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The Inbrace Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using appliances individualized for the orthodontic patient.

The Inbrace Orthodontic System is a treatment planning software and orthodontic appliance system designed to be affixed to the lingual side of the teeth to correct malocclusions in orthodontic patients.
The Inbrace software creates a 3-dimentional (3D) model of the patient 's dentition based on the digital scans of the patient's dentition provided by the orthodontist. The Inbrace technicians use this computer model to determine the placement of the brackets to achieve the intended repositioning of the teeth (ideal occlusion). The model is reviewed and approved by the orthodontist prior to fabrication of the actual orthodontic appliances comprising of metal brackets, patient-specific programmed multiloop arch wires, and patient-specific bracket placement trays (indirect bonding trays) used to affix the brackets in position on the patient teeth. The brackets are assembled into the indirect bonding trays and bonded with a commercially available dental adhesive.

The provided document is a 510(k) premarket notification for the Inbrace Orthodontic System. It does not include detailed information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/software performance study.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Insignia, K121524) based on:

• Intended Use and Indications for Use: Stating they are the same as the predicate device.
• Technological Characteristics, Principles of Operation, Mode of Use, Manufacturing Methodology: Demonstrating similarities to the predicate device.
• Biocompatibility Testing: Conducted in accordance with ISO 10993-1.
• Software Verification and Validation: Conducted in accordance with ISO/IEC 62304 and FDA guidance for software in medical devices.

Crucially, "No clinical testing was conducted for this device to support substantial equivalence." This means there is no performance study (clinical or even a rigorous retrospective study) described in this document that would provide the requested details about acceptance criteria, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, I cannot extract the information requested for point 1 through 9. This device's clearance was based on substantial equivalence to an existing device, and not on a new performance study demonstrating the outlined criteria.

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