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DentCare Aligners are indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion. The aligner guide teeth to their final position by way of continuous gentle forces.

The DentCare Aligners are transparent medical grade thermoplastic materials moulded for the use in orthodontic alignment of teeth from one position to another. The DentCare Aligners are used in correcting various malocclusions. Hence it requires precise treatment planning before fabrication. Thorough understanding of the process and steps are required before proceeding to provide a successful aligner treatment.

The provided text describes DentCare Aligners, an orthodontic device, and details its non-clinical testing for 510(k) clearance.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated based on material properties, with acceptance criteria implicit in the guideline standards and the reported values indicating compliance.

Additionally, the biocompatibility tests against ISO standards represent acceptance criteria:

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify sample sizes for the material property tests. These are typically conducted on a small number of material samples according to the respective ASTM standards.
The data provenance is not explicitly stated as "country of origin for data" or "retrospective/prospective." However, the tests are non-clinical (material property and biocompatibility evaluations) rather than patient-based studies. The applicant, DentCare Dental Lab Pvt Ltd., is based in India.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as the studies are non-clinical material and biocompatibility tests, not expert-opinion-based evaluations. The "ground truth" here is the adherence to established international standards (ASTM and ISO).

4. Adjudication Method

Not applicable for non-clinical material and biocompatibility testing. The "adjudication" is determined by whether the test results meet the specified criteria of the applicable standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "CLINICAL TESTING SUMMARY I. Not applicable - Clinical data is not needed for most devices cleared by the 510(K) process." This indicates no human-in-the-loop performance evaluation was performed.

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

No, a standalone algorithm performance study was not done. The device, DentCare Aligners, is a physical medical device (orthodontic aligners), not an algorithm or AI software for diagnosis or treatment planning. While software (3Shape Ortho System™) is used in the manufacturing process, the clearance is for the aligners themselves, not the software's standalone performance.

7. The Type of Ground Truth Used

For the material property tests, the "ground truth" is the established scientific and engineering principles embodied in the ASTM standards (e.g., how to correctly measure density, tensile strength). For biocompatibility, the "ground truth" is compliance with the safety thresholds and methodologies defined by the ISO 10993 series of standards.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned or implied as this is not an AI/ML device requiring a training phase for an algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set.

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