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GALILEOS Implant is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical implant treatments. GALILEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALILEOS medical cone beam scanner. The dental professionals' input information may be exported from GALILEOS Implant and used as input data for CAD or Rapid Prototyping Systems.

GALILEOS Implant is a pure software device. GALILEOS Implant is an Add-On to the 3D-viewing software Sirona GALAXIS. GALILEOS Implant adds features for pre-operative simulation / evaluation of dental implant placement and surgical treatment options. GALILEOS Implant allows to name, position, move, rotate, resize and visualize generic dental implants and other planning objects (i.e. nerve canals) within the 3D volume data visualized by Sirona GALAXIS. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures.

The GALILEOS Implant 510(k) summary does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks a dedicated section outlining acceptance criteria, a detailed study design, sample sizes for training or test sets, expert qualifications, or adjudication methods.

This document describes the device as substantially equivalent to a predicate device (SimPlant System K033849) based on intended use, features, and technical characteristics. It mentions "Performance testing to validate the safety and effectiveness of the GALILEOS Implant system included validation testing and bench tests of the software functions," but provides no details of these tests, their results, or the criteria used to judge them.

Here's a breakdown of what information is not available in the provided text, and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. It can be inferred that the software processes 3D volume data from the Sirona GALILEOS medical cone beam scanner, but the origin of data used for testing (e.g., country, retrospective/prospective) is not mentioned.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The device is intended for "qualified dental professionals," but whether these professionals were involved in establishing ground truth for testing is not detailed, nor are their credentials.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• Was an MRMC study done? Not mentioned. The document focuses on demonstrating substantial equivalence of the software rather than a comparative effectiveness study involving human readers with and without AI assistance.
• Effect Size: Not applicable, as no MRMC study is reported.

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

• Was a standalone study done? Yes, implicitly. The "validation testing and bench tests of the software functions" would fall under standalone performance assessment. However, no specific metrics or results from such a study are provided. The device itself is described as "pure software," thus any "performance testing" would inherently be standalone.

7. Type of Ground Truth Used

• Type of Ground Truth: Not specified. Given the nature of dental implant planning software, it's possible that ground truth could involve:
  • Expert consensus on optimal implant placement.
  • Comparison to physically planned models or surgical outcomes (though outcomes data is less likely for initial software validation).
  • Pathology (e.g., histological verification) is highly unlikely for this type of software.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified. (It's possible, given the time frame of the submission (2006) and the nature of "pure software" for planning, that traditional machine learning 'training' data in the modern sense might not have been a primary component of its development or validation. It might have been rule-based or algorithmic.)

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

• How Ground Truth Was Established (Training Set): Not specified. (As above, if traditional machine learning was not the primary methodology, then a 'training set' ground truth might not be applicable in the same way.)

Summary of what is known/inferred:

• Device Name: GALILEOS Implant
• Intended Use: Planning and simulation software to aid qualified dental professionals in placing dental implants and planning surgical treatments, based on medical imaging from Sirona GALILEOS 3D viewer.
• Regulatory Clearance: 510(k) (K061472) based on substantial equivalence to SimPlant System (K033849).
• Performance Claim: "Performance testing to validate the safety and effectiveness of the GALILEOS Implant system included validation testing and bench tests of the software functions."
• Nature of Software: Pure software device, an add-on to Sirona GALAXIS 3D-viewing software.

The provided 510(k) summary is typical for this type of submission from that era, focusing on substantial equivalence rather than detailed performance study reports with specific metrics, acceptance criteria, and ground truth methodologies that are common in more recent AI/ML device submissions.

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