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CephSimulation is a software application intended for storing and visualization of patient images and assisting in case diagnosis and surgical treatment planning. Results of the software are to be interpreted by trained and licensed dental and medical practitioners. It is intended for use by dentist, medical surgeons, and other qualified individuals using a standard PC. This device is not indicated for mammography use.

CephSimulation is an interactive imaging software device. It is used for the visualization of patient image files from scanning devices such as CT scanners, and for assisting in case diagnosis and review, treatment planning and simulation for orthodontic and craniofacial applications. Doctors, dental clinicians, medical surgeons and other qualified individuals can render, review and process the images, perform measurement, analysis and surgery simulation. The software runs with standard PC hardware and visualizes imaging data on standard computer screen. CephSimulation is designed as a plug-in component for InVivoDental software. It is seamlessly integrated into InVivoDental for extended capabilities. The key functionality includes image visualization, cephalometric tracing and measurements and 3D surgery simulation.

The CephSimulation device is a software application intended for storing and visualizing patient images, assisting in case diagnosis, and surgical treatment planning.

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it describes a general approach to performance validation. However, based on the narrative, the implicit acceptance criterion is that the software is "as effective as its predicate in its ability to perform essential functions."

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

• Test Set Sample Size: The document does not specify the exact sample size (number of cases or images) used for bench testing. It only mentions "evaluation of major function outputs from CephSimulation and predicate software."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: "an expert" (singular) was used.
• Qualifications of Experts: The expert was "in the field of radiology." No further details on years of experience or sub-specialization are provided.

4. Adjudication method for the test set:

The document does not describe a formal adjudication method (like 2+1 or 3+1). It states that the bench testing result "was evaluated by an expert in the field of radiology," implying a single-expert assessment rather than a consensus-based adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study, evaluating human reader improvement with vs. without AI assistance, was not conducted or reported in the provided document. The testing focused on the standalone performance of the CephSimulation software compared to a predicate.

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

Yes, a standalone performance assessment was done. The "bench testing of the software with predicate software" compared the outputs of CephSimulation directly against those of the predicate software, essentially evaluating the algorithm's performance without the user interface being the primary focus of comparison. The expert reviewer evaluated "major function outputs from CephSimulation and predicate software."

7. The type of ground truth used:

The ground truth for the bench testing was the "major function outputs" of the predicate software. This implies that the predicate's performance or outputs were considered the reference truth for comparison, rather than an independent expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

The document does not provide any information regarding the sample size used for the training set, as it describes validation testing (benchmarking) rather than development or training details.

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

Since no information on a training set is provided, there is no mention of how its ground truth was established.

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In VivoDental is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute images, utilizing standard PC hardware. Additionally, In VivoDental is a preoperative software application used for the simulation of dental implants, orthodontic planning and surgical treatments.

This device is not indicated for mammography use.

InVivoDental is a volumetric imaging software designed specifically for clinicians, doctors, physicians, and other qualified medical professionals. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. The software is downloaded over the internet and installed on the customer's computer. Users are able to examine anatomy on a computer screen and use software tools to move and manipulate rendered images by turning, zooming, flipping, adjusting contrast and brightness, cutting, and slicing. There are several rendering settings to emphasize bone and/or soft tissue. The software also has the ability to create panoramic images, superimpose images, and create measurements of volume, angle, and length. There are multiple tools to annotate and otherwise mark areas of interest on the images. The software has specialized tools to simulate surgical treatments using models rendered by Antomage, and any view or user modified area can be saved to a gallery. These simulations and galleries can then be reviewed by medical personnel or used for consultation between the doctor and patient.

This section describes the acceptance criteria and the study that proves the device meets the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size (number of cases or images) used for the test set during the bench testing. The data provenance (country of origin, retrospective or prospective) is also not specified.

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

The bench testing "was performed by an expert in the field of radiology." The specific qualifications (e.g., years of experience, subspecialty) of this expert are not detailed beyond "an expert in the field of radiology."

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method (such as 2+1, 3+1, or none) for the test set. The evaluation was performed by a single expert.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted according to the provided information. The testing involved comparing InVivoDental's performance to predicate devices by a single expert.

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

The primary evaluation described is a standalone performance assessment where the software's rendering and measurement capabilities were directly compared against predicate devices. The "human-in-the-loop" aspect was the expert radiologist evaluating the outputs of both the subject and predicate software, rather than evaluating the AI assisting a human. The software itself is designed to be used by clinicians independently.

7. Type of Ground Truth Used:

The ground truth for the bench testing was established by comparing the performance (specifically measurement and rendering accuracy) of InVivoDental against that of predicate software. The "truth" was based on the accepted functionality and output of already-marketed equivalent devices.

8. Sample Size for the Training Set:

The submission does not provide any information regarding a training set size. This suggests that the device's development and validation relied on comparison to predicate devices and established software engineering practices rather than a machine learning model that would require a distinct training set.

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

Since no information regarding a training set or machine learning model is provided, the method for establishing ground truth for a training set is not applicable in this context. The validation focuses on verification through quality assurance measures and performance testing against predicate devices.

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InVivoDental is intended for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a Dental CT scanner. It is also intended for use as a planning and simulation software in the placement of dental implants, orthodontics and surgical treatment

InVivoDental is a volumetric imaging software designed specifically for dental clinicians. The software reads DICOM data from dental CT machines including I-CAT, NewTom, MecuRay and Accuitomo. The software runs in Windows XP operating system and visualizes the DICOM data on the computer screen. The software is downloaded over the internet and installed on the customer's computer.

The provided text does not contain details about specific acceptance criteria or a study proving device performance against those criteria. It is a 510(k) summary indicating that the device is substantially equivalent to predicate devices based on its intended use, product, performance, and software information. The only mention of testing is a general statement: "Results of in-vitro testing demonstrate that the InVivoDental is safe and effective for its intended use."

Therefore, I cannot provide the requested information in the structured format you provided. The document lacks the detailed performance study data, sample sizes, ground truth establishment, or expert involvement that your questions inquire about.

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