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The ArchForm Orthodontic Software System 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 treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of the ArchForm Orthodontic Software System requires 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 ArchForm Orthodontic Software System is an orthodontic appliance design and treatment simulation software. This software is for use by Dental professionals to diagnose and design solutions for patients. Digital scans (3D) of a patient's dentition can be loaded into the software and the dental professional can then create treatment plans for each individual patient and their needs. The system can be used to fabricate dental casts using standard stereolithographic (STL) files for use in 3D printers. Dental casts printed can then be used to manufacture sequential aligner trays and retainers.
The provided FDA document for the ArchForm Orthodontic Software System (K213916) describes its acceptance criteria implicitly through comparison with a predicate device and states that the software underwent performance testing. However, it does not contain specific quantitative acceptance criteria or detailed results of a study that proves the device meets those criteria.
Instead, the document primarily focuses on establishing "substantial equivalence" to a predicate device, the Orchestrate 3D Orthodontic Software (K181112). It asserts equivalence based on indications for use, technological features, and the successful completion of verification and validation testing as per FDA guidance for software in medical devices.
Therefore, many of the requested details about acceptance criteria metrics, sample sizes, expert qualifications, and study design for performance evaluation are not explicitly provided in the given text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Implied by Predicate Equivalence and Software Testing Success)
The direct "acceptance criteria" for metrics like accuracy, precision, sensitivity, or specificity are not explicitly stated in the provided document. The document implies that the device is acceptable if its functional characteristics and performance are comparable to the predicate device and if it passes software verification and validation testing.
Reported Device Performance
The document states: "The software passed the testing and performed per its intended use." No specific quantitative performance metrics (e.g., accuracy percentages, error margins, etc.) from this testing are reported in the provided text.
Based on the comparison table (pages 5-6), the "performance" is primarily described in terms of functional and technological similarity to the predicate device.
| Characteristic | ArchForm Orthodontic Software System Performance (as reported) | Acceptance Criteria (Implied/Predicate Match) |
|---|---|---|
| Overall Performance | "The software passed the testing and performed per its intended use." | Device functions as intended and is "substantially equivalent" to predicate device (Orchestrate 3D Orthodontic Software - K181112) in terms of indications for use, technological features, and capabilities for orthodontic model management, inspection, analysis, treatment simulation, and virtual appliance design based on 3D dental models. |
| Functional Equivalence to Predicate | Same as Orchestrate 3D Orthodontic Software for: indications for use, device class, regulation number, product code, technological features (stand-alone software, imports digital scans, designs dental casts, useful for diagnosis, treatment planning, CAD design, virtual planning of tooth movement, supports STL files), supported anatomic areas (Maxilla/Mandible), managing patient/case base data, collection of study material, alignment of study material, measuring study material, analyzing study material, treatment simulation, virtual appliance design, surface scan for intraoral scanner, surface scan from STL file, Arch Shape analysis, Overbite/Overjet analysis, Occlusal Map, 3D Treatment Simulation, Orthodontic Appliance Virtual Preparation, Orthodontic Appliance Design, Orthodontic Appliance Export. | Must be substantially equivalent in indications for use and technological features to Orchestrate 3D Orthodontic Software (K181112). This includes having the same functional capabilities for orthodontic model management, systematic inspection, detailed analysis, treatment simulation, and virtual appliance design options (including dental casts for aligner trays or retainers) based on 3D dental models before, during, and after orthodontic treatment. |
| Software Verification & Validation (V&V) | Underwent "appropriate integration, verification, and validation testing" per FDA Guidance, and "passed the testing." | Software components and overall system meet specified requirements and perform reliably and safely for the intended use. (Specific V&V criteria are not detailed in this public summary.) |
| Minimum Hardware/Software Requirements Compatibility | Compatible with OS: Windows 10 and MacOS Catalina; RAM: 4 GB; Monitor Resolution: 1280 X 720; Video Card: HD620; Hard Drive Space: 128 GB; CPU: Intel 2nd Gen Core i5 or equivalent; Mouse: with wheel button. | Must specify and be compatible with standard hardware and software environments suitable for clinical use, and where possible, match or exceed predicate device requirements (predicate required Windows 7, 8, 10 64-bit; RAM: 8 GB; Monitor Resolution: 1280 X 800; Video Card Memory: 1 GB; Hard Drive Space: 10 GB; CPU: Intel compatible 2.6 GHz/Dual or Quad Core 2.6 GHz). Note: ArchForm's minimum RAM and Video Card Memory appear lower than the predicate, but this is compared as "Same" in the table. |
Study Details
The provided document refers to "appropriate integration, verification, and validation testing" as the study that proves the device meets (implied) acceptance criteria. However, it lacks granular details about this study.
Here's what can be answered and what information is missing:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document does not provide a number of dental models or patient cases used for testing.
- Data Provenance: Not specified. There is no information about the country of origin of the data or whether it was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document only states that the software's use "requires the user to have the necessary training and domain knowledge in the practice of orthodontics." It does not clarify if orthodontic experts were involved in establishing ground truth for testing, or if so, their specific qualifications.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. The document does not describe any adjudication methods used for establishing ground truth or evaluating the software's performance against a reference.
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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, an MRMC comparative effectiveness study was not done or reported. The document describes the device as a "front-end software tool" for orthodontists, implying human-in-the-loop use, but it does not present any study results on human performance with or without the software's assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document implies that "appropriate integration, verification, and validation testing" was performed on the software itself to ensure it "performed per its intended use." This likely refers to standalone functional and performance testing of the algorithms. However, no specific quantitative results from such a standalone performance study are provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly specified. Given the nature of the software (orthodontic treatment simulation and appliance design), ground truth for its internal testing would likely involve comparisons against:
- Pre-defined anatomical landmarks and measurements.
- Expected tooth movements and arch forms according to orthodontic principles.
- Reference 3D dental models or simulations.
- Expert assessment of simulated treatment plans.
- However, the document does not detail how this ground truth was established.
- Not explicitly specified. Given the nature of the software (orthodontic treatment simulation and appliance design), ground truth for its internal testing would likely involve comparisons against:
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The sample size for the training set:
- Not specified. The document does not provide any information about a training set, suggesting that if machine learning is involved, details were not included in this summary, or the software relies on rule-based or deterministic algorithms rather than trainable models.
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How the ground truth for the training set was established:
- Not applicable / Not specified, as no training set information is 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.