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GENIOVA Aligners are indicated for use in the alignment of permanent teeth (i.e., all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.

GENIOVA aligners are thermoformed plastic aligners designed to be used in sequence to facilitate the movement of teeth to the desired final position. Sequential aligners introduce incremental movements that move teeth by a gentle continuous force. Aligners should be worn 20 to 22 hours a day and should be removed for eating and cleaning.

GENIOVA aligners are designed based on traditional mold impression or digital scans of the patient's dentition submitted by a dental health professional (e.g., a dentist or orthodontist). From the scan, specialized orthodontic CAD/CAM software is used to develop the treatment plans, which consist of sequential dental models in which the teeth are gradually realigned at each step. For these 510(k) applications, the Ortho system from 3Shape A/S (K180941) will be used.

(K180941) from 3Shape A/S. Ortho System is approved for use in orthodontic model management, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options. The specialized orthodontic treatment planning software has 510k clearance for intended use under FDA Classification Product Code PNN, regulation 872.5470.

Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The Essix thermoplastic material used for BRIUS Clear Aligners has 510(k) clearance (K062828) for use as an aligner material; the 510(k) holder (of the material) conducted the physical properties testing for the material.

The aligner trays are then delivered to the patient by the prescribing dental health professional. This dental health professional then monitors the patient's treatment from the first aligner to the delivery of the final aligner and completion of treatment. The aligners are held in place by pressure and can be removed by the patient at any time.

The provided text describes the 510(k) summary for GENIOVA Aligners, seeking substantial equivalence to predicate devices. It details non-clinical testing for dimensional accuracy and material properties but explicitly states that clinical testing was not conducted. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for clinical performance cannot be extracted as it is not present in the document.

However, based on the non-clinical testing performed, here's what can be inferred and reported:

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

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

• Dimensional Accuracy/Manufacturing Validation: Not explicitly stated as a numerical sample size. The text mentions "The submitted intraoral scans, digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners were all assessed quantitatively or qualitatively in the validation." This suggests a test set encompassing various stages of the manufacturing process of the aligners.
• Data Provenance: The testing was an "internal manufacturing validation" performed by Geniova Technologies Sociedad Limitada. No country of origin is specified for the data itself, but the company is located in Madrid, Spain. The nature of the data is quantitative measurements and qualitative visual inspections from this internal validation.

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/Not provided. The ground truth for dimensional accuracy testing would be the "target input value" (the digitally designed dimensions), rather than a subjective expert assessment. The validation was a technical measurement against a predefined tolerance.

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

• Not applicable/Not provided. Adjudication methods are typically used for subjective assessments or when there's disagreement among human reviewers. This testing involved objective measurements.

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. No clinical testing, and no AI component involving human readers is described. The device is an orthodontic aligner, not an AI diagnostic tool.

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

• Not applicable. No standalone algorithm performance testing is described for the aligners themselves, as they are physical devices. The software used for design (3Shape A/S's Ortho System) is a cleared reference device, implying its own prior standalone validation, but this document does not detail performance of that software, only its use in the aligner manufacturing process.

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

• Dimensional Accuracy/Manufacturing Validation: The "ground truth" was the target input value (the predefined digital dimensions) against which the physical measurements were compared.

8. The sample size for the training set:

• Not applicable. This document describes the validation of a physical medical device and its manufacturing process, not the training of a machine learning model.

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

• Not applicable. As above, no training set for a machine learning model is described.

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The Clear Moves Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). Clear Moves Aligner positions teeth by way of continuous gentle force.

Clear Moves Aligners are comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. They are made of biocompatible thermoformable plastics, either from a copolyester or a composite of copolyester and polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides physical or scanned impressions of the patient's teeth to Clear Moves Aligners. A treatment plan using commercially available treatment planning software of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked with patient identifying information and treatment step. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.

This document is a 510(k) Premarket Notification from the FDA for a dental device called "Clear Moves Aligners." This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy from scratch through extensive clinical trials. Therefore, the information provided focuses on comparisons to existing devices and bench testing, rather than detailed human clinical study data with specific acceptance criteria, expert ground truth, or MRMC studies that would be typical for more novel or higher-risk medical devices.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device itself (e.g., accuracy of tooth movement in millimeters). Instead, the "performance" described is about demonstrating that the manufacturing process is valid and the materials are biocompatible, and that the device is "substantially equivalent" to predicate devices.

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

The document explicitly states: "In vivo Animal and Human Clinical performance testing are not required for this device category." Therefore, there is no test set of clinical patient data in the traditional sense, for which sample sizes or data provenance (country, retrospective/prospective) would be applicable concerning the device's clinical performance. The "test sets" mentioned would be for biocompatibility testing (material samples) and mechanical bench testing (prototype aligners/molds). These details are not provided in terms of specific sample numbers or origins within this document.

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

Not applicable. As no human clinical performance testing was required or conducted for this 510(k) submission, there was no "ground truth" derived from expert consensus on patient outcomes/diagnoses related to the device's effectiveness. Ground truth for bench testing would typically involve engineering specifications or physical measurements.

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

Not applicable. No clinical test set requiring adjudication was used.

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

Not applicable. This device is a physical orthodontic aligner, not an AI-powered diagnostic or assistive tool. While software is used for treatment planning, the submission focuses on the aligner itself and does not include an MRMC study comparing human performance with and without AI assistance.

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

Not applicable. This is not an AI algorithm being submitted for standalone performance. The software mentioned (Ortho Analyzer) is a pre-existing, referenced device used for treatment planning, not for autonomous diagnosis or treatment execution.

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

For the compliance requirements:

• Biocompatibility: Ground truth would be established by validated test methods (e.g., ISO standards) and comparison to known safe materials.
• Manufacturing Process Validation: Ground truth would be established by engineering specifications, CAD models, and precise measurements comparing the manufactured parts to the digital design.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set" for an algorithm to learn from data.

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

Not applicable, as no training set for an AI algorithm was used.

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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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Arkligners are indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.

The Arkligners device is fabricated of clear thin thermoformed Essix Ace plastic in sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.

Clinicians scan a patient, export the views needed for the patient model, and sends these scans to Arklign Laboratories. They import them into 3Shape Dental Manager 2020 to create a patient model. The patient model is imported into 3Shape Ortho System 2021 Clear Aligner Studio to design the models to make clear aligners for the treatment plan the clinician has ordered. This treatment plan (with models needed to make aligners for whichever treatment phases are being ordered) is then exported and sent to the clinician along with the original patient model file for them to approve. Then Arklign Laboratories exports the approved models needed to make the specific aligners ordered to Formlabs Form 2 3D printer running Formlabs PreForm 3.12.0. The aligner is thermoformed over the printed model. Every aligner is checked for fit on the printed patient model before sending to the clinician.

The provided text is a 510(k) summary for Arkligners, a type of orthodontic aligner. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with acceptance criteria and device performance results. As such, the information needed to fully answer the request is not present in the provided text.

Specifically, the document states: "Arkligners were checked for fit on the relevant patient model by lab personnel doing measurements and two clinicians using clinical criteria for fit." This is the only mention of performance evaluation. It does not provide quantitative acceptance criteria, reported performance values, sample sizes, expert qualifications, or details about adjudication methods.

Therefore, I can only partially address your request based on the very limited information available.

Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It only mentions that "Arkligners were checked for fit on the relevant patient model by lab personnel doing measurements and two clinicians using clinical criteria for fit."

Based on the limited information, a table cannot be constructed with specific acceptance criteria and reported numeric performance values.

Study Details for Device Performance

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

   • Sample size: The document mentions "patient scans representing three specific clinical scenarios" were used for manufacturing validation and fit checks. This indicates a sample size of n=3 clinical scenarios. It's unclear if this equates to 3 individual patient models or more.
   • Data Provenance: The data provenance is not explicitly stated (e.g., country of origin). The study appears to be descriptive of a manufacturing validation process rather than a formal clinical study.

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

   • Number of experts: "two clinicians" were used for fit checks.
   • Qualifications: The qualifications of these clinicians are not explicitly stated, beyond being referred to as "clinicians working with Arklign."

3. Adjudication method for the test set:

   • The document states "lab personnel doing measurements and two clinicians using clinical criteria for fit." This suggests a process where both lab personnel and clinicians evaluated fit. However, no specific adjudication method (like 2+1 or 3+1 consensus) is described for resolving disagreements or establishing a definitive "ground truth" for fit.

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

   • No, an MRMC comparative effectiveness study was not done. The document describes a manufacturing validation and fit check process, not a reader study involving human interpretation of data/images, nor does it involve AI assistance.

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

   • No, a standalone algorithm performance study was not done. The device itself is the physical aligner, created through a digital workflow but ultimately a physical product. The "fit" was checked by human lab personnel and clinicians.

6. The type of ground truth used:

   • The "ground truth" for the fit check was based on "clinical criteria for fit" as judged by two clinicians, and "measurements" by lab personnel. This can be categorized as expert judgment/clinical criteria.

7. The sample size for the training set:

   • The document mentions "patient scans representing three specific clinical scenarios" were used for manufacturing validation and design. It's unclear if this refers to the training of the software workflow (3Shape Dental Manager, 3Shape Ortho System Clear Aligner Studio) or the aligner manufacturing process. However, no separate "training set" for a device performance study is described. The focus is on the manufacturing process and material safety/equivalence.

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

   • This information is not provided as there isn't a clearly defined "training set" for a performance study in the context of this 510(k) summary. The "treatment plan" for generating the aligners was determined by "Clinicians working with Arklign."

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The KeyPrint® KeySplint Hard™ device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners and retainers.

KeyPrint® KeySplint Hard™ material is a UV-curable methacrylate-based resin, intended to be used by trained dental professionals for the 3D printing of various biocompatible dental devices such as mouthguards, splints, repositioners, and retainers. The printing of these devices is carried out using DLP printers utilizing pre-specified wavelengths. Each material is indicated for the fabrication of orthodontic and other dental appliances. Each material is recommended for the construction of specific Class I and II dental devices and appliances. In most cases, the devices are 3D printed to create custom devices or appliances.

The provided text describes a 510(k) premarket notification for a dental device, KeyPrint® KeySplint Hard™. However, it does not contain information related to a study proving the device meets acceptance criteria for an AI/ML powered device, nor does it detail acceptance criteria for such a device. The document focuses on demonstrating substantial equivalence to predicate devices through physical property testing and biocompatibility for a UV-curable methacrylate-based resin used for 3D printing dental appliances.

Therefore, I cannot extract the information required by your prompt, as it pertains to AI/ML device testing criteria. The document discusses:

• Device Name: KeyPrint® KeySplint Hard™
• Intended Use: Fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers.
• Testing Performed: Physical property testing (flexibility, strength, durability, kinetic interaction with water) and biocompatibility testing.
• Comparison Method: Demonstrating similar performance to predicate devices (KeyPrint® KeySplint Soft™ and Whip Mix VeriSplint) and meeting ISO and ASTM standardized testing requirements.

The document does not provide information on:

• A table of acceptance criteria and reported device performance for an AI/ML powered device.
• Sample size used for a test set in an AI/ML context.
• Number of experts or their qualifications for establishing ground truth for an AI/ML test set.
• Adjudication methods for an AI/ML AI/ML test set.
• MRMC comparative effectiveness study or related effect size for human readers.
• Standalone AI algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data) for AI/ML.
• Sample size for training set in an AI/ML context.
• How ground truth for the training set was established for AI/ML.

The provided text discusses a traditional medical device (resin for 3D printing) and its approval process, not an AI/ML powered device.

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BRIUS Clear Aligners are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.

The BRIUS Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 2 0 to 22 hours a day and are to be removed for eating and for cleaning.

BRIUS Clear Aligners are designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, specialized orthodontic CAD/CAM software will be used to develop the treatment plans that consist of sequential dental models wherein the teeth are gradually realigned with each step. For this 510(k), 3Shape A/S's Ortho System (K180941) will be used for this application. Ortho System is approved for use in the management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options. The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470.

Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligner trays are then delivered to the prescribing dental health professional. This dental health professional then monitors treatment from the placement of the first aligner to the delivery of the final aligner and completion of treatment.

The provided text from the FDA 510(k) summary for BRIUS Clear Aligners (K202792) primarily focuses on establishing substantial equivalence to a predicate device through comparison of specifications and non-clinical performance testing. It does not describe a study involving expert readers or AI performance in the typical sense of diagnostic or prognostic devices.

Instead, the non-clinical performance testing described is related to the manufacturing process and material properties of the aligners themselves. Therefore, the requested information elements related to AI performance, expert consensus, sample sizes for test/training sets in an AI context, MRMC studies, or standalone performance are not applicable based on the provided document.

Here's a breakdown of the applicable information based on the provided text, adapted to the context of the device's manufacturing and material validation:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported performance relate to the manufacturing validation of the BRIUS Clear Aligners.

2. Sample Size for the Test Set and Data Provenance

The document mentions an "internal manufacturing validation" but does not specify a numerical sample size for the aligners tested for dimensional accuracy and qualitative assessment.

• Test Set Sample Size: Not explicitly stated as a numerical value. The study refers to "the submitted intraoral scans, digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners" being assessed, implying a collection of these components.
• Data Provenance: The validation was an "internal manufacturing validation," indicating it was conducted by BRIUS Technologies, Inc. or their associated entities. The origin country is not specified, but the company is based in Carrollton, TX, USA. It is a retrospective assessment of manufactured products against internal specifications.

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

This information is not applicable as the validation was for manufacturing accuracy and material properties, not for diagnostic or prognostic AI performance requiring expert review of medical images or data. The "ground truth" was the target input values for measurements and predefined specifications for qualitative attributes.

4. Adjudication Method for the Test Set

This information is not applicable. The assessment involved objective measurements (digital calipers and 3rd party software) and qualitative visual inspections against predefined specifications, rather than an adjudication process typically used for subjective expert panel reviews.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this device is a clear aligner, not an AI software intended to assist human readers in a diagnostic task.

6. Standalone Performance Study (Algorithm Only)

A standalone algorithm performance study was not performed in the context of AI. The "manufacturing validation" described is a standalone assessment of the physical product's adherence to specifications.

7. Type of Ground Truth Used

• For Dimensional Accuracy: The ground truth was the "target input value" (digital design specifications) from the orthodontic CAD/CAM software (3Shape A/S's Ortho System).
• For Qualitative Assessment: The ground truth was predefined performance, cosmetic, and other detectable issue specifications.
• For Biocompatibility: The ground truth was adherence to international standards (ISO 10993-1 and ISO 10993-5).

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical device (clear aligner) whose manufacturing process was validated, not an AI algorithm that requires a training set. The orthodontic CAD/CAM software used (3Shape A/S's Ortho System) would have its own development and validation, but that is not the subject of this 510(k) for the BRIUS Clear Aligners.

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

This information is not applicable for the same reasons as #8.

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TP Orthodontics Clear Aligner System consists of a series of plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, TP Orthodontics Clear Aligner System sequentially positions teeth by way of continuous gentle force.

TP Orthodontics Clear Aligner System consists of a custom-made series of plastic aligners that apply gentle pressure to teeth, gradually moving them into alignment. A dentist or orthodontist assesses the patient to determine if the patient is a good candidate. Impressions are taken by the dental clinician and submitted to TP Orthodontics along with the physician's prescription. TP Orthodontics, using a standard dental software used for teeth alignment, designs a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription. The set-up and intermediate stages are sent back to the physician for review and approval. Once the doctor has approved the model scheme, the aligners are produced using a thermoplastic material and shipped to the dental practitioner. The doctor delivers the aligners 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. Aligners must be worn by the patient most of the day (20-22h), being removed only for eating, drinking and performing oral hygiene and should be replaced every 2-3 weeks as prescribed by the doctor.

This document describes the FDA's 510(k) clearance for the TP Orthodontics Clear Aligner System and its substantial equivalence to predicate devices, thus the information provided focuses on the regulatory submission rather than a detailed scientific study. Therefore, some of the requested information regarding a device's performance study might not be explicitly present if it deviates from what is typically required for a 510(k) submission.

Here's the summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to predicate devices. For this type of device (clear aligners), this primarily involves demonstrating equivalent indications for use, technological characteristics, and safety profiles.

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

The document explicitly states: "therefore there was no clinical testing to support this device." This means there was no specific test set of patients used for a clinical performance study of the TP Orthodontics Clear Aligner System. The device's clinical performance relies on the established performance of predicate devices.

For the non-clinical manufacturing validation, the sample size is not specified, nor is the data provenance.

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

Not applicable as no specific clinical 'test set' was used for this device in a de novo study. The ground truth for the overall category of sequential aligners (NXC) would have been established through years of clinical practice and research by orthodontists and dental professionals, leading to the FDA's clearance of the first device in 1998.

4. Adjudication Method for the Test Set

Not applicable as no specific clinical 'test set' was used for a new study on this device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This device is a physical medical device (clear aligner system), not an AI-assisted diagnostic or treatment planning system that would involve human "readers" or AI assistance in the way typically discussed in a MRMC study. The software mentioned is for designing the aligners, not for diagnostic interpretation by human readers.

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

Not applicable for a physical clear aligner device. The "software" mentioned passed its validations, which would imply standalone testing of the software's functionality, but this is not an "algorithm only" performance for diagnosis or treatment decision making in the typical sense.

7. The Type of Ground Truth Used

For the specific device, the ground truth for regulatory clearance was demonstration of substantial equivalence to predicate devices. This means that its design, materials, manufacturing, indications for use, and overall safety and effectiveness were compared against devices already legally marketed and proven effective.

For the manufacturing validation, the ground truth would be the software output specifications (i.e., the aligners were produced accurately according to the digital design).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set" in the computational sense. The design of the aligners is based on dental software that applies established biomechanical principles and clinician input, not a data-driven training set.

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

Not applicable, as no computational "training set" was used for this device.

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Thermoforming sheet materials are indicated for the fabrication of orthodontic and dental appliances.

Thermoforming Sheet Materials are pre-shaped flat plastic discs. The sheets are plastified in appropriate thermoforming units and adapted onto patients individual plaster models. After cooling the sheets are removed from the model and trimmed to fit.

The provided FDA 510(k) clearance document for "Thermoforming Sheet Materials" (K200125) describes non-clinical testing for biocompatibility and physical properties, but it does not contain information about a study involving acceptance criteria related to a device's performance that would require a test set, ground truth established by experts, or MRMC studies.

This submission is for a material (thermoforming sheets) used to fabricate orthodontic and dental appliances, not a diagnostic or AI-driven device. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted and a clear indication of what is not present in the document based on the device type:

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

The document provides a list of standards the materials were tested against, implying that meeting these standards constitutes the acceptance criteria. The reported performance is that the materials are in compliance with these standards for biocompatibility and that physical properties were tested.

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

• Sample Size: Not specified for the non-clinical tests.
• Data Provenance: Not specified. The company is based in Germany, so tests may have been conducted there or by a contract lab.

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

• Not Applicable. This device is a material, not a diagnostic device requiring expert interpretation of results. The "ground truth" here is compliance with established material science and biocompatibility standards.

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

• Not Applicable.

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 a material, not an AI-assisted diagnostic tool.

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

• Not Applicable.

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

• For biocompatibility: Adherence to established international and FDA-specific guidance documents and standards (EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350) which involve specific chemical and biological assays.
• For physical properties: Adherence to material testing standards (e.g., various ISO standards) which involve quantifiable measurements.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device.

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

• Not Applicable.

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ClearForm Aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusions. The aligners position teeth by way of continuous gentle forces.

ClearForm Aligners consist of a series of customized 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 an orthodontic treatment plan. Using the software dental technicians produce a series of intermediate digital models corresponding to each stage of treatment, gradually aligning the patient's teeth according to the dental health professional's prescriptions.

The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470.

The prescribing doctor reviews and approves the treatment plan before the models/molds are produced.

Once approved, physical models are produced from the digital model files. The aligner trays are formed over the physical models by using thermal forming equipment and a thermoplastic sheet. 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 dental health professional to gradually move the teeth to the desired position. The dental health professional monitors treatment from the moment 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 is a 510(k) Premarket Notification for ClearForm Aligners, an orthodontic device. It provides information for establishing substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device performance study.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them (such as acceptance criteria table, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this document. The document describes a comparison to predicate devices, non-clinical performance data (manufacturing validation, material properties, biocompatibility), and states that no clinical performance data was provided.

Here's what can be extracted based on the provided text, while noting the limitations:

Device Name: ClearForm Aligners

Device Type: Orthodontic Plastic Bracket (Class II)

Purpose of this Document: 510(k) Premarket Notification to demonstrate substantial equivalence to legally marketed predicate devices.

Summary of Device Acceptance/Evaluation from this Document:

The acceptance for this device is based on demonstrating substantial equivalence to predicate devices through similarities in indications for use, technology, and non-clinical performance testing.

1. Table of Acceptance Criteria and the Reported Device Performance:

Since this is a 510(k) submission for an orthodontic aligner and not an AI/ML-driven device with specific performance metrics like sensitivity/specificity, a direct "acceptance criteria" table with reported performance in that sense is not present. However, the document outlines "acceptance criteria" for the manufacturing validation.

Note: These are manufacturing process validation criteria, not clinical performance criteria for diagnosis or treatment outcome effectiveness.

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

• Test Set Sample Size: Not applicable in the context of an AI/ML performance study. The "test set" here refers to samples used for manufacturing validation. The document states "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 exact number of samples for each aspect is not specified, but it's related to a manufacturing process, not patient data for an algorithm's performance.
• Data Provenance: Not applicable in the context of patient data for an algorithm. The data provenance described is from their internal manufacturing validation process.

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

Not applicable. Ground truth for an AI/ML model for diagnostic/prognostic purposes is not established for this device's 510(k) submission. The "ground truth" here is the "target input value" (digital design) for manufacturing accuracy comparison.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication process for diagnostic labels or classifications is described. The "adjudication" for manufacturing validation was likely based on comparison to design specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states: "Clinical performance data was not provided for ClearForm Aligners." Therefore, no MRMC study or effect size of human readers improving with AI assistance vs. without AI assistance was reported.

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

No. This device is not an AI/ML algorithm. The software mentioned (3Shape A/S Ortho System) is for treatment planning and model creation, and it has its own 510(k) clearance (K180941). The ClearForm Aligners itself is a physical medical device.

7. The Type of Ground Truth Used:

• For Manufacturing Validation: The ground truth used was the "target input value," which refers to the digital design specifications derived from the orthodontic treatment plan created using the specialized CAD/CAM software. The accuracy of the manufactured components (digital dentition models, 3D printed molds, thermoformed aligners) was measured against these digital design specifications.
• For Substantial Equivalence: The ground truth for this regulatory pathway is the characteristics and safety/effectiveness profile of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm requiring a training set of data.

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

Not applicable. (See #8)

In summary: This 510(k) document is for a physical medical device (orthodontic aligners). The regulatory pathway for this device is primarily based on demonstrating substantial equivalence to existing predicate devices and providing non-clinical performance data related to manufacturing accuracy and material properties. It does not involve a "study that proves the device meets acceptance criteria" in the context of AI/ML algorithm performance on patient data, nor does it present clinical trial data for effectiveness.

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

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

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

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

Here's what can be extracted and inferred:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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