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WillCeph is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic treatment planning and case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.

WillCeph is a software device for Cephalometric Analysis & Maxillo-facial Surgical Simulation, Consulting, Diagnosis, Surgical Planning, Analysis, Growth Forecast. It includes features for patient data management, various gallery formats, image fusion and comparing, cephalogram and tracing on digitized X-ray film, treatment simulation (VTO / STO), chart and analysis, superimposition, photo-film image fusion, growth forecast, and PACS integration (Option). It can be used as a client or standalone software on Microsoft Windows 7 or higher.

The provided document, a 510(k) premarket notification for the "WillCeph" device, contains a limited amount of information regarding acceptance criteria and study details. It explicitly states that "No clinical studies were considered necessary and performed." This means there is no study described in this document that proves the device meets specific acceptance criteria through clinical performance.

However, the document does refer to "Non-Clinical Test Summary" and states that "WillCeph ... was designed and developed according to a software development process and was verified and validated." While it doesn't provide specific numerical acceptance criteria or detailed performance reports, it implies that the device was tested against design specifications.

Based on the available information, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As no clinical study was performed, there are no specific performance metrics reported for device clinical performance. The "acceptance criteria" here would be related to software verification and validation, but the document does not detail these criteria or their fulfillment numerically. The comparison table focuses on technological characteristics and intended use, demonstrating substantial equivalence to a predicate device, rather than explicit performance against predefined criteria.

Summary of Technological Characteristics (extracted from the comparison table, serving as a basis for substantial equivalence, not performance):

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

Since "No clinical studies were considered necessary and performed," there is no test set in the traditional sense for clinical performance evaluation. The "test set" would implicitly refer to data used for software verification and validation, but details on sample size, country of origin, or retrospective/prospective nature are not provided.

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

Given the absence of clinical studies, there is no mention of experts or ground truth establishment for a clinical test set. The document focuses on regulatory compliance through substantial equivalence.

4. Adjudication Method for the Test Set

As no clinical test set is described, no adjudication method is mentioned.

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

No MRMC comparative effectiveness study was performed or described. The document does not discuss human reader performance with or without AI assistance.

6. Standalone Performance

The product, WillCeph, is a standalone software that aids in cephalometric analysis. However, its effectiveness is assessed through substantial equivalence to a predicate device, not through a standalone clinical performance study. The statement "Results produced by the software tools are to be interpreted by trained and licensed dental practitioners" indicates human-in-the-loop, but the core functionality is algorithm-only. The document does not provide standalone performance metrics for the algorithm.

7. Type of Ground Truth Used

As no clinical study was performed, there is no explicit mention of ground truth types (e.g., expert consensus, pathology, outcomes data) for clinical performance evaluation. The "ground truth" for software verification and validation would likely be defined by internal software requirements and specifications.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This suggests the device's functionality is based on established algorithms and calculations for cephalometric analysis, rather than a machine learning model trained on a large dataset for image interpretation.

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

Since no training set is mentioned, there is no information on how ground truth for a training set was established.

In summary: The WillCeph device received 510(k) clearance based on demonstrating substantial equivalence to a legally marketed predicate device (ORTOMED - K131348). This means the FDA determined that the device is as safe and effective as the predicate device, primarily through a comparison of their intended use and technological characteristics, and through non-clinical software verification and validation activities (which are not detailed in terms of their criteria or results). No clinical studies or performance data against specific numerical acceptance criteria were deemed necessary or provided in this submission for device clearance.

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