(295 days)
BRIUS Software Suite is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, treatment simulation and virtual appliance design options (Patient-Specific Nitinol Wires, 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 BRIUS Software Suite 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.
The BRIUS Software Suite is an orthodontic appliance design and treatment simulation software. Until recently, this software was used only as a manufacturing software for nitinol wires, indirect bonding transfer media, and export of models. This software is now for use by professional technicians or physicians to design solutions for patients. Digital scans (3D) of a patient denture can be loaded into the software and a technician or physician can then create treatment plans for each individual patient and their needs. After approval by the patient's physician, the system can be used to fabricate patient-specific nitinol wires, indirect bonding transfer media, and export of models using standard stereolithographic (STL) and drawing exchange format (DXF) files for the design of custom shape-set nitinol wires. A 2D rendering of the nitinol wires needed for the patient can be created in the form of a DXF file and a 3D representation of the ideal tooth alignment for the patient can be created in the form of an STL file. The 2D rendering can then be used to laser cut a nitinol sheet to form a 2D version of the patient-specific nitinol wire shape. Finally, a high-temperature mold can be fabricated from the STL file to shape set the 2D cut nitinol wire for a specific fit for patients.
The provided text (K191720) describes the BRIUS Software Suite, an orthodontic appliance design and treatment simulation software, submitted for 510(k) clearance. The submission focuses on demonstrating substantial equivalence to a predicate device, the 3Shape OrthoSystem (K171634).
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with reported device performance in the manner typically seen for diagnostic performance studies (e.g., sensitivity, specificity, accuracy). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on functional specifications, technological features, and indications for use.
The "acceptance criteria" can be inferred as being functionally equivalent to the predicate device and performing as intended through verification and validation testing.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as per comparison to predicate) |
|---|---|
| Indications for Use: Similar to predicate device. | Similar: BRIUS Software Suite is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, treatment simulation, and virtual appliance design options (Patient-Specific Nitinol Wires, Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition. It can also be applied during treatment to inspect and analyze progress and at the end of treatment to evaluate outcome consistency. Users require necessary training and domain knowledge in orthodontics. |
| Technology Features: Similar to predicate device. | Same/Similar: Stand Alone Software Module, Imports Digital Patient Scans, Can be used to design Dental Casts, Useful for Diagnosis, treatment planning, and CAD design, Virtual Planning of tooth movement, Supports STL Files. Minimum Hardware/Software Requirements are similar. Login method is the same. |
| Functional Features: Similar to predicate device. | Similar: Manages patient/case base data, collects study material (surface scan for intraoral scanner, STL file), aligns study material, allows for treatment simulation (2D/3D), and virtual appliance design. Some differences noted in specific measurement/analysis tools (e.g., wire length, tooth width, Bolton, Space Analysis, CT image data support, specific alignment tools) and appliance search, but these differences "do not affect the ability of users to perform necessary functions within the software." |
| Safety and Effectiveness: Demonstrated through V&V testing. | Stated: "Utilizing FDA Guidance document 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (issued May 11, 2015), the BRIUS Software Suite underwent appropriate integration, verification, and validation testing." The conclusion states it is "appropriate for its indications for use." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a sample size for any clinical test set, nor does it describe data provenance (country of origin, retrospective/prospective). The submission primarily relies on comparisons of functional and technological specifications to a predicate device and general statements about verification and validation testing of the software itself. There is no mention of a particular "test set" in the context of patient data or clinical performance evaluation.
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)
This information is not provided in the document. Given that the submission focuses on substantial equivalence through feature comparison and software V&V rather than a clinical performance study with a test set requiring expert ground truth, such details would not typically be included.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. As there's no described clinical test set requiring expert ground truth, no adjudication method is mentioned.
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
There is no mention of an MRMC comparative effectiveness study being done. The document focuses on the software as a tool for orthodontists, not as an AI-assisted diagnostic aid that would typically involve a human-in-the-loop performance study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the BRIUS Software Suite as a "medical front-end device providing tools for management of orthodontic models, systematic inspection, treatment simulation and virtual appliance design options." It is explicitly stated that "The use of the BRIUS Software Suite 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." This indicates it's designed to be used by a qualified human user, not as a standalone AI algorithm making decisions without human oversight. Therefore, standalone (algorithm-only) performance in the sense of an independent diagnostic decision is not applicable and not reported. The "standalone software" mentioned refers to it being an independent software application, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe a type of ground truth used for performance evaluation in a clinical sense. The "ground truth" implicitly referred to in the context of software validation would be that the software functions according to its specifications and requirements (e.g., calculations are correct, designs are accurate representations of inputs, outputs are in correct formats). There is no mention of ground truth established from expert consensus, pathology, or outcomes data related to patient diagnosis or treatment efficacy; the software is a planning and design tool, not a diagnostic one.
8. The sample size for the training set
The document does not mention a training set or its sample size. This type of information is typically provided for AI/ML-based devices that learn from data. While the software is for "treatment simulation" and "virtual appliance design options," it's described in terms of CAD/CAM technology rather than a machine learning model.
9. How the ground truth for the training set was established
Since there is no mention of a training set, the method for establishing its ground truth is also not provided.
§ 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.