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3Shape Ortho System™ is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Custom metal bands, Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodonic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned the amment objectives.

The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

3Shape's Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzinq, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes only Export Model (also called dental casts), Custom Metal Bands (also called metal bands), and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). All devices are to be fabricated from FDA cleared materials.

The device has no patient contact.

The provided FDA 510(k) summary for the 3Shape Ortho System™ does not contain acceptance criteria or a study proving the device meets said criteria in the traditional sense of a performance study with defined metrics (sensitivity, specificity, accuracy, etc.) against a specific ground truth.

Instead, this submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of intended use, technical characteristics, and nonclinical testing that confirms the software acts as intended.

Here's a breakdown of the requested information based on the provided text, highlighting what is implicitly or explicitly stated and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present a table of specific quantitative acceptance criteria (e.g., "accuracy > 95%") nor does it report performance against such criteria. The "performance" assessment is primarily qualitative, focusing on whether the device's features match or are equivalent to the predicate devices.

| Acceptance Criteria Category | Specific Acceptance Criteria (from document) | Reported Device Performance (from document) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional Equivalence | The device must demonstrate the same intended uses and technical characteristics as predicate devices. | The 3Shape Ortho System™ Software is found to have the same intended use as the primary predicate OrthoCAD iQ (K082207) and similar technical characteristics to both OrthoCAD iQ and reference predicate Dolphin Imaging (K110430) across supported anatomic areas, patient/case management, study material collection/alignment/measurement/analysis, treatment simulation, and virtual appliance design. A detailed feature comparison table is provided (Page 5). |
| Safety and Effectiveness | The device must be as safe and effective as the predicate devices. | Based on nonclinical testing (software, hardware, and integration V&V) and comparison to predicates, the Ortho System™ is found to be "as safe and effective as the predicate devices." (Page 7). Risk management procedures related to device hazards were also validated. |
| Software Verification and Validation (V&V) | All verification and validation activities should be performed according to FDA guidance specific to software in medical devices. | Software, hardware, and integration V&V testing was performed according to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005). All test results were reviewed and approved. |

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

• Sample Size: Not explicitly stated as a separate "test set" in the context of clinical performance evaluation. The "nonclinical testing" involved software, hardware, and integration V&V, which typically uses various test cases and scenarios rather than a dataset of patient cases for clinical performance evaluation.
• Data Provenance: Not mentioned. Since it's a nonclinical V&V, synthetic data or internal test data would likely be used, but this is not specified. It's not a retrospective or prospective study on patient data.

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

• This information is not provided. As "clinical testing is not a requirement and has not been performed" (Page 7), there was no need for expert ground truth establishment for a patient-level test set.

4. Adjudication Method for the Test Set

• This information is not provided as there was no patient-level test set requiring ground truth adjudication.

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

• A MRMC comparative effectiveness study was not performed. The document explicitly states: "Clinical testing is not a requirement and has not been performed." (Page 7). The device is a "medical front-end device providing tools" rather than an AI-driven diagnostic aid for human readers.

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

• A standalone performance study in the sense of accuracy metrics (sensitivity, specificity, etc.) was not performed. The V&V testing ensures the software functions as designed (e.g., measurements are calculated correctly, models display properly), but not against a "ground truth" to measure diagnostic or predictive performance. The device is a tool to be used by a trained orthodontist.

7. The Type of Ground Truth Used

• For the nonclinical V&V, the "ground truth" would be the expected output or behavior of the software based on its design specifications and requirements. This is not explicitly detailed but is intrinsic to software testing. There's no use of expert consensus, pathology, or outcomes data, as no clinical study was conducted.

8. The Sample Size for the Training Set

• This device is described as a "software system" programmed in Delphi that applies "digital imaging tools." While it mentions "encrypted libraries of the bracket geometry provided by the manufacturers," this refers to pre-programmed data, not a "training set" for a machine learning model. There is no mention of a training set in the context of machine learning, as this does not appear to be an AI/ML device in the modern sense (e.g., deep learning classification).

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

• Since there's no explicit mention of a training set or machine learning, this information is not applicable or provided.

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