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The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligner positions teeth by way of continuous gentle force.

The Custom-made Invisible Aligners System is a series of dental aligners that fabricated of clear, thin thermoformed plastic to progressively reposition the teeth. The product is made from a composite multilayer material with thermoplastic polyurethane and polyethylene terephthalate-1, 4-cyclohexanedimethanol ester (TPU+PETG). Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner. They are designed to move the teeth to the target position and deliver desired clinical effect.

The provided text is a 510(k) summary for a medical device called "Custom-made Invisible Aligners." This document describes the device, its intended use, comparison to predicate devices, and the non-clinical testing performed to establish substantial equivalence.

However, the 510(k) summary explicitly states:
"H. Clinical Test Conclusion: No clinical study is included in this submission."

Therefore, based on the provided text, there is no information available regarding acceptance criteria based on clinical performance, nor any study proving the device meets such criteria through human clinical data. The document focuses solely on non-clinical testing to demonstrate performance and safety.

Even though the request asks for specific details about the study that proves the device meets the acceptance criteria, the provided document does not contain this information because no clinical studies were performed or included in the submission.

To directly address the request while accurately reflecting the content of the document:

1. A table of acceptance criteria and the reported device performance:

Based on the non-clinical testing described, the acceptance criteria relate to material properties, manufacturing accuracy, and biocompatibility.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: For manufacturing accuracy validation, aligners from "12 different patient case" were evaluated. No other specific sample sizes are mentioned for the general performance or biocompatibility testing (e.g., number of material samples for tensile strength).
• Data Provenance: Not explicitly stated, but the applicant (Zhejiang Yinchili Medical Technology Co., Ltd.) is based in China, suggesting the testing was likely conducted in China or by labs contracted by a Chinese company.
• Retrospective/Prospective: Not applicable, as these were non-clinical bench and lab tests, not clinical studies involving patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" for non-clinical tests is established by adherence to recognized standards (e.g., ISO 10993) and pre-established specifications, not by expert consensus on clinical findings.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods like 2+1 are used in clinical studies for interpretation of results, especially imaging. This document describes non-clinical testing.

5. 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. The document explicitly states, "No clinical study is included in this submission." This device is a physical medical device (aligners), not an AI-based diagnostic or assistive software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This section is generally relevant for AI/ML devices. The device described is a physical aligner. While there is software for ordering/processing, its V&V focused on its function in facilitating the device, not its standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For material performance and manufacturing accuracy: Ground truth was established by pre-established specifications, engineering principles, and compliance with recognized standards (e.g., ISO for biocompatibility).
• For biocompatibility: Ground truth was based on the results of specific biological tests (cytotoxicity, irritation, sensitization, sub chronic systemic toxicity, genotoxicity) interpreted against the requirements of ISO 10993.

8. The sample size for the training set:

• Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set of data.

9. How the ground truth for the training set was established:

• Not applicable (see point 8).

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The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligner positions teeth by way of continuous gentle force.

The Custom-made Invisible Aligners System is a series of dental aligners that are fabricated of clear, thin thermoformed Polyethylene terephthalate (PETG) plastic to progressively reposition the teeth. Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner.

The provided text describes a 510(k) premarket notification for a medical device, the "Custom-made Invisible Aligners." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. For this submission, the manufacturer primarily relies on non-clinical performance testing and biocompatibility testing, rather than clinical studies or AI algorithm performance studies. Therefore, many of the requested items related to AI and human reader studies are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

1. Table of acceptance criteria and the reported device performance:

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