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The ClearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force.

The ClearCorrect device is fabricated of clear thin thermoformed polyeurathane plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.

The provided text describes the ClearCorrect System, an invisible braces system, and its substantial equivalence to predicate devices, rather than presenting a study with detailed acceptance criteria and performance data for a new device. Therefore, much of the requested information regarding specific acceptance criteria, sample sizes, expert involvement, and statistical outcomes is not explicitly available in the provided text.

However, based on the information provided, here's a structured response addressing the requested points to the best of my ability, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of acceptance criteria with specific quantitative targets and corresponding device performance data. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparisons of intended use, technological characteristics, and principles of operation, along with general non-clinical testing.

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

The text does not specify a sample size for a test set as it relies on non-clinical testing and substantial equivalence to predicate devices, rather than a de novo clinical or performance study with a dedicated test set. The data provenance is not mentioned, as detailed data from a specific study is not presented.

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

This information is not applicable or available in the provided text. The submission focuses on demonstrating equivalence to existing devices and non-clinical testing, not on a study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable or available as there is no specific test set or clinical study described requiring adjudication.

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

No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission explicitly states, "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

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

The ClearCorrect System is a physical device (invisible braces) and not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context.

7. The Type of Ground Truth Used

Given that no clinical study with explicit ground truth determination is described, this information is not applicable or available. The submission's "ground" for approval is substantial equivalence to predicate devices, supported by non-clinical performance and biocompatibility testing.

8. The Sample Size for the Training Set

This information is not applicable or available. The ClearCorrect System is a physical medical device, not a machine learning algorithm that requires a "training set" in the conventional sense.

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

This information is not applicable or available for the same reason as point 8.

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The CearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force.

The ClearCorrect device is fabricated of clear, thin, thermoformed polycarbonate plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.

This 510(k) summary for the ClearCorrect device does not contain the detailed information required to fill out the requested table regarding acceptance criteria and a study proving those criteria. The document focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance studies with acceptance criteria.

Here's a breakdown of why the information is missing from the provided text:

• Type of Submission: This is a Traditional 510(k) for a device that is essentially identical to its predicates. The primary goal of such a submission is to show substantial equivalence through technological characteristics and intended use, rather than extensive de novo performance testing against specific acceptance criteria.
• Device Type: ClearCorrect aligners are physical, custom-made orthodontic devices. The "performance" in this context is the physical repositioning of teeth, which is a clinical outcome over time, not a measurable, instantaneous output like a diagnostic algorithm.
• Focus of the Document: The document explicitly states: "The information discussed above demonstrates that the ClearCorrect device is substantially equivalent to the predicate devices." It then provides a table comparing features like Intended Use, Mode of Action, and Material, to show this equivalence. No study data or acceptance criteria are presented.

Based on the provided text, I cannot complete the table or answer most of your detailed questions. The document does not describe:

• Specific acceptance criteria (e.g., accuracy, sensitivity, specificity, or any measurable clinical outcome percentages).
• A study validating device performance against such criteria.
• Sample sizes for test or training sets.
• Details about ground truth establishment or expert qualifications.
• Any multi-reader, multi-case studies or standalone algorithm performance.

Here's what can be inferred or stated as "not provided" based on the text:

Acceptance Criteria and Reported Device Performance

Missing Information Based on the Provided Text:

1. Sample sizes used for the test set and the data provenance: Not provided. The submission does not detail a specific test set or study.
2. 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): Not provided. No test set or ground truth establishment process is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
4. 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: Not applicable. This is not an AI-based diagnostic or interpretative device; it's a physical orthodontic appliance.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
7. The sample size for the training set: Not applicable. This device is not an AI/algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

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