(90 days)
The CRUXVIEW is a software intended for using and managing dental x-ray image sent by Cruxcan image plate scanner, storing the images and allowing the user to process and examine the images in order to achieve improved diagnoses.
The CRUXVIEW is dental x-ray image management software which provides various features to acquire, transfer, edit, display, and store scanned dental images which is specifically for a 510k cleared device (K183637), Cruxcan (CRX-1000). It also provides server/client model which allow users to upload and download the images and patient information from any workstations in the network environment. CRUXVIEW consists of two parts: CRUXVIEW Viewer and CRUXVIEW Server. CRX-1000 sends the scanned image to the CRUXVIEW viewer. The CRUXVIEW viewer sends the received image to the CRUXVIEW Server. The CRUXVIEW Viewer searches the image stored in the CRUXVIEW Server and shows the image to the user. The subject device has various functions for users' needs including length and angle measurement functions. The CRUXVIEW supports DICOM file formats.
The provided text describes the CRUXVIEW, a dental x-ray image management software, and notes its substantial equivalence to the predicate device, DIGORA FOR WINDOWS 2.0. However, the document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance study details.
Specifically, the document mentions "Performance test for accuracy of measurement function" and "SW Validation for Viewer & Server" but does not provide details on the acceptance criteria, study methodology, sample sizes, ground truth establishment, or expert involvement.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document states that "The test results of the tests performed on the subject device supported that it is substantially equivalent to the predicate device," but it does not specify the acceptance criteria used for these tests or the quantitative performance metrics achieved.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size
This information is not provided in the document. The document mentions "SW Validation for Viewer & Server" and "Performance test for accuracy of measurement function," which suggests technical validation, but not a clinical comparative effectiveness study with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
The document mentions "Performance test for accuracy of measurement function" and "SW Validation for Viewer & Server." While these are standalone tests of the software's functions, they are not presented as a "standalone (algorithm only)" performance study in the sense of a diagnostic effectiveness study, but rather as functional verification. Details on the methodology and results are not provided.
7. The Type of Ground Truth Used
This information is not provided in the document.
8. The Sample Size for the Training Set
This information is not provided in the document.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the document. Given that the CRUXVIEW is software for managing and processing images from a cleared device (Cruxcan image plate scanner) rather than an AI-driven diagnostic tool generating new findings, the concept of a "training set" for AI algorithms and associated ground truth establishment may not fully apply in the same way as it would for a machine learning-based diagnostic device. However, without details, this remains an assumption.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.