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GENIOVA Aligners are indicated for use in the alignment of permanent teeth (i.e., all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.

GENIOVA aligners are thermoformed plastic aligners designed to be used in sequence to facilitate the movement of teeth to the desired final position. Sequential aligners introduce incremental movements that move teeth by a gentle continuous force. Aligners should be worn 20 to 22 hours a day and should be removed for eating and cleaning.

GENIOVA aligners are designed based on traditional mold impression or digital scans of the patient's dentition submitted by a dental health professional (e.g., a dentist or orthodontist). From the scan, specialized orthodontic CAD/CAM software is used to develop the treatment plans, which consist of sequential dental models in which the teeth are gradually realigned at each step. For these 510(k) applications, the Ortho system from 3Shape A/S (K180941) will be used.

(K180941) from 3Shape A/S. Ortho System is approved for use in orthodontic model management, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options. The specialized orthodontic treatment planning software has 510k clearance for intended use under FDA Classification Product Code PNN, regulation 872.5470.

Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The Essix thermoplastic material used for BRIUS Clear Aligners has 510(k) clearance (K062828) for use as an aligner material; the 510(k) holder (of the material) conducted the physical properties testing for the material.

The aligner trays are then delivered to the patient by the prescribing dental health professional. This dental health professional then monitors the patient's treatment from the first aligner to the delivery of the final aligner and completion of treatment. The aligners are held in place by pressure and can be removed by the patient at any time.

The provided text describes the 510(k) summary for GENIOVA Aligners, seeking substantial equivalence to predicate devices. It details non-clinical testing for dimensional accuracy and material properties but explicitly states that clinical testing was not conducted. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for clinical performance cannot be extracted as it is not present in the document.

However, based on the non-clinical testing performed, here's what can be inferred and reported:

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

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

• Dimensional Accuracy/Manufacturing Validation: Not explicitly stated as a numerical sample size. The text mentions "The submitted intraoral scans, digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners were all assessed quantitatively or qualitatively in the validation." This suggests a test set encompassing various stages of the manufacturing process of the aligners.
• Data Provenance: The testing was an "internal manufacturing validation" performed by Geniova Technologies Sociedad Limitada. No country of origin is specified for the data itself, but the company is located in Madrid, Spain. The nature of the data is quantitative measurements and qualitative visual inspections from this internal validation.

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/Not provided. The ground truth for dimensional accuracy testing would be the "target input value" (the digitally designed dimensions), rather than a subjective expert assessment. The validation was a technical measurement against a predefined tolerance.

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

• Not applicable/Not provided. Adjudication methods are typically used for subjective assessments or when there's disagreement among human reviewers. This testing involved objective measurements.

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. No clinical testing, and no AI component involving human readers is described. The device is an orthodontic aligner, not an AI diagnostic tool.

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

• Not applicable. No standalone algorithm performance testing is described for the aligners themselves, as they are physical devices. The software used for design (3Shape A/S's Ortho System) is a cleared reference device, implying its own prior standalone validation, but this document does not detail performance of that software, only its use in the aligner manufacturing process.

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

• Dimensional Accuracy/Manufacturing Validation: The "ground truth" was the target input value (the predefined digital dimensions) against which the physical measurements were compared.

8. The sample size for the training set:

• Not applicable. This document describes the validation of a physical medical device and its manufacturing process, not the training of a machine learning model.

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

• Not applicable. As above, no training set for a machine learning model is described.

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The Clear Moves Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). Clear Moves Aligner positions teeth by way of continuous gentle force.

Clear Moves Aligners are comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. They are made of biocompatible thermoformable plastics, either from a copolyester or a composite of copolyester and polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides physical or scanned impressions of the patient's teeth to Clear Moves Aligners. A treatment plan using commercially available treatment planning software of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked with patient identifying information and treatment step. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.

This document is a 510(k) Premarket Notification from the FDA for a dental device called "Clear Moves Aligners." This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy from scratch through extensive clinical trials. Therefore, the information provided focuses on comparisons to existing devices and bench testing, rather than detailed human clinical study data with specific acceptance criteria, expert ground truth, or MRMC studies that would be typical for more novel or higher-risk medical devices.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device itself (e.g., accuracy of tooth movement in millimeters). Instead, the "performance" described is about demonstrating that the manufacturing process is valid and the materials are biocompatible, and that the device is "substantially equivalent" to predicate devices.

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

The document explicitly states: "In vivo Animal and Human Clinical performance testing are not required for this device category." Therefore, there is no test set of clinical patient data in the traditional sense, for which sample sizes or data provenance (country, retrospective/prospective) would be applicable concerning the device's clinical performance. The "test sets" mentioned would be for biocompatibility testing (material samples) and mechanical bench testing (prototype aligners/molds). These details are not provided in terms of specific sample numbers or origins within this document.

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

Not applicable. As no human clinical performance testing was required or conducted for this 510(k) submission, there was no "ground truth" derived from expert consensus on patient outcomes/diagnoses related to the device's effectiveness. Ground truth for bench testing would typically involve engineering specifications or physical measurements.

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

Not applicable. No clinical test set requiring adjudication was used.

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 device is a physical orthodontic aligner, not an AI-powered diagnostic or assistive tool. While software is used for treatment planning, the submission focuses on the aligner itself and does not include an MRMC study comparing human performance with and without AI assistance.

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

Not applicable. This is not an AI algorithm being submitted for standalone performance. The software mentioned (Ortho Analyzer) is a pre-existing, referenced device used for treatment planning, not for autonomous diagnosis or treatment execution.

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

For the compliance requirements:

• Biocompatibility: Ground truth would be established by validated test methods (e.g., ISO standards) and comparison to known safe materials.
• Manufacturing Process Validation: Ground truth would be established by engineering specifications, CAD models, and precise measurements comparing the manufactured parts to the digital design.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set" for an algorithm to learn from data.

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

Not applicable, as no training set for an AI algorithm was used.

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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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The SmileSeries™ is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in adult and adolescent patients with permanent dentition (i.e. all second molars). The SmileSeries™ positions teeth by way of continuous gentle force.

The SmileSeries™ is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. SmileSeries™ aligners are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) takes provides physical or scanned impressions of the patient's teeth to SmileSeries™. A digital setup of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.

This document is a 510(k) Premarket Notification from the FDA for the device "SmileSeries™" by Ordont Orthodontic Laboratories, Inc. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, not to prove that the device meets specific acceptance criteria through a clinical study in the way one might for a novel diagnostic AI algorithm.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of performance metrics that would be applicable to an AI device (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) is not present in this document.

Instead, this document describes a comparison to a predicate device based on intended use, technological characteristics, materials, and manufacturing processes, supported by bench testing for manufacturing accuracy and biocompatibility testing of the plastic material.

Here's how to address your points based on the provided document:

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

The document does not present quantitative performance acceptance criteria or reported performance results in the typical sense for a diagnostic device. Since SmileSeries™ is an orthodontic appliance (a physical device), the "acceptance criteria" revolve around demonstrating that it is substantially equivalent to a predicate device, meaning it is as safe and effective as a legally marketed device.

The "performance" is primarily shown through:

• Identical Indications for Use: The SmileSeries™ is used for the same purpose as the predicate.
• Similar Technological Characteristics: Same material (thermoformed plastic), similar manufacturing process (forming plastic sheets on models), and the same software used for planning.
• Successful Bench Testing: To validate the manufacturing process and ensure accuracy of the final aligner compared to the digital scan. No specific numerical results or benchmarks from this bench testing are provided in this summary, only that a "final report was part of the 510(k) package."
• Biocompatibility: The material meets requirements, referencing prior 510(k) submissions.

Table based on the document's comparison of characteristics:

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

This document describes bench testing for manufacturing accuracy, not clinical performance testing with a "test set" of patients or data, as would be common for an AI device. Therefore, a "sample size" in that context is not applicable or provided. The document states:

• "Bench testing was performed to validate the manufacturing process, to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan."
• "A final report was part of the 510(k) package."

No details on the sample size of items tested, data provenance, or retrospective/prospective nature are provided for this bench testing in this summary.

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. This device is an orthodontic appliance, not a diagnostic AI system requiring expert-derived ground truth for a test set. The validation focuses on manufacturing accuracy and material safety, not diagnostic performance.

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

Not applicable. As above, this is not a diagnostic study requiring adjudication of expert readings.

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-assisted diagnostic device. The study performed was bench testing of the physical aligner and its manufacturing process, and biocompatibility testing of the material. The document explicitly states: "In vivo Animal and Human Clinical performance testing are not required for this device category."

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

Not applicable. This is not an algorithm-only device. The reference to software (Ortho Analyzer) is for treatment planning and 3D printing of models for the creation of the aligners, not for standalone diagnostic performance.

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

For the bench testing, the "ground truth" would implicitly be the initial digital scan or design specifications of the aligner, against which the accuracy of the final thermoformed aligner was compared. It's a comparison to a precise digital model, not a biological or clinical ground truth in the sense of disease presence.

8. The sample size for the training set

Not applicable. This refers to an AI training set, which is not relevant to this physical device submission.

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

Not applicable. As per point 8.

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Ohlendorf Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars). The Ohlendorf Clear Alginer positions teeth by way of continuous gentle force.

The Ohlendorf Clear Aligner consists of a series of dental-clinician prescribed customized clear plastic removable orthodontic aligner trays that are made from a clear, thin thermoformed polyurethane.

A dental clinician prescribes the Ohlendorf Clear Aligner based on an evaluation of the patient's teeth. Either intraoral scans or physical impressions of the patient's teeth are taken, after which the clinician determine course of treatment with the system. The clinician completes a prescription form using standard dental software used for tooth alignment. The series of plastic aligner trays are designed according to the using standard dental software for planning the tooth alignments.

The software used is Ortho Analyzer by 3Shape (Reference device K180941). It is used for managing 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements and design of a variety of orthodontic appliances based on 3D scanned orthodontic models.

After the plan is developed by Ohlendorf, the prescribing dental clinician reviews and approves the model scheme before the molds are produced. Following approval, Ohlendorf produces the aligner trays. The trays are provided to the dental clinician who provides them to the patient assuring fit and function during the entire treatment period.

The clear, thin, thermoplastic polyurethane-polyester composite resin material used for fabrication of the Ohlendorf Clear Aligner is commonly used in many dental and orthodontic appliances, including the predicate clear aligners.

The provided document is a 510(k) summary for the Ohlendorf Clear Aligner. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing an extensive study proving the device meets specific performance acceptance criteria for an AI/algorithm-driven medical device.

The "Device Testing" section mentions "Laboratory Testing" and states:
"Test data were submitted to:

• assure the mechanical properties of the aligner material ■ meet specifications for up to 5 years shelf life [according to ASTM D638 standard’s testing for: tensile strength (PSI), elongation (%), tensile@ yield (PSI), elongation @ yield (PSI) and tensile modulus (PSI)];
• assure the aligner material packaging retains the required moisture barrier properties;
• validate the processes used for the design and manufacture of the customized aligners, to ensure consistency between the aligner’s digital design and the manufactured aligners."

It then concludes with: "All testing met the pre-determined acceptance criteria."

However, the document does not provide the specific acceptance criteria values or the reported performance data for these physical and manufacturing properties. It also explicitly states: "Neither animal nor human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device."

Therefore, based on the provided text, it's not possible to fully answer your request regarding the acceptance criteria and study details as they would apply to an AI/algorithm-driven device with typically robust clinical or performance studies. The device in question is a physical medical device (clear aligners) and its clearance is based on substantial equivalence to a predicate device, primarily focusing on material and manufacturing process similarity, not on an AI algorithm's diagnostic or predictive performance.

The questions you've posed (e.g., MRMC studies, ground truth for AI, training set size) are highly relevant for AI/ML-based medical devices that perform tasks like image analysis or diagnosis. This document, however, does not describe such a device or its associated studies.

Given the information, I can only provide a hypothetical table based on the mention of "pre-determined acceptance criteria" for the physical and manufacturing aspects, and state that the detailed study information for AI-specific performance is not available in this document.

Based on the provided document, here's what can be extracted and what cannot:

The document describes the Ohlendorf Clear Aligner, a physical medical device for orthodontic treatment, and its 510(k) clearance process. The clearance is based on substantial equivalence to an existing predicate device. The performance claims primarily relate to the material properties and manufacturing consistency of the physical aligners, not the performance of an AI algorithm in a diagnostic or treatment planning context that would typically involve human-in-the-loop performance or standalone AI performance evaluation.

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

Based on the document, specific numerical acceptance criteria and reported performance values for the mechanical properties (tensile strength, elongation, etc.) or manufacturing validation are not provided. The document states: "All testing met the pre-determined acceptance criteria."

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

The document does not specify the sample sizes for the material property or manufacturing consistency tests. It also does not mention the provenance of any data in terms of country of origin or clinical (retrospective/prospective) studies, as such studies were explicitly stated as "not required" for this submission.

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

This information is not applicable as the device is a physical product (clear aligner), and the studies described are related to its material and manufacturing properties, not an AI algorithm requiring expert ground truth for clinical performance. The "ground truth" here would relate to laboratory standards (e.g., ASTM D638).

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

This information is not applicable for the type of testing described (material and manufacturing process validation).

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 study was not done. The document explicitly states: "Neither animal nor human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device." This type of study is relevant for AI-assisted diagnostic devices, which the Ohlendorf Clear Aligner is not described as.

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 description mentions the use of "Ortho Analyzer by 3Shape (Reference device K180941)" software for planning, but the submission is for the physical aligner product, not the software itself as a novel AI/ML device. The software is used by a dental clinician, who then approves the plan before manufacturing.

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

For the material and manufacturing tests, the "ground truth" would be established by engineering standards (e.g., ASTM D638 for material properties) and internal quality control specifications for manufacturing consistency. It does not involve clinical ground truth types like pathology or outcomes data for performance evaluation.

8. The sample size for the training set

This question is not applicable. The device itself is a physical product. While software (Ortho Analyzer) is used for planning, the document does not describe the development or training of a novel AI algorithm by the applicant, nor does it specify a training set for such a purpose. The 3Shape software is referenced as a separate device (K180941).

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

This question is not applicable as no training set for a novel AI algorithm developed by the applicant is described in this document.

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Archworx is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Archworx is intended to position teeth by way of continuous gentle force.

Devices are intraoral thermoformed plastic aligner trays for tooth malocclusion correction.

The provided text describes the regulatory clearance of an orthodontic device called "Archworx." It details the device's intended use, manufacturing process, and comparison to a predicate device for substantial equivalence. However, the document does not contain information about the acceptance criteria and the results of a study (especially a clinical or AI-related study) that proves the device meets those criteria.

Specifically, the document mentions:

• Biocompatibility testing: "Biocompatibility testing was conducted...and that the device met the acceptance criteria for all tests." It does not specify what these criteria were or provide the results.
• Bench Performance Testing: "Physical properties testing was conducted, and testing information was obtained from the material manufacturer. All the physical properties testing met the pre-specified acceptance criteria." Again, the criteria and results are not detailed.
• Verification and Validation Testing: "Yes, Performed. For 3 different patient cases, aligners were evaluated at 3 different points through the sequence for each sequence point, 3 critical dimensions based on intended positions of these critical tooth structures. Testing indicated the aligner designed in the software meets the planned location, positions and all dimensions as expected; and as prescribed." This is the closest to study results, but it's very high-level and lacks specific quantitative data or acceptance criteria. It also doesn't fit the typical structure of an AI/human-in-the-loop study.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or details about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training sets, or how ground truth was established, as this information is not present in the provided text.

The information provided is largely for a 510(k) submission for a physical medical device (orthodontic aligners), not an AI/ML-driven device that would necessitate the study details inquired about. The only software mentioned is "3Shape Ortho System Software (K180941)" which is used for scanning and designing models, implying it's a tool used in the manufacturing process rather than an AI-driven component of the "Archworx" device itself that requires clinical performance validation as per the prompt's implied context (e.g., diagnostic AI).

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BRIUS Clear Aligners are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.

The BRIUS Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 2 0 to 22 hours a day and are to be removed for eating and for cleaning.

BRIUS Clear Aligners are designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, specialized orthodontic CAD/CAM software will be used to develop the treatment plans that consist of sequential dental models wherein the teeth are gradually realigned with each step. For this 510(k), 3Shape A/S's Ortho System (K180941) will be used for this application. Ortho System is approved for use in the management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options. The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470.

Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligner trays are then delivered to the prescribing dental health professional. This dental health professional then monitors treatment from the placement of the first aligner to the delivery of the final aligner and completion of treatment.

The provided text from the FDA 510(k) summary for BRIUS Clear Aligners (K202792) primarily focuses on establishing substantial equivalence to a predicate device through comparison of specifications and non-clinical performance testing. It does not describe a study involving expert readers or AI performance in the typical sense of diagnostic or prognostic devices.

Instead, the non-clinical performance testing described is related to the manufacturing process and material properties of the aligners themselves. Therefore, the requested information elements related to AI performance, expert consensus, sample sizes for test/training sets in an AI context, MRMC studies, or standalone performance are not applicable based on the provided document.

Here's a breakdown of the applicable information based on the provided text, adapted to the context of the device's manufacturing and material validation:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported performance relate to the manufacturing validation of the BRIUS Clear Aligners.

2. Sample Size for the Test Set and Data Provenance

The document mentions an "internal manufacturing validation" but does not specify a numerical sample size for the aligners tested for dimensional accuracy and qualitative assessment.

• Test Set Sample Size: Not explicitly stated as a numerical value. The study refers to "the submitted intraoral scans, digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners" being assessed, implying a collection of these components.
• Data Provenance: The validation was an "internal manufacturing validation," indicating it was conducted by BRIUS Technologies, Inc. or their associated entities. The origin country is not specified, but the company is based in Carrollton, TX, USA. It is a retrospective assessment of manufactured products against internal specifications.

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

This information is not applicable as the validation was for manufacturing accuracy and material properties, not for diagnostic or prognostic AI performance requiring expert review of medical images or data. The "ground truth" was the target input values for measurements and predefined specifications for qualitative attributes.

4. Adjudication Method for the Test Set

This information is not applicable. The assessment involved objective measurements (digital calipers and 3rd party software) and qualitative visual inspections against predefined specifications, rather than an adjudication process typically used for subjective expert panel reviews.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this device is a clear aligner, not an AI software intended to assist human readers in a diagnostic task.

6. Standalone Performance Study (Algorithm Only)

A standalone algorithm performance study was not performed in the context of AI. The "manufacturing validation" described is a standalone assessment of the physical product's adherence to specifications.

7. Type of Ground Truth Used

• For Dimensional Accuracy: The ground truth was the "target input value" (digital design specifications) from the orthodontic CAD/CAM software (3Shape A/S's Ortho System).
• For Qualitative Assessment: The ground truth was predefined performance, cosmetic, and other detectable issue specifications.
• For Biocompatibility: The ground truth was adherence to international standards (ISO 10993-1 and ISO 10993-5).

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical device (clear aligner) whose manufacturing process was validated, not an AI algorithm that requires a training set. The orthodontic CAD/CAM software used (3Shape A/S's Ortho System) would have its own development and validation, but that is not the subject of this 510(k) for the BRIUS Clear Aligners.

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

This information is not applicable for the same reasons as #8.

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NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The NEOLab Clear Aligners position teeth through the use of continuous gentle force.

NEOLab Clear Aligners consist of a series of customized clear plastic removable aligners that are fabricated from a clear, thin thermoformed polyurethane-polyester resin, and are intended to be worn 22 hours a day. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state.

The provided document (K203339) is a Special 510(k) summary for the NEOLab Clear Aligners. It focuses on demonstrating substantial equivalence to a predicate device (Ormco Spark Aligner System, K182826) by showing that the new device has the same intended use, similar technological characteristics, and meets material and manufacturing specifications.

However, this document does NOT describe the acceptance criteria and the study that proves a device (e.g., an AI-powered device or a diagnostic device) meets specific performance criteria through a clinical or algorithmic performance study.

The testing described in this document is primarily related to:

• Mechanical properties of the aligner material: Ensuring it meets specifications for shelf life.
• Validation of manufacturing processes: Confirming the custom aligner fabrication.
• Biocompatibility testing: According to ISO 10993 standards for the thermoplastic polyurethane-polyester resin and the finished aligner.

There is no mention of a study involving:

• A test set of data (e.g., medical images, patient records).
• Any form of algorithm performance evaluation (e.g., accuracy, sensitivity, specificity, AUC).
• Human expert readers establishing ground truth.
• Multi-reader multi-case (MRMC) studies.
• Effect sizes of human reader improvement with AI assistance.
• Stand-alone algorithm performance.

Therefore, I cannot populate the requested table and information based on the provided text, as the document does not contain the study details you are asking for.

The document states:

• "Test data were submitted to: Assure the aligner mechanical properties of the aligner material meet specifications for up to 5 years shelf life; Validate the processes used for the design and manufacture of the customized aligners."
• "Biocompatibility: The thermoplastic polyurethane-polyester resin used for making the aligner series has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993..."
• "This testing showed that the material and manufactured aligner met the acceptance criteria, passed the respective tests, and are safe and biocompatible for the stated intended use."

This indicates that acceptance criteria existed for the material properties and biocompatibility, but these are not performance metrics for a diagnostic or AI device that interacts with patient data in the way implied by your questions about ground truth, expert readers, and test sets.

To fulfill your request, the document would need to describe a study evaluating the performance of a device, for example, an AI algorithm that analyzes orthodontic scans, or a diagnostic tool. Since this is a 510(k) for physical clear aligners, the type of performance evaluation differs significantly.

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The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner positions teeth by way of continuous gentle force.

The ClearPath clear aligner is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. The aligners are provided non-sterile and are customized for each patient according to the dental clinician's prescription.

The dental health professional (dentist/orthodontist) takes provides physical or scanned impressions of the patient's teeth to ClearPath. A digital setup of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked.

The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.

The provided text describes the ClearPath Aligner, a series of clear plastic appliances for correcting dental malocclusion. The submission (K202857) seeks substantial equivalence to a predicate device (K162609). The key difference is the new device's use of software (Ortho Analyzer, 3Shape A/S, K180941) for treatment planning and 3D printing of models.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative (e.g., minimum accuracy, sensitivity, specificity) acceptance criteria for the device from a clinical performance standpoint for the software's functionality. Instead, the focus is on the manufacturing process and materials.

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

The document explicitly states that "Bench testing was performed to validate the manufacturing process: to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan."

• Sample Size for Test Set: The exact sample size for this bench testing is not specified in the provided text.
• Data Provenance: The nature of the bench testing suggests it would be prospective data generated specifically for this validation. The country of origin of the data is not specified, but the applicant's address is Lahore-Pakistan.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the bench testing. Given the type of testing (accuracy of thermoformed aligner vs. digital scan), ground truth would likely be established through precise metrological measurements, not expert clinical assessment in this context.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method, as the testing described is bench testing for manufacturing accuracy, not a clinical study involving human interpretation or consensus.

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

No, an MRMC comparative effectiveness study was not done or reported. The submission focuses on the substantial equivalence of the device, primarily through material and manufacturing process validation, and not on the comparative effectiveness of human readers with or without AI assistance. This device is not an AI diagnostic tool that assists human readers.

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

The document mentions that the software system (Ortho Analyzer) is used for "management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of orthodontic appliances based on 3D scanned orthodontic models."

However, a standalone performance study specifically for the algorithm's accuracy in these tasks, independent of the human-in-the-loop manufacturing process, is not explicitly described or quantified in terms of specific metrics (e.g., accuracy of tooth movement simulation). The bench testing described validates the manufacturing process based on the digital plan, rather than the intrinsic diagnostic or planning accuracy of the software itself in a standalone context.

7. The Type of Ground Truth Used

For the bench testing, the ground truth was the initial digital scan used as the reference against which the final thermoformed physical aligner was compared for accuracy. This implies a precise, measurable digital model.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. The device is an orthodontic aligner and the new part of the submission relates to the use of existing software in its manufacturing process. There's no indication that a new algorithm or AI model was developed by ClearPath Orthodontics that required a separate training set. The "Ortho Analyzer" software itself would have had its own development and validation, but that information is not part of this 510(k) submission for the ClearPath Aligner.

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

As no training set is discussed for the ClearPath Aligner device itself (other than potentially for the pre-existing Ortho Analyzer software), this information is not provided in the document.

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TP Orthodontics Clear Aligner System consists of a series of plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, TP Orthodontics Clear Aligner System sequentially positions teeth by way of continuous gentle force.

TP Orthodontics Clear Aligner System consists of a custom-made series of plastic aligners that apply gentle pressure to teeth, gradually moving them into alignment. A dentist or orthodontist assesses the patient to determine if the patient is a good candidate. Impressions are taken by the dental clinician and submitted to TP Orthodontics along with the physician's prescription. TP Orthodontics, using a standard dental software used for teeth alignment, designs a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription. The set-up and intermediate stages are sent back to the physician for review and approval. Once the doctor has approved the model scheme, the aligners are produced using a thermoplastic material and shipped to the dental practitioner. The doctor delivers the aligners to the patient in sequential stages, provides instructions for use (such as when to change aligners), and monitors the case progression and fit and function from the first aligner through the end of treatment through follow-up appointments. Aligners must be worn by the patient most of the day (20-22h), being removed only for eating, drinking and performing oral hygiene and should be replaced every 2-3 weeks as prescribed by the doctor.

This document describes the FDA's 510(k) clearance for the TP Orthodontics Clear Aligner System and its substantial equivalence to predicate devices, thus the information provided focuses on the regulatory submission rather than a detailed scientific study. Therefore, some of the requested information regarding a device's performance study might not be explicitly present if it deviates from what is typically required for a 510(k) submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to predicate devices. For this type of device (clear aligners), this primarily involves demonstrating equivalent indications for use, technological characteristics, and safety profiles.

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

The document explicitly states: "therefore there was no clinical testing to support this device." This means there was no specific test set of patients used for a clinical performance study of the TP Orthodontics Clear Aligner System. The device's clinical performance relies on the established performance of predicate devices.

For the non-clinical manufacturing validation, the sample size is not specified, nor is the data provenance.

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

Not applicable as no specific clinical 'test set' was used for this device in a de novo study. The ground truth for the overall category of sequential aligners (NXC) would have been established through years of clinical practice and research by orthodontists and dental professionals, leading to the FDA's clearance of the first device in 1998.

4. Adjudication Method for the Test Set

Not applicable as no specific clinical 'test set' was used for a new study on this device.

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 device is a physical medical device (clear aligner system), not an AI-assisted diagnostic or treatment planning system that would involve human "readers" or AI assistance in the way typically discussed in a MRMC study. The software mentioned is for designing the aligners, not for diagnostic interpretation by human readers.

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

Not applicable for a physical clear aligner device. The "software" mentioned passed its validations, which would imply standalone testing of the software's functionality, but this is not an "algorithm only" performance for diagnosis or treatment decision making in the typical sense.

7. The Type of Ground Truth Used

For the specific device, the ground truth for regulatory clearance was demonstration of substantial equivalence to predicate devices. This means that its design, materials, manufacturing, indications for use, and overall safety and effectiveness were compared against devices already legally marketed and proven effective.

For the manufacturing validation, the ground truth would be the software output specifications (i.e., the aligners were produced accurately according to the digital design).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set" in the computational sense. The design of the aligners is based on dental software that applies established biomechanical principles and clinician input, not a data-driven training set.

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

Not applicable, as no computational "training set" was used for this device.

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