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

The MEM Clear Aligner System is a customized plastic orthodontic system, consisting of a series of transparent, removable aligners prescribed by a doctor to correct misaligned or crooked teeth. These customized, removable transparent plastic aligners gradually reposition teeth with continuous gentle pressure.

The product is a series of transparent, removable orthodontic aligners, custom-made according to the dentist's prescription and designed using the "3Shape A/S (K171634)" software. They are manufactured using thermoforming technology. These aligners are designed to provide a comfortable teeth straightening experience and achieve optimal correction through precise design using advanced technology.

The provided FDA 510(k) clearance letter for the MEM Clear Aligner System does not contain any information regarding a study that proves the device meets specific acceptance criteria based on diagnostic performance, reader studies, or AI algorithm performance. This document primarily focuses on establishing substantial equivalence to a predicate device (ULab Systems Dental Aligner Kit, K192596) by comparing intended use, technological characteristics, and material properties.

The "Non-Clinical Performance Data" section lists various ISO standard tests related to biocompatibility and material properties, along with transportation, packaging, and shelf-life testing. These are primarily for demonstrating the safety of the material and the product's integrity, not its diagnostic efficacy or performance in a clinical setting related to treatment outcomes or accuracy of tooth movement prediction.

Therefore, based solely on the provided text, I cannot produce a table of acceptance criteria and reported device performance related to a diagnostic or AI-driven study, nor can I answer questions about sample sizes, data provenance, expert panels, MRMC studies, or ground truth types for such a study.

The document implicitly suggests the "acceptance criteria" for clearance are met by demonstrating:

• Same Intended Use: Treatment of tooth malocclusion in patients with permanent dentition.
• Similar Technological Characteristics: Mode of action, principles of operation, method of use, OTC/Rx status, duration of use, method of manufacturing, design, application (removable).
• Comparable Material Biocompatibility and Mechanical Properties: Demonstrated through ISO and ASTM standards.

Here's what can be extracted and what cannot:

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

Since this is a substantial equivalence submission for a physical medical device (aligners), not an AI/diagnostic device, the "acceptance criteria" are related to equivalence to the predicate, and material/biocompatibility performance rather than diagnostic accuracy.

Note: There are no "acceptance criteria" in the sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because this is not an AI/diagnostic device.

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

• Not Applicable. The document describes tests on the device materials and physical properties, not on a "test set" of patient data for an algorithm. The biocompatibility tests are likely performed on a limited number of animal subjects or cell cultures, and the physical property tests on samples of the material.
• Data Provenance: Not specified for biocompatibility or material tests beyond the standards referenced. The company is based in Taiwan.

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

• Not Applicable. There is no "test set" requiring expert ground truth in the context of this 510(k) submission. The ground truth for material properties is the physical measurement itself according to standard protocols.

4. Adjudication method for the test set

• Not Applicable. No human adjudication panel for a test set of data.

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 physical aligner device, not an AI or imaging diagnostic device. No MRMC study would be performed for this product type.

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

• Not Applicable. This is a physical aligner device. There is no AI algorithm being evaluated for standalone performance. The design of the aligners uses "3Shape A/S (K171634) software," but the 510(k) is for the physical aligner product, not the software itself or its AI capabilities for treatment planning.

7. The type of ground truth used

• For Biocompatibility: In vitro (cytotoxicity, gene mutation), in vivo (animal studies for irritation, toxicity, pyrogenicity, sensitization, implantation).
• For Mechanical Properties: Measurements derived from standardized laboratory tests (e.g., ISO 20795-2:2013, ASTM D570).

8. The sample size for the training set

• Not Applicable. There is no training set for an AI algorithm described in this 510(k). Fabrication is custom for each patient based on a doctor's prescription.

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

• Not Applicable. No training set, thus no ground truth establishment for it.

In conclusion: The provided document is a 510(k) clearance for a physical medical device (clear aligners), not a software-as-a-medical-device (SaMD) or an AI/diagnostic imaging device. Therefore, the questions related to AI performance metrics, test sets, training sets, human readers, and expert ground truth are not applicable to the information contained within this specific FDA clearance letter. The study described in the document primarily involves materials testing and biocompatibility assessments to demonstrate the safety and equivalence of the aligner product itself.

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

Dental health professionals achieve orthodontic tooth movement through prescription of aligners which apply force to the patient's teeth so that each tooth follows a prescribed, predetermined displacement. LuxCreo Clear Aligner System is custom plastic aligner system which are a series of doctor prescribed clear removable aligners that are used as alternative treatment for the alignment of maloccluded or misaligned teeth. This series of aligners gently move the patient's teeth in small increments from their original state to a treated state.

A 3D printer, based on a 3D stereolithographic drawing, prints the predetermined shape of each aligner. Final polymerization is achieved by placing the printed aligner in a UV-light curing box. 3D printing uses specialty liquid resins, which help the aligners achieve mechanical properties similar to thermoplastics, and increased processability.

The aligners are packaged and labeled according to the sequence in which they are intended for use, determined by the prescribing dental health professional. The finished set of aligners is shipped with twelve-month-shelf-life to the prescribing physician, who is accountable for ensuring the patient uses the device properly and safely.

The LuxCreo Clear Aligner System mechanism of operation, and software usage, are identical to the predicate devices, and support a determination of substantial equality. Both the LuxCreo Clear Aligner System and the predicate devices are manufactured from a biocompatible, non-sterile polyurethane materials that supports a determination of substantial equality.

This FDA 510(k) clearance letter and supporting Special 510(k) Summary for the LuxCreo Clear Aligner System (K250343) does not describe an AI medical device or a study involving AI.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K212680) by comparing:

• Intended Use/Indications for Use: Identical for both devices.
• Mode of Action: Identical (application of continuous gentle force for teeth alignment).
• Method of Use: Identical (sequential use of preformed plastic trays).
• Manufacturing Process: Identical (light-cured 3D printing).
• Material: Different, but the new material's mechanical and chemical properties were tested against pre-determined acceptance criteria and found to be equivalent or better.
• Biocompatibility: Extensive ISO 10993 testing was performed to demonstrate biocompatibility of the new material, with all results meeting requirements.
• Shelf Life: Increased from 6 months to 12 months, supported by stability and packaging integrity testing.

The document does not mention any software that performs medical functions requiring AI/ML performance evaluation, nor does it refer to terms like "algorithm performance," "diagnostic accuracy," "human-in-the-loop," "ground truth," or "expert readers" in the context of an AI study. The "software usage" mentioned (Section H, page 7) refers to ordering workflow, not a medical function.

Therefore, I cannot extract the requested information (acceptance criteria, study details for AI performance, sample sizes, expert qualifications, etc.) because the provided text describes a medical device clearance based on material and shelf-life changes, not an AI/ML component.

If the LuxCreo Clear Aligner System had an AI component (e.g., AI-powered treatment planning, AI for predicting tooth movement, or AI for assessing aligner fit from scans), that information would typically be detailed in a separate section addressing the software's performance, validation, and clinical results. This document does not contain such information.

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

The Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal, treated state. Treatment planning, aligner manufacture are supported by a proprietary software system. 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 aligners are held in place by presure and can be removed by the patient at any time. Several treatment options may be integrated into the Spark Clear Aligners, such as cutouts, hooks, and/or other attachment shapes, bite ramps, etc. to aid the aligners with teeth movement. The integrated occlusion guides on the upper and lower aligners allow the option of incrementally repositioning the mandible (lower jaw) forward to address in patients who have not reached full skeletal maturity.

This document is a 510(k) clearance letter for the Spark™ Clear Aligner System. It describes the device, its intended indications for use, and confirms its substantial equivalence to previously cleared devices. However, it does NOT contain the detailed information necessary to answer your questions about acceptance criteria and the study proving the device meets those criteria.

Typically, such information, especially related to the performance of a device against specific acceptance criteria and the methodologies of studies (like sample sizes, expert qualifications, ground truth establishment, etc.), would be found in detailed performance study reports or summaries submitted as part of the 510(k) application, but this clearance letter does not include that level of detail.

Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory clearance and substantial equivalence, not the specifics of performance testing or clinical study design.

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The Pearl Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by continuous gentle forces.

Pearl Clear Aligner is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to align teeth during the orthodontic treatment of malocclusions. They are made of biocompatible thermoplastic 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 a digital file (scan) of the patient's teeth to Pearl Digital. Based on the dental health professional's treatment plan, Pearl Digital develops a digital plan using commercially available treatment planning software. Upon approval by the dental health professional, molds are created with 3D-printing technology and the clear aligners are vacuum formed on the molds. The finished, customized aligners are provided to the dental health care professional who delivers the aligners to the patients in sequential stages checking for fit and function.

The provided document is a 510(k) premarket notification for the Pearl Clear Aligner. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics and acceptance criteria for the new device.

Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth for a performance study is not available within this document. The document mainly discusses the technical characteristics and biocompatibility testing of the Pearl Clear Aligner and compares them to the predicate device.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, specific quantitative acceptance criteria for the device's performance (e.g., accuracy of tooth movement, treatment success rates) are not detailed. The performance aspects highlighted are related to the manufacturing process validation and the general concept of applying forces for tooth alignment.

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

• The document mentions "Bench testing was performed to validate the manufacturing process to ensure the accuracy of the final aligners compared to the initial digital scans." However, the sample size for this test set is not specified.
• Data provenance is not specified (e.g., country of origin, retrospective or prospective).

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 in the document. The manufacturing process validation likely involved internal technical experts, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set:

• This information is not provided in the document.

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 comparative effectiveness study is not mentioned for this device. The device itself (Pearl Clear Aligner) is an orthodontic appliance, not a diagnostic AI system with human-in-the-loop interaction for interpretation. The "treatment planning software" is mentioned as a reference device, but no MRMC study involving it is described here.

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

• This information is not applicable in the context of an orthodontic aligner device. While an algorithm is used for treatment planning (referencing PlaniMax Orthodontic Software, K201036), this document is for the aligner itself, and no standalone algorithm performance study for the aligner's effectiveness is detailed. The closest would be the "bench testing" to ensure manufacturing accuracy, which is a validation of the physical product, not a standalone algorithm performance.

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

• For the "bench testing" of manufacturing accuracy, the "initial digital scans" (likely of the patient's teeth or desired final positions) served as the reference or ground truth against which the final aligners were compared.

8. The sample size for the training set:

• The document implies that "commercially available treatment planning software is used" (referencing PlaniMax Orthodontic Software, K201036). If this software utilized a training set (as AI/ML software often does), its sample size is not specified in this document, as the document focuses on the aligner device.

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

• As the document references an already cleared "commercially available treatment planning software," how its training set's ground truth was established is not detailed in this 510(k) submission for the Pearl Clear Aligner. That information would typically be part of the 510(k) for the software itself (K201036).

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

The Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear, plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal, treated state. Treatment planning, aligner design, and aligner manufacture are supported by a proprietary software system. 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 aligners are held in place by pressure and can be removed by the patient at any time. The aligners are individually identified and dispensed to patients and are to be worn in a specific prescribed sequence. Several treatment options may be integrated into the Spark Clear Aligners consisting of:

• Attachments: Attachments are small protuberances of tooth-colored dental bonding material and may be prescribed by the dental clinician to act as anchor points on the teeth to focus the forces of the aligner to help with teeth movement.

o Templates: Attachments are placed onto the teeth via Templates. The dental practitioner may choose a standard dental composite, to fill into the Template themselves, and adhesive to bond the attachments onto the dentition. The option for composite material to be prefilled into the Template during manufacturing is also available via Prefilled Attachment (PFA) Templates.

• Hooks & Cutouts: Hooks and Cutouts may be designed into the aligner to accommodate elastics for aiding in applying additional aligner forces. Integrated Hooks are an optional alternative to the traditional Hooks.

• Bite ramps: Bite ramps are step features built into the lingual surfaces of the upper and lower aligner arch that are used by the clinician to prop open the bite temporarily so that certain teeth have a clearer path for movement without interference.

• Pontics: Pontics are cavity spaces (that may or may not be "tooth-shaped") built into the aligner per clinician's request to fill voids of missing teeth or other gaps that the clinician may wish to retain during treatment.

· Posterior Bite Turbos: Posterior Bite Turbos (PBT) are designed to prevent complete closure of jaws.

The provided text is a 510(k) summary for the Spark™ Clear Aligner System. It describes the device and its intended use, and compares it to a legally marketed predicate device to establish substantial equivalence. However, this document does not contain the specific details about acceptance criteria, device performance, or a study designed to prove the device meets those criteria, as typically found in a clinical or performance study report.

The document states: "Non-Clinical performance bench testing to international standards and FDA recognized consensus standards for Aligner, Sequential Device has been conducted to determine conformance" and lists several ISO and ASTM standards. It also mentions biocompatibility testing. Crucially, it states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because the provided text explicitly states that clinical testing was not conducted, and it does not detail the specific performance results or acceptance criteria from the non-clinical bench testing.

Here's a breakdown of why each specific point you asked for cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document mentions conformance to international standards (e.g., ASTM F 1980-21, ISO 14971, ISO 10993 series, ISO 7405, ANSI ADA Standard No. 41-2020) for non-clinical bench testing and biocompatibility. However, it does not detail specific acceptance criteria (e.g., a certain tensile strength or alignment accuracy) or quantify the device's performance against those criteria.
2. Sample size used for the test set and the data provenance: Not mentioned. Since no clinical testing was conducted and the details of non-clinical bench testing are not provided beyond listing standards, the sample size or data provenance (e.g., country of origin, retrospective/prospective) for any test set are not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. Ground truth is typically established in clinical studies or human-in-the-loop evaluations, which were explicitly stated as not being conducted.
4. Adjudication method for the test set: Not mentioned. Adjudication is relevant for expert-based ground truth establishment, which did not occur according to the document.
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 and not mentioned. MRMC studies are typically for diagnostic AI systems involving human readers interpreting images, which is not the nature of this physical aligner system. The device is a physical orthodontic appliance, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical appliance, not a standalone algorithm in the typical sense of AI and software. While it has proprietary software for treatment planning, the document does not discuss its standalone performance in a quantifiable manner against specific criteria.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. As clinical testing was not performed by the applicant (for this submission), there's no ground truth established in that context. The "ground truth" for the non-clinical testing would refer to the validated methods and metrics within the specified international standards, but specific details are not provided.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model that undergoes "training" the way machine learning models do. While its proprietary software might use data, the document does not describe it in terms of AI model training.
9. How the ground truth for the training set was established: Not applicable, for the same reasons as point 8.

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Indicated for use in alignment of teeth through orthodontic treatment of malocclusion.

The Proposed Device is indicated for use in the alignment or mixed dentition teeth through orthodontic treatment of misalignment and malocclusion, with 20 to 22 hours of daily wear for at least 10 days. The Proposed Device allows the option of forward repositioning of the mandible to a more optimal bite profile.

This premarket notification is submitted to notify the FDA of Wuxi EA Medical Technologies' intent of changes to the Clear Aligner (hereafter referred to as "Proposed Device") to the currently marketed reference device's, Clear Aligner (K203688, cleared October 8, 2021) (hereafter referred to as "Reference Device") indications for use to include mixed dentition, a wear time of at least 10 days, and mandibular repositioning features.

The Proposed Device consists of multiple stages of thermoformed plastic aligners designed to be worn in sequence to facilitate the movement of a patient's teeth to the final desired treatment position. The sequential stages of aligners introduce incremental move teeth by way of gentle continuous force and reposition the mandible to achieve a more optimal bite profile. The aligners are to be worn 20 to 22 hours a day and are to be removed for cleaning. Patients can be prescribed with more than one aligner of different materials within a single stage.

The Proposed Device is designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential stages of dental models are designed and approved by a physician prior to physical manufacturing. The Proposed Device includes mandibular repositioning features known as "A6" on each upper and lower aligner. A6 is intended for use in patients with growing mandibles presenting with retrognathic Class II malocclusions in permanent dentition or stable late mixed dentition.

Once the treatment plan is reviewed and approved by a dental health professional, the 3D model of each stage from the treatment plan is manufactured by 3D printed models are then thermoformed over with a suitable dental thermoplastic sheet. The final manufactured aligner stages are then delivered to the patient. The patients' dental health professional then monitors their treatment from the placement of delivered initial aligner stage to the final aligner stage.

The provided text is a 510(k) summary for a medical device (Clear Aligner) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a rigorous test set evaluation usually seen with AI/ML-enabled devices.

This document describes a "special 510(k)" submission, which is typically used for modifications to a company's own already-cleared device where the modification does not raise new questions of safety and effectiveness. In this case, the modifications are to the indications for use (adding mixed dentition, shorter wear time, and mandibular repositioning features) and material options.

The "clinical performance testing" section states: "Retrospective clinical data has been provided the Proposed Device. The data collected for the study showed that successful alignment of teeth through orthodontic treatment of misalignment and malocclusion with at 20 to 22 hours of daily wear for at least 10 days was achieved when using the Proposed Device."

This statement is very general and does not provide the quantitative details needed to fill out the requested table or address most of the specific questions about acceptance criteria and study methodology. It mentions "retrospective clinical data" and "successful alignment," but lacks specific metrics, sample sizes for the test set, ground truth creation details, expert qualifications, or MRMC study information.

Therefore, I cannot provide the requested information from the given text. The document focuses on demonstrating substantial equivalence to a predicate device based on similarities in indications for use, technological characteristics, and non-clinical performance data, rather than presenting a detailed performance study against specific acceptance criteria for a novel AI/ML algorithm.

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The STR8 Clear Aligner is indicated for the aligment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

STR8 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 20 to 22 hours a day and are to be removed for eating and for cleaning.

STR8 Clear Aligners are designed from digital scans of a patient's dentition. 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), ArchForm Treatment Planning System (K213916) will be used for this application. ArchForm 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 STR8 Oral Care 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 aligners are then provided to the patient by the prescribing dental professional group.

This document is a 510(k) premarket notification for a medical device called "STR8 Clear Aligners." It is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study showcasing AI model performance.

Therefore, the document does not contain the specific information required to answer your questions about acceptance criteria for an AI model, the study proving it meets those criteria, sample sizes, expert adjudication, MRMC studies, standalone performance, or ground truth establishment.

The document discusses the following:

• Device Description: STR8 Clear Aligners are thermoformed plastic aligners for orthodontic treatment.
• Comparison to Predicate Device: The document extensively compares the STR8 Clear Aligners to a predicate device (uLab Systems Dental Aligner Kit, K211510) across various specifications like regulation, classification, materials, indications for use, and manufacturing process. The goal is to show the new device is "substantially equivalent."
• Non-Clinical Performance Testing: This section mentions durability testing and an internal manufacturing validation to ensure dimensional accuracy (measurements within 0.3 mm of target).
• Biocompatibility Testing: Conducted according to ISO 10993-1 and ISO 10993-5.
• Clinical Performance Testing: States that no clinical studies were deemed necessary because of the similarities to the predicate device.

To directly answer your questions based only on the provided text, the answer for almost all points is that this information is not present or not applicable to an AI model evaluation.

Here's why, addressing each of your points:

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

   • Acceptance Criteria for the 510(k) process: The primary acceptance criterion here is "substantial equivalence" to a legally marketed predicate device. This is demonstrated by showing similar indications for use, technological characteristics, and materials.
   • Reported Device Performance: The document reports that for non-clinical performance testing, "All measurements were within 0.3 mm of the target input value" for manufacturing accuracy, and "no performance, cosmetic, or other detectable issues were identified" during qualitative assessment. Biocompatibility testing was also conducted and presumably met relevant standards.
   • No AI-specific acceptance criteria or performance metrics are provided.

2. Sample sized used for the test set and the data provenance: Not applicable. This document describes a 510(k) submission for a physical aligner, not an AI test set. The manufacturing validation involved assessing intraoral scans, digital models, 3D printed molds, and thermoformed aligners, but specific sample sizes for this internal validation are not detailed beyond "All measurements."

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. "Ground truth" in the context of an AI model assessment is not relevant to this submission. The "ground truth" for the device's function is its ability to align teeth as prescribed, which is assumed to be similar to the predicate based on design and materials.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human expert review/adjudication of an AI model's output is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This submission does not involve an AI assistant for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm. The device relies on a "specialized orthodontic CAD/CAM software" (ArchForm Treatment Planning System, K213916) for treatment planning, which itself has a 510(k) clearance, but this document does not evaluate its standalone performance, only its use as a tool in the aligner's manufacturing process.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the manufacturing validation, the "ground truth" was the "target input value" from the digital treatment plan. For the overall device, the implicit "ground truth" for showing substantial equivalence is the established safety and effectiveness of the predicate device (uLab Systems Dental Aligner Kit).

8. The sample size for the training set: Not applicable. This is not an AI model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a regulatory filing for a physical medical device (clear aligners) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information related to the rigorous testing and validation of an AI model.

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The Clear Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.

The Clear Aligners are intraoral thermoformed plastic aligners that are worn 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. The 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 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.

The provided text describes the 510(k) submission for the Shenzhen Meiming Dentistry Technology Co., Ltd Clear Aligner. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria related to clinical performance or an AI component.

The document primarily details non-clinical tests for manufacturing validation and biocompatibility. There is no mention of an AI algorithm or an AI-powered device, nor is there any AI-specific study described. The software mentioned (3Shape®) is for treatment planning and producing 3D printer files, which is a common CAD/CAM software used in dentistry, not an AI for diagnosis or treatment recommendation.

Therefore, many of the requested sections regarding AI-specific criteria, such as "Multi Reader Multi Case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," "adjudication method," and "sample size for the training set" cannot be answered from the provided text, as these are not relevant to this device's submission.

Here's a breakdown of the information that is available based on your request:

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)

• Manufacturing Validation Accuracy: The document states that "digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligner" were assessed, but it does not specify the sample size (e.g., number of models, molds, or aligners) used for this testing.
• Biocompatibility: The text indicates that these tests were conducted on the "material," but the sample size for these tests is not specified.
• Data Provenance: Not specified, but implied to be internal testing by the manufacturer or a contracted lab.

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

• Not applicable as this is not an AI device submission requiring expert human adjudication for a test set. The manufacturing validation used "an independent 3rd party software and digital calipers" for measurement, which implies objective measurement, not expert opinion for ground truth.

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

• Not applicable. The manufacturing validation relied on objective measurements rather than expert adjudication.

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

• No. This is not an AI device, and no MRMC study was conducted or described.

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

• Not applicable. This is not an AI device.

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

• Manufacturing Validation Accuracy: The ground truth for translational measurements was the "target input value" from the digital treatment plan. The actual measurements were then compared against this target.
• Biocompatibility: The ground truth for biocompatibility tests is based on established scientific standards and protocols for cytotoxicity, irritation, and sensitization, with results compared against these defined requirements.

8. The sample size for the training set

• Not applicable. This device does not involve an AI algorithm with a training set. The 3Shape® software mentioned is a commercial CAD/CAM treatment planning software, not a custom-trained AI model.

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

• Not applicable. This device does not involve an AI algorithm with a training set.

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

LuxCreo Clear Aligner System is custom plastic aligner system which are a series of doctor prescribed clear removable aligners that are used as alternative treatment for the alignment of maloccluded or misaligned teeth. This series of aligners gently move the patient's teeth in small increments from their original state to a treated state. A 3D printer, based on a 3D stereolithographic drawing, prints the predetermined shape of each aligner. Final polymerization is achieved by placing the printed aligner in a UV-light curing box. 3D printing uses specialty liquid resins, which help the aligners achieve mechanical properties similar to thermoplastics, and increased processability. The aligners are packaged and labeled according to the sequence in which they are intended for use, determined by the prescribing dental health professional. The finished set of aligners is shipped with six-month-shelf-life to the prescribing physician, who is accountable for ensuring the patient uses the device properly and safely.

This document is a 510(k) premarket notification for the LuxCreo Clear Aligner System and describes its substantial equivalence to predicate and reference devices. It details the device's indications for use, technological characteristics, and performance data from various tests. However, the document does not contain an acceptance criteria table with reported device performance in the context of device accuracy or clinical performance. Instead, it focuses on demonstrating substantial equivalence through comparisons of:

• Biocompatibility: The document lists several ISO 10993 tests performed (genotoxicity, cytotoxicity, subcutaneous implantation, oral mucosa irritation, pyrogenicity, skin irritation, skin sensitization, acute systemic toxicity, and sub-chronic systemic toxicity). It generally states that these tests indicated the light-cured polyurethane resin is safe to use and that the biocompatibility risks were considered.
• Physical and Mechanical Properties: The document provides values for flexural strength, flexural modulus, Shore D hardness, stress relaxation, water solubility, and water sorption for the proposed device and compares them to reference devices. The comparison often notes "Different" or "Similar" but does not explicitly state acceptance criteria or whether the new device met specific thresholds for these properties.
• Manufacturing Process and Materials: The document highlights the light-cured 3D printing process and light-cured polyurethane resin used for the LuxCreo system, comparing it to the thermoforming process and different materials of predicate devices. It states that "The difference in manufacturing process and base materials did not raise other safety and efficacy concerns" and that these differences "have been tested and validated."
• Design Verification, Validation, and Manufacturing Validation: The document broadly states that these were "completed" and "All the results meet the product specification requirements." However, specific acceptance criteria and detailed results are not provided in this summary.
• Transportation and Accelerated Aging Tests: These were validated and completed.

Based on the provided text, the following information can be extracted:

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

The document does not explicitly provide a table of acceptance criteria for device performance (e.g., accuracy, clinical efficacy metrics for orthodontic treatment) alongside the reported performance. Instead, it presents various test results for material properties and general statements regarding biocompatibility and manufacturing validation. The comparisons made are primarily to predicate and reference devices to establish "substantial equivalence," not to pre-defined performance acceptance criteria stated within this summary.

Here's a compilation of the reported physical and mechanical properties:

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

The document does not specify sample sizes for any of the tests conducted (biocompatibility, physical/mechanical properties, transportation, aging, design/manufacturing validation). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

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 in the document. The studies described are primarily material and device characterization tests, not clinical evaluations requiring expert interpretation of patient data to establish ground truth.

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

This information is not applicable and not provided. The document describes laboratory testing and validation, not studies requiring expert adjudication for a test set.

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 and not provided. The LuxCreo Clear Aligner System is a physical medical device (clear aligners) and not an AI-assisted diagnostic tool or software designed to assist human readers.

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

This information is not applicable and not provided. As mentioned above, this device is a physical clear aligner system, not an algorithm, and the application is not an AI-driven standalone system. While it states software is used for ordering workflow, the performance data provided relates to the physical characteristics and safety of the aligners themselves.

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

The concept of "ground truth" as typically applied to diagnostic algorithms or clinical outcomes data is not directly relevant to the performance data presented here. The "ground truth" for the material and physical property tests would be established by the standardized methods and measurements specified (e.g., ASTM D790, ISO 20795-2, ISO 10993 series for biocompatibility). The "truth" for these tests are the measured values themselves as determined by the specific testing protocols.

8. The sample size for the training set

This information is not applicable and not provided. The document describes a physical medical device and its material properties, not an AI/ML algorithm that requires a training set.

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

This information is not applicable and not provided for the same reasons as point 8.

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Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).

The Clear Aligner System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state.

The Clear Aligners are fabricated by thin thermoformed polyurethane or thermoformed multilayer copolyester and polyurethane composite (TPU +PETG) plastic. The corrective forces are generated via differences between current teeth arrangement and each step's aligner. They are designed to move the teeth to the target position and deliver desired clinical effect.

The traction accessory, also called "Angel Button", made of thermoplastic polyurethane can be selected and will be bonded to the outer surface of the aligner by adhesive made of acrylic polyurethane.

The provided text describes the regulatory clearance of a medical device, the "Clear Aligner," and summarizes the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. However, it does not contain the detailed information requested regarding acceptance criteria and the study proving the device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, or accuracy, which are typical for studies involving diagnostic AI/ML devices.

The document focuses on:

• Biocompatibility testing
• Software validation & risk analysis
• Performance Testing of the traction accessory and shelf life
• Real-world data for the traction accessory's effectiveness and adverse event analysis.

Based on the provided text, I can only extract information related to the non-clinical tests and their general acceptance criteria. There is no mention of a device that requires performance metrics against specific acceptance criteria like sensitivity/specificity or accuracy in the way described in your request. The device in question is a clear aligner for orthodontic treatment, not an AI/ML-driven diagnostic tool.

Therefore, many of your specific numbered requests cannot be directly answered from this document.

Here's an attempt to answer based on the available information, noting where information is missing:

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

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