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The ClearCorrect System is indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion.

The aligners of the ClearCorrect System are a sequential series of clear thermoformed orthodontic appliances that, when worn in the prescribed sequence and duration, progressively reposition the teeth. The aligner is an orthodontic appliance intended for intra-oral use. Individual devices will be used between 20 – 22 hours per day for a period ranging from one to three weeks. The corrective forces to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the appliance. Features can be added to the aligner that engage with composite resin tooth attachments to improve aligner retention and/or to apply forces in directions that cannot be achieved by engaging with tooth surfaces alone.

The provided FDA 510(k) summary (K220140) for ClearCorrect System does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.

Specifically, it lacks:

• A table of acceptance criteria and the reported device performance. While "Performance Data" is listed, it only mentions types of tests conducted (e.g., package integrity, biocompatibility, tensile performance, etc.) but does not provide specific acceptance criterion values or the results obtained from these tests.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
• If a standalone (algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics (mode of action, materials, sterilization, use, packaging, and treatment planning software), and general performance data types. It states that performance data was generated but does not present the detailed results or the methodology in the way requested for a typical AI/medical imaging device submission.

It explicitly lists the following performance data categories:

• Package integrity via simulated transport test per ISTA 2A
• Validation of shelf life per ASTM F1980
• Biocompatibility per the ISO 10993 series standards
• Water absorption testing per ISO 62
• Tensile performance testing per ISO 527-3
• Flexural performance testing per ISO 178
• Impact performance testing per ISO 8256
• Tear resistance testing per ISO 6383-1
• Fatigue resistance testing per ASTM D7774
• Stress relaxation testing
• Dimensional stability per internal methods
• Usability testing per IEC 62366-1
• Software development per IEC 62304

However, for each of these, the specific acceptance criteria and the numerical results demonstrating that the device meets those criteria are not detailed in this summary.

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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 aligners of the ClearCorrect System are a sequential series of clear thermoformed orthodontic appliances that, when worn in the prescribed sequence and duration, progressively reposition the teeth. The aligner is an orthodontic appliance intended for intra-oral use. Individual devices will be used between 20 – 22 hours per day for a period ranging from one to three weeks The corrective force to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the tray. Features can be added to the aligner that engage with composite resin tooth attachments to improve aligner retention and/or to apply force in directions that cannot be achieved by engaging with tooth surfaces alone.

The retainers of the ClearCorrect System are clear thermoformed appliances intended to keep the teeth from relapsing after they have been treated with aligners. Retainers are an optional component of aligner therapy. Retainers are typically prescribed for use at the conclusion of aligner treatment but can be prescribed at other times should there be a need to interrupt aligner treatment.

The engager templates of the ClearCorrect System are clear thermoformed appliances used to accurately apply composite resin attachments to the teeth as needed to achieve the desired tooth movement. The use of engagers and engager templates is an optional component of aligner treatment. Cavities are formed in the film having the desired shape, orientation and tooth position of the engager attachments to be bonded to the patient's teeth. At the time of use, the clinician fills the cavities in the engager template with light-curing composite resin. The engager template is then placed onto the patient's teeth and the resin cured. Once the resin is cured, the engager template is removed and discarded.

The provided text is a 510(k) Premarket Notification from the FDA for the ClearCorrect System, an orthodontic device. While it details the device's indications for use, materials, and a comparison to predicate devices, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies.

Instead, the "Performance Data" section lists various types of studies conducted to establish substantial equivalence (e.g., package integrity, shelf life, biocompatibility, material property testing, usability, software development). It states that these studies were used to demonstrate substantial equivalence, but it does not provide the results of these studies nor does it define acceptance criteria for these studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample sized used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on establishing substantial equivalence to existing predicate devices based on technological characteristics and general performance testing, rather than reporting on a clinical or performance study with defined acceptance criteria and detailed methodology for AI/software performance.

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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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