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The Argen Clear Aligner and Argen Clear Aligner Premium are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.

The Argen clear aligners are comprised of series of clear plastic removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. A dental health professional (e.g. orthodontist or dentist) prescribes the Argen Clear Aligner or the Argen Clear Aligner Premium based on an assessment of the patient's teeth. The dental health professional (dentist/orthodontist) takes intraoral scans or physical impressions of the patient's teeth, determines a course of treatment with the system, and completes a prescription form using a standard dental software used for tooth alignment. The series of plastic trays are designed in accordance with the physician's prescription using standard dental software for planning the tooth alignment. The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by 3Shape A/S (K180941). It 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. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Argen produces trays, which are formed of clear, thin, thermoformed plastic. The trays are provided to the dental health care professional who provides them to the patient, confirming fit and design. The thermoplastic materials used in the manufacture of the Argen aligners are similar to the materials commonly used in many dental and orthodontic appliances including clear aligners. The Argen Clear Aligner is made of a thermoplastic polyurethane resin and the Argen Clear Aligner Premium is made of a thermoplastic polyurethane-polyester composite resin.

The provided text describes the "Argen Clear Aligner" and "Argen Clear Aligner Premium" devices. These are orthodontic devices, and the information is from an FDA 510(k) summary, which focuses on substantial equivalence to predicate devices rather than detailed performance studies for AI/software components as would be described for diagnostic AI tools.

Therefore, many of the requested details, such as specific acceptance criteria related to diagnostic performance metrics, sample sizes for test sets (in the context of AI models), number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for AI performance, are not applicable for this type of medical device submission.

This document describes a physical medical device (clear aligners) and its manufacturing process, incorporating a software system (Ortho Analyzer) for treatment planning and design. The "performance data" referred to in Section VII of the 510(k) summary (page 3) relates to physical properties and biocompatibility testing, and verification and validation activities to ensure consistency between the aligner series' design and manufactured aligners. This is distinct from the performance evaluation of a diagnostic AI algorithm.

Here's a breakdown of the requested information based on the provided text, indicating where information is not applicable or not provided:

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

The document does not explicitly state acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because it's not a diagnostic AI device. The "acceptance criteria" mentioned refer to the manufacturing and design consistency of the physical aligners.

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

This information is not applicable as the device is a physical orthodontic aligner, and its 510(k) submission primarily relies on substantial equivalence and engineering/biological verification and validation, not a clinical study involving a "test set" of patient data for AI performance evaluation. The "software" mentioned (Ortho Analyzer) is a tool for design and planning, not a diagnostic AI.

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 for the reasons stated above.

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

This information is not applicable for the reasons stated above.

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 for the reasons stated above.

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

This information is not applicable. While there is software involved in the design and planning of the aligners (Ortho Analyzer), it is not described as a standalone diagnostic AI algorithm. The process explicitly involves a "dental health professional (dentist/orthodontist)" who "determines a course of treatment" and a "prescribing physician reviews and approves the model scheme." This indicates a human-in-the-loop design and prescription process.

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

This information is not applicable in the context of diagnostic AI performance. For the aligners, the "ground truth" would relate to successful orthodontic treatment outcomes, which are assessed clinically by the treating dentist/orthodontist over time, not through a single reference standard for an AI algorithm.

8. The sample size for the training set

This information is not applicable. The device itself is a physical product. While the "Ortho Analyzer" software likely has an underlying model or algorithm for generating treatment plans, the document does not provide details of its training set, as this is not an AI diagnostic submission.

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

This information is not applicable for the reasons stated above.

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The Argen Clear Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.

The Argen Clear Aligner is comprised of a series of clear plastic removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. A dental health professional (e.g. orthodontist or dentist) prescribes the Argen Clear Aligner based on an assessment of the patient's teeth, determines a course of treatment with the system, and completes a prescription form using a standard dental software used for tooth alignment. The series of plastic trays are designed in accordance with the physician's prescription using standard dental software for planning the tooth alignment. The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by 3Shape A/S (K180941). It 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. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Argen produces trays, which are formed of clear, thin, thermoformed plastic. The trays are provided to the dental health care professional who provides them to the patient, confirming fit and design. The thermoplastic material used in the manufacture of the Argen aligners is similar to the material commonly used in many dental and orthodontic appliances including clear aligners.

This document is a 510(k) Premarket Notification for the Argen Clear Aligner. It primarily demonstrates substantial equivalence to a predicate device, rather than presenting a standalone study with specific acceptance criteria and performance metrics for the Argen Clear Aligner itself. As such, no specific acceptance criteria or a dedicated study proving the device meets those criteria are directly provided for the Argen Clear Aligner's efficacy in tooth alignment.

Instead, the submission relies on the established safety and efficacy of its predicate device and the similarity of its design and materials.

Here's an analysis of what is and isn't available based on your request:

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

• Acceptance Criteria for the Argen Clear Aligner: Not explicitly stated as performance metrics for tooth alignment. The submission focuses on demonstrating substantial equivalence to a predicate device (The Align System, K981095). Therefore, the "acceptance criteria" are implicitly that the Argen Clear Aligner is as safe and effective as the predicate.
• Reported Device Performance of Argen Clear Aligner: No specific performance metrics (e.g., accuracy of tooth movement, treatment success rates) are reported for the Argen Clear Aligner. The document states that "Animal and human performance testing are not required for this product type," indicating clinical efficacy trials were not performed for this 510(k) submission.

The comparison table (Page 5) highlights similarities between the Argen Clear Aligner and the predicate device, which serves as the basis for substantial equivalence:

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

• Sample Size: Not applicable. No dedicated performance study with a test set was conducted for the Argen Clear Aligner for its 510(k) submission. The submission relies on non-clinical performance and biocompatibility testing referencing another device (Dentsply's K062828), which is not detailed here.
• Data Provenance: Not applicable for a performance study of the Argen Clear Aligner. The data presented is for the predicate device comparison and general device description.

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

• Not applicable. No ground truth establishment by experts for a test set is described for the Argen Clear Aligner's 510(k) submission.

4. Adjudication method for the test set

• Not applicable. As no test set performance study was conducted, no adjudication method 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

• No. This device is a physical medical device (clear aligners), not an AI-assisted diagnostic or therapeutic tool. Therefore, a multi-reader multi-case comparative effectiveness study with AI assistance is not relevant or described.

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

• No. This device is a physical medical device. While software is used in its design (Ortho Analyzer by 3Shape A/S), the submission does not detail a standalone algorithm performance study for tooth movement prediction or clear aligner design, as this is typically handled by the software manufacturer's own submissions. The Argen Clear Aligner is the manufactured product based on the software's output.

7. The type of ground truth used

• Not applicable for a performance study of the Argen Clear Aligner. The "ground truth" implicitly referenced across the entire 510(k) process for substantial equivalence is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a training set in the context of its 510(k) submission. The "designs" of the aligners are based on physician prescriptions and standard dental software, not a learned model from a training set in the way AI algorithms are trained.

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

• Not applicable. See point 8.

In summary, the provided document is a 510(k) premarket notification primarily demonstrating substantial equivalence due to physical and functional similarities to an existing predicate device. It does not contain a study of the Argen Clear Aligner's clinical performance against specific acceptance criteria, nor does it detail AI algorithm performance metrics.

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