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The DailyMate Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force.

The DailyMate® Orthodontic Aligner System is a series of dental aligners fabricated of clear, plastic removable aligners are designed and custom-made by dental professionals. The aligners are made of aesthetic and medical grade materials. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them, specifically for the DailyMate Orthodontic Aligner System (K212803).

Based on the document, it's clear this is a premarket notification (510(k)) submission for an orthodontic aligner system. The review focuses on substantial equivalence to predicate devices rather than proving specific device performance criteria through clinical studies or AI algorithm validation in the way one might for a diagnostic AI device.

Therefore, the requested information about "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in terms of performance metrics for an AI algorithm is largely not applicable in the context of this 510(k) submission. This document describes a medical device, but not an AI/ML powered device that would have the specific types of performance studies (e.g., MRMC, standalone algorithm performance, ground truth establishment by experts) commonly associated with AI/ML medical devices.

The acceptance criteria here are for demonstrating substantial equivalence primarily through comparison of design, materials, indications for use, and a limited set of non-clinical (bench) tests.

Despite the non-applicability to AI/ML device validation, I will extract and present the relevant information that is available in the document, framed within the lens of substantial equivalence.

Overview of "Acceptance Criteria" for K212803 (DailyMate Orthodontic Aligner System)

The "acceptance criteria" for this 510(k) submission are not defined as specific performance metrics of an AI algorithm, but rather as meeting the requirements for substantial equivalence to predicate devices. This is achieved by demonstrating comparable:

• Indications for Use
• Mechanism of Action
• Method of Use
• Method of Manufacture
• Raw Material (Biocompatibility)
• Software Use (for aligner design)
• Sterilization (or lack thereof)
• And performing specific non-clinical (bench) tests to show material equivalence.

The "study that proves the device meets the acceptance criteria" refers to the entire 510(k) submission package, which includes a comparative analysis table and results from non-clinical bench testing.

Details as per the requested format:

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

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

• Test Set Sample Size: Not applicable in the context of an AI/ML test set. The "testing" referred to is biocompatibility testing (material samples) and non-clinical bench testing (device material samples). No human patient "test set" was used for performance evaluation.
• Data Provenance: The document does not specify the country of origin for the non-clinical testing data. The biocompatibility and bench testing data would be from laboratory experiments rather than patient data. The manufacturer is 3D Global Biotech Inc. from Taiwan. The correspondent contact is in California, USA.
• Retrospective/Prospective: Not applicable, as no clinical study on patient data was performed. The non-clinical tests are prospective laboratory studies.

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

• Not applicable. There was no AI/ML test set requiring expert-established ground truth. The "ground truth" equivalent for this device is the established safety and efficacy profiles of the predicate devices and the physical/chemical properties of the materials and device.

4. Adjudication method for the test set

• Not applicable. No expert adjudication was relevant or required for this type of submission.

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 performed, as this is not an AI/ML assistance device for human readers.

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

• No. This is not a standalone AI algorithm device. The device itself is the physical aligner system. The software mentioned (3Shape Ortho System) is separate, already 510(k) cleared software used in the design process of the aligners and is human-in-the-loop (dental practitioner reviews and approves).

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

• For biocompatibility and material equivalence, the "ground truth" is established laboratory testing standards (e.g., ISO 10993) and the known properties/performance of the predicate device materials. There is no "truth" in the diagnostic sense (like pathology or outcomes data).

8. The sample size for the training set

• Not applicable. This device does not involve a training set for an AI/ML algorithm.

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

• Not applicable. As there is no AI/ML training set, no ground truth needed to be established for it.

Summary regarding AI/ML related criteria:

The provided document describes a 510(k) submission for a physical medical device (orthodontic aligners). While software (3Shape Ortho System) is used in the design and manufacturing process of the aligners, the submission emphasizes that this software is already 510(k) cleared (K152086) and is used by a human dental practitioner who reviews and approves the treatment plan. Therefore, the DailyMate Orthodontic Aligner System itself is not an AI/ML-powered diagnostic or therapeutic device requiring validation studies typical for AI/ML products (e.g., MRMC, standalone algorithm performance, specialized ground truth establishment). The "acceptance criteria" and "proof" in this context are solely related to demonstrating substantial equivalence to predicate devices through design comparison, material testing, and adherence to manufacturing standards.

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

The Inman Digital Clear Aligners consist 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 aligners based on an evaluation of the patient's teeth. Either intraoral scans or physical impressions of the patient's teeth are provided to Inman Orthodontic Lab by the dental clinician, along with the prescription. The series of plastic aligner trays are designed according to the prescription using standard dental software for planning the tooth alignments. The software used is 3Shape Ortho System (Reference device K152086). 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 Inman Orthodontic Lab, the prescribing dental clinician reviews and approves the model scheme before the molds are produced. Following approval, the customized aligner trays are fabricated by Inman Orthodontic Lab by press thermoforming of the material on the molds using standard thermoforming equipment. The trays are provided to the dental clinician who provides them to the patient assuring fit and function during the entire treatment period.

The provided document is a 510(k) summary for the Inman Digital Clear Aligners. It describes the device's indications for use, its description, and a comparison to a predicate device to establish substantial equivalence. The document details performance testing related to material properties, packaging, and manufacturing process validation, as well as biocompatibility testing.

However, this document does not contain information about a study that uses a test set, expert ground truth, or statistical measures of performance (like sensitivity, specificity, or AUC) for the Inman Digital Clear Aligners in the context of an AI/ML device.

The "Performance Testing" section (page 5) refers to:

• Laboratory Testing: Mechanical properties of the aligner material, moisture barrier properties of the packaging, and validation of design/manufacture processes. These tests are about the physical properties and manufacturing quality of the device, not its clinical diagnostic or treatment planning performance in a setting that would involve AI/ML output validation against expert consensus.
• Biocompatibility: Testing of the thermoplastic polyurethane material according to ISO 10993.

The document explicitly states: "Neither animal nor human testing are needed for this device because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device." This indicates that the 510(k) relies on substantial equivalence to a predicate device, rather than a de novo clinical performance study against specific acceptance criteria for a new and innovative AI/ML feature.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device. The device described is a physical medical device (clear aligners) and its regulatory submission focuses on material properties, manufacturing, and substantial equivalence to a predicate device.

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

Illusion Aligners are intraoral thermoformed plastic aligners that are worn at least 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. Illusion Aligners are fabricated using a ten-step process.

The Step 1 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. Step 3, the scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning. In the Step 3, Laxmi Dental Exports Pvt Ltd, Inc. 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. Step 4, the treatment plan is sent to the doctor for approval. Upon approval, a 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed. Step 5 is the printing of 3D models of the treatment plan for use in Step 7 thermoforming. The thermoforming process is accomplished using a standard thermoforming equipment and the appropriate material as outlined in this submission.

The provided document, K211010, describes a 510(k) premarket notification for "Illusion Aligners." This document primarily focuses on establishing substantial equivalence to a predicate device (Smylio Invisible Clear Aligner, K173784) rather than presenting a detailed study proving the device meets specific performance acceptance criteria in the manner of a clinical trial for a novel AI/software medical device.

Therefore, the information required for a comprehensive answer regarding acceptance criteria and a study proving device performance (especially for an AI/ML device) is largely not present in this document.

However, I can extract the information that is available and explain why other requested information is missing.

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

This document does not present quantitative acceptance criteria or reported device performance for a software-driven clinical outcome in the format typically seen for AI/ML devices. Instead, it focuses on demonstrating equivalence through material properties and manufacturing processes.

• Part 5 (Cytotoxicity Elution - MEM)
• Part 10 (Skin Irritation)
• Part 10 (Guinea Pig Maximization Test) | - PETG (Polyethylene terephthalate glycol) material tested according to Good Laboratory Practices.
• Tests performed as per ISO 10993 Parts 5 and 10.
• "No effect on biocompatibility. ISO 7405 directly references the same test as conducted using ISO 10993 et.al." (referring to the predicate device's biocompatibility summary). |
  | Non-Clinical Physical Properties | Adherence to ASTM standards:
• Elongation @ Yield (%) ASTM D638
• Elongation @ Break (%) ASTM D638
• Tensile @ Yield (PSI) ASTM D638
• Tensile Strength (PSI) ASTM D638
• Tensile Modulus (PSI) ASTM D638
• Water Absorption (%) 24 hours @ 23°C ASTM D570 | - Device material tested to the listed ASTM standards.
• Stated that the material "meet the acceptance criteria" (specific values not provided in this summary). |
  | Intended Use | "Alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion." | The "Illusion Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion." This matches the predicate device's intended use. |
  | Technological Principle (Mode of Action) | "Alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays." | "In the same manner as the predicate device, each aligner exerts gentle force to achieve progressive realignment of the teeth until the final correction has been attained. This is based on the treatment plan and proceeds over time." |
  | Manufacturing Process / Software | Use of FDA 510(k) cleared software for treatment planning. | Utilizes "3Shape Software K180491 and K152086," which are "FDA 510K cleared."
  "The use/manufacturing process has been validated by Laxmi."
  "Laxmi Dental Exports Pvt Ltd. prepares the treatment plan in Step 2... for subsequent approval by a doctor," which is considered "No effect, both treatment plans are doctor approved" when compared to the predicate. |
  | Material (Equivalence to Predicate) | Material properties suitable for clear aligners, showing no safety or effectiveness differences when compared to the predicate. | Illusion Aligners use PETG (Polyethylene terephthalate glycol) material versus the predicate's "Thin thermoformed polyurethane" (Smylio Uses Zendura polyurethane).
  "No effect, PETG (Polyethylene terephthalate glycol) material is manufacturing validated and biocompatible." |

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

This information is not provided in the document. The document describes non-clinical physical and biocompatibility testing of the material itself, not a clinical study on patient outcomes with a "test set" of patient data. The "testing" referred to is laboratory testing of the material. There is no mention of a test set for assessing algorithmic performance on patient data.

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)

This information is not applicable/not provided. There is no "test set" with ground truth established by experts described in this 510(k) summary relating to clinical performance or AI/ML algorithm output. The document focuses on material properties and manufacturing process equivalence.

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

This information is not applicable/not provided. No adjudication method for a test set is 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

This information is not applicable/not provided. This device is a physical orthodontic aligner. While its manufacturing process involves software for treatment planning, the document does not describe it as an AI-assisted diagnostic or decision-support tool that would undergo an MRMC study comparing human performance with and without AI assistance. The software mentioned (3Shape) is for designing the aligners, not for interpreting medical images or providing clinical diagnoses.

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

This information is not applicable/not provided. This device is not an algorithm-only standalone diagnostic or treatment device. It is a physical aligner whose design process uses software. The software, 3Shape, is referred to as "FDA 510K cleared," indicating it has its own clearance. The current submission is for the physical aligners.

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

This information is not applicable/not provided in the context of an AI/ML device performance study. The "ground truth" here would relate to the physical and biocompatibility properties of the material, which are measured directly by laboratory tests (e.g., precise measurements for ASTM standards, cellular responses for ISO 10993).

8. The sample size for the training set

This information is not applicable/not provided. Since this is a submission for a physical medical device (aligners) and not a de novo AI/ML algorithm, there is no mention of a "training set" in the context of machine learning. The "training" here would refer to the historical data and experience used to develop the manufacturing process and material selection.

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

This information is not applicable/not provided 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 uLab Systems uDesign is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of dental casts, which may be used for sequential aligner trays or retainers, and of Indirect Bonding Transfer Media, based on 3D models of the patient's dentition before the start of an orthodontie treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the treatment to evaluate if the outcome is consistent with the planned desired treatment objectives. The use of ul ab Systems uDesign requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

The ULab Systems UDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. UDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers, and of indirect bonding transfer trays.

The provided document is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for the ULab Systems uDesign Software. This document focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with rigorous acceptance criteria typical for AI/ML devices that make new diagnostic claims or require clinical performance validation.

Based on the provided text, the device is a "medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of dental casts." It is not an AI/ML device making diagnostic or prognostic claims requiring clinical performance studies with acceptance criteria based on sensitivity, specificity, or AUC. Instead, it is a software device intended for use by dental professionals for orthodontic treatment planning and design, and its performance validation revolves around software verification and validation.

Therefore, the information regarding acceptance criteria and performance study details as requested (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) is not explicitly present in the provided document because the nature of the device and its regulatory pathway (510(k) for substantial equivalence of software tools) do not typically require such detailed clinical performance studies.

However, I will extract what information is available regarding performance and acceptance criteria and explicitly state where the requested information is not provided.

Device: ULab Systems uDesign Software

Regulatory Pathway: 510(k) Premarket Notification

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for software tools rather than a diagnostic AI/ML algorithm, the "acceptance criteria" discussed are related to software verification and validation, not clinical performance metrics like sensitivity or specificity.

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

The document does not specify the sample size for a test set in the context of clinical or performance data (e.g., number of patient cases or 3D models used for a performance evaluation). The testing mentioned is "Software and integration verification and validation testing." This typically involves testing scenarios, functions, and workflows, rather than a fixed "test set" of patient data in the same way an AI model would be evaluated.

Data provenance (e.g., country of origin, retrospective/prospective) is also not applicable or specified, as the evaluation is not a clinical study involving patient data collection for performance assessment.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. The "ground truth" for this type of software (an orthodontic design tool) is its ability to accurately execute its functions (e.g., allowing precise measurements, correct treatment simulation, proper STL file generation). This is validated through internal software testing, not typically through expert consensus on a dataset.

4. Adjudication Method for the Test Set

This information is not provided, as it's not relevant for software verification and validation testing of a design tool. Adjudication methods are typically used in clinical studies where expert readers resolve discrepancies in interpretations of medical images or data.

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

An MRMC study was not done. This type of study is typically conducted for diagnostic AI/ML devices to assess how the AI assists human readers in tasks like disease detection or diagnosis. The uDesign software is a tool for orthodontic planning and design, not an AI for assisting with diagnostic accuracy. Therefore, there is no effect size reported for how human readers improve with AI vs. without AI assistance.

6. If a Standalone Performance Study Was Done

A standalone performance study in the sense of an algorithm-only (without human-in-the-loop) diagnostic accuracy study was not performed. The "performance data" refers to the successful completion of software verification and validation tests. The device itself is described as "providing tools for management," indicating it is an assistive software tool for a user, not a standalone diagnostic AI.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of its software V&V, would be the correct functional behavior of the software components. For example:

• Correct Measurement: If the software calculates a distance, the ground truth is the mathematically correct distance for the virtual model.
• Accurate Simulation: If it simulates tooth movement, the ground truth is that the simulation adheres to the programmed algorithms and orthodontic principles.
• Correct File Generation: The ground truth for STL file output is that the generated file accurately represents the virtual design and is in the correct format.

This "ground truth" is established through software engineering best practices, including requirements traceability, design specifications, and automated/manual testing against these specifications. It is not based on clinical outcomes, pathology, or expert consensus on clinical cases.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The uLab Systems uDesign software is described as a "medical front-end device providing tools" and as "orthodontic diagnosis and treatment simulation software." The document does not indicate that it is an AI/ML device trained on a dataset. It appears to be a rule-based or algorithmic software tool rather than one developed through machine learning. Therefore, there is no "training set" in the context of AI/ML.

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

This information is not applicable, as there is no indication of a "training set" for an AI/ML algorithm.

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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. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state.

The aligners, customized for each patient's prescription, are designed and manufactured based on either standard impressions or intraoral scans taken by the dental clinician and which are then sent to the company. The aligners are then sent back to the dental clinician who then distributes them in sequential stages to the patient and follows up with the patient through orthodontic examinations to check device fit and function.

During manufacturing, models are made from physical impressions or intraoral scans. Those made from stone or plaster impressions are scanned into the computer and made into digital files. The intraoral scans arrive as digital files. The digital files are 3D printed and are used to produce the aligner series with the thermoplastic polyurethane.

The thermoplastic material used for fabrication of the aligners is commonly used in many dental appliances, including the predicate aligners.

The NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition by positioning teeth through the use of continuous gentle force.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document primarily describes laboratory and bench testing of the device material and manufacturing process and biocompatibility testing.
• There is no mention of a "test set" in the context of patient data or clinical performance evaluation for the NEOLab Clear Aligners.
• The comparison to the predicate device (ClearCorrect System) is based on technological characteristics and indications for use, not on specific clinical performance data from a test set.
• Data provenance: Not applicable as no clinical test set data is described. The performed tests are laboratory-based.

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

• Not applicable. The provided document does not describe a clinical study with a test set requiring expert ground truth establishment for diagnostic or treatment efficacy. The testing performed is focused on material properties, manufacturing validation, and biocompatibility.

4. Adjudication method for the test set

• Not applicable. No clinical test set.

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 aligners), not an AI-powered diagnostic or assistive tool for human readers. There is no AI component or human reader interaction described that would necessitate an MRMC study.

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

• Not applicable. This is not an algorithm or software device that would have standalone performance. It is a physical aligner system. While software is used for planning and manufacturing, its performance is not assessed in "standalone" mode in the context of patient outcomes.

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

• For the described tests:
  • Mechanical properties: The ground truth is established by the specified ASTM D638 standard and internal specifications for tensile strength, elongation, etc.
  • Biocompatibility: The ground truth is established by the ISO 10993 series of standards for biological evaluation of medical devices.
  • Manufacturing process validation: The ground truth would be the design specifications and expected output consistency of the aligners.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device that requires training data. The device's manufacturing process may involve internal process controls and validation using samples, but these are not referred to as a "training set" in the context of AI.

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

• Not applicable, as no training set is described for this device.

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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 DenMat Orthodontic Aligners are in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

The DenMat Orthodontic Aligner consists of a series of clear plastic trays, which fit over a patient's teeth, and move the teeth by external force a small amount daily. This material is the only patient contacting material, there are no lubricants, coatings, or colorants. The dental professional determines the ultimate movement needed, and an FDA-cleared software design tool is used to produce a treatment series of aligners to achieve this goal. The trays are produced when the software design tool outputs a file to a 3-D printer, which produces a resin model. The resin used to manufacture the model has been tested for cytotoxicity and has been shown to be non-cytotoxic. The positive mold is cleaned with isopropyl alcohol prior to vacuum forming the aligner. The resin model is then used with the FDA-cleared plastic material to thermoform the plastic aligner. The aligners, once formed, are rinsed with distilled water only, and air dried. Depending on the prescription, 10 to 15 aligners are produced for a single patient set. Each aligner is worn for 2 weeks, and the dental professional checks progress during treatment.

This FDA 510(k) summary does not contain the detailed study information to complete the table for Acceptance Criteria and Reported Device Performance, nor does it provide other specific details such as sample sizes for test and training sets, data provenance, expert qualifications, or adjudication methods for a diagnostic device.

The document is a declaration of substantial equivalence for a medical device (DenMat Orthodontic Aligners) to a previously cleared predicate device (Clear Image Aligners). For such devices, the primary demonstration of safety and effectiveness is often through comparisons to existing, legally marketed devices, rather than conducting new clinical trials with detailed performance metrics.

Here's what can be extracted and inferred:

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

The document does not explicitly list acceptance criteria or reported device performance metrics in the way one might expect for a diagnostic or algorithmic device that produces quantitative outputs. Instead, the "performance" is demonstrated through substantial equivalence to a predicate device.

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

This information is not provided in the document because this is not a study reporting specific performance data from a test set. The submission focuses on demonstrating equivalency to an already cleared device, not on presenting novel performance study results.

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)

This information is not provided. This type of detail is typically associated with studies evaluating diagnostic accuracy, which is not the focus of this 510(k) submission for an orthodontic aligner.

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

This information is not provided. Similar to the above, adjudication methods are relevant for studies establishing ground truth, which is not documented here.

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

An MRMC study was not conducted as part of this submission, nor is it mentioned. This device is a physical orthodontic aligner for tooth movement, not an AI-assisted diagnostic tool for human readers.

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

A standalone performance study of an algorithm was not conducted or reported here. While the manufacturing process includes "FDA-cleared software design tool," the performance being assessed is of the physical aligner itself through substantial equivalence. The software's performance would have been assessed in its own 510(k) submission (K171634/K152086 for 3Shape Ortho System).

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

The "ground truth" in this context is the safety and effectiveness established for the predicate device, Clear Image Aligners (K183643). The DenMat Orthodontic Aligner claims substantial equivalence based on sharing identical design, manufacturing materials, intended use, principles of operation, and technical characteristics. Therefore, the "ground truth" for the current submission is the established regulatory clearance of the predicate device, implying its safety and effectiveness.

8. The sample size for the training set

This information is not provided. This is not a study that involved machine learning model training.

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

This information is not provided. This is not a study that involved machine learning model training.

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

The SmileAlign® Orthodontic Aligner System is a series of dental aligners fabricated of clear, thin thermoformed polyethylene terephthalate glycol (PETG) plastic to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.

This document describes the 510(k) premarket notification for the SmileAlign® Orthodontic Aligner System (K191774). However, it does not contain any information about an AI/Algorithm-driven device that would require an evaluation against specific acceptance criteria for algorithm performance, a test set, expert ground truth establishment, or clinical performance data related to AI assistance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Byte Aligner System, K180346) based on material properties, indications for use, technological characteristics, and biocompatibility. It explicitly states: "Clinical data was not included in this submission."

Therefore, based on the provided text, I cannot fill in the requested table and information points regarding acceptance criteria and study data for an AI-driven device's performance, as this information is not present in the given FDA 510(k) summary.

The document describes the device as: "a series of dental aligners fabricated of clear, thin thermoformed polyethylene terephthalate glycol (PETG) plastic to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner." The only mention of software is that "Both the subject and predicate devices use independent dental software to translate tooth movements in developing the model schemes and allow the dental practitioner to review and approve the model schemes before aligner fabrication." This refers to standard CAD/CAM software used in the dental industry, not an AI algorithm performing diagnostic or treatment planning functions.

If this was a request for an AI-driven device, the provided text does not contain the necessary information.

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