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The uLab Systems Dental Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctorprescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed and customized by dental professionals using uLab Systems technology. The aligners are made of aesthetic and medical grade materials. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient's teeth gradually to the ideal position.

I am sorry, but the provided text (K211510 FDA 510(k) Summary for uLab Systems Dental Aligner Kit) describes an orthodontic treatment system (aligners) and not a device that would typically have the kind of acceptance criteria, test set, ground truth, and human-in-the-loop performance studies as outlined in your request.

The document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through comparison of:

• Intended Use: "alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces."
• Technological Characteristics: clear plastic sequential aligners, principles of operation, aligner design process using dental software, materials (thermoplastic), and general features.

The "Performance Data" section (Page 6) briefly mentions that performance testing remains unchanged from the company's previous reference device submission (K192596) and includes:

• Biocompatibility (ISO 10993-10)
• Design verification and process validation testing
• User validation testing
• Packaging verification and shelf life testing
• Physical properties testing by the material manufacturer

This type of information is typical for a 510(k) submission for a physical medical device like an aligner, which is considered a Class II device (Orthodontic Plastic Bracket, Product Code NXC). It does not involve an AI algorithm or software that performs diagnostic or imaging analysis requiring the specific types of studies (e.g., MRMC, standalone AI performance, expert adjudication of ground truth for AI model testing) that your detailed request outlines.

Therefore, I cannot extract the information requested as it is not present in the provided document. The document is about a physical dental aligner product, not an AI/software device that analyzes data or images.

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The uLab Systems Dental Aligner is indicated for the alignment of permanent teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctorprescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed and custom-made by dental professionals using uLab Systems proprietary technology. The aligners are made of aesthetic and medical grade materials chosen by doctors for their patients. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient's teeth gradually to the ideal position.

The provided document does not describe a study that proves the device meets specific acceptance criteria in the context of AI performance for a diagnostic or treatment planning system.

The document is a 510(k) summary for the ULab Systems Dental Aligner Kit, a physical medical device (clear aligners) used for orthodontic treatment. The "performance data" section focuses on biocompatibility, design verification, user validation, packaging verification, and physical properties testing for the physical aligner product itself, not the performance of an AI algorithm in a diagnostic or treatment planning capacity.

Therefore, I cannot extract the requested information regarding AI acceptance criteria and study details from this document. The document describes the aligners as "designed and custom-made by dental professionals using uLab Systems proprietary technology," and mentions "dental software, the uLab Systems uDesign, K171295, for tooth alignment." However, it does not provide details on the AI performance or any studies related to its AI components.

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