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SurgPLAN and PanPLAN are Software packages that scan film using optical scanner or Direct Digital Capture using Solid State Sensors (from the Sensor) and store images produced by Imaging Sciences International's (or other manufacturer's) Tomographic, Panoramic and Cephlometric imaging machines. Additionally, the software has the ability to import DICOM images from volumetric data sets for analysis and reporting. The software allows the practitioner to perform surgical demonstrations for dental implant planning, cephlometric analysis, measurements and bone graft visualizations. The purpose of the software is to provide the doctor with a convenient method for visualization of the imaging modalities, facilitates communication between multiple practitioners and to demonstrate treatment plan for the patient.

SurgPLAN / PanPLAN is a comprehensive software package that can scan films or certain solid state detectors, read DICOM images or DICOM volumetric data sets and display the images for the practitioner to perform analysis, measurements and surgical demonstrations for dental implants.

The provided text is a 510(k) Summary for the SurgPLAN / PanPLAN software, a device for dental implant planning and analysis. While it mentions performance testing and validation, it does not explicitly detail specific acceptance criteria or the study that proves the device meets those criteria. The summary focuses on establishing substantial equivalence to predicate devices and addressing potential hazards.

Therefore, for several of your requested points, the information is not available in the provided document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Information Not Available in the Document. The document states: "The performance testing of the Imaging Sciences International Inc. SurgPLAN / PanPLAN would indicate that the system is substantially equivalent to both predicated devices." However, it does not provide specific performance metrics or acceptance criteria for these metrics.

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

Information Not Available in the Document. The document mentions "performance testing" but does not specify the sample size, type of test data (e.g., patient cases), or its provenance.

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)

Information Not Available in the Document. The document does not describe how ground truth was established for any testing, nor does it mention the involvement or qualifications of experts in that process.

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

Information Not Available in the Document. The document does not describe any adjudication method used for testing or ground truth establishment.

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

Information Not Available in the Document. The document does not mention an MRMC study or any study comparing human reader performance with and without AI assistance. The device's primary function described is analysis and planning, not necessarily aiding human readers in interpretation.

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

Information Not Available in the Document. While the software performs analysis and measurements, the document does not distinguish between standalone algorithm performance testing and performance in a human-in-the-loop scenario. The overall context suggests it's a tool for the practitioner: "The software allows the practitioner to perform analysis, measurements and surgical demonstrations..."

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

Information Not Available in the Document. The document does not specify the type of ground truth used for performance testing or validation.

8. The sample size for the training set

Information Not Available in the Document. The document does not mention a training set or its size. While software often involves training data (especially if it uses AI/machine learning, which isn't explicitly stated here), this information is not provided.

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

Information Not Available in the Document. As no training set or its ground truth establishment is mentioned, this information is not provided.

Summary of what is available:

The 510(k) summary for SurgPLAN / PanPLAN focuses on:

• Substantial Equivalence: Claiming substantial equivalence to SimPlant (Materialise/Columbia Scientific) and CDRPan and CDR DICOM (Schick Technologies Inc.).
• Device Description: A software package that scans films or solid-state detectors, reads DICOM images/volumetric data, and displays images for analysis, measurements, and surgical demonstrations for dental implants.
• Intended Use: Providing a convenient method for visualization in planning (implants, cephlometric analysis, bone graft), facilitating communication, and demonstrating treatment plans.
• Hazards Control: Stating that potential hazards (e.g., incorrect measurements, imprecision) are controlled by the software development and validation system.

The document is a regulatory submission demonstrating a belief in equivalence and safety, but it is not a detailed technical report of performance criteria and empirical study results.

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