(70 days)
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:
- 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.
- 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.
- 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.
- Adjudication method for the test set: How disagreements among experts were resolved (e.g., majority vote, senior expert decision).
- 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.
- 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.
- 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).
- 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.
- 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.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).