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Devices of the GALILEOS family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support in adult and pediatric care.

Devices of the GALILEOS family comprise a package of PC software modules to expand SIDEXIS capabilities to handling 3D data. This includes 3D reconstruction, storage, retrieval, viewing and processing of 3D-image data.

The GALILEOS family is an extraoral source dental X-ray system intended to produce Xrays for obtaining three dimensional volume reconstructions of the teeth, jaw, and the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support in adult and pediatric care.

The GALILEOS family device generates a conical x-ray beam that rotates around the patient's head within a certain angle.

The device comprises an image receptor for 3D volume exposure with an adjustable diaphragm. Three volume regions are defined through this. Class I laser beam light localizers serve to position the patient's head that may be fixed through bite block and adjustable forehead and temple supports.

From the obtained exposures a three dimensional image is reconstructed and can be viewed as well as panoramic/cephalometric images. The constructed 3D volume and simulated projection exposures as well as panoramic/cephalometric data are conveyed to SIDEXIS and stored in the SIDEXIS data base.

An operator control panel allows height adjustment, selection of mode and program, and indicates machine states.

A separate handhold push-button serves for exposure release An optional remote control is available.

The provided text describes a 510(k) submission for the Sirona Dental Systems GALILEOS family of devices but does not include any acceptance criteria or details of a study demonstrating the device meets such criteria.

The submission states:

• "Nonclinical Testing" involved system functions testing, which "covers the requirements from the function specification, the risk/hazard analysis and the functionality of the equipment from the user's perspective." Additionally, "The exposure programs have been tested utilizing test phantoms. The tests evaluate the equality of exposures of proposed GALILEOS family and predicate device GALILEOS."
• "Clinical Testing": "Clinical tests have not been performed."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The submission relies on demonstrating substantial equivalence to a predicate device, as highlighted by the conclusion: "Based on a comparison of intended use, indications, construction materials, principle of operation, features, and technical data, the Sirona Dental GALILEOS family and the new member GALILEOS Comfort" is safe and effective to perform its intended use and is substantially equivalent to the predicate devices."

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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 (Computer-Aided Design) or Rapid Prototyping , Systems.

GALILEOS Implant V1.7 is a pure software device. GALILEOS Implant V 1.7 is a 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. GALILEOS Implant V1.7 allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerve canals) within the visualized 3D volume. 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 dental professionals' planning data may be exported from GALILEOS Implant V1.7 and used as input data for CAD (Computer-Aided Design) or Rapid Prototyping Systems.

The provided document is a 510(k) summary for the GALILEOS Implant V 1.7 software. It describes the device's intended use and claims substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or the detailed performance metrics of the device itself.

The submission focuses on establishing substantial equivalence based on intended use, features, and technical characteristics, and mentions "Performance testing to validate the safety and effectiveness of the GALLEOS Implant V 1.7 system included validation testing and bench tests of the software functions." However, the results of this performance testing are not provided in this summary.

Therefore, I cannot provide the requested information. The document explicitly states:

• There is no table of acceptance criteria and reported device performance.
• There is no sample size used for a test set, nor data provenance.
• There is no information on the number or qualifications of experts used for ground truth.
• There is no adjudication method mentioned.
• There is no multi-reader multi-case (MRMC) comparative effectiveness study mentioned, nor any effect size.
• There is no standalone (algorithm only) performance study detailed.
• The type of ground truth used is not specified.
• There is no sample size for the training set.
• There is no information on how ground truth for the training set was established.

The document is a regulatory filing focused on establishing substantial equivalence, not a detailed technical report of performance studies.

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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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GALILEOS consists of an x-ray device that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support.

GALILEOS comprises a package of PC software modules to expand SIDEXIS capabilities to handling 3D data. This includes 3D reconstruction, storage, retrieval, viewing and processing of 3D-image data.

The GALILEOS comprises of the GALILEOS-device, the reconstruction server and the 2D and 3D viewing client SIDEXIS. The GALILEOS device generates a conical x-ray beam that rotates round the patient's head within a certain angle. From the obtained exposures a three dimensional image is reconstructed and can be viewed. The GALILEOS features the navigation within this displayed volume and special views may be selected, calculated and eventually displayed.

The provided documentation for K060892, Sirona Dental Systems GALILEOS, is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria or extensive performance study results. Therefore, much of the requested information regarding specific performance metrics, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.

Based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It broadly states that "Performance testing to validate the safety and effectiveness of the GALILEOS included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions." This indicates that the device met internal performance standards for these general categories to be considered substantially equivalent.

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

This information is not provided in the document.

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device is described as an x-ray system with 3D reconstruction and viewing software, not an AI-assisted diagnostic tool in the modern sense.

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

The document describes the GALILEOS as an "x-ray device that uses a cone beam... providing two-dimensional images and three-dimensional volume reconstructions... for use in planning and diagnostic support," and "comprises a package of PC software modules to expand SIDEXIS capabilities to handling 3D data." This implies a standalone performance of the imaging and reconstruction system itself, as the primary function is to generate and display images for human interpretation. However, specific standalone performance metrics (e.g., image quality, resolution, contrast-to-noise ratio) are not detailed beyond the general statement of "validation testing of both hardware and software functions."

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

This information is not provided in the document. Given the nature of a 510(k) submission for an imaging device, ground truth for image quality might be assessed internally, but clinical ground truth (e.g., disease presence) would likely not be the primary focus of this type of submission unless a specific diagnostic claim was being made beyond "diagnostic support."

8. The sample size for the training set

This information is not provided in the document. The device is described as an imaging system and software, implying traditional engineering validation rather than machine learning training sets in the contemporary sense.

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

This information is not provided in the document. Assuming a lack of machine learning, a "training set" and associated "ground truth" for training are not applicable in this context.

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