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.

Device Description

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.

AI/ML Overview

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.

Summary

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7.A 510(k) SUMMARY KOS2840

(As required by Section 807.92(c))

Applicant's Name: Denx Ltd. DENX Advanced Dental Systems Ltd. Moshav Ora 106 Jerusalem 90880 ISRAEL Tel: -- 972 (2) 641-7748 Fax: - 972 (2) 642-6901

Contact Person: Rachel Weissbrod Denx Ltd. DENX Advanced Dental Systems Ltd. Moshav Ora 106 Jerusalem 90880 ISRAEL Tel: +972 (2) 641-7748 Fax: +972 (2) 642-6901
Email: rachelw@denx.com

Date Prepared: May 2005

Trade Name: IGI-System™

Classification: The FDA has classified "sterotaxic Instruments" devices as class 11. pursuant to 21 C.F.R. § 882.4560 (product code HAW), and it is reviewed by the General & Plastic Surgery Advisory Committee.

Predicate Devices: IGI- Image Guided Implantology System cleared under (K)023424

Description of the Device: 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.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is composed of three parallel lines that curve and converge. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.

DEC 16 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DenX Advanced Dental Systems % Patricia Murphy Kema Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914

Re: K052840

Trade/Device Name: IGI-System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: December 7, 2005 Received: December 8, 2005

Dear Ms. Murphy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarer a see ice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stared in the encreations of the enactment date of the Medical Device Amendments, or to commerce pror to this 2011-03-12 11:53
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been resuire approval of a premarket approval application (PMA). and Cosmetter For (110) that the device, subject to the general controls provisions of the Act. The r ou may , interest provisions of the Act include requirements for annual registration, listing of general controls provisions of wactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your device to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any reathated is requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 607), adoling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Ms. Murphy

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and in your to begin finding of substantial equivalence of your device to a legally prematted predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please in you a the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buellm

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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7. C INDICATIONS FOR USE STATEMENT

510(k) Number (if known): KOSQ840

Device Name: IGI Image Guided Implantion System

Indications for Use:

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

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Labare Buelindsen UKM

Division of General, Restorative, and Neurological Devices

510(k) Number 1053840

Regulation Number and Section

§ 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).