(90 days)
Planmeca ProMax 3D Mid, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Volumetric Tomography (CBVT) to produce three-dimensional images of the human teeth, jaws and skull. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified health care professionals.
The Planmeca ProMax 3D Max is in principle a conventional digital panoramic/tomography xray system with three-dimensional Cone Beam Volumetric Tomography (CBVT) system add on. The product rotates around the patient and takes still images with a flat panel sensor synchronized to x-ray generator pulsing. A 3D reconstruction engine calculates the cylindrical 3-dimensional volume image, which then is viewed in 3D viewing stations.
This document is a 510(k) summary for the Planmeca ProMax 3D Mid, an X-ray system. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria.
Based on the provided text, there is no information regarding acceptance criteria or a study that proves the device meets specific performance metrics. The document is a regulatory submission for premarket notification, establishing "substantial equivalence" to predicate devices. It does not contain the detailed technical performance data typically found in a clinical or standalone performance study report.
Therefore, I cannot populate the requested table or provide answers to most of the questions as the information is not present in the provided text.
Here's an overview of what can be extracted based on your request, highlighting the missing information:
1. A table of acceptance criteria and the reported device performance
- No information provided. The document does not specify any quantitative acceptance criteria or report performance metrics (e.g., sensitivity, specificity, resolution, image quality scores) against such criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information provided. No test set or data provenance is mentioned as there is no performance study described.
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)
- No information provided. Ground truth establishment for a test set is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No information provided. No adjudication method is described.
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 information provided. This device is an X-ray imaging system, not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No information provided. This is an imaging device, not an algorithm, so this concept is not applicable in this context. No standalone performance data is presented.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- No information provided. No ground truth is discussed as no performance study is detailed.
8. The sample size for the training set
- No information provided. No training set is mentioned.
9. How the ground truth for the training set was established
- No information provided. No training set or ground truth establishment is mentioned.
Summary of available information relevant to regulatory submission:
- Device Name: Planmeca ProMax 3D Mid
- Manufacturer: Planmeca Oy (Helsinki, Finland)
- Intended Use: Panoramic and cephalometric x-ray unit using Cone Beam Volumetric Tomography (CBVT) to produce three-dimensional images of human teeth, jaws, and skull. Operated by dentists and other legally qualified healthcare professionals.
- Product Description: Conventional digital panoramic/tomography X-ray system with a 3D CBVT add-on. Rotates around the patient, takes still images with a flat panel sensor, and reconstructs a 3D volume image for viewing.
- Predicate Devices:
- Regulatory Classification: Class II, Product Code MUH, Regulation Number 872.1800 (Extraoral Source X-Ray System)
- 510(k) Number: K103689
- Date of Submission: December 14, 2010
- FDA Clearance Date: March 17, 2011
The document's purpose is to demonstrate that the Planmeca ProMax 3D Mid is "similar in design, composition and function" and "as safe and effective" as the predicate devices, thereby establishing substantial equivalence for regulatory clearance without requiring a new, full-scale performance study to meet specific acceptance criteria.
§ 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.