnosis independently. The performance metrics (DQE, MTF, Resolution) are intrinsic to the device's image acquisition quality, not an algorithm's diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not explicitly stated. For a "concurrence study" of diagnostic capability, the ground truth would likely be based on expert interpretation/consensus of the images, possibly referencing existing clinical diagnoses or follow-up, but the document does not elaborate.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is a digital X-ray detector (hardware), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as this is a hardware device and not an AI algorithm requiring a 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.