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The MVP Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The MVP Aligners position teeth by way of continuous gentle force.

The MVP Aligner system is a prescription (Rx) device comprised of a series of dentist prescribed clear, biocompatible, plastic shells that fit over the teeth designed to incrementally improve malocclusion by providing progressive force and moving patient dentition from an initial condition to a preferred corrected condition. After a scan or physical impression of the patient's teeth is taken by or under the direct supervision of the patient's orthodontically trained dentist, each aligner in the sequential set is created by a trained technician utilizing Ortho System software (K180941) according to the orthodontic screening and tooth movement recommendations provided by the same prescribing orthodontically trained dentist. The recommendations are patient specific and can only be relied upon for an individual patient for whom the device is prescribed. Furthermore, the orthodontically trained dentist reviews and approves the model scheme before the molds are produced. Once approved, the trays which are formed of clear, thin, thermoformed plastic are fabricated.

The indirect fabrication process involves a 3D print of a plastic model representing the patient specific upper and lower dentition of the patient's jaw. The models are cured. Biocompatible plastic sheets are thermoformed over the cured models with pressure and heat, marked with a patient identifier on the occlusal surface, and trimmed in a 5-axis CNC machine. The aligner containing an individualized trim line is polished, cleaned, sorted and packaged with a UDI.

MVP Aligners are provided non-sterile and are completely removable by the patient. Once approved, the trays are sent back to the orthodontically trained dentist who then provides them to the patient, in sequential stages confirming fit and design. The orthodontically trained dentist monitors treatment from the delivery of the first to final aligner.

This document is a 510(k) Pre-market Notification summary for MVP Aligner System, seeking substantial equivalence to existing devices. As such, it does not contain information about a study proving that the device meets acceptance criteria for an AI/ML powered device, nor does it contain a table of acceptance criteria or performance metrics for such a device.

The "Clinical Data" section explicitly states: "The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998. There is sufficient information available from scientific literature to support safety and efficacy. Therefore, clinical testing was not necessary to demonstrate substantial equivalence of the MVP Aligners to the predicate device."

This means:

• No specific acceptance criteria or device performance data is presented. The device is considered substantially equivalent based on its similarities to already cleared devices and existing scientific literature on aligners in general.
• No study to prove the device meets acceptance criteria was conducted or necessary according to this document. The FDA cleared this device based on predicate similarity, not on a new clinical study.
• All other points in your request (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, ground truth, training set size, training ground truth) are not applicable because no such clinical study for this specific device's performance was performed or submitted as part of this 510(k).

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The U-Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The U-aligner system repositions teeth by way of continuous gentle force.

The U-Aligner system is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.

A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes the U-Aligner system based on an assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth and completes a prescription form. Universal Orthodontic Lab then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment (Ortho System™, K180941). The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Universal Orthodontic Lab produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. Over a period, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

The technology is essentially identical to that used by a number of sequential aligner systems, including the two predicate devices.

The provided text describes a 510(k) premarket notification for a medical device called "U-Aligner." This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria through a standalone study. The document primarily focuses on comparing the U-Aligner's characteristics (indications for use, materials, mode of action) to those of predicate devices.

Therefore, the requested information regarding detailed acceptance criteria, a specific study proving the device meets them, sample sizes for test/training sets, expert qualifications, and adjudication methods for a medical image analysis or diagnostic device is not applicable to this document.

Here's why and what information can be extracted or inferred:

• Type of Device: The U-Aligner is an orthodontic plastic bracket (sequential aligner), not an AI/ML-driven diagnostic or image analysis device. Its "performance" is largely related to its physical properties, manufacturing accuracy, and biocompatibility, not its ability to interpret data or make classifications.
• Purpose of Submission: A 510(k) is about demonstrating "substantial equivalence" to a predicate device, meaning it is as safe and effective as a device already on the market. It's not typically about establishing entirely new performance benchmarks through de novo clinical trials.

Information that is relevant or can be inferred from the document:

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

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

• Not applicable for typical test set definitions. This device is a physical orthodontic aligner.
• For the manufacturing validation, the sample size is not stated, nor is the provenance of the data points (which would likely be internal manufacturing measurements).
• For biocompatibility testing, the "sample size" would refer to the number of biological samples or subjects used in the in-vitro and in-vivo tests, which is not specified but implicitly met the requirements of ISO 10993-1.

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. There is no "ground truth" establishment in the context of image analysis or diagnostic performance as this is a physical device. The "truth" for biocompatibility is whether the material is toxic, sensitizing, or irritating, as measured by established biological tests. The "truth" for manufacturing accuracy is whether the physical output matches the digital design.

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

• Not applicable. No adjudication on diagnostic findings is relevant 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:

• Not applicable. This is not an AI-assisted diagnostic or imaging device, so such a study would not be performed. The device itself is the treatment tool.

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

• Not applicable. This refers to AI algorithm performance. The U-Aligner is a physical device.

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

• For biocompatibility: Established laboratory testing protocols (e.g., ISO 10993-1 standards for cytotoxicity, sensitization, irritation).
• For manufacturing accuracy: Comparison of the physical aligner's dimensions to the digital design specifications (expected locations and positions of tooth structures).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of AI/ML or a clinical study. The "design" phase involves dental software (Ortho System™, K180941), which itself would have been validated, but the specifics of its training data are not part of this 510(k).

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

• Not applicable. As above, no training set for the U-Aligner device itself.
  The "ground truth" for the overall process would be the desired tooth movement prescribed by a licensed dental professional (orthodontist or dentist), based on their assessment of the patient's teeth. The software then generates a series of aligners to achieve this target.

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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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Magic Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

Magic Clear Aligners consist of a series of custom-made removable plastic orthodontic appliances which sequentially reposition teeth by way of continuous gentle force. A digital or traditional mold impression of the patient's teeth is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data created of the patient's teeth, specialized orthodontic CAD/CAM software is used to develop treatment plans. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health professional's prescription. The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced. Once approved, the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Voodoo Manufacturing produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The aligner trays are sent to the dental health professional who then delivers them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the patient by the dental health professional to gradually move the teeth to the desired position. The dental health professional monitors treatment from the first aligner is delivered to when the final aligner is delivered and treatment complete. The aligners are held in place by pressure and can be removed by the patient at any time.

This document describes the premarket notification (510(k)) for "Magic Clear Aligners" by Voodoo Manufacturing, Inc. It does not concern an AI/ML medical device, but rather a physical orthodontic device manufactured using CAD/CAM software. Therefore, many of the requested criteria related to AI/ML device performance, such as MRMC studies, ground truth establishment for training sets, and expert adjudication, are not applicable.

However, I can extract information related to the device's acceptance criteria and the studies that prove it meets those criteria, focusing on the manufacturing process and biocompatibility, which are the relevant aspects for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Manufacturing Dimensional Accuracy: Not explicitly stated as a "test set" in the traditional sense of a clinical or AI study. The "test" involved assessing the accuracy of the manufacturing process. It stated that "Three critical aspects of the manufacturing process were assessed for accuracy: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners." The number of samples for each aspect (e.g., how many models, molds, or aligners were measured) is not quantified.
• Biocompatibility Testing: The sample sizes for each biological test (Cytotoxicity, Sensitization, Irritation, Subacute/SubChronic Toxicity, Genotoxicity) are not specified in the document.
• Data Provenance: Not applicable in the context of clinical data provenance for an AI/ML device as this is a manufacturing and biocompatibility study. The manufacturing validation was performed by Voodoo Manufacturing, Inc. The biocompatibility testing was conducted according to international standards (ISO 10993 series).

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

• Not applicable as this is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for manufacturing accuracy was the target input value in the CAD/CAM software. The "ground truth" for biocompatibility was compliance with international standards (ISO 10993).

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

• Not applicable as this is not an AI/ML device requiring human adjudication of results.

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 an orthodontic aligner and does not involve human readers or AI assistance in the diagnostic or interpretation process.

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

• Not applicable. While the device's design relies on CAD/CAM software, the "device" itself is the physical aligner. The software's performance is not being evaluated as a standalone diagnostic tool, rather its output is a component of the manufacturing process of the physical device. The document mentions the 3Shape A/S Ortho System software has a 510(k) clearance (K180941) under the PNN product code, indicating its own prior regulatory evaluation.

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

• Manufacturing Dimensional Accuracy: The "ground truth" was the target input value generated by the specialized orthodontic CAD/CAM software, representing the intended geometric specifications for the digital dentition models, 3D printed molds, and thermoformed aligners.
• Biocompatibility Testing: The "ground truth" was compliance with the pass/fail criteria defined by the relevant international standards (ISO 10993 series) for biological evaluation of medical devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set. The CAD/CAM software used for design and manufacturing is presumably a commercially available, previously validated tool.

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

• Not applicable. This is not an AI/ML device requiring a training set.

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

The Ormco™ Spark™ Aligner System consists of a series of doctor-prescribed, custom manufactured, clear plastic removable orthodontic appliances (aligners) that incrementally move the patient's teeth from an original state to a treated state. Treatment planning, aligner design and aligner manufacture are supported by a proprietary software system. The Ormco™ SparkTM Aligner system consists of multiple interfacing software modules; Web, Design, 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. Ormco technicians use a reference Anatomy software and the Ormco™ Spark™ Aligner 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.

Several treatment options may be integrated into the Ormco Spark/Kappa aligner. Attachments or "buttons" may be prescribed by the dental practitioner to facilitate tooth movement and aligner anchorage. The dental practitioner may choose a standard dental composite and adhesive to bond the attachments to the dentition. The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Hooks may be designed into the aligner, then connected by an elastic to a toothbonded button on the opposite arch. to apply additional forces. Bite ramps are step features built into the lingual surfaces of the upper aligner arch that used by the clinician to prevent movement of the teeth during overbite correction treatment. Pontics are cavity spaces (that may or may not be "tooth-shaped") built into the aligner per clinician's request to address voids of missing teeth or other gaps during treatment.

The provided text describes the Ormco™ Spark™ Aligner System and its substantial equivalence to a predicate device, the Invisalign System (K143630). However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria through specific performance metrics. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device based on technological characteristics, performance testing, and a literature review.

Therefore, the requested information elements related to the acceptance criteria and a study proving the device meets them cannot be fully extracted as they are not explicitly present in the provided text.

Here's a breakdown of what can be extracted or inferred based on the supplied document, addressing the prompt's points where possible:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of explicit acceptance criteria with numerical targets and reported performance values for those targets. Instead, it discusses "performance testing" to demonstrate substantial equivalence to the predicate device.

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

• Sample Size for Test Set: Not specified for any of the performance tests. The document only mentions "all tested samples" for material property tests (translucency, staining, shelf life, shipping) and "specified cycles" for aligner features.
• Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. The performance testing appears to be bench testing conducted by the manufacturer ("Ormco").

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

• This information is not provided. The document mentions "orthodontic specialists" conducted a "comprehensive scientific literature review and analysis" to support substantial equivalence, but not for establishing ground truth for a test set of the proposed device.

4. Adjudication method for the test set

• This information is not provided. There is no mention of an independent adjudication method for performance tests.

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 mentioned. The device described (Ormco™ Spark™ Aligner System) is a physical orthodontic appliance system, not an AI-assisted diagnostic or treatment planning tool that would typically involve human "readers" or "AI assistance" in the sense of image interpretation. The software components described are for treatment planning, design, and manufacturing workflow, not for AI-driven interpretation or assisted reading by human experts.

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

• This question is not directly applicable. The "algorithm" here refers to the software that assists in designing and manufacturing the aligners. The overall device is a system involving both software and physical aligners, prescribed and managed by a dental professional. The performance tests evaluate the physical properties of the aligners and the accuracy of certain features, not the standalone diagnostic performance of an algorithm.

7. The type of ground truth used

• For the physical and material performance tests (stress relaxation, flexural/tensile strength, translucency, staining, shelf life, shipping, attachment accuracy, etc.), the ground truth would implicitly be measured physical and chemical properties against established industry standards or comparable predicate device properties.
• For biocompatibility, the ground truth was adherence to ISO 10993-1 standards.
• For the overall claim of substantial equivalence, the "ground truth" for efficacy and safety relies heavily on the established performance and safety record of the predicate device (Invisalign System) and general scientific literature on clear aligners, as no clinical performance testing was done on the proposed device.

8. The sample size for the training set

• This information is not provided. The document describes a "proprietary software system" with "multiple interfacing software modules" for treatment planning, aligner design, and manufacture. If these modules involve machine learning, no details about training set size are given. Given the nature of the device (orthodontic aligners), "training set" may refer to data used for software development and design rather than a clinical AI model training.

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

• This information is not provided. As with point 8, if there's an AI/ML component implying a "training set," the document does not elaborate on how ground truth for such a set would be established. For traditional software development, "ground truth" might align with engineering specifications and clinical requirements documented by the developers and dental professionals.

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The Orthocaps TwinAligner® System is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

Orthocaps TwinAligner® System consists of a series of custom made removable clear plastic orthodontic aligners that sequentially positions teeth by way of continuous gentle force.

An electronic scan or mold impression of the patient's teeth in an untreated state is provided by a dental or orthodontic professional. From the digital scan, Orthocaps technicians design a series of intermediate models corresponding to each stage of treatment intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Orthocaps produces the aligner trays formed from clear, thin thermoformed plastic. The trays are sent back to the physician for patient fit and treatment. Additional trays are provided sequentially to gradually move the target teeth to the designed position, which is monitored throughout treatment by the physician. The aligner trays are held in place by pressure and can be removed by the patient at any time. Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printed files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation for this subject device is the 3Shape reference predicate.

The Orthocaps TwinAligner® System is a medical device for orthodontic treatment. The information provided does not detail specific acceptance criteria for performance metrics (such as accuracy of tooth movement or treatment efficacy). Instead, the submission focuses on demonstrating "substantial equivalence" to predicate devices based on indications for use, technological characteristics, and safety (biocompatibility).

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since specific quantitative performance acceptance criteria are not explicitly stated for the device's functional efficacy (e.g., degree of tooth movement precision), the acceptance criteria primarily revolve around demonstrating substantial equivalence to predicate devices and acceptable biocompatibility.

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

• Biocompatibility Testing: The document does not specify a "sample size" in terms of number of devices tested for biocompatibility. The tests were performed "in accordance to ISO 10993-1 and its applicable parts," but the number of samples or batches is not mentioned.
• Verification and Validation Testing: The document mentions using "a physical model cast impression" but does not specify the sample size (i.e., how many casts or digital models were compared).
• Data Provenance: Not explicitly stated for biocompatibility or V&V testing, but it can be inferred that these were laboratory-based tests conducted by/for Ortho Caps GmbH. No country of origin for patients or specific retrospective/prospective study design is relevant here as no clinical data was submitted.

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

• Biocompatibility Testing: The ground truth is established by the specified ISO standards (e.g., ISO 10993-5, 10993-10). No human experts were used to "establish ground truth" beyond the standard laboratory procedures and interpretation of results according to ISO guidelines.
• Verification and Validation Testing: This involved comparing physical and digital models. The "ground truth" here is the design specification or the intended digital model. The comparison would likely be performed by engineers or technicians, but no specific "experts" for ground truth establishment are mentioned.

4. Adjudication Method for the Test Set:

• Biocompatibility Testing: No human adjudication method (like 2+1 or 3+1) is described. The results are based on standardized laboratory assays and their interpretation against pass/fail criteria defined by the ISO standards.
• Verification and Validation Testing: No adjudication method is mentioned. The comparison of physical and digital models would likely involve quantitative measurements and adherence to pre-established specifications.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not included in this submission." The submission relies on substantial equivalence to predicate devices which have established clinical safety and effectiveness.

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

The device is a physical product (aligners) manufactured using software for treatment planning. The "software application used for the manufacturing validation for this subject device is the 3Shape reference predicate."
Verification and validation testing confirmed "no measurable deviation between physical and digital models." This can be considered a standalone performance assessment of the manufacturing process driven by the software, ensuring the physical output matches the digital plan. However, this is not a standalone clinical performance study of the algorithm's ability to predict tooth movement in patients.

7. The Type of Ground Truth Used:

• Biocompatibility: The ground truth is defined by the objective pass/fail criteria specified in the international ISO 10993 standards for biological evaluation of medical devices.
• Verification and Validation: The ground truth is the "preestablished specifications" and the intended digital model for the aligners.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product (aligners) and the manufacturing process uses "standard dental software" (like 3Shape Ortho System) which is a reference predicate. There is no mention of a proprietary AI algorithm developed by Ortho Caps GmbH that underwent a training phase.

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

Not applicable, as there is no described training set for a proprietary algorithm. The software used is described as "standard dental software" or a "reference predicate." The ground truth for such software would typically be derived from extensive orthodontic principles, biomechanical models, and clinical experience embedded in their design and development, rather than a specific "training set" in the context of machine learning.

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The Smylio Invisible Clear Aligners is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

The Smylio Invisible Clear Aligners are intraoral thermoformed plastic aligners that are worn 20 to 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.

Smylio Invisible Clear Aligners are 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. 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.

Here's an analysis of the provided text regarding the Smylio Invisible Clear Aligners' acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text describes a "manufacturing validation" study. While it states that "three critical aspects of the manufacturing process were assessed," it does not explicitly state the sample size (e.g., number of aligners, number of 3D models tested).

The data provenance is not specified regarding country of origin, nor whether it was retrospective or prospective. Given it's a manufacturing validation, it's inherently prospective in the sense of testing newly manufactured prototypes.

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

The document does not mention the use of experts to establish ground truth for the manufacturing validation. The ground truth was established by "target input values" or "predefined tolerance of the manufacturing process." An "independent 3rd party software and digital calipers" were used for measurements.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as experts were not used to establish ground truth. Measurements were taken using instrumentation and compared against predefined tolerances.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing was not conducted."

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

The manufacturing validation study appears to be a standalone performance assessment of the manufacturing process and resulting product (aligners). While software (3Shape®) is involved in the design and planning, the validation focuses on the physical accuracy of the manufactured components (digital models, 3D printed molds, thermoformed aligners) against their intended values, not on the performance of the software as a standalone diagnostic or treatment planning tool in comparison to a human. The independent 3rd party software and digital calipers act as the measurement tools, not as the AI algorithm itself being evaluated.

7. The Type of Ground Truth Used

The ground truth used for the manufacturing validation was based on pre-defined target input values for translational and rotational measurements. These targets represent the intended or desired dimensions and angles planned during the treatment design.

8. The Sample Size for the Training Set

No training set is mentioned or applicable here. The study described is a manufacturing validation, not an AI algorithm development study that would involve training data.

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

Not applicable, as there was no training set.

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