(246 days)
The PlaniMax Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are 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 PlaniMax 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 PlaniMax Orthodontic Software for dental retainers and dental cast for sequential aligners is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models , virtual planning of orthodontic treatments by simulating tooth movements , and design of orthodontic appliances based on 3D scanned orthodontic models.
The provided text describes the regulatory clearance of the PlaniMax Orthodontic Software but does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria in a quantitative sense as typically seen with performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Ortho System from 3ShapeA/S, K171634) through a comparison of:
- Indications for Use
- Technological Characteristics
- Performance Testing (Non-Clinical)
- Software Validation Test Results
Therefore, the acceptance criteria outlined are primarily qualitative, focusing on functional equivalence and safety rather than quantitative performance metrics.
Here's an attempt to structure the answer based on the provided text, acknowledging the limitations in scope of the original document:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The PlaniMax Orthodontic Software's regulatory clearance is based on demonstrating substantial equivalence to a predicate device, the Ortho System (K171634). The "acceptance criteria" can therefore be inferred as meeting the functional and technical characteristics of the predicate device, along with successful software verification and validation.
1. Table of Acceptance Criteria and Reported Device Performance
| Category / Acceptance Criteria (Inferred from comparison to predicate) | Reported Device Performance (PlaniMax) | Comparison Result / Status |
|---|---|---|
| Indications for Use | "The PlaniMax Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are 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 PlaniMax 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." | Similar: The key difference noted is that PlaniMax's virtual appliance design options specifically include dental casts, which may be used for sequential aligner trays or retainers, whereas the predicate listed "Custom Metal Bands, Export of Models, Indirect Bonding Transfer Media." This difference is deemed "similar" and not to impact substantial equivalence. |
| Technology Features | • 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 | Same. | |
| Minimum Hardware/Software Requirements | • OS: Windows 7 32-bit or later | |
| • RAM: 4 GB | ||
| • Monitor Resolution: 1024 X 768 | ||
| • Video Card Memory: 1 GB | ||
| • Hard Drive Space: 100 GB | ||
| • CPU: Intel Core i3 or equivalent | ||
| • Network: Network Internet connection | ||
| • Mouse: Any Mouse with scrolling wheel or button | Similar: PlaniMax has slightly lower minimum requirements for OS (32-bit Windows 7 vs. 64-bit Windows 7, 8, 10), RAM (4 GB vs. 8 GB), Monitor Resolution (1024x768 vs. 1280x800), Hard Drive Space (100 GB vs. 250 GB), and CPU (Core i3 vs. Core i5). This is stated to have "No effect to the indications for use." | |
| Supported Anatomic Structures | Maxilla/Mandible | Both devices support Maxilla/Mandible. |
| Intended Use Features (Managing data, Study Material) | Managing Patient and case base data: Yes | |
| Collection of study material: Yes | ||
| Alignment of study material: Yes | ||
| Measuring study material: Yes | ||
| Analyzing Study material: Yes | ||
| Treatment Simulation: Yes | ||
| Virtual Appliance Design: Yes | ||
| Creating, editing, deleting and copying patient data: Yes | ||
| Creating, editing, deleting and copying case data: Yes | ||
| Surface scan for intraoral scanner: Yes | ||
| Surface scan from STL file: Yes | ||
| CT image data (DICOM): No (Predicate: Yes) | ||
| 2D overlay (PNG, JPG, BMP): Yes | Mostly Same/Similar: PlaniMax does not support CT image data (DICOM) or aligning surface scan and CT images or DICOM scan segmentation, unlike the predicate which supports DICOM input and alignment. This difference is not presented as an impediment to substantial equivalence, implying it does not affect the core intended uses common to both. | |
| Intended Use Features (Alignment) | Aligning surface scan and CT image: No (Predicate: Yes) | |
| Aligning Cephalometric Images: Yes | ||
| Alignment of 2D overlays: Yes | ||
| Ability to check/adjust DICOM visibility: No (Predicate: Yes) | ||
| DICOM scan Segmentation: No (Predicate: No) | Mostly Same/Similar: Differences in DICOM support as noted above. | |
| Intended Use Features (Measurement & Analysis) | 2D Measurement tool box: Yes | |
| 3D Measurement tool box: Yes | ||
| Arch shape: Yes | ||
| Wire length: Yes | ||
| Tooth width: Yes | ||
| Bolton: Yes | ||
| Space Analysis: Yes | ||
| Overjet/Overbite: Yes | ||
| Occlusion Map: Yes | Same. | |
| Intended Use Features (Treatment Simulation & Appliance Design) | 2D & 3D simulation: Yes | |
| Virtual Appliance Design: Yes | ||
| Orthodontic Appliance Search: No (Predicate: Yes) | ||
| Orthodontic Appliance Virtual Preparation: Yes | ||
| Orthodontic Appliance Design: Yes | ||
| Orthodontic appliance Export: Yes | Mostly Same/Similar: PlaniMax does not have an "Orthodontic Appliance Search" feature, which the predicate has. This difference is not presented as affecting substantial equivalence. | |
| Non-Clinical Testing / Software Validation | "Software, hardware, and integration 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 11, 2005). The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures. All test results have been reviewed and approved, showing the PlaniMax to be substantially equivalent to the reference devices." | Met: The non-clinical testing and software validation were deemed sufficient by the FDA to demonstrate safety and effectiveness for substantial equivalence. No specific quantitative performance metrics from these tests are provided. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a clinical performance study with patient data. The evaluation was primarily based on a comparison to a predicate device and software verification/validation. No patient data sample size for a test set is mentioned. Data provenance (country of origin, retrospective/prospective) is therefore not applicable to the documentation provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a test set requiring expert-established ground truth for performance evaluation with patient data.
4. Adjudication method for the test set
Not applicable, as no described test set with ground truth adjudication is present in the document.
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
No MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence based on technical and functional comparison and non-clinical software testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire device, the "PlaniMax Orthodontic Software," is a standalone software tool. The non-clinical testing and software validation would broadly cover its standalone performance and functionality as compared to the predicate, but specific quantitative performance metrics (e.g., accuracy of a particular measurement vs. ground truth) are not provided. The phrase "standalone software module" is listed under technology features.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical software validation, the "ground truth" would implicitly be defined by the expected behavior and outputs derived from the software requirements and design specifications, which are validated against during testing. There is no mention of clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient images) being used for performance evaluation in this 510(k) summary.
8. The sample size for the training set
Not applicable. The document describes a software product, but it does not mention training sets, implying it's not an AI/ML-based device that learns from a dataset in the typical sense for performance characterization in this document. If it uses AI, the development methods are not detailed.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned in the provided text.
§ 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.