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The Invisalign® System is intended for the orthodontic treatment of malocclusion in patients with primary, mixed (primary and permanent), or permanent dentition. The optional mandibular advancement feature(s) are indicated for the treatment of skeletal malocclusion in patients with mixed or permanent dentition.

The subject device Invisalign® System is a proposed modification to add integrated button, an optional feature into the predicate device, Invisalign System (K241412). The Invisalign® System consists of removable orthodontic appliances (aligners) and proprietary 3D treatment planning software. This submission adds an optional integrated button to aligners which is similar to the predicate device's precision cut feature that allows doctors to add orthodontic accessories such as elastics during treatment. The 3D treatment planning software allows the visualization and button placement on the aligners. The doctor still approves the treatment plan prior manufacturing, which is the same as that in the predicate.

Like the predicate device, the Invisalign® System consists of a series of doctor prescribed, customized, thin, clear plastic aligners that gently move the patient's teeth in small increments from their original state to a more optimal, treated state to address malocclusion. The optional MAF positions patients jaw forward to address skeletal malocclusion. The system is used in patients with primary, mixed, and permanent dentition. There are no changes introduced to the user workflow other than the addition of optional integrated button feature.

This FDA 510(k) clearance letter describes a modification to an existing medical device, the Invisalign System. It does not contain the detailed information typically found in a study report for proving device performance against acceptance criteria, especially for AI/software devices. The provided text primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device for an additional physical feature (integrated button) rather than a software-driven performance claim that would necessitate a rigorous clinical or performance study with acceptance criteria and specific test methodologies for AI.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document because such a study, in the context of an AI/software device, does not appear to be the primary focus of this specific 510(k) submission as presented. The submission is for a physical device modification, not a new AI algorithm.

However, based on the information provided, here's what can be inferred or stated that such an approval did not involve:

Summary of Device Performance Study Based on Provided Text:

This 510(k) clearance letter for the Invisalign System (K252380) primarily concerns a modification to an existing device, specifically the addition of an "integrated button" feature to the aligners. The regulatory pathway is based on substantial equivalence to a predicate device (Invisalign System, K241412). The "study" described is a set of non-clinical tests to demonstrate that this physical modification does not negatively impact the device's safety and effectiveness. It does not present a study proving the performance of an AI/software component against acceptance criteria in the typical sense of a diagnostic or therapeutic AI device.

Therefore, most of the requested information regarding AI algorithm performance (e.g., sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable or not provided in this document.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The subject device, Invisalign® System underwent a complete set of functional and performance testing, including durability, shear bond, retention, and biocompatibility testing. All testing passed acceptance criteria and demonstrated the device modification does not affect the safety and effectiveness of Invisalign® System and does not raise any new questions of safety and effectiveness."

However, the specific quantitative acceptance criteria and the corresponding reported performance values for these tests (durability, shear bond, retention, biocompatibility) are not detailed in this 510(k) summary. These are typically listed in an internal test report, not the public-facing FDA clearance letter.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (since the tests are physical and chemical, not clinical data for an AI algorithm).
• Retrospective/Prospective: Not specified.

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

• Not Applicable. The described tests (durability, shear bond, retention, biocompatibility) are laboratory-based engineering and materials tests, not clinical evaluations requiring expert consensus on a test set of patient data as would be the case for an AI diagnostic device.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3.

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

• No. This document does not mention an MRMC study. The device modification is a physical feature (integrated button) and its impact on human readers or clinical interpretation in an AI-assisted workflow is not discussed.

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

• No, not in the context of AI algorithm performance. The "Invisalign System" does include "proprietary 3D treatment planning software," and this submission notes the software allows "visualization and button placement on the aligners." However, the 510(k) focuses on the physical button's safety and effectiveness, not a new or modified AI algorithm's standalone performance. The software's role is described as "the doctor still approves the treatment plan prior manufacturing," indicating a human-in-the-loop scenario. No standalone algorithm performance evaluation is detailed.

7. The Type of Ground Truth Used:

• For the physical tests (durability, shear bond, retention, biocompatibility): The ground truth would be established through scientific measurement standards and validated laboratory methodologies (e.g., ISO standards for materials testing).
• For any software component related to the new feature: The ground truth for software functionality (e.g., correct button placement visualization, accurate manufacturing instructions) would internally be established through testing against design specifications and requirements. This is not detailed in the document.

8. The Sample Size for the Training Set:

• Not Applicable/Not Specified. This document does not describe the development or training of a new AI algorithm. If the "proprietary 3D treatment planning software" utilizes machine learning, its training set details are not provided as part of this specific 510(k) for a physical modification.

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

• Not Applicable/Not Specified. See point 8.

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This product is suitable for making invisible orthodontic appliances by additive manufacturing (light curing 3D printing) process. The orthodontic appliance is designed for orthodontic treatment. It uses continuous gentle force to adjust tooth position, correct malocclusion, and maintain the results of completed orthodontic treatment.

It can also be used for printing splints and night guards.

Additively Manufactured Aligner Resin 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.

Additively Manufactured Aligner Resin is a light-curing resin used to print orthodontic appliances. The resin is a light yellow transparent liquid. The appliance printed by a 3D printer is de-supported, cleaned and post-cured to obtain an orthodontic appliance that can correct the patient's malocclusion. This product is a light-curing 3D printing resin composed of acrylate resin oligomers and acrylate monomers as well as initiators and additives.

Additive manufacturing (light cured) orthodontic resin is a light cured acrylic resin commonly used in the manufacture of orthodontic appliances. The resin is stored in a black HDPE bottle according to the weight of the resin liquid. The color of the resin is colorless or yellowish liquid, polymerized by UV light at 385 nm or 405 nm.

The provided FDA 510(k) clearance letter details the clearance of an "Additively Manufactured Aligner Resin." This document is for a material, not a diagnostic AI device. Therefore, the information typically requested in a description of an AI device's acceptance criteria and study proving its performance (e.g., sample sizes for test and training sets, number of experts establish ground truth, MRMC studies, standalone performance) is not applicable to this submission.

The acceptance criteria and supporting studies for this material device primarily focus on bench testing (physical and mechanical properties), biocompatibility, sterility, and shelf-life. The purpose of these tests is to demonstrate that the new aligner resin is safe and effective for its intended use, comparable to already marketed predicate devices.

Here's an interpretation of the relevant information provided:

Acceptance Criteria and Performance of "Additively Manufactured Aligner Resin"

As this is a material device, the "acceptance criteria" are based on meeting established international standards for dental materials and demonstrating comparable or superior performance to existing predicate devices. The "study that proves the device meets the acceptance criteria" refers to the non-clinical bench testing, biocompatibility testing, and shelf-life testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

The primary standard referenced for mechanical characteristics is ISO 20795-2:2013 Dentistry – Base polymers – Part 2: Orthodontic base polymers. The acceptance criteria for each property are implicitly defined by the requirements of this standard, and the device's performance is reported as meeting these requirements or being comparable to predicate devices.

*Note: For Flexural Modulus and Ultimate Flexural Strength, the subject device's performance was statistically significantly higher than the predicate, which is considered an improvement and not an adverse difference in terms of safety or effectiveness for the material properties. For Water Solubility and Sorption, slight differences were observed but all conformed to the ISO standard.

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

The document does not specify the exact sample sizes for each mechanical property test (e.g., number of specimens tested for flexural strength). This level of detail is typically found in the full testing report, not the 510(k) summary. However, tests were conducted as "bench testing" meaning in a laboratory setting. The data provenance is implied to be from the manufacturer's internal testing facilities, Aidite (Qinhuangdao) Technology Co., Ltd., which is based in China. The testing is retrospective in the sense that it's pre-market validation performed on manufactured material samples.

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

This question is not applicable as this is a material device and not an AI or diagnostic device that requires expert-established ground truth for a test set. Ground truth for material properties is established by objective physical and chemical testing methods adhering to international standards (e.g., ISO, ASTM).

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

This question is not applicable as there is no human interpretation or subjective assessment being performed that would require an adjudication method. The testing results are quantitative 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

This question is not applicable. An MRMC study is relevant for diagnostic AI devices where human readers (e.g., radiologists) interpret images with and without AI assistance. This submission is for a dental material.

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

This question is not applicable. There is no algorithm or software for standalone performance evaluation in this material device submission.

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

The "ground truth" for this material device is established by objective, standardized laboratory testing methods against pre-defined specifications and international material standards (e.g., ISO 20795-2:2013). This is analogous to a "gold standard" for material properties.

8. The sample size for the training set

This question is not applicable. This is a material device, not an AI/machine learning model, and therefore does not have a "training set" in the computational sense.

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

This question is not applicable for the same reason as point 8.

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Clear Miracle is a clear orthodontic appliance designed to treat malocclusions in patients with permanent dentition (i.e., all second molars). It uses a series of gradual tooth movements to position teeth sequentially with continuous gentle force. Clear Miracle is intended for professional use only.

Clear Miracle is a methacrylate-based resin designed for creating clear, light-cured aligners. It is supplied in 250-gram bottles made of high-density polyethylene (HDPE) and is a light yellow in color. Exposure to ultraviolet (UV) light within the 405–412-nanometer (nm) wavelength range causes the liquid resin to solidify into a three-dimensional structure. The resin contains a photoinitiator that begins the curing process at wavelengths between 405 and 412 nm. During additive manufacturing, Clear Miracle forms 50-μm-thick layers, achieving a resolution of 0.022 mm in the X and Y axes. This ensures the creation of high-precision orthodontic aligners through a layer-by-layer curing process.

This document is a 510(k) Clearance Letter from the FDA for a medical device called "Clear Miracle," an orthodontic clear aligner. According to the document, clinical testing was not required for this device due to its substantial equivalence to a predicate device. Therefore, the provided text does not contain information about explicit acceptance criteria for device performance based on a study, a test set, expert involvement, or any human-in-the-loop (MRMC) or standalone algorithm performance studies.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (TERA HARZ CLEAR, K223355) through non-clinical testing and comparison of technological characteristics.

Here's a breakdown of the information that can be extracted or inferred, and what cannot:

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

The document doesn't explicitly state "acceptance criteria" in the sense of predefined thresholds for a clinical study that the device must meet to prove its efficacy/safety in real-world scenarios. Instead, it reports performance values obtained from non-clinical mechanical property tests and compares them to the predicate device's values and relevant ISO standards. The implicit "acceptance criteria" here are that the 'Clear Miracle' device performs at least as well as the predicate device or meets the relevant ISO standard requirements.

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

• Test Set (for performance validation): The document does not specify a "test set" in the context of patient data or clinical cases. The "testing" referred to is laboratory-based non-clinical testing of materials and manufacturing processes. Therefore, information about patient sample sizes or their provenance (country, retrospective/prospective) is not applicable/provided.
• The mechanical properties tests were conducted on "specimen plates" as per ISO 20795-2:2013. The exact number of specimens tested for each characteristic is not provided in this summary.

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

• Not applicable/provided. As there was no clinical study testing the device's performance against human ground truth (e.g., diagnostic accuracy), there were no experts establishing ground truth in that sense. The "ground truth" for the non-clinical tests is based on the methods and measurements defined by the ISO standards.

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

• Not applicable/provided. No adjudication method was mentioned as there was no clinical reading or expert review process involved.

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. The device "Clear Miracle" is described as a "clear orthodontic appliance" made of resin, a physical device, and not an AI/software. Therefore, no MRMC study or AI assistance evaluation would be relevant or conducted for this type of product.

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

• Not applicable. See point 5. This is a physical medical device, not an algorithm.

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

• For the non-clinical mechanical property tests, the "ground truth" is established by the measurement standards and methodologies prescribed by ISO 20795-2:2013. This involves precise laboratory measurements of physical properties.

8. The sample size for the training set:

• Not applicable/provided. There is no "training set" in the context of machine learning for this physical device. The manufacturing process does involve "optimization" and "validation" of print parameters, but this is not a machine learning training process.

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

• Not applicable/provided. As there's no training set for an AI model, this question is not relevant.

In summary:

This FDA clearance for "Clear Miracle" is for a physical medical device (orthodontic aligner resin), not an AI/software product. The substantial equivalence determination was primarily based on non-clinical laboratory testing against well-established international standards (ISO 20795-2:2013, ISO 10993-1) and direct comparison of its material properties and manufacturing process with a previously cleared predicate device. Therefore, many of the questions related to clinical trials, AI performance, expert review, and ground truth establishment in a diagnostic context are not relevant to this specific device clearance.

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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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Fas Aligner System is intended for the orthodontic treatment of malocclusion.

Fas Aligner System consist of a series of customized removable plastic orthodontic appliances which sequentially reposition teeth by way of continuous gentle force. This removable plastic orthodontic aligners intended as an alternative to conventional wire and bracket technology. Fas Aligner System 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).

Fas Aligner System 's staff in the Prescription and Planning area create the virtual planning including the attachments, as well as the movements they consider necessary to achieve the intended tooth correction. For this process the following previously released software Nemocast (K232549).

The 3D specialists use the planned data to produce the complete product design. The responsible of the Planning/Prescription department reviews the design to verify that it has been done as required and, if necessary, proposes changes.

Once the design has been approved by the clinician, the next phase of printing and preparation of models is carried out. This phase takes place in the Printer Room and is carried out by 3D Printing Technicians. For the entire manufacturing process, the models are identified with the clinical case number.

The thermoforming equipment is used for the manufacturing process of the aligners. The printed model is placed on the platform and the thermoforming sheet is placed, which is made with material previously released by means of the K200125 (Erkodur).

Once the printed thermoforming sheet is obtained, the contour of the thermoforming sheet is cut out, eliminating the edges. The gingival margins are trimmed.

The product is not sent sterile, it is cleaned to remove all residues that may have remained from the manufacturing process.

The product, the splint, is placed in labeled bags. The aligners are sent back to the dentist for distribution to the patient in sequential stages and that the dentist checks the aligners for fit and function and monitors the treatment from the first aligner until treatment is completed.

This document is a 510(k) Pre-Market Notification from the FDA regarding the "Fas Aligner System." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the Fas Aligner System itself. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for the Fas Aligner System is not explicitly provided in this document.

However, based on the non-clinical testing summary, we can infer some information about general performance and safety criteria, primarily through comparison to the predicate device and relevant standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for substantial equivalence, the "acceptance criteria" for the Fas Aligner System are primarily that its technological characteristics and performance are comparable to the predicate device, Nuvola® Aligner (K222418), and that it meets relevant safety standards.

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

• Test Set Sample Size: Not applicable/Not provided for the Fas Aligner System in this document. The document describes non-clinical testing (durability, manufacturing validation, biocompatibility) but does not refer to a "test set" of patient data for performance evaluation in the way a clinical study would.
• Data Provenance: The durability and manufacturing validation tests were "internal." The biocompatibility testing followed ISO standards. The material characterization references K200125, which would contain its own original data provenance.

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

• This information is not provided as no clinical or comparative performance study using human readers/experts to establish ground truth is described. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles for material properties, manufacturing robustness, and biocompatibility, as verified by technical personnel during the internal tests.

4. Adjudication Method for the Test Set

• Not applicable/Not provided as there is no described test set requiring human adjudication.

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

• No, a MRMC comparative effectiveness study was not conducted or presented in this submission. The document explicitly states: "No clinical testing was performed in support of this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone performance study of the Fas Aligner System (as a whole device) or its underlying planning algorithm was not conducted or presented. The submission focuses on the substantial equivalence of the physical aligners and manufacturing process, and acknowledges the use of FDA-cleared Nemocast software for planning, but does not present a standalone performance evaluation of that software in the context of this submission.

7. Type of Ground Truth Used

• For the non-clinical tests described:
  • Durability and Manufacturing Validation: The "ground truth" would be established engineering specifications and internal quality standards for mechanical integrity and process robustness as validated through internal testing.
  • Material Characterization: Scientific and engineering standards for material properties.
  • Biocompatibility: International standard ISO 10993-1 and ISO 10993-5, representing accepted biological safety benchmarks.

8. Sample Size for the Training Set

• Not applicable/Not provided. This submission does not describe a machine learning algorithm developed by Xplora 3D Europe S.L. for which a training set would be relevant. The planning software mentioned (Nemocast) is a previously cleared device (K232549), and any training data for that software would have been part of its original submission.

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

• Not applicable/Not provided. See point 8.

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Cristaline Aligners A FLX are series of clear, lightweight, plastic appliances, indicated for treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous force.

Cristaline Aligners Z FLX 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 manufactured using a biocompatible thermoplastic sheet composed of a composite of co-polyester 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 a digital file (scan) of the patient's teeth to Cristaline. Based on the dental health professional's treatment plan, Cristaline 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 formed on the molds. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design.

The provided document is a 510(k) Premarket Notification from the FDA for a device called "Cristaline Aligners Z FLX." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with specific acceptance criteria as might be seen for novel devices.

Therefore, the document does not contain information regarding traditional acceptance criteria or a study that proves the device meets such criteria in the way a clinical trial would. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously cleared predicate device.

Here's an breakdown of the relevant information provided, specifically addressing your numbered points, and highlighting what is not applicable in this context:

1. A table of acceptance criteria and the reported device performance:
   As this is a 510(k) submission, there are no specific performance acceptance criteria or reported device performance metrics in the way a clinical study would define them (e.g., sensitivity, specificity, accuracy against a gold standard). The "acceptance criteria" here are met by demonstrating substantial equivalence to a predicate device.

   The table on pages 4 and 6 titled "SUBSTANTIAL EQUIVALENCE CONCLUSION" and "Substantial Equivalence Comparison Table" serves to compare the new device to the predicate device across various characteristics.

   Implicit "Acceptance Criteria" and "Reported Performance" (as per 510(k) standards):

   Characteristic	Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate)	Reported Device Performance (as demonstrated by comparison)
   Indications for Use	Same as predicate device (Blue Sky Bio Aligner Z and Blue Sky Bio Z FLX).	"Same for the Z FLX Aligner."
   Mode of Action	No differences from predicate device (removable appliance applies continuous gentle forces on teeth).	"No differences."
   Description of Use	No differences from predicate device (removable preformed plastic tray worn by patient for 1-2 weeks, prior to next sequential aligner tray).	"No differences."
   Material	Same as predicate device (Blue Sky Bio Aligner Z FLX - Thermoplastic co-polyester polyurethane composite).	"No differences."
   Manufacturing Process	Processes used are standard in the field and similar to predicate's (forming plastic sheets on 3D printed dental models designed with treatment planning software). Does not raise new questions of safety/effectiveness.	"Manufacturing processes used are standard in the field and similar to predicate's." Any differences do not raise new questions of safety and effectiveness.
   Software	Same commercially available treatment planning software as predicate.	"Same software is used."
   Prescription Use	Both are prescription use (Rx).	"Both are Rx."
   Biocompatibility	Testing to meet requirements for Category C, relying on the same testing performed by the thermoplastic material manufacturer as the predicate.	"Relied on the same testing performed by thermoplastic material manufacturer." (Passed In vitro Cytotoxicity, Oral Mucosal Irritation, Skin Sensitization per ISO 10993).
   Process Validation	Validation to determine fit and form of manufactured aligners, similar to predicate testing.	"Similar testing performed." (Bench testing performed to validate manufacturing process accuracy against digital scans).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   This document focuses on demonstrating substantial equivalence through comparison of materials, design, and manufacturing processes, rather than a clinical "test set" in the traditional sense.

   • Test Set Sample Size: Not applicable. The "testing" involved biocompatibility and bench testing.
   • Data Provenance:
     • Biocompatibility testing: Performed by a GLP-certified contract research laboratory. No specific country of origin is mentioned for the data, but the submitter (Cristaline Aligners GmbH) is based in Pforzheim, Germany.
     • Bench testing: Performed by the submitter. No specific country of origin is mentioned for the data.
     • The basis for substantial equivalence is comparison to the predicate device (Blue Sky Plan Software, Blue Sky Bio Aligner Z and Blue Sky Bio Z FLX; Blue Sky Bio, LLC).

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 as established by experts for a specific performance metric (like diagnostic accuracy) is not relevant to this 510(k) submission, which relies on engineering and biological safety testing, and comparison to a predicate device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable. There was no clinical "test set" requiring 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:
   Not applicable. This device is an orthodontic aligner, not an AI diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is an orthodontic aligner. While its manufacturing involves "commercially available treatment planning software," the filing describes the aligner itself, not the software as a standalone AI algorithm for diagnostic purposes. The software is part of the manufacturing process to create the physical aligners.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable in the context of clinical performance ground truth. The "ground truth" for this submission revolves around:

   • Biocompatibility standards (ISO 10993).
   • Engineering validation of manufacturing accuracy against digital scans.
   • The established safety and effectiveness of the legally marketed predicate device.

8. The sample size for the training set:
   Not applicable. This is not an AI/ML device that undergoes a training phase with a specific dataset.

9. How the ground truth for the training set was established:
   Not applicable. As above, this is not an AI/ML device with a training set.

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