(47 days)
The DIGIVIEW 395, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.
The DIGIVIEW 395 is a flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:TI scintillator. The DIGIVIEW 395 detector has an active area of 43.2 cm x 35.5 cm at a pixel pitch of 100μm. Data and control communication is accomplished via a Gigabit Ethernet interface or 802.11n WiFi. The detector can be integrated into a fixed room X-ray system to enable digital radiography.
The provided document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of test set/training set sizes, ground truth establishment, or expert involvement in the way requested.
This document is a 510(k) summary for a medical device (Kubtec DIGIVIEW 395), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance metrics against specific acceptance criteria.
Here's what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Not available in the document. The document states "Kubtec's DIGIVIEW 395 successfully completed internal safety testing requirements to recognized consensus standards listed below." However, it does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy) or the quantitative acceptance criteria for those metrics. The comparison chart (page 6) shows physical and technical specifications of the device and its predicate, not performance against clinical or technical acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available in the document. The document explicitly states: "No clinical studies were conducted in support of the DIGIVIEW 395 as agreed upon during Pre-Submission discussions with the Agency for the predicate device (K140551). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence." This means there was no test set of patient data for evaluating performance.
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)
- Not applicable. As no clinical studies were conducted, there was no test set and therefore no ground truth established by experts in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. As no clinical studies were conducted, there was no test set requiring adjudication.
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
- No, an MRMC study was not done. The device is a stationary X-ray system (hardware), not an AI-powered diagnostic tool intended to assist human readers. The document states "No clinical studies were conducted."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a flat panel X-ray detector, which is hardware for image generation, not an algorithm being evaluated for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. As no clinical studies were conducted, there was no ground truth for diagnostic performance evaluation. The device's "performance" was assessed against recognized consensus standards for physical and technical characteristics of X-ray imaging devices.
8. The sample size for the training set
- Not applicable. The device is a hardware component (a flat panel X-ray detector). While it uses "DIGICOM software to manage operation of detector," there is no mention of machine learning or AI that would require a "training set" in the context of diagnostic performance evaluation. The software mentioned is for detector operation, not for diagnostic interpretation.
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
Summary of what the document does state regarding validation:
- Basis for Equivalence: The primary method for demonstrating the safety and effectiveness of the Kubtec DIGIVIEW 395 was by proving its "substantial equivalence" to a legally marketed predicate device (PerkinElmer, XRpad 4336 MED, K140551). This means showing that it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
- No Clinical Studies: Explicitly states "No clinical studies were conducted in support of the DIGIVIEW 395 as agreed upon during Pre-Submission discussions with the Agency for the predicate device (K140551). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence."
- Technical Standards: Safety testing was completed to recognized consensus standards, including:
- IEC 62220-1 (Determination of the detective quantum efficiency)
- IEC 62220-1-3 (DQE for dynamic imaging)
- IEC 62494-1 (Exposure index for general radiography)
- IEC PAS 61910-1 (Radiation dose documentation)
- NEMA PS 3.1 - 3.20 (DICOM Set)
- IEC 60601-2-43 (Safety and essential performance of X-ray equipment)
- NEMA XR 24-2008 (Primary user controls for interventional angiography x-ray equipment)
- Comparison Chart (Similarities to Predicate): The document provides a detailed comparison chart (pages 6-7) highlighting that the proposed device and the predicate device share identical intended use/indications for use, panel type, scintillator, pixel matrix, pixel pitch, active area, external dimensions, weight, housing material, communication interface, and power. The only difference noted is the utilization of Kubtec's DIGICOM software for detector operation, which itself was previously cleared in other 510(k) submissions.
In conclusion, for this specific 510(k) document, the device approval was based on substantial equivalence and compliance with engineering standards, not on clinical performance metrics or studies involving patient data or human readers.
§ 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.