Search Results

This device employs previously scanned DICOM CT images in a software tool which serves as an aid to visualizing and pre-planning of dental implant surgery.

Virtual Implant Placement, or simply VIP, is a software program that will allow dental implant clinicians to pre-plan their implant surgeries and/or to design surgical appliances that will be used during surgery. The program will presents the clinician with various reformatted CT images of their patient's jaw(s), allow the placement and manipulation of virtual implants, and provide measurement and other tools to assist the clinician. In typical usage a dentist evaluating a patient for dental implant surgery will often refer the patient for a CT scan to better visualize the patient's anatomy, and check the amount and density of the bone for its suitability for placing implants. The CT scan site will return the axial images from the CT scan on a CD in industry-standard DICOM format. Upon receipt of the CD, the doctor will "process" the case using VIP. Axial images are well-known to radiologists, but foreign to dentists. Processing involves the removal of unnecessary images which are outside the region of interest, and drawing a curve which will be used for the later reformatting of the data to produce images more familiar to dentists. After opening a disk of images, VIP will display the axial images and thumbnails of these, along with a scout view and a checklist of stops to follow in processing the case. After the case has been processed, the axial data will be processed to make panoramic images, which are parallel to the curve that was drawn during processing, and cross-sectional images, which are perpendicular to the panoramic image. Both types of images are normally generated by the Panorex machines dentists are familiar with. Since the primary purpose of VIP is to aid in the planning of implant surgeries, VIP will allow the surgeon to place simulated implants on the image and to gauge their size and position relative to the surrounding anatomy. The simulated implants will be generic models of standard dental implants, which range from cylindrical to conical. When the data becomes available from various implant manufacturers, VIP will allow the user to pick from specific, currently-manufactured implants to approximately model any of their favorite implants.

The provided text is a 510(k) summary for the Virtual Implant Placement™ (VIP) Dental Implant Surgery Planning Software. It details the device's intended use and compares it to legally marketed predicate devices to establish substantial equivalence.

Based on the provided text, here's an analysis of the requested information:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state "acceptance criteria" in a quantitative, measurable form for the device's performance. Instead, it focuses on establishing substantial equivalence to predicate devices through a qualitative comparison of features and intended use. The device's performance is implicitly judged by its ability to perform similar functions as the predicate devices.

No specific quantitative performance metrics (e.g., accuracy, precision, sensitivity, specificity) or corresponding acceptance criteria are provided in this document. The "device performance" is described through its functionalities and comparison to existing devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not mention any specific sample size for a test set or the provenance of any data used for testing. The submission is focused on establishing substantial equivalence based on a comparison of features and indications for use.

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):

The document does not mention the use of experts to establish ground truth for a test set. No details are provided regarding any clinical validation studies with expert review.

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

Since no test set or expert ground truth establishment is mentioned, there is no information on adjudication methods.

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:

The document does not indicate that an MRMC comparative effectiveness study was done. The device itself is described as a "software tool which serves as an aid," implying human-in-the-loop, but no data on human performance improvement with or without the software is provided.

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

The device is explicitly described as "an aid to visualizing and pre-planning," meaning it's intended to be used with human involvement. Therefore, a standalone (algorithm only) performance assessment would not be directly relevant to its intended use, and no mention of such a study is made.

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

The document does not describe the type of ground truth used because it does not refer to any formal performance study that would require ground truth. The basis for substantial equivalence is primarily a functional and indications-for-use comparison with predicate devices.

8. The sample size for the training set:

The document does not mention any sample size for a training set. As the application describes software for planning based on existing DICOM CT images, it's not clear if a machine learning model requiring a traditional "training set" (in the AI/ML sense) was used or if it's primarily rule-based or image processing software.

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

Since no training set is mentioned, no information is provided on how ground truth for a training set was established.

Ask a specific question about this device