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Indicated for use in alignment of teeth through orthodontic treatment of malocclusion.

The Proposed Device is indicated for use in the alignment or mixed dentition teeth through orthodontic treatment of misalignment and malocclusion, with 20 to 22 hours of daily wear for at least 10 days. The Proposed Device allows the option of forward repositioning of the mandible to a more optimal bite profile.

This premarket notification is submitted to notify the FDA of Wuxi EA Medical Technologies' intent of changes to the Clear Aligner (hereafter referred to as "Proposed Device") to the currently marketed reference device's, Clear Aligner (K203688, cleared October 8, 2021) (hereafter referred to as "Reference Device") indications for use to include mixed dentition, a wear time of at least 10 days, and mandibular repositioning features.

The Proposed Device consists of multiple stages of thermoformed plastic aligners designed to be worn in sequence to facilitate the movement of a patient's teeth to the final desired treatment position. The sequential stages of aligners introduce incremental move teeth by way of gentle continuous force and reposition the mandible to achieve a more optimal bite profile. The aligners are to be worn 20 to 22 hours a day and are to be removed for cleaning. Patients can be prescribed with more than one aligner of different materials within a single stage.

The Proposed Device is designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential stages of dental models are designed and approved by a physician prior to physical manufacturing. The Proposed Device includes mandibular repositioning features known as "A6" on each upper and lower aligner. A6 is intended for use in patients with growing mandibles presenting with retrognathic Class II malocclusions in permanent dentition or stable late mixed dentition.

Once the treatment plan is reviewed and approved by a dental health professional, the 3D model of each stage from the treatment plan is manufactured by 3D printed models are then thermoformed over with a suitable dental thermoplastic sheet. The final manufactured aligner stages are then delivered to the patient. The patients' dental health professional then monitors their treatment from the placement of delivered initial aligner stage to the final aligner stage.

The provided text is a 510(k) summary for a medical device (Clear Aligner) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a rigorous test set evaluation usually seen with AI/ML-enabled devices.

This document describes a "special 510(k)" submission, which is typically used for modifications to a company's own already-cleared device where the modification does not raise new questions of safety and effectiveness. In this case, the modifications are to the indications for use (adding mixed dentition, shorter wear time, and mandibular repositioning features) and material options.

The "clinical performance testing" section states: "Retrospective clinical data has been provided the Proposed Device. The data collected for the study showed that successful alignment of teeth through orthodontic treatment of misalignment and malocclusion with at 20 to 22 hours of daily wear for at least 10 days was achieved when using the Proposed Device."

This statement is very general and does not provide the quantitative details needed to fill out the requested table or address most of the specific questions about acceptance criteria and study methodology. It mentions "retrospective clinical data" and "successful alignment," but lacks specific metrics, sample sizes for the test set, ground truth creation details, expert qualifications, or MRMC study information.

Therefore, I cannot provide the requested information from the given text. The document focuses on demonstrating substantial equivalence to a predicate device based on similarities in indications for use, technological characteristics, and non-clinical performance data, rather than presenting a detailed performance study against specific acceptance criteria for a novel AI/ML algorithm.

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The Clear Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.

The Clear Aligners are intraoral thermoformed plastic aligners that are worn 22 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligners are to be removed for eating and for cleaning. The Clear Aligners are fabricated using a three-step process. The first step is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression. This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning. The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, the doctor utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the their final desired position. A 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed. The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission.

The provided text describes the 510(k) submission for the Shenzhen Meiming Dentistry Technology Co., Ltd Clear Aligner. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria related to clinical performance or an AI component.

The document primarily details non-clinical tests for manufacturing validation and biocompatibility. There is no mention of an AI algorithm or an AI-powered device, nor is there any AI-specific study described. The software mentioned (3Shape®) is for treatment planning and producing 3D printer files, which is a common CAD/CAM software used in dentistry, not an AI for diagnosis or treatment recommendation.

Therefore, many of the requested sections regarding AI-specific criteria, such as "Multi Reader Multi Case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," "adjudication method," and "sample size for the training set" cannot be answered from the provided text, as these are not relevant to this device's submission.

Here's a breakdown of the information that is available based on your request:

1. A table of acceptance criteria and the reported device performance

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

• Manufacturing Validation Accuracy: The document states that "digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligner" were assessed, but it does not specify the sample size (e.g., number of models, molds, or aligners) used for this testing.
• Biocompatibility: The text indicates that these tests were conducted on the "material," but the sample size for these tests is not specified.
• Data Provenance: Not specified, but implied to be internal testing by the manufacturer or a contracted lab.

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)

• Not applicable as this is not an AI device submission requiring expert human adjudication for a test set. The manufacturing validation used "an independent 3rd party software and digital calipers" for measurement, which implies objective measurement, not expert opinion for ground truth.

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

• Not applicable. The manufacturing validation relied on objective measurements rather than expert adjudication.

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. This is not an AI device, and no MRMC study was conducted or described.

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

• Not applicable. This is not an AI device.

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

• Manufacturing Validation Accuracy: The ground truth for translational measurements was the "target input value" from the digital treatment plan. The actual measurements were then compared against this target.
• Biocompatibility: The ground truth for biocompatibility tests is based on established scientific standards and protocols for cytotoxicity, irritation, and sensitization, with results compared against these defined requirements.

8. The sample size for the training set

• Not applicable. This device does not involve an AI algorithm with a training set. The 3Shape® software mentioned is a commercial CAD/CAM treatment planning software, not a custom-trained AI model.

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

• Not applicable. This device does not involve an AI algorithm with a training set.

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Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).

The Clear Aligner System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state.

The Clear Aligners are fabricated by thin thermoformed polyurethane or thermoformed multilayer copolyester and polyurethane composite (TPU +PETG) plastic. The corrective forces are generated via differences between current teeth arrangement and each step's aligner. They are designed to move the teeth to the target position and deliver desired clinical effect.

The traction accessory, also called "Angel Button", made of thermoplastic polyurethane can be selected and will be bonded to the outer surface of the aligner by adhesive made of acrylic polyurethane.

The provided text describes the regulatory clearance of a medical device, the "Clear Aligner," and summarizes the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. However, it does not contain the detailed information requested regarding acceptance criteria and the study proving the device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, or accuracy, which are typical for studies involving diagnostic AI/ML devices.

The document focuses on:

• Biocompatibility testing
• Software validation & risk analysis
• Performance Testing of the traction accessory and shelf life
• Real-world data for the traction accessory's effectiveness and adverse event analysis.

Based on the provided text, I can only extract information related to the non-clinical tests and their general acceptance criteria. There is no mention of a device that requires performance metrics against specific acceptance criteria like sensitivity/specificity or accuracy in the way described in your request. The device in question is a clear aligner for orthodontic treatment, not an AI/ML-driven diagnostic tool.

Therefore, many of your specific numbered requests cannot be directly answered from this document.

Here's an attempt to answer based on the available information, noting where information is missing:

1. A table of acceptance criteria and the reported device performance

Missing Information for AI/ML-specific questions:

Given the nature of the device (a physical clear aligner), the following information typically found in AI/ML medical device submissions is not present in this document:

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 as this is not an AI/ML diagnostic device with a "test set" in that context. The "real-world data" mentioned for traction accessory effectiveness is not detailed enough to provide this.

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)

• Not applicable.

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

• Not applicable.

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

• Not applicable.

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

• Not applicable.

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

• For the effectiveness of the traction accessory, "real-world data" was used, which generally implies outcomes data from patient treatments. The exact nature of this data (e.g., direct measurement of tooth movement, patient satisfaction, clinical assessments) is not specified.

8. The sample size for the training set

• Not applicable. The "software" mentioned is for manufacturing and design, not an AI/ML algorithm that requires a training set in the diagnostic sense.

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

• Not applicable.

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This device is indicated for use in the alignment of all permanent dentition through orthodontic treatment and malocclusion.

The Clear Aligner is intraoral thermoformed plastic aligner that worn 20 to 22 hours per day and is designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligner is to be removed for eating and for cleaning.

Clear Aligner is fabricated using a three-step process.

The first step is to obtain the dimensions and details of the patient's baseline dentition from the prescribing clinician who takes impressions or scans of the patient's teeth and sends them to the lab. The scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning.

The second step is to sent the treatment plan to the dentist for review and approval, then print the 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, we utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. A 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed.

The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission. And the thermoformed aligners are sent back to the dentist for distribution to the patient in sequential stages and that the dentist checks the aligners for fit and function and monitors the treatment from the first aligner until treatment is completed.

Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printer files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation is this submission is the 3Shape Ortho System ™ Software which have 510(k) (K152086).

The provided text is a 510(k) Summary for a medical device (Clear Aligners). While it details non-clinical studies and testing, it explicitly states that no clinical studies or tests were conducted (Section 11). This means the information requested regarding a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or the establishment of ground truth for training/test sets based on expert consensus or pathology data is not applicable and not present in this document.

The document focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical performance testing related to manufacturing validation and biocompatibility.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and reported device performance

The document contains a table comparing the subject device to a predicate device, but it's not a table of acceptance criteria and reported performance in the traditional sense of a clinical or AI study. Instead, the "acceptance criteria" for the manufacturing validation are described in the text.

Manufacturing Validation Acceptance Criteria & Performance:

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

• Test set sample size: Not explicitly stated as a numerical count of aligners or patients. The text mentions "Three critical aspects of the manufacturing process were assessed: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligner." This implies a set of these items were tested, but no specific quantity is given.
• Data provenance: Not specified. It's implied this was internal testing performed by the manufacturer. The location of the test (if external) is not mentioned beyond the manufacturer's address in Shenzhen, China. The document does not specify if the data was retrospective or prospective.

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

Not applicable. The ground truth for the manufacturing validation was established by measurements against target input values using "an independent 3rd party software and digital calipers," not by human expert assessment.

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

Not applicable, as the ground truth was based on physical measurements, not human interpretation requiring adjudication.

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 MRMC study was done. The document explicitly states: "Clinical studies and tests were not conducted." (Section 11)

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

This device (Clear Aligner) is a physical medical device, not an AI algorithm. The 3Shape Ortho System™ Software is mentioned as a reference device used in the manufacturing process (for treatment planning and generating 3D printer files), but no performance study of this software itself (standalone or otherwise) is presented in this 510(k) summary for the Clear Aligner. The manufacturing validation assessed the output of the process that uses the software, not the software's performance as an AI system.

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

The ground truth for the manufacturing validation was target input values from the treatment plan, against which physical measurements of the produced aligners/molds were compared. These are physical measurement standards.

8. The sample size for the training set

Not applicable. This document describes the validation of a manufactured medical device, not the training of an AI model.

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

Not applicable, as there was no AI model training set.

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This device is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

The Clear Aligner is intraoral thermoformed plastic aligner that worn 20 to 22 hours per day and is designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligner is to be removed for eating and for cleaning. Clear Aligner is fabricated using a three-step process. The first step is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression by a dental health professional (e.g. clinician). This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning. The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, the doctor utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. A 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed. The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission. Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printer files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation is this submission is the 3Shape Ortho System ™ Software which have 510(k) (K152086).

The provided document is a 510(k) Pre-market Notification from the FDA for a device called "Clear Aligner." It describes the device, its intended use, and provides information on non-clinical studies performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaways:

• This submission focuses on establishing substantial equivalence to an existing predicate device rather than proving de novo clinical efficacy.
• The primary study described is a manufacturing validation to ensure the aligner adheres to dimensional and rotational precision during its creation, which is crucial for its intended function.
• No human-in-the-loop or standalone algorithm performance studies are described as this is a physical medical device (aligner) primarily manufactured using a digital process, not an AI or software algorithm that analyzes patient data to output a diagnosis or treatment plan recommendation. The software mentioned (3Shape Ortho System™ Software) is used for the manufacturing process, not for diagnostic interpretation.
• No clinical studies were performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify an exact numerical sample size for the manufacturing validation study. It states that "Three critical aspects of the manufacturing process were assessed: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligner." This implies multiple measurements were taken across these aspects, but the specific number of units, models, or measurements is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study is a non-clinical manufacturing validation, meaning it would typically involve controlled laboratory testing rather than patient data.

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

• This section is not applicable as the ground truth for this non-clinical manufacturing validation was not established by human experts. Instead, the ground truth was the "target input value" derived from the treatment planning software, and measurements were compared against this engineering specification.

4. Adjudication method for the test set

• Not applicable. There was no human adjudication process described for the manufacturing validation. The comparison was against objective numerical tolerances (0.3mm for translation, 3 degrees for rotation).

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 performed. The device is a physical aligner, and this submission focuses on its manufacturing precision and biocompatibility, not on an AI algorithm that assists human readers/diagnosticians.

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

• No. This is not an AI or software device that performs standalone interpretations or recommendations. The software (3Shape Ortho System™ Software) is used for the manufacturing process of the physical aligner, not for standalone diagnostic performance.

7. The type of ground truth used

• For the manufacturing validation, the ground truth was the predefined "target input value" (engineering specifications) for translational and rotational movements as determined by the treatment planning software. This is a form of engineering specification/design ground truth.
• For biocompatibility, the ground truth was compliance with international standards (ISO).

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set." The manufacturing process validation does not involve machine learning model training.

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

• Not applicable. As there is no training set, this question is irrelevant.

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The CLEAR ALIGNER ADHESIVE is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces.

The Clear Aligner Adhesive is a light cure, orthodontic adhesive for metal, composite and porcelain brackets and appliances to bond to a thermoplastic aligner. The Clear Aligner Adhesive is formulated in a viscosity that flows easily from the syringe and bonds chemically to a typically difficult to adhere to surface. a thermoplastic aligner now common in the dental industry. This adhesive, upon polymerization, is clear and virtually indistinguishable from the thermoplastic aligner thereby making it aesthetically pleasing to the patient. The light cure property of the adhesive allows the user to determine the polymerization time required by simply exposing the adhesive to an LED light source until set. The Clear Aligner Adhesive will be marketed in a push syringe for dispensing.

The provided text describes a medical device called "Clear Aligner Adhesive" and its 510(k) submission for premarket notification. The information pertains to the adhesive's composition, intended use, and a comparison to a predicate device. However, the document does not contain information about acceptance criteria or specific studies that would typically be described for a diagnostic AI/ML device approval (e.g., sensitivity, specificity, clinical endpoints, reader studies).

Therefore, I cannot provide a detailed answer to your request in the format specified. The information about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, and ground truth establishment for a diagnostic AI/ML device is not present in the provided text.

The document primarily focuses on establishing substantial equivalence for a physical medical adhesive based on its technical characteristics and an assessment of shear bond strength and cytotoxicity.

Here's what can be extracted from the provided text about the device:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly list quantitative "acceptance criteria" for regulatory approval in the typical sense for an AI/ML device. Instead, it compares the new device's properties to a predicate device and reports on specific tests.

Regarding the study proving the device meets criteria, the document states:

"Clear Aligner Adhesive was tested and compared to Reliance Orthodontic Products, Inc. Flowtain in conjunction with Plastic Conditioner for Shear Bond Strength. Testing resulted in highly increased bond strength values for the Clear Aligner adhesive when compared to the use of Flowtain with a Plastic conditioner. Clear Aligner Adhesive has been tested for cytotoxicity via the ISO 10993-5 elution test method and showed no evidence of causing cell lysis or toxicity."

The following information cannot be provided from the given text:

• 2. Sample size used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/mentioned for this type of device and submission.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/mentioned.
• 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: Not applicable. This is not an AI/ML device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For Shear Bond Strength, the "ground truth" would be the measured force. For cytotoxicity, it would be the cellular response observed in the lab. These are not clinical "ground truths" in the diagnostic sense.
• 8. The sample size for the training set: Not applicable for this type of device.
• 9. How the ground truth for the training set was established: Not applicable.

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