(97 days)
Planmeca ProSensor, digital intraoral x-ray imaging system, is an accessory to dental intraoral x-ray devices. It is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device is digital, and the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer. The device is to be operated and used by dentists and other legally qualified professionals.
The Planmeca ProSensor is an accessory to the intraoral x-ray unit, and it captures the x-ray image with a sensor placed inside the patient's mouth. The digitized image is then sent either via Ethernet or a USB connection to a computer for viewing and archiving. The system consists of a sensor, a control box and a PoE (only needed for the Ethernet version).
This 510(k) summary for the Planmeca ProSensor does not contain the detailed acceptance criteria or a study demonstrating the device meets such criteria.
The provided document is a 510(k) Premarket Notification summary that primarily focuses on establishing substantial equivalence to a predicate device (Planmeca Dixi2, K000428). It outlines the product's intended use, description, and claims of similarity to the predicate without detailing specific performance studies against acceptance criteria.
Therefore, I cannot provide the requested information. The document explicitly states: "The comparison of characteristics supports substantial equivalence. Planmeca ProSensor is as safe and effective as the predicate device." This indicates that the regulatory pathway pursued was based on demonstrating equivalence, not necessarily on a de novo study proving performance against predefined acceptance criteria in the manner you've outlined.
To answer your specific points:
- A table of acceptance criteria and the reported device performance: Not provided in the document.
- Sample size used for the test set and the data provenance: Not provided in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
- 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 applicable. This device is a digital intraoral x-ray imaging system, not an AI-assisted diagnostic tool. No such study is mentioned or implied.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware imaging system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the document, as no specific performance study against ground truth is detailed.
- The sample size for the training set: Not applicable, as this is not an AI-based system.
- How the ground truth for the training set was established: Not applicable, as this is not an AI-based system.
§ 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.