(207 days)
DIBS by OrthoSelect 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 (Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic 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/desired treatment objectives.
The use of the DIBS by OrthoSelect 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.
DIBS by OrthoSelect is a software system used for the management of 3D scanned orthodontic models of the patients' dentition and allows orthodontic measurements, analysis, inspection, and visualization. The primary purpose of DIBS is to allow virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets, and design of orthodontic appliances based on the 3D scanned orthodontic models. Output includes STL files that can be used to make Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). The device has no patient contact. DIBS is a software-only device.
The provided text is a 510(k) Summary for the DIBS (Digital Indirect Bonding System) device. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for a standalone study against a rigorous ground truth.
Here's an analysis based on the information provided, specifically addressing your points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results against a defined ground truth. Instead, it focuses on comparing features and intended use with a predicate device (3Shape Ortho System, K152086) to establish substantial equivalence.
The "PERFORMANCE DATA" section states:
"Medical device verification and validation testing was performed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 2005). Validation was performed in conformity with IEC 62304 - Medical device software - Software lifecycle processes. Documentation was also prepared in accordance to FDA quidance documents, "General Principles of Software Validation" (issued January 2002) and "Off-The-Shelf Software Use in Medical Devices" (issued September 1999)."
This indicates that general software testing and validation were performed to ensure the software functions as intended and safely, but it does not detail specific performance metrics (e.g., accuracy, precision) against a clinical ground truth for the device's functions like "treatment simulation" or "virtual appliance design."
2. Sample Size Used for the Test Set and Data Provenance
The document does not disclose the sample size for any specific clinical or performance test set, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective). The validation described is primarily software validation and verification.
3. Number of Experts and their Qualifications for Ground Truth Establishment
The document does not mention the use of experts to establish ground truth for a test set or their qualifications. The validation mentioned focuses on software functionality rather than clinical accuracy adjudicated by experts.
4. Adjudication Method
No adjudication method is described, as there's no mention of a clinical test set with ground truth established by experts.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence through feature comparison and software validation, not on evaluating the improvement of human readers with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
While the device is a "Stand Alone Software," the document does not describe a standalone performance study where the algorithm's output is directly evaluated against a clinical ground truth without human intervention, specifically in terms of its ability to accurately simulate treatment or design appliances. The performance data section refers to general software verification and validation, not a clinical performance study.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for any performance evaluation in terms of clinical outcomes, pathology, or expert consensus related to the device's core functions (treatment simulation, appliance design). The validation relates to internal software functionality.
8. Sample Size for the Training Set
The document does not mention any training set size. This implies that the device likely relies on deterministic algorithms and pre-existing models/rules rather than being a machine learning-based device that would require a large training dataset. The software performs calculations and designs based on user input and 3D models.
9. How the Ground Truth for the Training Set was Established
Since no training set is mentioned, there is no information on how its ground truth would have been established.
Summary of Acceptance Criteria and Study Information:
Based on the provided text, the device's acceptance criteria and the "study" proving it meets them are framed in the context of software verification and validation and demonstration of substantial equivalence to a predicate device, rather than a clinical performance study with specific quantifiable metrics against a clinical ground truth.
- Acceptance Criteria (Implicit from the document's focus):
- The software functions as intended and safely.
- The device manages orthodontic models, enables systematic inspection, detailed analysis, treatment simulation, and virtual appliance design options.
- The features are comparable to the predicate device (3Shape Ortho System K152086).
- No new questions of safety or effectiveness are raised compared to the predicate.
- Reported Device Performance (Implicit):
- The software successfully underwent medical device verification and validation testing according to FDA guidance (May 2005, January 2002, September 1999) and IEC 62304.
- The device performs functions such as managing patient data, collection, alignment, measurement, and analysis of study material, treatment simulation, and virtual appliance design, aligning with the predicate device's capabilities.
- Study Details: The document outlines a comparative analysis against a predicate device (3Shape Ortho System) and detailed software verification and validation. It does not describe a clinical performance study with human readers, specific patient cohorts, or adjudicated ground truth for accuracy metrics.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.