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The uLab Systems Dental Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctorprescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed and customized by dental professionals using uLab Systems technology. The aligners are made of aesthetic and medical grade materials. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient's teeth gradually to the ideal position.

I am sorry, but the provided text (K211510 FDA 510(k) Summary for uLab Systems Dental Aligner Kit) describes an orthodontic treatment system (aligners) and not a device that would typically have the kind of acceptance criteria, test set, ground truth, and human-in-the-loop performance studies as outlined in your request.

The document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through comparison of:

• Intended Use: "alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces."
• Technological Characteristics: clear plastic sequential aligners, principles of operation, aligner design process using dental software, materials (thermoplastic), and general features.

The "Performance Data" section (Page 6) briefly mentions that performance testing remains unchanged from the company's previous reference device submission (K192596) and includes:

• Biocompatibility (ISO 10993-10)
• Design verification and process validation testing
• User validation testing
• Packaging verification and shelf life testing
• Physical properties testing by the material manufacturer

This type of information is typical for a 510(k) submission for a physical medical device like an aligner, which is considered a Class II device (Orthodontic Plastic Bracket, Product Code NXC). It does not involve an AI algorithm or software that performs diagnostic or imaging analysis requiring the specific types of studies (e.g., MRMC, standalone AI performance, expert adjudication of ground truth for AI model testing) that your detailed request outlines.

Therefore, I cannot extract the information requested as it is not present in the provided document. The document is about a physical dental aligner product, not an AI/software device that analyzes data or images.

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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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The uLab Systems Dental Aligner is indicated for the alignment of permanent teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctorprescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed and custom-made by dental professionals using uLab Systems proprietary technology. The aligners are made of aesthetic and medical grade materials chosen by doctors for their patients. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient's teeth gradually to the ideal position.

The provided document does not describe a study that proves the device meets specific acceptance criteria in the context of AI performance for a diagnostic or treatment planning system.

The document is a 510(k) summary for the ULab Systems Dental Aligner Kit, a physical medical device (clear aligners) used for orthodontic treatment. The "performance data" section focuses on biocompatibility, design verification, user validation, packaging verification, and physical properties testing for the physical aligner product itself, not the performance of an AI algorithm in a diagnostic or treatment planning capacity.

Therefore, I cannot extract the requested information regarding AI acceptance criteria and study details from this document. The document describes the aligners as "designed and custom-made by dental professionals using uLab Systems proprietary technology," and mentions "dental software, the uLab Systems uDesign, K171295, for tooth alignment." However, it does not provide details on the AI performance or any studies related to its AI components.

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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 a series of dental casts, which may be used for sequential aligner travs or retainers, based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the plamed/desired treatment objectives. The use of ULab Systems UDesign requires 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 output of 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.

The provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the typical sense of a clinical performance study. Instead, it discusses the software validation and verification.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance Study Information

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

The document states: "All test results met acceptance criteria, demonstrating the ULab Systems UDesign performs as intended, raises no new or different questions of risk and is substantially equivalent to the predicate device."

• Acceptance Criteria: Not explicitly detailed in the document. It mentions "acceptance criteria" generally for software and integration verification and validation testing, but specific metrics (e.g., accuracy percentages, error margins for tooth movement) are not provided.
• Reported Device Performance: Again, not explicitly detailed. The statement is a general affirmation that the software performed as intended during the validation process. There are no quantitative performance metrics (e.g., this software can predict tooth movement with X% accuracy).

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

• Sample Size for Test Set: Not specified. The document does not refer to a "test set" in the context of patient data, but rather "testing" for software validation.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as no "test set" with ground truth established by experts is described for performance evaluation. The "ground truth" mentioned in the context of the device's function is the patient's dentition (3D models).

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

• Not applicable. No expert adjudication process for a test set is described.

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 comparative effectiveness study was done or reported. The document focuses on the software as a tool for "orthodontic diagnosis and treatment simulation" and does not describe studies involving human readers or AI assistance in decision-making or improvement. The device itself performs calculations and simulations, not interpretation for a human reader to then act upon (though it informs the orthodontist).

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

• The document describes the ULab Systems UDesign as "orthodontic diagnosis and treatment simulation software." Its purpose is to output treatment plans which may be used to fabricate dental casts. While the software itself performs calculations and simulations (a standalone algorithmic function), the "use of ULab Systems UDesign requires 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." This indicates that it's a tool for a trained professional, implying a human-in-the-loop process for clinical application, even if the core simulation is standalone. However, no specific "standalone performance study" in the sense of accuracy against a clinical outcome is described. The performance data section refers to "Software and integration verification and validation testing."

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

• For the software functions, the "ground truth" would be the mathematical and logical correctness of its calculations and simulations based on the input 3D models of the patient's dentition. The document doesn't detail how this "ground truth" was established or used for the software validation, other than stating testing was performed. It's safe to assume it's based on known geometric principles and potentially clinical scenarios, but not explicitly stated as expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not applicable. The document describes software for design and simulation, not a machine learning or AI model that requires a "training set" of data in the typical sense. The "software and integration verification and validation testing" would be for the developed software code.

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

• Not applicable, as there is no "training set" for an AI model mentioned.

Summary of what's provided:

The submission focuses on the regulatory clearance process for a medical device (software) based on:

• Its intended use and indications for use.
• Comparisons to a predicate device (3Shape Ortho System) showing substantial equivalence in technological characteristics.
• General affirmance that "Software and integration verification and validation testing was performed" in accordance with FDA guidance, and "All test results met acceptance criteria."

The document does not delve into the clinical performance metrics of the software in real-world or simulated orthodontic treatment accuracy, nor does it describe AI-specific validation or clinical efficacy studies with expert review or patient outcomes. The "performance data" discussed is about software engineering validation, not clinical performance for treatment simulation or diagnosis accuracy.

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