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Will3D is a software application used for the display and 3D visualization of medical image files from scanning devices, such as Dental CT scanner. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, store, print, assist in diagnosis, and distribute images utilizing standard PC hardware. Additionally, Will3D is a preoperative software application and evaluation and evaluation of dental implants, orthodontic planning and surgical treatments.

Will3D is one of the components of a Picture Archiving and Communications System(PACS). Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.

The provided document describes the Will3D software, a medical image management and processing system. The core of the submission is to demonstrate its substantial equivalence to a previously cleared device, K170180 HDX WILL CORP. Will3D. As a result, the document primarily focuses on comparing the new Will3D with its predicate rather than detailing a specific study to prove new acceptance criteria.

The document does not explicitly state "acceptance criteria" and "reported device performance" in a separate section with specific numerical targets. Instead, it asserts substantial equivalence based on identical indications for use and technological characteristics to the predicate device. The "acceptance criteria" are implied to be that the device performs functionally identically and safely to the predicate.

Here's an attempt to extract and infer the requested information based on the provided text, acknowledging that some details might be missing or indirectly stated due to the nature of a 510(k) summary focused on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As the submission focuses on substantial equivalence to a predicate device with identical specifications, the "acceptance criteria" are implicitly met by demonstrating that the new device shares the exact same indications for use and technological characteristics as the predicate. The "reported device performance" is, therefore, that it performs as expected for these features.

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

The document does not specify a separate "test set" or its sample size. The review relies on the assertion that "performance testing conducted demonstrate that the subject device is as safe as effective as the predicate." However, no details about the specific test data (e.g., number of cases, retrospective or prospective nature, country of origin) are provided. This is typical for a 510(k) submission where substantial equivalence is claimed based on identical design and function to a predicate.

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

This information is not provided in the document. Given the nature of a substantial equivalence claim for a medical image management and processing system, the "ground truth" for verifying its technical functionalities (like MPR, 3D visualization, measurements) would likely involve comparing output to known standards or expert interpretation, but specific expert involvement for a 'test set' isn't detailed.

4. Adjudication Method for the Test Set

This information is not provided.

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

No MRMC comparative effectiveness study is mentioned. The document focuses on the device's performance and characteristics, not on how human readers improve with or without AI assistance, as the Will3D is described as an image management and processing system rather than a diagnostic AI aid with a comparative effectiveness study.

6. Standalone (Algorithm Only) Performance Study

The device is described as "standalone software" and "one of the components of a Picture Archiving and Communications System(PACS)" that "provides image viewing and manipulation." The performance testing mentioned is implied to be for this standalone software. However, no specific details of a standalone performance study (e.g., metrics, methodologies) are provided beyond the general statement that "performance testing conducted demonstrate that the subject device is as safe as effective as the predicate."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance testing. For a device like Will3D, which handles display, visualization, and processing of medical images, the "ground truth" for its functionalities would typically involve:

• Technical specifications: Verifying that the software accurately renders images, performs measurements, and generates reconstructions according to predefined technical standards and algorithms.
• Expert Consensus/Clinical Evaluation (implied): Ensuring that the processed images and visualizations are clinically acceptable and provide accurate information for diagnostic and planning purposes, likely through evaluation by radiologists, clinicians, and other qualified individuals, as mentioned in its indications for use.
• Comparison to Predicate (implied): Demonstrating that its output and functionality are identical or equivalent to the predicate device.

8. Sample Size for the Training Set

No information about a training set or its sample size is provided. This is expected as Will3D is described as an image processing and visualization software, not a machine learning or AI algorithm that typically requires a separate training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned for this device.

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Will3D is a software application used for the display and 3D visualization of medical image files from scanning devices, such as Dental CT scanner. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis, and distribute images utilizing standard PC hardware. Additionally, Will3D is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.

The Will3D is one of the components of a PACS (Picture Archiving and Communications System). The Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.

The provided document is a 510(k) premarket notification for the medical device "Will3D," a software application for dental imaging. It outlines the device's intended use, technological characteristics, and comparison to predicate devices to establish substantial equivalence.

However, the document states: "No clinical studies were considered necessary and performed."

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details cannot be provided from this document because no clinical studies were conducted to prove the device meets acceptance criteria derived from such studies. The equivalence is established purely on technological characteristics and intended use compared to predicate devices.

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