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Planmeca Viso is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital X-ray images as well as three-dimensional (3D) optical 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 Viso -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 (panoramic) imaging) as well as conventional 2D radiography (cephalometric imaging, 2D views). 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 pre-programmed target area. These samples are used for 3D reconstruction (using a dedicated 3D reconstruction hardware) that can be viewed in three dimensions using separate workstation and Planmeca Romexis software.

The provided text does not contain detailed acceptance criteria or a comprehensive study report for the Planmeca Viso device that would allow for a complete response to all aspects of your request. Specifically, the document focuses on demonstrating substantial equivalence to a predicate device through technical comparisons and general performance claims, rather than detailing specific quantitative acceptance criteria for image quality or clinical performance and exhaustive evidence proving they are met.

However, based on the information provided, here's a partial response:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: For the AI Denoising feature evaluation, the study included eleven patients.
• Data Provenance: Not explicitly stated, but the submission is from a Finnish company (Planmeca Oy), suggesting the data could originate from Finland or other European countries. The study appears to be prospective for the AI denoising evaluation, as it explicitly describes "comparing images with no denoising and AI denoising" for 11 patients, implying new data collection. For the general clinical evaluation, it mentions evaluation of "human phantom images," which could be retrospective or simulated, but again, details are lacking.

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

• Number of Experts: Three dental professionals were involved in the evaluation of the AI Denoising feature.
• Qualifications of Experts: The specific qualifications (e.g., years of experience, subspecialty) of these dental professionals are not specified in the provided text.

4. Adjudication Method for the Test Set

• The adjudication method for the AI Denoising study is not explicitly stated. It mentions that a team of dental professionals "evaluated human phantom images" and that the AI denoising was "evaluated in a study performed by three dental professionals." It does not specify if they reached a consensus, if a majority vote was used, or if there was an independent adjudicator.

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

• A formal MRMC comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance is not explicitly described in the provided text.
• The clinical evaluation mentions that the device's image quality was evaluated by "product relevant team of professionals who evaluated human phantom images," and this was "substantially equivalent to the evaluation performed on primary predicate device."
• The AI Denoising feature was evaluated by three dental professionals "by comparing images with no denoising and AI denoising," which is a comparative aspect. However, it doesn't quantify an "effect size of how much human readers improve with AI vs without AI assistance" in terms of diagnostic performance metrics. It only states the AI improved images to "produce diagnostic image quality."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• The AI Denoising feature was evaluated based on its "ability to produce diagnostic image quality in its intended application." While the evaluation involved human professionals comparing images, the goal was to assess the algorithm's output (denoised images). However, a purely standalone assessment without human input or comparison for decision-making is not explicitly detailed. The evaluation seems to be focused on the impact of the AI on image quality for human interpretation.

7. Type of Ground Truth Used

• For AI Denoising: The ground truth appears to be based on expert assessment/consensus (three dental professionals) regarding the "diagnostic image quality" of images with and without AI denoising.
• For General Image Quality: The clinical evaluation involved "human phantom images" assessed by "product relevant team of professionals," suggesting a form of expert assessment against an assumed standard of diagnostic suitability.
• For Bench Testing: The ground truth for bench testing (Sedentex and DIN 6868 Phantoms) would be the physical properties and known characteristics of the phantoms, with the device's performance measured against those.

8. Sample Size for the Training Set

• The sample size for the training set used for the AI Denoising feature (or any other AI component/algorithm) is not mentioned in the provided text.

9. How the Ground Truth for the Training Set Was Established

• How the ground truth for the training set (if any was used for AI model development) was established is not mentioned in the provided text.

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Planmeca Romexis is a medical imaging software intental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, diagnose, review, store, print, and distribute images of both adult and pediatric patients.

Planmeca Romexis is also a preoperative software used for dental implant planning. Based on the plant position a model of a surgical guide for a guided implant surgery can be designed objects can be exported to manufacture a separate physical product.

Planmeca Romexis is also a preoperative software for simulating surgical treatment options.

Planmeca Romexis is also intended to be used for monitoring, storing and displaying mandibular jaw positions and movements relative to the maxilla.

Additionally, Planmeca Romexis includes monitoring features for Planmeca devices for maintenance purposes. The software is designed to work as a stand-alone or as an accessory to Planmeca dental unit products in standard PC.

The software is for use by authorized healthcare professionals. Use of the software for implant planning requires that the user has the necessary medical training in implantology and surgical dentistry. Use of the software for surgical treatment planning requires that the user has the necessary medical training in maxillofacial surgery.

Indications of the dental implants do not change with guided surgery compared to conventional surgery.

Planmeca Romexis is a modular imaging software for dental and medical use. It is divided into modules to provide user access to different workflow steps involving different diagnostic views of images. Patient management screen with search capabilities lets users to find patients and identify correct patient file before starting work with a patient. After creating or selecting patient, new images can be acquired using select Planmeca X-ray units.

Planmeca Romexis is capable of processing and displaying 2D images in different formats and 3D CBCT images in DICOM format. 3D CBCT images can be viewed in near real-time multi projection reconstruction (MPR) views. 2D and 3D image browsers are provided to allow user access to relevant images. Typical image enhancement filters and tools are available to assist the user in making diagnosis, but original exposure is always kept in the database for reference.

lmages can be exported to files or writable media, printed to paper or DICOM media or transferred securely to other users using Planmeca online services. Interfaces to select external software are provided to facilitate exchange of patient information and images or data between Software and 3rd party applications.

The provided text describes Planmeca Romexis, a medical imaging software. However, it does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

Therefore, I cannot directly answer your request based on the provided text. The document lists the following:

• Indications for Use: The software's intended uses (displaying 2D/3D images, dental implant planning, surgical treatment simulation, jaw movement monitoring, device maintenance).
• Technological Characteristics Comparison: A table comparing features of Planmeca Romexis with predicate and reference devices, highlighting similarities in operating environment, functionalities, image files, and major features.
• Non-Clinical Test Results: A general statement about quality assurance measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, Performance testing, Safety testing, Final acceptance testing, Bench testing). It concludes that testing confirmed stability, operation as designed, hazard evaluation, and risk reduction. It also states that bench testing compared images rendered by Planmeca Romexis with predicate software and confirmed they are "equally effective in performing the essential functions and provide substantially equivalent clinical data."

Missing Information:

The document does not provide:

1. A table of specific acceptance criteria and reported device performance against those criteria.
2. Sample sizes for a test set, data provenance, or details about retrospective/prospective nature of a study.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study details, including effect size.
6. Details about a standalone (algorithm only) performance study.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

In summary, while the document confirms non-clinical testing was performed to establish substantial equivalence, it does not detail the specific acceptance criteria or the study methodology (sample sizes, ground truth, expert involvement, etc.) that would prove the device quantitatively meets such criteria.

Ask a specific question about this device

Planmeca Viso is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital x-ray images as well as three-dimensional (3D) optical images of the dento-maxillo-facial, cervical spine and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.

The Planmeca Viso -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 (panoramic) imaging) as well as conventional 2D radiography (cephalometric imaging, 2D views). 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 pre-programmed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions using separate workstation and Planmeca Romexis software.

The provided text describes a 510(k) premarket notification for the Planmeca Viso, a CT X-ray system. However, the document focuses on establishing substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving the device meets those criteria, as would typically be seen in a clinical performance study for an AI/CAD device.

The document primarily compares the technical characteristics and intended uses of the Planmeca Viso with its predicate device (Planmeca ProMax 3D Max) and reference devices. It states that "Results from performance bench testing demonstrate that Planmeca Viso produces substantially equivalent image quality compared to the predicate and reference devices," but does not provide specific acceptance criteria or the details of these performance bench tests.

Therefore, based on the provided text, it is not possible to fully answer all aspects of your request, especially regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment in a clinical performance study context for an AI device. The document is a regulatory clearance letter, not a detailed study report.

However, I will extract and infer what information is available and highlight what is missing.

Acceptance Criteria and Device Performance (based on provided text):

The document does not explicitly state quantitative acceptance criteria or corresponding device performance in a table format for diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" appear to be met by demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and image quality as determined through "performance bench testing."

Study Details (as much as can be inferred from the provided text):

1. Sample size used for the test set and the data provenance:

   • The document mentions "performance bench testing" but does not specify the sample size of images or patients used for these tests.
   • Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided. The document refers to "diagnostic support for pediatric and adult patients" at the "direction of healthcare professionals," but it does not detail the process of establishing ground truth for evaluating device performance.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not provided.

4. 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:

   • The document does not describe an MRMC study or any AI components, nor does it discuss human reader improvement with or without AI assistance. The device is a "Computed tomography x-ray system" (hardware).

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The document focuses on the imaging system itself (hardware) rather than an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable or discussed.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • This information is not provided. For an imaging device, ground truth for image quality often involves quantitative metrics (e.g., spatial resolution, contrast-to-noise ratio, dose efficiency) derived from phantoms or objectively evaluated clinical images against a reference standard, but the specific methods are not detailed here.

7. The sample size for the training set:

   • This information is not applicable as the document describes a hardware device (CT X-ray system), not a machine learning/AI algorithm that would typically have a "training set."

8. How the ground truth for the training set was established:

   • This information is not applicable for the same reason as above.

Summary of Missing Information (Critical for a complete answer to your prompt):

The provided document is a 510(k) clearance letter for an imaging device (Planmeca Viso). It confirms the device's substantial equivalence to a predicate device. It lacks the detailed clinical study information (acceptance criteria, specific metrics, sample sizes, ground truth establishment, expert involvement, and reader studies) that would typically be required for evaluating the performance of an AI-driven diagnostic device. The "performance data" mentioned is stated to be from "bench testing" demonstrating image quality equivalence, rather than a clinical performance study with human readers or diagnostic accuracy metrics.

Ask a specific question about this device

Planmeca Romexis is a medical imaging software intended for use in dental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, diagnose, review, store, print, and distribute images of both adult and pediatric patients.

Planmeca Romexis is also a preoperative software application used for dental implant planning. Based on the planned implant position a model of a surgical guide for a guided implant surgery can be designed data can be exported to manufacture a separate physical product.

Additionally, Planmeca Romexis includes monitoring features for Planmeca devices for maintenance purposes. The software is designed to work as a stand-alone or as an accessory to Planmeca dental unit products in a standard PC. The software is for use by authorized healthcare professionals. Use of the software for implant planning requires that the user has the necessary medical training in implantology and surgical dentistry.

Indications of the dental implants do not change with guided surgery compared to conventional surgery.

Planmeca Romexis is also intended to be used for monitoring, storing and displaying mandibular jaw positions and movements relative to the maxilla.

This device is not indicated for mammography use.

Planmeca Romexis is a modular imaging software for dental and medical use. It is divided into modules to provide user access to different workflow steps involving different diagnostic views of images. Patient management screen with search capabilities lets users to find patients and identify correct patient file before starting work with a patient. After creating or selecting patient, new images can be acquired using select Planmeca X-ray units.

Planmeca Romexis is capable of processing and displaying 2D images in different formats and 3D CBCT images in DICOM format. 3D CBCT images can be viewed in near real-time multi projection reconstruction (MPR) views. 2D and 3D image browsers are provided to allow user access to relevant images. Typical image enhancement filters and tools are available to assist the user in making diagnosis but original exposure is always kept in the database for reference.

Images can be exported to files or writable media, printed to paper or DICOM media or transferred securely to other users using Planmeca online services. Interfaces to select external software are provided to facilitate exchange of patient information and images or data between Software and 3rd party applications.

The provided text does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria. The document is a 510(k) summary for a medical imaging software (Planmeca Romexis) and focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table and detailed study information.

Here's what the document does provide in relation to non-clinical testing:

• Non-Clinical Test Results:
  • Quality Assurance Measures Applied: Risk Analysis, Requirements Reviews, Design Reviews, Performance testing (Verification), Safety testing (Verification), Final acceptance testing (Validation), Bench testing to compare with predicate software.
  • Confirmation: "Testing confirmed that Planmeca Romexis is stable and operating as designed. Testing also confirmed that Planmeca Romexis has been evaluated for hazards and that the risk has been reduced to acceptable levels."
  • Bench-testing with Predicate Software: "The non-clinical bench-testing of Planmeca Romexis with predicate software version was performed by comparison of images rendered by Planmeca Romexis and the predicate software version. The results confirm that the software applications are equally effective in performing the essential functions and provide substantially equivalent clinical data."

This information indicates that general software development and testing practices were followed, and a comparison was made to a predicate device, but it does not specify:

1. Acceptance criteria (e.g., specific metrics like accuracy, sensitivity, specificity, or error rates).
2. Reported device performance against any specific criteria.
3. Sample size for any test sets.
4. Data provenance (country of origin, retrospective/prospective).
5. Number of experts or their qualifications.
6. Adjudication method.
7. MRMC comparative effectiveness study details or effect size.
8. Standalone performance details.
9. Type of ground truth used.
10. Sample size for the training set.
11. How ground truth for the training set was established.

The document concludes that the device is "substantially equivalent in technology, functionality, and indicated use to the currently marketed predicate device" based on "intended use, product, performance, and testing information provided in this notification," but it does not elaborate on the specific performance data that led to this conclusion.

Ask a specific question about this device

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.

Ask a specific question about this device

Planmeca Romexis is a medical imaging software, and is intended for use in dental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended to retrieve, process, render, diagnose, review, store, print, and distribute images.

It is also a preoperative software application used for the simulation and evaluation of dental implants. The software includes monitoring features for Planmeca devices for maintenance purposes. It is designed to work as a stand-alone or as an accessory to Planmeca imaging and Planmeca dental unit products in a standard PC. The software is for use by authorized healthcare professionals.

Planmeca Romexis software is:

• Not intended for capturing optical impressions for dental restorations.
• Not intended for optically scanning stone models and impressions for dental restorations.
• Not intended for optically scanning intraoral preparations for use in designing implants and/or abutments.
• Not intended for optically scanning intra-orally for use in orthodontics.
• Not intended for mammography use.

Planmeca Romexis is a modular imaging software for dental and medical use. It is divided into modules to provide user access to different workflow steps involving different diagnostic views of images. Patient management screen with search capabilities lets users to find patients and identify correct patient file before starting work with a patient. After creating or selecting patient, new images can be acquired using select Planmeca X-ray units.

Planmeca Romexis is capable of processing and displaying 2D images in different formats and 3D CBCT images in DICOM format. 3D CBCT images can be viewed in near real-time multi projection reconstruction (MPR) views. 2D and 3D image browsers are provided to allow user access to relevant images. Typical image enhancement filters and tools are available to assist the user in making diagnosis but original exposure is always kept in the database for reference.

The submitter, Planmeca Oy, describes the Planmeca Romexis, a modular imaging software for dental and medical use.

Here's the breakdown of acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for a test set in the traditional sense of a clinical study with patient data. The "non-clinical test results" section describes bench testing and quality assurance measures.

• Test Set Nature: The testing performed was a "bench-testing to compare with predicate software" and involved assessing the software's stability, functionality, and hazard reduction. It did not involve a test set of patient images for diagnostic performance evaluation or a clinical trial.
• Data Provenance: Not applicable as it was bench testing of software, not analysis of patient data.

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

Not applicable. The testing described is non-clinical bench testing and quality assurance, not a study involving expert readers establishing ground truth for diagnostic image interpretation.

4. Adjudication Method for the Test Set

Not applicable, as no human reader studies with specific adjudication methods are described.

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

No. The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The evaluation focused on bench testing against a predicate device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The evaluation was of the software itself in its intended functionality, which includes processing and displaying images for human interpretation. The "bench-testing to compare with predicate software" was a standalone evaluation of the software's rendering capabilities and effectiveness in performing essential functions compared to another software. It was not measuring an AI algorithm's diagnostic performance in isolation.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

• Design Specifications/Requirements: Software was tested against its defined requirements and design.
• Predicate Device Performance: Equivalence was established by comparing images rendered by Planmeca Romexis with those rendered by the predicate software (InVivoDental). The implicit ground truth here is the established and accepted performance of the predicate device.

8. Sample Size for the Training Set

Not applicable. The Planmeca Romexis is described as an "imaging software" that processes and displays images, not an AI/ML algorithm that is trained on a dataset. The document does not mention any machine learning components requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for a machine learning model is mentioned or implied.

Ask a specific question about this device

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:
  • K060328: Planmeca ProMax 3D
  • K093590: Planmeca ProMax 3D Max
• 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.

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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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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:

1. A table of acceptance criteria and the reported device performance: Not provided in the document.
2. Sample size used for the test set and the data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the 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: 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.
6. 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.
7. 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.
8. The sample size for the training set: Not applicable, as this is not an AI-based system.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI-based system.

Ask a specific question about this device

Planmeca ProOne, dental panoramic x-ray imaging system, is an extraoral source x-ray system, which 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 ProOne is a conventional panoramic x-ray system utilizing the digital imaging method. The tube head assembly and sensor rotates around the patient and takes a dental panoramic image of the patient. The product is a new model, with simple and reliable design, but with all necessary functions included. The computer is linked to the device via Ethernet.

This document is a 510(k) summary for the Planmeca ProOne dental panoramic x-ray system. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as it predates current requirements for clinical performance data for AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Therefore, I cannot provide the requested information. The document is primarily concerned with regulatory approval based on the device's similarity to existing, legally marketed devices, rather than detailed performance metrics and clinical study results that would typically be found in more recent submissions for AI-enabled devices.

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