(41 days)
VIVIX-S 1417N Series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film / screen systems. The VIVIX-S 1417N Series is not intended for mammography applications.
FXRD-1417NAW and FXRD-1417NBW are indicated for digital imaging solution designed as a general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purposes of diagnostic procedures. It is not to be used for mammography.
Models FXRD-1417NAW and FXRD-1417NBW intercept X-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create an electrical signals. After the electrical signals are generated, these are converted to a digital value, and an image will be displayed on the monitor.
These devices should be integrated with an operating PC and an X-Ray generator to digitalize Xray images and transfer the digitalized images for radiography diagnostic.
Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, andimage information sharing on the network.
The provided document is a 510(k) premarket notification for a medical device, specifically a digital flat panel X-ray detector (VIVIX-S 1417N). It focuses on demonstrating substantial equivalence to a predicate device (VIVIX-S 1717N), rather than providing detailed acceptance criteria and a study to prove meeting those criteria for an AI/CADe device.
Therefore, this document does not contain the information required to answer the prompt regarding acceptance criteria and a study proving a device meets those criteria, especially for an AI/CADe device.
The document details the technical characteristics and non-clinical and clinical data used to support the substantial equivalence claim for a hardware device (an X-ray detector). It does not describe the performance of an AI or CADe algorithm or a study designed to evaluate such a system against specific performance metrics for diagnostic accuracy.
Here's why the requested information cannot be found in the provided text:
- No AI/CADe device: The VIVIX-S 1417N is an X-ray detector, which captures images. It is not an AI algorithm or a computer-aided detection (CADe) system that analyzes images for specific findings.
- Focus on Substantial Equivalence: The entire submission is built around proving the new device is "substantially equivalent" to an existing predicate device based on similar intended use, technological characteristics, and performance, primarily in terms of image quality metrics (MTF, DQE, etc.).
- "Clinical Data" section: While a "clinical data" section exists, it refers to a "single-blinded concurrence study" to confirm the new X-ray detectors provide "images of equivalent diagnostic capability" to the predicate devices. This is about image quality for human interpretation, not about the performance of an AI algorithm in detecting or diagnosing conditions, and it doesn't specify how "diagnostic capability" was quantified or what the acceptance criteria for it were. It serves to show the hardware works as intended for human readers.
To answer the prompt, I would need a document that describes the development and validation of an AI or CADe medical device, including:
- Specific diagnostic task: What condition is the AI designed to detect or diagnose (e.g., lung nodules, fractures, diabetic retinopathy)?
- Performance metrics: What metrics are used to measure the AI's accuracy (e.g., sensitivity, specificity, AUC, FROC, precision, recall)?
- Ground truth derivation: How was the definitive diagnosis for the test cases established (e.g., biopsy, follow-up, expert consensus with adjudication)?
- Study design for AI performance: Details of an MRMC study, standalone performance study, etc.
Since none of this is present, I cannot fill out the requested table or answer the specific questions about AI/CADe device performance directly from this document.
§ 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.