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The Invisalign System is intended for the orthodontic treatment of malocclusion in patients with primary, mixed (primary and permanent), or permanent dentition. The optional mandibular advancement feature(s) are indicated for the treatment of skeletal malocclusion in patients with mixed or permanent dentition.

The subject device, Invisalian System with Mandibular Advancement Featuring Occlusal Blocks (Invisalign System, MAOB) is a modification to the predicate device, Invisalign System (K220287, cleared on April 07, 2022) and the reference device. Invisalign System with Mandibular Advancement Features (K181739, cleared on October 26th, 2018). The Invisalign System, MAOB (subject device) consists of removable orthodontic appliances (aligners with mandibular advancement features including occlusal blocks), proprietary treatment planning 3D software (doctor facing - ClinCheck and Align employee facing -Treat) and attachment templates.

The provided text describes a 510(k) premarket notification for a medical device (Invisalign System with Mandibular Advancement Featuring Occlusal Blocks) and its substantial equivalence to a predicate device. However, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria, particularly concerning AI or software performance characteristics.

The document primarily focuses on:

• Regulatory Clearance: The FDA's substantial equivalence determination.
• Device Description: What the device is and how it functions.
• Comparison to Predicate: How the modified device compares to existing, cleared devices.
• Testing Summary: High-level statements about bench testing, biocompatibility, and software V&V.

**Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance (since specific performance metrics and acceptance thresholds for the software are not detailed).
2. Sample sizes for a test set or data provenance (no specific AI performance study data is presented).
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used for specific AI performance.
8. Sample size for the training set.
9. How ground truth for the training set was established.**

The document states:

• Software Testing: "In accordance with IEC 62304, Medical device software - Software life cycle processes; successful software verification and validation (V&V) testing at the unit, integration, and system level was performed to qualify the modified software with the subject device." This indicates that standard software V&V was performed, but details on specific acceptance criteria for performance related to image analysis or treatment planning accuracy that would typically be associated with an AI/ML device are not provided. The phrase "proprietary, 3D treatment planning software" is mentioned, but no performance claims or supporting study data for this software's accuracy are included in this FDA letter/summary.
• No Animal or Clinical Testing: "No animal or clinical testing was required or performed for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks." This further indicates that the detailed performance study you are asking for, especially involving human observers or patient outcomes, was not part of this specific submission.

In summary, the provided text is a regulatory clearance document, not a detailed technical report on AI/ML model performance. It confirms that the device's modifications (addition of occlusal blocks and associated software updates) were deemed substantially equivalent to a predicate device based on bench testing, biocompatibility, and general software V&V, without specific performance metrics or studies relating to AI/ML accuracy or efficacy as you've requested.

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