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The Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional (2D) and three- dimensional (3D) digital X-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.

The Planmeca ProMax 3D Max or Planmeca Maximity -x-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method. In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain preprogrammed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions in the Planmeca Romexis program (on a separate PC system). Ethernet computer networking technology is used.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Planmeca ProMax 3D Max and Planmeca Maximity devices:

The provided document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive acceptance criteria and exhaustive study results in the manner one might find in a full clinical trial report or a performance study for novel AI/standalone devices.

Here's a breakdown of the requested information based on the provided text, with acknowledgments where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it relies on demonstrating that the device's performance for the expanded indications (ENT region) is clinically usable and comparable to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document states "clinical images for nose, sinuses, airways, middle ear, temporal bone and vertebrae" were taken, implying a collection of images, but the exact number is not provided.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The term "clinical images" suggests they were acquired from human subjects, but details are lacking.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: "a specialist" (singular).
• Qualifications of Experts: Only stated as "a specialist." No further details (e.g., radiologist, years of experience, specific sub-specialty) are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: "a specialist" reviewed the images. This implies a single-reader assessment rather than a consensus or adjudication process involving multiple readers (like 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not reported or implied. The device is an imaging system, not explicitly an AI diagnostic tool in this context, and the evaluation focused on image quality for diagnostic use.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No, a standalone algorithm-only performance study was not explicitly reported. The evaluation described is of the image acquisition and reconstruction system providing images for human interpretation. The "diagnostic support" refers to the images themselves, not an automated diagnostic algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established by expert clinical review. The "specialist" deemed the images to be of "clinically usable diagnostic quality," indicating a subjective expert assessment of the image data for diagnostic purposes, rather than being compared to a higher standard like pathology or long-term outcomes data.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not provided. The document describes a traditional imaging device, not an AI/machine learning algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable/not provided, as there is no mention of an AI/machine learning training set.

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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.

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