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The IGI-System™, Image-Guided Implantation System, is a computerized navigational system intended to provide assistance in both the planning (preoperative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides accurate navigational guidance of surgical instruments, with regard to the pre-operative planning in dental implantation procedure.

The device is intended for use for partially edentulous and edentulous patients who require dental implants as part of their treatment plan.

System enabling image guided surgery for dental implant surgery through the utilization of planning software based on patient CT, registration through the use of fiducial markers and real time navigation by tracking both patient and handpiece movement and comparing to the pre-defined surgery plan.

This document, K052840, is a 510(k) summary for the IGI-System™ by Denx Ltd. It provides information about the device's classification, predicate devices, description, and indications for use. However, the provided text does not contain the specific details required to answer your questions about acceptance criteria and the study that proves the device meets those criteria.

Here's a breakdown of why I cannot answer your specific questions based on the provided text, and what kind of information would be needed:

The provided text focuses on:

• Administrative details: Applicant name, contact, date prepared, trade name.
• Regulatory classification: Device class, product code, predicate device.
• Device description: General overview of its function (image-guided surgery for dental implants).
• Indications for use: What the device is intended for (planning and surgical phases of dental implantation, for partially edentulous and edentulous patients).
• FDA correspondence: The letter from the FDA acknowledging the 510(k) submission and substantial equivalence.

Information NOT present in the provided text that is needed to answer your questions:

1. A table of acceptance criteria and the reported device performance: This would typically be found in a detailed performance study section, outlining specific metrics (e.g., accuracy, precision, success rates) and the target values for these metrics.
2. Sample sized used for the test set and the data provenance: Details on the number of cases/patients used, where the data came from (e.g., a specific dental clinic), and if it was collected retrospectively or prospectively.
3. Number of experts used to establish the ground truth and their qualifications: Information about the panel of experts, their specialty (e.g., oral surgeons, prosthodontists), and years of experience.
4. Adjudication method for the test set: How disagreements among experts were resolved (e.g., majority vote, senior expert decision).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This describes a very specific type of study, usually for diagnostic or assistive AI devices, comparing human performance with and without the device. The IGI-System™ is described as a "computerized navigational system" for surgery, not primarily a diagnostic AI, making such a study less directly applicable or highly specific to its navigation accuracy.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This would be relevant if the device had an autonomous decision-making component, but as a navigation system, its performance is inherently human-in-the-loop.
7. The type of ground truth used: How the "true" outcome or measurement was determined (e.g., histology, CT measurements by an independent expert, follow-up outcomes).
8. The sample size for the training set: This refers to the data used to develop or "train" the underlying algorithms, which is distinct from the test set used for validation.
9. How the ground truth for the training set was established: Similar to the test set, but for the training data.

To provide the answers you're looking for, I would need to analyze a "Performance Data" or "Clinical Study" section of the 510(k) submission, which would detail the validation studies conducted to demonstrate the device's safety and effectiveness. This information is typically proprietary and not fully disclosed in the public 510(k) summary.

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The IGI Image-Guided Implantation system, is a computerized navigational system intended to provide assistance in both the planning (preoperative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides accurate navigational guidance of surgical instruments, with regard to the pre-operative planning in dental implantation procedure.

The IGI-System is an electro-optical device, which was specifically designed to greatly improve the surgical implantation procedure by providing the surgeon an accurate guidance to the location of the surgical tools prior to, and more importantly, during the surgical operation. The novel device both increases surgical success rate, and reduces potential damage to adjacent anatomical structures and tissues. The IGI-System introduces, for the first time, the element of objective, state-of-the-art measurements to the field of dental implantation. Equipped with the IGI-System, the dental surgeon is able to plan the implantation procedure and align the actual placement of the implant in the pre-planned position with great accuracy. The IGI-System allows the user to view the reconstructed 2D images of the patient anatomy together with overlaid graphic information depicting the position of dental surgical instrument and pre-planned position of dental implant. The IGI-System utilises an infra-red (IR) optical tracking system, comprised of emitters, camera and a tracking data processor (computer), to determine the location and orientation of the dental hand-piece and the patient. The position and orientation of both the dental surgical instrument and the patient are transmitted to an image data processor (computer) which makes necessary calculations to provide the guidance graphic overlay depicting the dental surgical instrument and planned dental implant location on the medical image. Alignment of the patient and medical images is accomplished through a process termed fiducial registration. The goal is to indicate to the dentist, based on the preimplantation medical images, the exact position of the tracked dental surgical instrument together with the location of planned dental implant location, with regard to the patient's anatomy. The dentist will place a virtual implant image in the optimal location by use of the IGI software and available CT data. Once an implant has been optimally positioned, the system will correlate between the dentist's plan and the actual performance. In case of significant variance between the plan and the performance the system will alert the user. The system is used in two stages of the implantation procedure. The first stage is preplanning of the surgical implantation procedure. The second stage is the clinical one in which the system is used for accurate guidance of dental surgical instruments according to the pre-planned implant position. In addition, the system assists the dentist in avoiding critical anatomical structures. The system is used to pre-plan the surgical implantation procedure. Consequently, the system provides accurate guidance during the dental implantation, of surgical instruments with regard to pre-operative planning, and assists the dentist in avoiding the risk of causing damage to critical anatomical structures. The IGI-System is defined as a supporting device, providing a significant contribution to the decision-making process, which continuously takes place during the implantation process. It is by no means intended to replace human judgement. The final decisions as to the exact location, timing, intensity and depth of the drilling are the sole responsibility of the surgeon. The surgeon is at liberty, at any time throughout the surgical procedure, to determine the final drilling position, or to modify implants' planned position. Thus, under no circumstances does the device relieve the surgeon of his or her ultimate clinical responsibility.

The provided text describes the IGI-System™, an image-guided implantation system for dental surgery, and its substantial equivalence to predicate devices. It discusses performance standards and the acceptance criteria for accuracy.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

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 a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). The claim of +/- 0.5mm accuracy is made in the context of comparing the IGI-System to predicate devices, stating that "All three devices provide navigational accuracy of +/-0.5mm." This suggests the accuracy was likely established through internal testing or by referencing the accuracy of the predicate devices, rather than a specific clinical study described here.

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

The document states, "The level of accuracy, defined to be acceptable in dental implantation navigation, was +/-1mm. This level of accuracy was defined based on review of state of the art technology, opinions by experts in the field..."
However, the number and specific qualifications of these experts are not provided. It's unclear if these experts were involved in establishing ground truth for a test set, or merely in defining the acceptable accuracy threshold.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for a test set. This implies that there was no formal human adjudication process for evaluating the device's performance against a ground truth in a clinical or simulated setting described here.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with AI assistance. The device is described as a "supporting device" that provides "accurate guidance" and "significant contribution to the decision-making process," but "is by no means intended to replace human judgement." This suggests its role is assistive rather than a direct replacement or an AI that significantly alters human reader performance in a diagnostic context.

6. Standalone Performance Study

The document implies a standalone performance due to the statement: "All three devices provide navigational accuracy of +/-0.5mm. This level of accuracy cannot be achieved by human visual inspection." This highlights that the device's accuracy is a standalone measurement of its navigational capability, independent of human input, though it is used with a human surgeon. However, a dedicated standalone study is not detailed. The accuracy is presented as an inherent characteristic of the device and its predicate technologies.

7. Type of Ground Truth Used

The type of ground truth used to establish the +/-0.5mm accuracy is not explicitly stated. Given it's a navigational system based on CT scans, the ground truth for accuracy would likely involve precise physical measurements against a known spatial reference, potentially using phantoms or highly accurate instruments to verify the device's ability to track and guide to precise locations defined by the CT data. The "optimal location" of an implant is planned using CT data and IGI software, and the system correlates this plan with "actual performance."

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is common for devices of this nature, which are typically based on established principles of optical tracking and image processing rather than machine learning models that require large training datasets in the conventional sense.

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

Since there is no mention of a training set, there is no information on how its ground truth was established. The device's functionality relies on algorithms for image reconstruction, instrument tracking, and registration, which are likely developed and validated through engineering principles and calibration rather than a machine learning training paradigm.

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