(174 days)
Planmeca Promax 3D Max, is a three dimensional Cone Beam Volumetric Tomography (CBVT) x-ray system, which is intended to produce three-dimensional images of the human teeth, jaw 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 510(k) summary for the Planmeca Promax 3D Max does not include information about specific acceptance criteria or a study that directly proves the device meets such criteria.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K060328 Planmeca ProMax 3D). This means the manufacturer is asserting that the new device is as safe and effective as a previously cleared device, rather than providing a new, standalone study against specific performance metrics/acceptance criteria.
Therefore, many of the requested details (sample sizes, expert qualifications, ground truth methods, MRMC studies) are not present in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., image resolution, contrast-to-noise ratio, diagnostic accuracy). The acceptance basis is substantial equivalence to the predicate device.
- Reported Device Performance:
- Intended Use: To produce three-dimensional images of the human teeth, jaw and skull.
- Function: Uses a cone-shaped x-ray beam projected onto a flat panel detector; produces a 3D reconstructed volume image viewable in 3D stations.
- Claim: "Planmeca Promax 3D Max is as safe and effective as the predicate device."
2. Sample size used for the test set and the data provenance:
- Not applicable as no specific performance study with a test set is described. The submission relies on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific performance study with a ground truth established by experts is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no specific performance study with a test set requiring adjudication 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 MRMC comparative effectiveness study is mentioned. This device is an imaging system, not an AI-assisted diagnostic tool in the sense of improving human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is an imaging system. Its "performance" is implicitly tied to image quality for human interpretation. There is no description of a standalone algorithm performance study independent of image acquisition.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no specific performance study requiring ground truth is described.
8. The sample size for the training set:
- Not applicable as this is not a machine learning/AI device requiring a training set in the typical sense.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Approach:
The manufacturer, Planmeca, used the substantial equivalence pathway to demonstrate the safety and effectiveness of the Planmeca Promax 3D Max. This means they compared their new device to a previously cleared predicate device (K060328 Planmeca ProMax 3D) and asserted that it is similar in design, composition, and function, and therefore "as safe and effective." This type of submission does not typically include detailed performance studies with acceptance criteria, sample sizes, and expert review as one might find for novel diagnostic algorithms.
§ 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.