(331 days)
The Invisalign System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
The Invisalign System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3-D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. The Invisalign System is intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion.
The proprietary Invisalign System 3-D software generates the image of a final, treated state and then interpolates a series of images that represent intermediate teeth states. The dental practitioner then reviews these images to depict, edit, view, monitor, and approve an orthodontic treatment plan. The dental practitioner has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the doctor approves the set-up, the series of custom-made aligners are then manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.
The provided document is a 510(k) K143630 substantial equivalence determination for the Invisalign System, specifically focusing on modifications to its 3-D software. It does not provide detailed acceptance criteria and a study proving the device meets them in the way one might find in a full clinical trial report or a performance study for a diagnostic device.
However, based on the information provided, here's a breakdown of what can be extracted regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the "study" described here is a comparison to a predicate device (K081960). The acceptance criteria, implicitly, are that the modified Invisalign System (K143630) performs equivalently to the predicate device, especially considering the changes made to the software's functionality and platform.
The document states:
- "The acceptance criteria were established in order to demonstrate the modified Invisalign System is substantially equivalent to the primary predicate device."
- "Therefore, the results of this testing demonstrate the modified Invisalign System 3-D software is substantial equivalent to the primary predicate 3-D software."
Implicit Acceptance Criteria from Predicate Comparison (Table 4 of the document):
| Characteristic | Predicate Device (K081960) Performance | Modified Device (K143630) Performance | Acceptance Criteria Met? |
|---|---|---|---|
| Intended Use Statement | "The Invisalign System is indicated for the alignment of teeth during orthodontic treatment of malocclusion." | "The Invisalign System is indicated for the alignment of teeth during orthodontic treatment of malocclusion." | Yes (Same) |
| 3-D Software Description | Uses PVS impression or digital scan to generate final, treated state image, interpolates intermediate states, allows dental practitioner review/modification/approval, converts files for aligner fabrication. | Uses PVS impression or digital scan to generate final, treated state image, interpolates intermediate states, allows dental practitioner review/modification/approval, converts files for aligner fabrication. | Yes (Same) |
| Mode of Operation for 3-D Software | Produces 3D-model file, identifies teeth for repositioning, creates treatment plan (3-D models), allows dental practitioner review/modification/approval via ClinCheck. | Produces 3D-model file, identifies teeth for repositioning, creates treatment plan (3-D models), allows dental practitioner review/modification/approval via ClinCheck. | Yes (Same) |
| Elements of ClinCheck Software (Electronic Prescription Form) | Depicts, edits, views, monitors, and approves an orthodontic treatment plan. | Depicts, edits, views, monitors, and approves an orthodontic treatment plan. | Yes (Same) |
| Treatment Plan File Storage/Access | Downloads and stored on desktop/laptop computer. | Downloads to other computing devices (e.g., tablets), deleted upon exiting application. Comparison notes: "The Treatment Plan File is not downloaded and saved on desktop/laptop for K143630 as it is downloaded to a tablet and deleted upon exiting the application." | Yes (Functionally Equivalent in purpose, different mechanism deemed safe) |
| Tool Bar and Buttons | Includes Rotate/Translate, PAST, OCCLUS, View Attachment, Number, IPR, etc. | Includes Attachment, Number, IPR, etc. Comparison notes: "The following are not available on Subject Device tool Bar: Rotate/Translate, PAST, OCCLUS, and View" | Yes (Functionally Equivalent with text comments for missing features) |
| Menu Bar | Includes File, View, Export, Tools, Movie, Printing, Help, etc. | Includes File, View, Export, Tools, Help, etc. Comparison notes: "Subject Device is same as predicate device, but without Movie and Printing" | Yes (Functionally Equivalent with text comments for missing features) |
| Animation Controls | Includes Display, Play/Stop, Step Forward, Step Backward, etc. | Includes Play/Stop, Step Forward, and Step Backward. Comparison notes: "Subject Device controls are limited to: Play/Stop, Step Forward, and Step Backward" | Yes (Functionally Equivalent) |
| Viewing Options Toolbar | Includes grid, superimposition, basic buttons, etc. | Includes grid, superimposition, basic buttons, etc. | Yes (Equivalent) |
| Using Text Comments | Supported. | Supported. | Yes (Equivalent) |
| 3-D Modification Mode (3-D Controls) | Present. | Absent. Comparison notes: "Not available in the Subject Device" | Yes (Functionally Equivalent with text comments for missing features) |
| Advanced Software Features (Bolton Analysis, Movie/Screenshot gen.) | Present. | Absent. Comparison notes: "Not available in the Subject Device" | Yes (Functionally Equivalent with text comments for missing features) |
| Minimum Hardware Requirements | Intel® Core™ i5, 4 GB RAM, 2 GB free disk space; Graphics card: Intel HD Graphics; Windows 7, 32 bit; Internet Explorer 11, Chrome, Firefox, Edge. | iPad 2 with iOS 8 or higher; 16 GB storage or more. Android 4.1.2 or higher; 16 GB storage or more. Comparison notes: "Subject Device is not used on a laptop/desktop computer as it operates on a tablet." | Yes (Different platform, deemed safe and effective for intended use) |
Reported Device Performance:
The document explicitly states: "Results of verification and validation testing demonstrate the Invisalign System showed conformity with pre-established specifications and acceptance criteria." And further, "Therefore, the results of this testing demonstrate the modified Invisalign System 3-D software is substantial equivalent to the primary predicate 3-D software."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of patient data or specific clinical cases with a numerical sample size. The testing appears to be focused on software verification and validation against pre-established specifications and the predicate device's functionality, rather than a clinical performance study using a sample of patient data.
- Test Set Sample Size: Not specified as a numerical sample of clinical cases or patient data. The testing described is software V&V.
- Data Provenance: Not applicable as the testing described is primarily software engineering verification and validation, not a clinical study on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since the "test set" and "ground truth" are framed around software functionality and substantial equivalence to a predicate, rather than a diagnostic accuracy claim, the document does not mention experts establishing ground truth in the typical clinical sense. The "ground truth" for the software's functionality would have been its design specifications and comparison to the predicate's known functionality.
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
Not applicable as it's not a clinical study requiring adjudication of expert opinions on patient cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study is not mentioned. The study described is a software verification and validation, and a comparison against a predicate device for substantial equivalence. It does not evaluate how human readers (dental practitioners) improve with or without AI assistance from this specific version of the software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device explicitly includes a "human-in-the-loop" aspect: "The dental practitioner then reviews these images to depict, edit, view, monitor, and approve an orthodontic treatment plan." The software generates the plan, but the practitioner approves or modifies it. Therefore, a standalone algorithm-only performance assessment in a vacuum is not the design or intent of this system's approval. The focus is on the software supporting the practitioner's workflow.
7. The Type of Ground Truth Used
The "ground truth" for this submission appears to be related to the functional specifications of the software and the established performance/functionality of the predicate device (K081960). The modified software met its design specifications and was deemed functionally equivalent for its intended use, despite some differences in feature implementation and platform. The safety and effectiveness are established by comparison to the predicate and the documented V&V of the modified software.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning model development. This submission is for an updated version of an existing software system, not the initial development or a new AI model requiring a distinct training phase to learn from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a training set, in the machine learning sense, is not described.
§ 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.