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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.

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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.

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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.

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