(34 days)
Planmeca Promax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. 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 professionals.
The Planmeca Promax 3D is in principle a conventional digital panoramic x-ray system with three-dimensional Cone Beam Computed Tomography (CBCT) 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.
The provided document is a 510(k) summary for the Planmeca Promax 3D, a Cone Beam Computed Tomography (CBCT) x-ray system. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, several requested sections, particularly those pertaining to detailed study design, sample sizes, and expert adjudication, are not explicitly available in the provided text.
Specifically, K060328 is a 510(k) premarket notification for a new device, and its purpose is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (3D Accu-i-tomo XYZ Slice View Tomograph # K052587). This process typically involves showing that the new device is as safe and effective as the predicate device, often through comparison of design, composition, and technological characteristics, and sometimes through performance data if there are significant differences. However, the exact "acceptance criteria" in the sense of a numerical performance threshold and a detailed study proving the device meets those criteria in an independent clinical trial is not part of this 510(k) summary as provided.
Here's an attempt to answer the questions based on the available information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria with numerical thresholds or report detailed device performance metrics against such criteria. The "acceptance criteria" in the context of this 510(k) submission are implicitly tied to demonstrating substantial equivalence to the predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Summary from Document) |
|---|---|
| Similar in design, composition, and function | "similar in design, composition and function to the... predicate device." (Section: SUBSTANTIAL EQUIVALENCE) |
| As safe and effective as the predicate device | "Planmeca Promax 3D is as safe and effective as the predicate device." (Section: SUBSTANTIAL EQUIVALENCE) |
| Intended Use | "intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures." (Section: INTENDED USE) |
| Technology | "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." (Section: INTENDED USE) |
2. Sample size used for the test set and the data provenance
Not specified. The provided document does not mention any specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a study assessing the device's performance against defined acceptance criteria. The claim of substantial equivalence is made based on design and functional similarity to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. As no specific "test set" or explicit ground truth establishment process is detailed in the provided 510(k) summary, information regarding the number or qualification of experts for this purpose is absent.
4. Adjudication method for the test set
Not applicable/Not specified. There is no mention of a test set or an adjudication method in the provided document.
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. The document describes an x-ray system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this submission and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not specified. This is a hardware device (x-ray system), not an algorithm or AI. Standalone algorithm performance is not relevant to this submission.
7. The type of ground truth used
Not specified. Given that no specific study with defined acceptance criteria and performance data is detailed, the type of ground truth used is not mentioned. The submission relies on claiming equivalence to a predicate device already on the market.
8. The sample size for the training set
Not applicable/Not specified. This is a medical imaging device, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI development is not relevant to this 510(k) submission and no information is provided.
9. How the ground truth for the training set was established
Not applicable/Not specified. As this is not an AI/ML device, the concept of a training set and its ground truth establishment is not applicable.
§ 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.