(185 days)
RAYDENT SW is a software designed to assist dental professionals in planning patient treatment devices. The software performs simulations based on patient images, allowing reference to treatment plans, and is used as a tool to design treatment devices based on 3D mesh data. Treatment devices include prosthetic devices (Veneer, Crown, Bridge, In/Onlay) and orthodontic devices (Clear Aligner).
To use RAYDENT SW, users must have the necessary education and domain knowledge in orthodontic practice and receive dedicated training in the use of the software.
RAYDENT is a software that provides tools to simulate treatment plans based on patient images generated by compatible scanners and design treatment devices based on appropriate three-dimensional images. It allows dental offices to acquire patient data in conjunction with software on compatible imaging equipment and utilize the acquired images to create treatment plans and devices for skilled dentists and oral and maxillofacial specialists.
The document K233625 is a 510(k) Premarket Notification for the device "RAYDENT SW," a software designed to assist dental professionals in planning patient treatment devices. As such, the document provides information on the device's intended use, comparison to predicate devices, and a summary of performance testing. However, it does NOT include detailed information about acceptance criteria or a specific study proving the device meets those criteria, particularly not in the context of an AI/ML-enabled medical device performance study.
The document states that RAYDENT SW includes "Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices: YES" in its comparison table (Page 7). However, the "Performance Testing" section (Page 9) does not describe an AI/ML-specific performance study with acceptance criteria, sample sizes, ground truth establishment, or human-in-the-loop evaluation. It merely states that "Software, hardware, and integration and validation testing was performed in accordance with the FDA Guidance Document 'Guidance for the Content of Premarket Submissions for Device Software Functions' and 'Guidance for the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions'." It then concludes that "All test results have been reviewed and approved, showing the RAYDENT SW to be substantially equivalent to the predicate devices."
Therefore, based on the provided text, I cannot extract the information required to answer your prompt about the acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.
To answer your specific points:
- A table of acceptance criteria and the reported device performance: Not found in the provided document. The document mentions general validation testing but no specific performance metrics or acceptance criteria for an AI component.
- Sample sized used for the test set and the data provenance: Not found.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not found.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not found.
- 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: Not found. The document explicitly states "Clinical testing is not a requirement and has not been performed" (Page 9), implying no such MRMC study was conducted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed for an AI component. The general performance testing is mentioned, but without specifics for the AI.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not found.
- The sample size for the training set: Not found.
- How the ground truth for the training set was established: Not found.
The document focuses on substantiating equivalence primarily through comparison of indications for use, technological characteristics, and general software/hardware validation, rather than an in-depth AI/ML performance study.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.