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Orthodontic Acrylic 2 is intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.)

Orthodontic Acrylic 2 is a fast curing self-cure 2 part system consists of a powder and a liquid. The combination of the powder and liquid is converted into a hard methacrylate finished product.

The provided text describes the regulatory clearance for "Orthodontic Acrylic 2" and details its performance against specific acceptance criteria.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Clinical Study: "a limited clinical study involving 32 patients"
• In-vitro Testing (QAMS inhibition): Not explicitly stated, but performed "In-vitro."
• In-vitro Studies (3-month biofilm reduction): Not explicitly stated, but performed "in-vitro."
• Physical/Mechanical Properties: Not explicitly stated, but performed according to ISO 20795-2:2010.
• Biocompatibility Testing: Not explicitly stated, but tested per ISO 10993-1:2009 for various tests.

The provenance of clinical data is not specified (e.g., country of origin, retrospective or prospective), but the mention of a "limited clinical study" suggests it was likely a prospective study. The in-vitro tests are laboratory-based.

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

This information is not provided in the document. The studies conducted (physical/mechanical, in-vitro antimicrobial, biocompatibility, and a limited clinical study) likely relied on standard laboratory measurements and clinical observations rather than expert consensus for ground truth determination in the way it's typically applied to AI model evaluations (e.g., radiologists reviewing images).

4. Adjudication method for the test set:

This information is not provided. Given the nature of the tests (laboratory measurements, in-vitro studies, and a limited clinical trial comparing biofilm formation), a formal adjudication method like "2+1" or "3+1" for establishing ground truth from multiple readers/experts is not applicable here.

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, an MRMC comparative effectiveness study was not conducted. This device is a material (Orthodontic Acrylic), not an AI-assisted diagnostic or therapeutic tool for human readers.

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

No, this is not an AI algorithm. The performance evaluation is for a physical medical device (orthodontic acrylic material), not a software or AI product.

7. The type of ground truth used:

• Physical/Mechanical Properties: Manufacturer's specifications and compliance with international standards (ISO 20795-2:2010) for material properties (e.g., flexural strength).
• Anti-bacterial/Anti-fungal Testing: Laboratory assays measuring microbial inhibition and biofilm reduction.
• Biocompatibility: Results from validated in-vitro and in-vivo tests as per ISO 10993-1:2009 (e.g., cytotoxicity, irritation, sensitization).
• Clinical Study: Direct measurement of biofilm formation on orthodontic appliances in patients.

8. The sample size for the training set:

This information is not applicable/provided. This is a physical material being evaluated, not a machine learning model that requires a training set. The development of the material involved chemical formulation and testing, not AI training.

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

This information is not applicable/provided as there is no training set for this type of device.

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