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

The Byte Aligner System consists of a sequential series of aligners fabricated of clear, thin, lightweight and flexible thermoformed polyethylene terephthalate glycol (PETG) [copolyester] plastics. The mechanism of action of the proposed Byte Aligner System is mechanical in nature; that is, tooth movement induced by orthodontic force application using continuous gentle forces. The aligners are made from elastic thermoplastic material that applies continuous gentle force to the teeth for treatment of tooth malocclusion. Treatment plans are modeled using CAD-CAM (computer-aided-design and computer-aided-manufacturing) software. Model archforms are created using rapid prototyping techniques like stereo-lithography. The aligners are thermoformed over the model archforms and are not themselves 3D printed. With the aligners seated on the patient's upper and/or lower dental arches, the teeth are progressively and gradually straightened over time by mechanical forces that are delivered via minor, incremental changes in tooth positions in each subsequent set of aligner trays that have been customized for the patient, delivered as a sequential series of trays to progressively reposition the teeth. The mechanics of how this happens is based on the forces caused by the elastic deformation of the aligner when worn by the patient. The forces are applied to the teeth, and also to the roots, causing pressure to the periodontium in the direction of the desired movement. Each aligner moves the patient's teeth in small increments from their original state.

The furnished document is a 510(k) Summary for the Byte Aligner System (K230199). It is a declaration of substantial equivalence to a predicate device, not a report detailing a clinical study with acceptance criteria for an AI-powered device. Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets these criteria is not present in the provided text.

Specifically:

• No acceptance criteria or device performance report: The document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for device performance, nor does it present reported device performance metrics against such criteria.
• No test set details: There is no mention of a test set size, data provenance, or whether the study was retrospective or prospective.
• No expert adjudication details: The document does not discuss the number or qualifications of experts used for establishing ground truth, nor does it specify any adjudication methods.
• No MRMC study: There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted or any effect size for human readers improving with AI assistance.
• No standalone performance: The document does not report on the standalone performance of an algorithm without human intervention.
• No ground truth type: The type of ground truth used (e.g., expert consensus, pathology, outcomes data) is not specified because a study of this nature was apparently not performed.
• No training set details: There is no information about the sample size of a training set or how ground truth for a training set was established.

The 510(k) Summary primarily focuses on demonstrating substantial equivalence of the modified Byte Aligner System (K230199) to its predicate device (K180346) and reference devices by comparing their intended use, indications for use, technological characteristics, and safety aspects (biocompatibility, shelf-life, material review). It explicitly states: "No data from human clinical studies was included to support the substantial equivalence of the proposed Byte Aligner System." Therefore, it's not possible to extract the requested information from this document.

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

The aligners of the ClearCorrect System are a sequential series of clear thermoformed orthodontic appliances that, when worn in the prescribed sequence and duration, progressively reposition the teeth. The aligner is an orthodontic appliance intended for intra-oral use. Individual devices will be used between 20 – 22 hours per day for a period ranging from one to three weeks The corrective force to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the tray. Features can be added to the aligner that engage with composite resin tooth attachments to improve aligner retention and/or to apply force in directions that cannot be achieved by engaging with tooth surfaces alone.

The retainers of the ClearCorrect System are clear thermoformed appliances intended to keep the teeth from relapsing after they have been treated with aligners. Retainers are an optional component of aligner therapy. Retainers are typically prescribed for use at the conclusion of aligner treatment but can be prescribed at other times should there be a need to interrupt aligner treatment.

The engager templates of the ClearCorrect System are clear thermoformed appliances used to accurately apply composite resin attachments to the teeth as needed to achieve the desired tooth movement. The use of engagers and engager templates is an optional component of aligner treatment. Cavities are formed in the film having the desired shape, orientation and tooth position of the engager attachments to be bonded to the patient's teeth. At the time of use, the clinician fills the cavities in the engager template with light-curing composite resin. The engager template is then placed onto the patient's teeth and the resin cured. Once the resin is cured, the engager template is removed and discarded.

The provided text is a 510(k) Premarket Notification from the FDA for the ClearCorrect System, an orthodontic device. While it details the device's indications for use, materials, and a comparison to predicate devices, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies.

Instead, the "Performance Data" section lists various types of studies conducted to establish substantial equivalence (e.g., package integrity, shelf life, biocompatibility, material property testing, usability, software development). It states that these studies were used to demonstrate substantial equivalence, but it does not provide the results of these studies nor does it define acceptance criteria for these studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample sized used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on establishing substantial equivalence to existing predicate devices based on technological characteristics and general performance testing, rather than reporting on a clinical or performance study with defined acceptance criteria and detailed methodology for AI/software performance.

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SparkTM Clear Aligner System: The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

SparkTM Software System: The Spark™ Software System 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 trays, retainers or bracket bonding templatesor 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 planned/desired treatment objectives.

The use of the Spark™ Clear Aligner System and Spark™ Software System 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 Ormco Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal, treated state.

Treatment planning, aligner design and aliqner manufacture are supported by a proprietary software system. The Spark™ Clear Aligner system consists of multiple interfacing software modules; Web, Design, Anatomy, Approver, and Fabrication. The Spark Aligner Web software module is an online portal, where clinicians can create new patient profiles, plan treatments, manage patients and submit prescriptions, photos, images and digital scans to Ormco. Trained technicians use the Ormco™ Spark™ Aligner Anatomy and Design software to create a 3D model of the patient's teeth from dental scans and to generate a 3D image of a final, treated state, as well as 3D aligner transitional treatment stage models, and submits them to the clinician. The clinician uses the Approver Software to review and approve the models, then Ormco uses the Fabrication software to produce resin molds for thermoforming the aligners.

The clinician receives the aligners and provides them, in sequential "stages", to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligner. The trays are held in place by pressure and can be removed by the patient at any time.

The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Several treatment options may be integrated into the Ormco Spark aligner consisting of: Attachments, Hooks, Bite ramps, Pontics, Posterior Bite Turbos.

The provided document is a 510(k) summary for the Spark™ Clear Aligner System, seeking substantial equivalence to predicate devices. It primarily focuses on comparing the subject device to existing devices and outlining performance bench testing, rather than describing a study to prove acceptance criteria for an AI device.

Therefore, the document does not contain the requested information about acceptance criteria and a study proving an AI device meets them.

The document describes a medical device (Spark™ Clear Aligner System) which includes a "Spark™ Software System" intended for treatment simulation and virtual design of dental casts. However, it does not provide details on specific AI acceptance criteria or a study demonstrating the software's performance against such criteria. The "Non-Clinical Test Data" section mentions "Comparative performance testing of the functions of the Proposed device compared to the cleared stand-a-lone device," and lists several ISO and ASTM standards for biocompatibility, risk management, software life-cycle, usability engineering, and material properties, but does not offer concrete performance metrics or studies in the context of AI.

The document states that "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product." This further confirms that a study to prove AI performance against acceptance criteria, as typically understood in the context of diagnostic or predictive AI, was not performed or reported here.

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The Concinnity Aligners™ is intended for orthodontic treatment and correction of misaligned and maloccluded permanent teeth (i.e. all second molars).

The Concinnity Aligners™ is a custom clear aligner system. They are a series of doctor (orthodontist or dentist) prescribed clear plastic removable aligners that are used as alternative to traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligner moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment.

The Concinnity Aligners™ comes in two forms: a polyurethane-based material used to treat malocclusion in heavy bruxers, and a second form made from cycloaliphatic co-polyester polyurethane used in for all other patients. The polyurethane material is identical to the predicate device's material, and the cvcloaliphatic co-polyester and polyurethane materials are used in the reference device.

The manufacturing of Concinnity™ Aligners begins with the clinician prescribing aligners to treat a patient's malocclusion. The decision to use clear aligner-based treatment is made by the clinician. In addition to the prescription the clinician also provides Drake Precision Dental Laboratory (DPDL) with a model of the patient's dentition. The clinician can generate a digital file by scanning the patient's mouth directly using Intraoral scanner (IOS) software, such as 3Shape Trios or iTero software. A mold of the patient's dentition is obtained using traditional impression material or by converting the mold to a stone model.

Impressions are taken by the dental clinician and submitted to Drake Labs along with the physician's prescription. All incoming impressions are logged and tracked under the DPDL QMS system. If DPDL receives a digital file it is tracked through its QMS system without any modifications. If DPDL receives a stone model from the information is entered and tracked as per QMS. The stone model is scanned using a digital scanner and converted into a digital file. Upon receipt of traditional impression molds, they are converted to stone models which can be scanned and digitized.

The digital files are sent to a third party design firm which develops the treatment plan. The third-party design firm utilizes the digital files and the prescription from the clinician to create a customized treatment plan that is reviewed and approved by the clinician. The customized plan generates a series of *.stl CAD files for building models that allow fabrication of aligners that gently move the teeth in small increments. The third party uses the 3Shape Clear Aligner Studio (K180941) to develop the treatment plan. The treatment plan is sent to the prescribing clinician for approval before it is sent back to DPDL.

Once DPDL receives these *.stl CAD files of the treatment plan the CAD unit in DPDL receives the documents, updates the QMS documentation and manufacturing begins. The DPDL manufacturing unit generates sequential 3D printed models replicating the clinician approved treatment plan. The sequential models are 3D printed and are used to generate clear thermoplastic aligners.

The aligners are cut to fit dentition, the cleaned and polished to remove rough edges. The sequential aligners are the packaged and labeled. Quality assurance ensures that the correct aligners are being shipped to the prescribing physician. The final product is released and shipped to the prescribing clinician who is responsible for ensuring the patient's safe use of the device.

The Concinnity™ Aligners are manufactured using thermoplastic polymers used by the predicate and reference devices. Manufacturing, processing, labeling, and shipping of the aligners are performed under strict quality control procedures that ensures Concinnity Aligners™ is manufactured under the QMS.

Drake Labs sends the aligners to the doctor who delivers them 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.

The provided text describes the Concinnity Aligners™ and a study conducted to demonstrate their performance. However, much of the requested information regarding acceptance criteria and performance study details (e.g., specific metrics for acceptance, sample sizes for test and training sets, expert qualifications, and detailed statistical results) is not explicitly present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices, biocompatibility, and manufacturing fit validation, rather than a clinical trial with human-in-the-loop or standalone AI performance.

Therefore, many sections of your request will be answered with "Not explicitly stated in the document" or derived from the available information.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Details

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

• Sample Size for Test Set: For the "manufacturing fit validation study," four complete orthodontic cases were evaluated.
• Data Provenance: The document does not explicitly state the country of origin for these four cases. It implies they are real orthodontic cases from clinicians providing prescriptions and dental impressions to Drake Precision Dental Laboratory. The study was conducted by Drake Precision Dental Laboratory (DPDL). The study is retrospective in the sense that existing case data (impressions/digital scans) for the chosen cases would have been used for the manufacturing validation.

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

• Number of Experts: "A licensed clinician then evaluated the clear aligner's quality for fit, function, and adaptability." This suggests at least one licensed clinician.
• Qualifications of Experts: Assumed to be a "licensed clinician." Specific qualifications (e.g., orthodontist, years of experience) are not explicitly stated.

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

• Adjudication Method: None explicitly described. The evaluation was performed by "a licensed clinician." There is no mention of multiple reviewers or an adjudication process for the manufacturing fit validation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typical for AI-assisted diagnostic devices. The Concinnity Aligners™ are a physical medical device (orthodontic aligners), not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant or applicable to this submission.

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

• Standalone Performance: The core device (Concinnity Aligners™) is not an algorithm, but a manufactured product. The software used for treatment planning (3Shape Clear Aligner Studio, K180941) is a third-party design firm's tool. The submission is for the aligners themselves, not independent software performance. Therefore, a "standalone algorithm performance" study is not applicable in the context of this device. The closest equivalent would be the assessment of the digital model files' accuracy, which was part of the manufacturing fit validation.

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

• Type of Ground Truth: For the "manufacturing fit validation," the ground truth or reference points were:
  • The digital model files (presumably approved by the clinician, representing the intended treatment plan).
  • The "pre-determined evaluation criteria" used by the licensed clinician for assesssing fit, function, and adaptability. These criteria are not detailed in the document.
  • It is not based on pathology or clinical outcomes data, but on the physical accuracy of the manufactured aligners against the digital design and their subjective fit assessment by a clinician.

8. The sample size for the training set

• Sample Size for Training Set: The document describes the device, its manufacturing process, and a manufacturing fit validation study. There is no mention of a "training set" as this is not a machine learning/AI device that requires a training phase.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no "training set" or AI component described in the submission that would require establishing ground truth for training.

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Eon Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). Eon Aligner System positions teeth by way of continuous gentle force.

The Eon Aligners is a custom clear aligner system. They are a series of doctor-approved clear plastic removable aligners that are used as alternative traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligner moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment.

The Eon Aligner device is an orthodontic plastic bracket used for the treatment of tooth malocclusion in patients with permanent dentition. The provided text outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to a predicate device (Ormco Spark Aligner System, K182826).

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device, rather than defining specific performance metrics typically found in AI/ML performance studies (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are based on demonstrating equivalence in materials, manufacturing processes, intended use, operating principles, and biocompatibility.

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

The manufacturing fit validation study used a sample size of eight (8) patients who had successfully undergone malocclusion treatment. The provenance of this data (e.g., country of origin, retrospective or prospective) is not explicitly stated in the provided text. It is assumed to be retrospective as it involved re-creating models from "successfully undergone malocclusion treatment."

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

The text does not explicitly state the number of experts or their qualifications for establishing the ground truth for the manufacturing fit validation study. The study involved recreating 3D printed models and aligners based on "successful treatment," implying that the "ground truth" was the outcome of successful treatment as prescribed and achieved by a dentist/orthodontist. The process involves a "prescribing physician" reviewing and approving the treatment setup, suggesting ongoing expert involvement, but not a specific ground truth adjudication panel for the manufacturing validation.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method (e.g., 2+1, 3+1) in the context of an expert review panel for the manufacturing fit validation study. The standard for "ground truth" in this context appears to be the successful outcome of malocclusion treatment for the eight patients. The validation aimed to show that the manufacturing process could accurately reproduce the digital plan, with differences being "minimal."

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

An MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device submission. The Eon Aligner is a physical medical device (orthodontic plastic bracket), not an AI-assisted diagnostic or therapeutic tool for which human-reader performance would be evaluated. The submission focuses on demonstrating the physical and functional equivalence of the device to an existing predicate.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study for an algorithm was not performed, as the Eon Aligner is a physical medical device. While the device relies on "dental software intended for tooth alignment" for its design, the submission focuses on the manufactured product and its biological interaction, not the performance of the software itself as a standalone diagnostic tool. The manufacturing workflow validation included aspects of the "design software" and "3D-Printing," validating the process of creating the aligners, not the interpretative accuracy of the algorithm.

7. Type of Ground Truth Used

For the manufacturing fit validation study: The ground truth was based on the successful outcome of malocclusion treatment in eight (retrospective) patients, where the 3D printed models and aligners were recreated to demonstrate that the manufacturing process could achieve the intended therapeutic outcome with minimal deviation from the digital plan.
For biocompatibility: The ground truth was established by standardized laboratory tests per ISO 10993 series and confirmed against the identical materials of the predicate device.

8. Sample Size for the Training Set

The text does not mention a training set in the context of an AI/ML algorithm. The "training" for this device would relate to the manufacturing validation and biocompatibility, not an algorithmic model.

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

As there is no mention of an algorithm training set, this question is not applicable. The ground truth for the manufacturing validation was indirectly established by the successful treatment outcomes of previously treated patients. The "prescribing physician reviews and approves the treatment setup before the plastic trays are produced," implying that the clinician's approval of the treatment plan serves as the internal 'ground truth' for the design stage.

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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 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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