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Biotech Dental SMILERS® aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e., all second molars) during orthodontic treatment of malocclusion. SMILERS® aligners position teeth by way of continuous gentle force.

The Biotech Dental SMILERS® aligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial position to a different end position using a software-generated sequence of intermediate states. Biotech Dental SMILERS® sequentially reposition teeth by way of continuous gentle force.

The provided text is an FDA 510(k) summary for the Biotech Dental SMILERS® aligners. It focuses on demonstrating substantial equivalence to a predicate device (Byte Aligner System K180346) rather than detailing acceptance criteria and a study that proves the device meets them in the context of an AI/algorithm-driven device.

However, I can extract the information relevant to non-clinical performance testing and conceptualize how it relates to acceptance criteria and "proving the device meets them," even if it’s not an AI performance study.

Key takeaway from the document: This submission is for orthodontic aligners, which are physical medical devices, not an AI/algorithm. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to manufacturing validation, material testing, and shelf-life studies, not clinical performance or AI algorithm performance. The FDA determined that no clinical data was needed due to the well-established nature of sequential aligners.

Therefore, the requested information points 1 through 9, which are largely geared towards AI/algorithm performance studies, are not explicitly present in the provided document in the way they would be for an AI-medical device. I will address them based on the information available and note where it's not applicable.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for a Physical Device)

1. Table of Acceptance Criteria and Reported Device Performance

Regarding AI/Algorithm-Specific Questions (Not Applicable to this Device Approval, but addressed for completeness):

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

• Not Applicable (N/A): This submission is for a physical medical device (orthodontic aligners), not an AI algorithm. No test set of clinical data (images, etc.) for AI performance was used. The "test set" for this application refers to physical samples used in manufacturing validation and biocompatibility testing. The number of cases for manufacturing validation is not specified, nor is the provenance of those cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• N/A: As this is physical device approval, there's no clinical "ground truth" established by experts in the context of an AI algorithm's diagnostic performance. For the fit validation, it states "qualitatively evaluated by a qualified individual," but specific number or detailed qualifications beyond "qualified" are not provided.

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

• N/A: No clinical data or AI performance test set requiring adjudication in this context.

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:

• N/A: This is not an AI-assisted device. No MRMC study was performed. The clinical performance of sequential aligners is stated to be "well established" and "no clinical data is included in this submission."

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

• N/A: This is not an algorithm. The Nemocast software (K193003) is mentioned as a tool for planning cases, but the approval is for the aligners themselves, not the software's performance as a standalone diagnostic or treatment algorithm.

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

• N/A (for AI context): For the physical device, "ground truth" for manufacturing and fit would be based on engineering specifications and qualitative assessment of fit by a "qualified individual." Biocompatibility is assessed against published international standards.

8. The sample size for the training set:

• N/A: There is no AI training set for this device approval.

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

• N/A: There is no AI training set for this device approval.

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