(27 days)
IMIX PanoRad and PanoRad SL X-Ray Systems are indicated for use in generating radiographic images of human anatomy. They have Solid State X-ray Imaging systems intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (Not for mammography.)
The modified device can produce digital x-ray images in various configurations.
The provided text is a 510(k) summary for the IMIX ADR Finland OY PanoRad and PanoRad SL Systems. This document aims to demonstrate substantial equivalence to previously cleared devices, rather than establishing acceptance criteria for a new, distinct device's performance.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, and ground truth establishment because it is focused on demonstrating that the revised device is substantially equivalent to existing, legally marketed devices.
Here's why each of your requested points is not present in the provided text:
- A table of acceptance criteria and the reported device performance: This document doesn't define new performance criteria or report performance against them. Instead, it compares the characteristics of the modified device to a predicate device to show they are essentially the same.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific test sets or clinical studies for performance evaluation are described. The filing relies on the established safety and effectiveness of the existing predicate devices and the individual components.
- 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): Since no new performance studies are detailed, there's no mention of experts establishing ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there's no new test set described.
- 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: This is not an AI/CAD device. It's an X-ray imaging system, so MRMC studies, especially with AI assistance, are not relevant to this filing.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a hardware device (X-ray system), not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no new performance study requiring ground truth.
- The sample size for the training set: Not applicable, as this is not an AI/Machine Learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable for the same reason as point 8.
In summary, the provided document focuses on demonstrating substantial equivalence of a modified X-ray system to a predicate device by comparing technical specifications and intended use, rather than presenting a de novo performance study with specific acceptance criteria and ground truth validation.
§ 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.