(107 days)
The DelWorks DR System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. DelWorks DR System allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
The DelWorks DR System represents the straightforward integration of a number of digital x-ray receptor panels using digital acquisition software. The DelWorks DR System is compatible with all modern HF generators. DelWorks DR System is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) The DelWorks DR System is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. Many of the compatible panels provide Auto-exposure detection. A synchronization module is available where exposure sync is required. This module connects between the digital panel and the x-ray high voltage generator. It provides "ready" synchronization and optical isolation between the two devices. Some of the detectors feature wireless Wi-Fi connection via a wireless access point. The software features Image Stitching (4 views can be combined into one single view) and other image enhancement features. The system software interacts with and controls technique factors of compatible generators via serial interfaces. DICOM output allows for transmission of images to the hospital radiology information system. The system employs Digital Radiography Operator Console (DROC) software, outputs a DICOM image. A USB "dongle" is provided to assure the authenticity of the software.
The medical device in question is the DelWorks DR System, a digital X-ray system. The documentation provided focuses on establishing its substantial equivalence to a predicate device, the Sedecal Digital Radiographic Upgrade, Model: SDRU-T (K130883), rather than presenting a detailed study with specific acceptance criteria and performance metrics for the DelWorks DR System itself.
Based on the provided text, here's what can be extracted and inferred regarding acceptance criteria and the supporting "study":
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of quantitative acceptance criteria with corresponding performance metrics for the DelWorks DR System. Instead, it relies on a qualitative assessment of "equal or better image quality" compared to the predicate device.
| Acceptance Criterion (Inferred from clinical testing summary) | Reported Device Performance (Qualitative) |
|---|---|
| Diagnostic Quality of Images | "images were of good diagnostic quality." and "equal or better image quality as compared to our predicates." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Clinical images were acquired," implying a set of images, but the number of cases or images is not provided.
- Data Provenance: Not specified. It's unclear where the clinical images were acquired (e.g., country of origin, specific institution) or whether they were retrospective or prospectively collected.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: "a board certified radiologist" (singular).
- Qualifications of Experts: "board certified radiologist." No mention of years of experience or subspecialty.
4. Adjudication Method for the Test Set
- Adjudication Method: "evaluated by a board certified radiologist." This indicates a single reader evaluation, so no adjudication method (like 2+1 or 3+1) was employed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described or performed. The evaluation involved a single radiologist making a judgment on diagnostic quality. There is no mention of comparing human readers with and without AI assistance, as the DelWorks DR System itself is a digital imaging system, not an AI-assisted diagnostic tool in the sense of offering interpretations.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance: Not applicable/not performed in the context of an algorithm's diagnostic performance. The device is a digital X-ray system; its "performance" is tied to image acquisition and display quality for human interpretation. The clinical evaluation focuses on the human interpretation of images produced by the system.
- Bench Testing: The document does mention "MTF and DQE measurements were supplied by the panel manufacturer in accordance with the FDA guidance document." These are objective, standalone measurements of the detector's physical performance, but they are from the panel manufacturer, not explicitly part of a system-level standalone performance study for the DelWorks DR System as a whole.
7. Type of Ground Truth Used
- Ground Truth: Expert consensus with pathology or outcomes data was not used. The ground truth was based on the qualitative assessment of "good diagnostic quality" by a single board-certified radiologist. This is a form of expert opinion/clinical judgment.
8. Sample Size for the Training Set
- Sample Size: Not applicable/not stated. The DelWorks DR System is an imaging acquisition and display system, not a machine learning algorithm that requires a "training set" in the conventional sense for diagnostic tasks. Its software is configured for image processing and output, but there's no indication of a machine learning-based training process for diagnostic output.
9. How Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no mention of a training set for a machine learning 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.