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510(k) Data Aggregation
(198 days)
Inman Digital Clear Aligners
Inman Digital Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The Inman Digital Clear Aligners position teeth by way of continuous gentle force.
The Inman Digital Clear Aligners consist of a series of dental-clinician prescribed customized clear plastic removable orthodontic aligner trays that are made from a clear, thin thermoformed polyurethane. A dental clinician prescribes the aligners based on an evaluation of the patient's teeth. Either intraoral scans or physical impressions of the patient's teeth are provided to Inman Orthodontic Lab by the dental clinician, along with the prescription. The series of plastic aligner trays are designed according to the prescription using standard dental software for planning the tooth alignments. The software used is 3Shape Ortho System (Reference device K152086). It is used for managing 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements and design of a variety of orthodontic appliances based on 3D scanned orthodontic models. After the plan is developed by Inman Orthodontic Lab, the prescribing dental clinician reviews and approves the model scheme before the molds are produced. Following approval, the customized aligner trays are fabricated by Inman Orthodontic Lab by press thermoforming of the material on the molds using standard thermoforming equipment. The trays are provided to the dental clinician who provides them to the patient assuring fit and function during the entire treatment period.
The provided document is a 510(k) summary for the Inman Digital Clear Aligners. It describes the device's indications for use, its description, and a comparison to a predicate device to establish substantial equivalence. The document details performance testing related to material properties, packaging, and manufacturing process validation, as well as biocompatibility testing.
However, this document does not contain information about a study that uses a test set, expert ground truth, or statistical measures of performance (like sensitivity, specificity, or AUC) for the Inman Digital Clear Aligners in the context of an AI/ML device.
The "Performance Testing" section (page 5) refers to:
- Laboratory Testing: Mechanical properties of the aligner material, moisture barrier properties of the packaging, and validation of design/manufacture processes. These tests are about the physical properties and manufacturing quality of the device, not its clinical diagnostic or treatment planning performance in a setting that would involve AI/ML output validation against expert consensus.
- Biocompatibility: Testing of the thermoplastic polyurethane material according to ISO 10993.
The document explicitly states: "Neither animal nor human testing are needed for this device because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device." This indicates that the 510(k) relies on substantial equivalence to a predicate device, rather than a de novo clinical performance study against specific acceptance criteria for a new and innovative AI/ML feature.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device. The device described is a physical medical device (clear aligners) and its regulatory submission focuses on material properties, manufacturing, and substantial equivalence to a predicate device.
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(30 days)
Smylio Invisible Clear Aligners
The Smylio Invisible Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.
The Smylio Invisible Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement 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.
Smylio Invisible Clear Aligners are designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential dental models are designed and approved by the treating physician prior to manufacturing.
Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligner trays are then delivered to the patients' dental health professional then monitors their treatment of the first aligner to the delivery of the final aligner.
The provided text is a 510(k) Premarket Notification summary for Smylio Invisible Clear Aligners. It focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and non-clinical performance testing. Crucially, the document explicitly states that "Clinical performance testing was not conducted for this 510(k) Notification." Therefore, there is no study described that proves the device meets acceptance criteria through clinical performance.
The "acceptance criteria" discussed in this document pertain to demonstrating substantial equivalence to existing legally marketed devices, rather than a direct evaluation of clinical efficacy or safety against performance metrics. The proof of meeting these "acceptance criteria" comes from the comparisons made in the tables and the statement that non-clinical testing was sufficient.
Here's an analysis based on the information provided, specifically addressing the questions you raised, while acknowledging the absence of a clinical study:
1. A table of acceptance criteria and the reported device performance:
Since no clinical performance study was conducted, there aren't "acceptance criteria" in the traditional sense of clinical endpoints (e.g., bone density improvement, disease detection accuracy). Instead, the "acceptance criteria" for this 510(k) submission are implied by the comparison to predicate devices, demonstrating equivalence in various specifications, materials, and non-clinical testing.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Comparison to Predicates) |
|---|---|
| Regulation Number: Same regulation number as predicate (21 CFR 872.5470) | Same (21 CFR 872.5470) |
| Classification Name: Same classification name as predicate (Orthodontic Plastic Bracket) | Same (Orthodontic Plastic Bracket) |
| Product Code: Same product code as predicate (NXC) | Same (NXC) |
| Classification: Same classification as predicate (Class II) | Same (Class II) |
| OTC or Rx: Same prescription status as predicate (Rx) | Same (Rx) |
| Material: Same as predicate (Thermoplastic polyurethane-polyester composite resin) or similar acceptable material. | Same as primary predicate; material for reference predicate is Co-polyester or co-polymer, but stated "Same as predicate" due to the subject device matching the primary predicate. |
| Material Properties: Acceptable for use as an aligner. | Acceptable materials properties established for use as an aligner (same as predicates). |
| Material Testing: Compliance with ASTM D790-10 for flexural properties. | ASTM D790-10 testing conducted and found compliant (same as predicates). |
| Biocompatibility: Biocompatible according to ISO 10993-1. | Biocompatible according to ISO 10993-1 (same as predicates). Additional cytotoxicity testing per ISO 10993-5:2009 performed on final product. |
| Sterility: Matching predicate status (Non-sterile). | Non-sterile (same as predicates). |
| Device Description: Sequential thermoformed plastic aligners. | Sequential thermoformed plastic aligners (same as predicates). |
| Patient Removable: Yes. | Yes (same as predicates). |
| Indication for Use: Indicated for alignment of teeth during orthodontic treatment of malocclusion (same as predicate). | Same as primary predicate. Differences from reference predicate ("alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion") do not raise substantial equivalence questions. |
| Intended Use: Orthodontic tooth movement. | Same (same as predicates). |
| Mode of Action: Continuous gentle force applied to teeth. | Same (same as predicates). |
| Durability Testing: Simulate real-world use to ensure suitability for prescribed period of use. | Durability testing was conducted, and the aligner material and manufacturing process produced suitable aligners. |
| Manufacturing Validation: Robustness of the process from 3D printing through thermoforming. | Internal manufacturing validation performed and robustness demonstrated. |
2. Sample size used for the test set and the data provenance:
- Test Set (Clinical): Not applicable. No clinical performance test set was used, as explicitly stated: "Clinical performance testing was not conducted for this 510(k) Notification."
- Non-Clinical Testing: The document refers to "durability testing" and "material characterization" (ASTM D790-10, ISO 10993-1, ISO 10993-5) but does not provide specific sample sizes for these tests. Data provenance for non-clinical tests is internal to Smylio, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Since no clinical test set was used, there were no experts establishing ground truth for evaluating clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical 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:
- Not applicable. This device is a physical aligner, not an AI-assisted diagnostic or treatment planning tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical aligner. Performance is demonstrated through material properties and design, not an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For demonstrating substantial equivalence: The "ground truth" used are the established characteristics and performance metrics of the legally marketed predicate devices (Spark Clear Aligner System K203737 and Smylio Invisible Clear Aligners K173784).
- For non-clinical testing: The "ground truth" is based on industry standards (ASTM D790-10, ISO 10993-1, ISO 10993-5) for material properties and biocompatibility, as well as internal validation procedures for manufacturing robustness.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set. The "design" is based on established orthodontic principles and the design of predicate devices. Patient-specific aligners are manufactured based on individual patient digital scans.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
In summary, the provided document describes a 510(k) submission where substantial equivalence for a physical medical device (clear aligners) is demonstrated through a comparison of design, materials, indications for use, and non-clinical testing to legally marketed predicate devices. No clinical performance study was conducted or deemed necessary for this submission.
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(200 days)
Clear Aligners
This device is indicated for use in the alignment of all permanent dentition through orthodontic treatment and malocclusion.
The Clear Aligner is intraoral thermoformed plastic aligner that worn 20 to 22 hours per day and is 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 aligner is to be removed for eating and for cleaning.
Clear Aligner is fabricated using a three-step process.
The first step is to obtain the dimensions and details of the patient's baseline dentition from the prescribing clinician who takes impressions or scans of the patient's teeth and sends them to the lab. The scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning.
The second step is to sent the treatment plan to the dentist for review and approval, then print the 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, we utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. A 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed.
The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission. And the thermoformed 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.
Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printer files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation is this submission is the 3Shape Ortho System ™ Software which have 510(k) (K152086).
The provided text is a 510(k) Summary for a medical device (Clear Aligners). While it details non-clinical studies and testing, it explicitly states that no clinical studies or tests were conducted (Section 11). This means the information requested regarding a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or the establishment of ground truth for training/test sets based on expert consensus or pathology data is not applicable and not present in this document.
The document focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical performance testing related to manufacturing validation and biocompatibility.
Here's a breakdown of the available information based on your request:
1. Table of acceptance criteria and reported device performance
The document contains a table comparing the subject device to a predicate device, but it's not a table of acceptance criteria and reported performance in the traditional sense of a clinical or AI study. Instead, the "acceptance criteria" for the manufacturing validation are described in the text.
Manufacturing Validation Acceptance Criteria & Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All translational measurements within 0.3mm of target input value | All translational measurements were within 0.3mm of the target input value. |
| All rotational measurements within 3 degrees of target input value | All rotational measurements were within 3 degrees of the target input value. |
| No statistical differences in the intended and measured values observed from any of the groups | There were no statistical differences in the intended and measured values observed from any of the groups. (Implicitly met based on the above) |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated as a numerical count of aligners or patients. The text mentions "Three critical aspects of the manufacturing process were assessed: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligner." This implies a set of these items were tested, but no specific quantity is given.
- Data provenance: Not specified. It's implied this was internal testing performed by the manufacturer. The location of the test (if external) is not mentioned beyond the manufacturer's address in Shenzhen, China. The document does not specify if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for the manufacturing validation was established by measurements against target input values using "an independent 3rd party software and digital calipers," not by human expert assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the ground truth was based on physical measurements, not human interpretation 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
No MRMC study was done. The document explicitly states: "Clinical studies and tests were not conducted." (Section 11)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device (Clear Aligner) is a physical medical device, not an AI algorithm. The 3Shape Ortho System™ Software is mentioned as a reference device used in the manufacturing process (for treatment planning and generating 3D printer files), but no performance study of this software itself (standalone or otherwise) is presented in this 510(k) summary for the Clear Aligner. The manufacturing validation assessed the output of the process that uses the software, not the software's performance as an AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the manufacturing validation was target input values from the treatment plan, against which physical measurements of the produced aligners/molds were compared. These are physical measurement standards.
8. The sample size for the training set
Not applicable. This document describes the validation of a manufactured medical device, not the training of an AI model.
9. How the ground truth for the training set was established
Not applicable, as there was no AI model training set.
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(122 days)
BRIUS Clear Aligners
BRIUS Clear Aligners are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.
The BRIUS Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 2 0 to 22 hours a day and are to be removed for eating and for cleaning.
BRIUS Clear Aligners are designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, specialized orthodontic CAD/CAM software will be used to develop the treatment plans that consist of sequential dental models wherein the teeth are gradually realigned with each step. For this 510(k), 3Shape A/S's Ortho System (K180941) will be used for this application. Ortho System is approved for use in the management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options. The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470.
Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligner trays are then delivered to the prescribing dental health professional. This dental health professional then monitors treatment from the placement of the first aligner to the delivery of the final aligner and completion of treatment.
The provided text from the FDA 510(k) summary for BRIUS Clear Aligners (K202792) primarily focuses on establishing substantial equivalence to a predicate device through comparison of specifications and non-clinical performance testing. It does not describe a study involving expert readers or AI performance in the typical sense of diagnostic or prognostic devices.
Instead, the non-clinical performance testing described is related to the manufacturing process and material properties of the aligners themselves. Therefore, the requested information elements related to AI performance, expert consensus, sample sizes for test/training sets in an AI context, MRMC studies, or standalone performance are not applicable based on the provided document.
Here's a breakdown of the applicable information based on the provided text, adapted to the context of the device's manufacturing and material validation:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported performance relate to the manufacturing validation of the BRIUS Clear Aligners.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Dimensional Accuracy: All measurements within 0.3 mm of the target input value. | All measurements (point-to-point and critical displacement) were within 0.3 mm of the target input value, the predefined tolerance of the manufacturing process. |
| Qualitative Assessment: No performance, cosmetic, or other detectable issues identified. | Throughout the qualitative assessment of the aligners, no performance, cosmetic, or other detectable issues were identified. |
| Biocompatibility: Meet ISO 10993-1 and ISO 10993-5 standards. | Biocompatibility testing for the aligner material (Essix thermoplastic) was conducted by the 510(k) holder of the material in accordance with ISO 10993-1. Additional cytotoxicity testing according to ISO 10993-5:2009 was performed on final manufactured BRIUS Clear Aligners. |
2. Sample Size for the Test Set and Data Provenance
The document mentions an "internal manufacturing validation" but does not specify a numerical sample size for the aligners tested for dimensional accuracy and qualitative assessment.
- Test Set Sample Size: Not explicitly stated as a numerical value. The study refers to "the submitted intraoral scans, digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners" being assessed, implying a collection of these components.
- Data Provenance: The validation was an "internal manufacturing validation," indicating it was conducted by BRIUS Technologies, Inc. or their associated entities. The origin country is not specified, but the company is based in Carrollton, TX, USA. It is a retrospective assessment of manufactured products against internal specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the validation was for manufacturing accuracy and material properties, not for diagnostic or prognostic AI performance requiring expert review of medical images or data. The "ground truth" was the target input values for measurements and predefined specifications for qualitative attributes.
4. Adjudication Method for the Test Set
This information is not applicable. The assessment involved objective measurements (digital calipers and 3rd party software) and qualitative visual inspections against predefined specifications, rather than an adjudication process typically used for subjective expert panel reviews.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this device is a clear aligner, not an AI software intended to assist human readers in a diagnostic task.
6. Standalone Performance Study (Algorithm Only)
A standalone algorithm performance study was not performed in the context of AI. The "manufacturing validation" described is a standalone assessment of the physical product's adherence to specifications.
7. Type of Ground Truth Used
- For Dimensional Accuracy: The ground truth was the "target input value" (digital design specifications) from the orthodontic CAD/CAM software (3Shape A/S's Ortho System).
- For Qualitative Assessment: The ground truth was predefined performance, cosmetic, and other detectable issue specifications.
- For Biocompatibility: The ground truth was adherence to international standards (ISO 10993-1 and ISO 10993-5).
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical device (clear aligner) whose manufacturing process was validated, not an AI algorithm that requires a training set. The orthodontic CAD/CAM software used (3Shape A/S's Ortho System) would have its own development and validation, but that is not the subject of this 510(k) for the BRIUS Clear Aligners.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
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(55 days)
NEOLab Clear Aligners
NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The NEOLab Clear Aligners position teeth through the use of continuous gentle force.
NEOLab Clear Aligners consist of a series of customized clear plastic removable aligners that are fabricated from a clear, thin thermoformed polyurethane-polyester resin, and are intended to be worn 22 hours a day. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state.
The provided document (K203339) is a Special 510(k) summary for the NEOLab Clear Aligners. It focuses on demonstrating substantial equivalence to a predicate device (Ormco Spark Aligner System, K182826) by showing that the new device has the same intended use, similar technological characteristics, and meets material and manufacturing specifications.
However, this document does NOT describe the acceptance criteria and the study that proves a device (e.g., an AI-powered device or a diagnostic device) meets specific performance criteria through a clinical or algorithmic performance study.
The testing described in this document is primarily related to:
- Mechanical properties of the aligner material: Ensuring it meets specifications for shelf life.
- Validation of manufacturing processes: Confirming the custom aligner fabrication.
- Biocompatibility testing: According to ISO 10993 standards for the thermoplastic polyurethane-polyester resin and the finished aligner.
There is no mention of a study involving:
- A test set of data (e.g., medical images, patient records).
- Any form of algorithm performance evaluation (e.g., accuracy, sensitivity, specificity, AUC).
- Human expert readers establishing ground truth.
- Multi-reader multi-case (MRMC) studies.
- Effect sizes of human reader improvement with AI assistance.
- Stand-alone algorithm performance.
Therefore, I cannot populate the requested table and information based on the provided text, as the document does not contain the study details you are asking for.
The document states:
- "Test data were submitted to: Assure the aligner mechanical properties of the aligner material meet specifications for up to 5 years shelf life; Validate the processes used for the design and manufacture of the customized aligners."
- "Biocompatibility: The thermoplastic polyurethane-polyester resin used for making the aligner series has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993..."
- "This testing showed that the material and manufactured aligner met the acceptance criteria, passed the respective tests, and are safe and biocompatible for the stated intended use."
This indicates that acceptance criteria existed for the material properties and biocompatibility, but these are not performance metrics for a diagnostic or AI device that interacts with patient data in the way implied by your questions about ground truth, expert readers, and test sets.
To fulfill your request, the document would need to describe a study evaluating the performance of a device, for example, an AI algorithm that analyzes orthodontic scans, or a diagnostic tool. Since this is a 510(k) for physical clear aligners, the type of performance evaluation differs significantly.
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(197 days)
NEOLab Clear Aligners
NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The NEOLab Clear Aligners position teeth through the use of continuous gentle force.
NEOLAB Clear Aligners consist of a series of customized clear plastic removable aligners that are fabricated from a clear, thin thermoformed polyurethane. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state.
The aligners, customized for each patient's prescription, are designed and manufactured based on either standard impressions or intraoral scans taken by the dental clinician and which are then sent to the company. The aligners are then sent back to the dental clinician who then distributes them in sequential stages to the patient and follows up with the patient through orthodontic examinations to check device fit and function.
During manufacturing, models are made from physical impressions or intraoral scans. Those made from stone or plaster impressions are scanned into the computer and made into digital files. The intraoral scans arrive as digital files. The digital files are 3D printed and are used to produce the aligner series with the thermoplastic polyurethane.
The thermoplastic material used for fabrication of the aligners is commonly used in many dental appliances, including the predicate aligners.
The NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition by positioning teeth through the use of continuous gentle force.
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Aligner material meets specifications for up to 5 years shelf life (according to ASTM D638) for: - Tensile strength (PSI) - Elongation (%) - Tensile @ yield (PSI) - Elongation @ yield (PSI) - Tensile modulus (PSI) | "All testing met the pre-determined acceptance criteria." (Specific numerical results are not provided, only a statement of conformance.) |
| Packaging Integrity | Aligner material packaging retains the required moisture barrier properties. | "All testing met the pre-determined acceptance criteria." (Specific methodology or results for moisture barrier are not detailed.) |
| Manufacturing Process Validation | Processes used for the design and manufacture of customized aligners ensure consistency between the aligner's design and the manufactured aligners. | "All testing met the pre-determined acceptance criteria." (Specific details of validation methods or quantitative consistency measures are not provided.) |
| Biocompatibility (Material) | Thermoplastic polyurethane material tested according to ISO 10993: - Part 3 (Bacterial Mutagenicity – Ames Assay) - Part 5 (Cytotoxicity Elution - MEM) - Part 10 (Intracutaneous/Intradermal Reactivity) - Part 10 (Oral Mucosa Irritation) - Part 10 (Maximization for Delayed-Type Hypersensitivity) - Part 11 (Subacute Systemic Toxicity) | "All testing showed that the material... met the requirements of the test methods and are safe and biocompatible for the stated intended use." (Again, a statement of conformance without specific results.) |
| Biocompatibility (Finished Device) | Finished customized aligner tested according to ISO 10993, Part 5 (Cytotoxicity). | "Results show it is non-cytotoxic." (Specific details of the cytotoxicity assay or quantitative results are not provided.) |
2. Sample size used for the test set and the data provenance
- The document primarily describes laboratory and bench testing of the device material and manufacturing process and biocompatibility testing.
- There is no mention of a "test set" in the context of patient data or clinical performance evaluation for the NEOLab Clear Aligners.
- The comparison to the predicate device (ClearCorrect System) is based on technological characteristics and indications for use, not on specific clinical performance data from a test set.
- Data provenance: Not applicable as no clinical test set data is described. The performed tests are laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The provided document does not describe a clinical study with a test set requiring expert ground truth establishment for diagnostic or treatment efficacy. The testing performed is focused on material properties, manufacturing validation, and biocompatibility.
4. Adjudication method for the test set
- Not applicable. No clinical 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
- Not applicable. This device is a physical medical device (clear aligners), not an AI-powered diagnostic or assistive tool for human readers. There is no AI component or human reader interaction described that would necessitate an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or software device that would have standalone performance. It is a physical aligner system. While software is used for planning and manufacturing, its performance is not assessed in "standalone" mode in the context of patient outcomes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the described tests:
- Mechanical properties: The ground truth is established by the specified ASTM D638 standard and internal specifications for tensile strength, elongation, etc.
- Biocompatibility: The ground truth is established by the ISO 10993 series of standards for biological evaluation of medical devices.
- Manufacturing process validation: The ground truth would be the design specifications and expected output consistency of the aligners.
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device that requires training data. The device's manufacturing process may involve internal process controls and validation using samples, but these are not referred to as a "training set" in the context of AI.
9. How the ground truth for the training set was established
- Not applicable, as no training set is described for this device.
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(165 days)
Clear-Aligners
The Clear-Aligner system is indicated for the treatment of malocclusion in patients with permanent dentition. The Clear-Aligner system positions teeth by way of continuous gentle force.
A dental health care professional (e.q. orthodontist or dentist), using a standard personal computer prescribes the Clear-Aligner system based on an assessment of thee patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth, and completes a prescription form. Utilizing standard dental software used for tooth alignment, CDB then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription. The prescribing physician reviews and approves the treatment plan before the molds are produced. Once approved, CDB produces the trays, which are formed of clear, thin, thermoformed, copolyester plastic. The trays sent back to the dental health care professional, who then provides them to the patient, confirming fit and design. Over a period of months, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the desired position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicates referenced in Table 1.
The provided text describes the acceptance criteria and study for the "Clear-Aligners" device. However, it does not detail a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study, as the device is a physical product (orthodontic aligners) rather than a diagnostic AI. The "performance testing" section refers to bench testing of the manufacturing process, not clinical performance for diagnostic accuracy.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Characteristics: | |
| Fit of the aligner against the treatment plan as determined by a dental health professional | The acceptance results observed during verification and validation testing have shown that the devices are capable of performing to their stated intended use and specification requirements. |
| Process consistency from the treatment plan file to 3D printed mold to final aligner | Measured against internal acceptance criteria derived by considering all sources of variation. The acceptance results observed during verification and validation testing have shown that the devices are capable of performing to their stated intended use and specification requirements. |
| Biocompatibility Testing (for mucosal membrane contacting for >30 days): | |
| Cytotoxicity | Met the requirements of the study protocols; material is considered non-cytotoxic. |
| Sensitization | Met the requirements of the study protocols; material is considered non-sensitizing. |
| Irritation | Met the requirements of the study protocols; material is considered not an intracutaneous irritant. |
| Software Functionality (for ordering process and treatment planning): | Software usage is considered of moderate concern. Software testing has been performed to verify the function, supporting a substantial equivalence decision. (Specific performance metrics for software are not provided in this document). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of clinical data, as this is a device for physical tooth alignment, not a diagnostic algorithm. The performance testing refers to bench testing for manufacturing and fit. Therefore, information on data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The performance testing involves "dental health professional" assessment of aligner fit, and manufacturing process consistency, not diagnostic expert consensus for a clinical ground truth.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a diagnostic 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
No such study was conducted or is applicable to this device, as it is a physical orthodontic aligner, not an AI-powered diagnostic tool. The document focuses on the substantial equivalence of the aligners themselves to predicate devices in terms of function, materials, and manufacturing process.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Clear-Aligners are a physical medical device. The software mentioned is for ordering and treatment planning, not for standalone diagnostic performance.
7. The Type of Ground Truth Used
For the functional characteristics (fit, process consistency), the "ground truth" seems to be the pre-established internal specification and acceptance criteria, along with assessment by a dental health professional. For biocompatibility, the ground truth is established by the results of standardized biological tests (Cytotoxicity, Sensitization, Irritation).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Overall Study Information:
The study described is primarily focused on bench testing to ensure the manufacturing accuracy and functional characteristics of the Clear-Aligners, and biocompatibility testing of the materials used. The approach taken is to demonstrate substantial equivalence to already legally marketed predicate devices (Clear Correct and Invisalign) based on similar indications for use, technological characteristics, mechanism of action, materials, and performance. The document explicitly states: "Further testing was not performed given there is sufficient information available from the scientific literature and from the predicate devices to demonstrate that sequential aligners provide reasonable assurance of substantial equivalence."
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(28 days)
Magic Clear Aligners
Magic Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
Magic Clear Aligners consist of a series of custom-made removable plastic orthodontic appliances which sequentially reposition teeth by way of continuous gentle force. A digital or traditional mold impression of the patient's teeth is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data created of the patient's teeth, specialized orthodontic CAD/CAM software is used to develop treatment plans. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health professional's prescription. The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced. Once approved, the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Voodoo Manufacturing produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The aligner trays are sent to the dental health professional who then delivers them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the patient by the dental health professional to gradually move the teeth to the desired position. The dental health professional monitors treatment from the first aligner is delivered to when the final aligner is delivered and treatment complete. The aligners are held in place by pressure and can be removed by the patient at any time.
This document describes the premarket notification (510(k)) for "Magic Clear Aligners" by Voodoo Manufacturing, Inc. It does not concern an AI/ML medical device, but rather a physical orthodontic device manufactured using CAD/CAM software. Therefore, many of the requested criteria related to AI/ML device performance, such as MRMC studies, ground truth establishment for training sets, and expert adjudication, are not applicable.
However, I can extract information related to the device's acceptance criteria and the studies that prove it meets those criteria, focusing on the manufacturing process and biocompatibility, which are the relevant aspects for this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Manufacturing Dimensional Accuracy: All translational measurements within 0.15 mm of the target input value (predefined tolerance of the manufacturing process). | All translational measurements were within 0.15 mm of the target input value. No statistical differences were observed between intended and measured values. This criterion was met. |
| Material Biocompatibility: Satisfy requirements of ISO 10993-1 for the intended use and specific biological endpoints. | The aligner material met the requirements for Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Irritation (ISO 10993-10:2010), Subacute/SubChronic Toxicity (ISO 10993-11:2006), and Genotoxicity (ISO 10993-3:2014). This criterion was met. |
2. Sample size used for the test set and the data provenance:
- Manufacturing Dimensional Accuracy: Not explicitly stated as a "test set" in the traditional sense of a clinical or AI study. The "test" involved assessing the accuracy of the manufacturing process. It stated that "Three critical aspects of the manufacturing process were assessed for accuracy: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners." The number of samples for each aspect (e.g., how many models, molds, or aligners were measured) is not quantified.
- Biocompatibility Testing: The sample sizes for each biological test (Cytotoxicity, Sensitization, Irritation, Subacute/SubChronic Toxicity, Genotoxicity) are not specified in the document.
- Data Provenance: Not applicable in the context of clinical data provenance for an AI/ML device as this is a manufacturing and biocompatibility study. The manufacturing validation was performed by Voodoo Manufacturing, Inc. The biocompatibility testing was conducted according to international standards (ISO 10993 series).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for manufacturing accuracy was the target input value in the CAD/CAM software. The "ground truth" for biocompatibility was compliance with international standards (ISO 10993).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML device requiring human adjudication of results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an orthodontic aligner and does not involve human readers or AI assistance in the diagnostic or interpretation process.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. While the device's design relies on CAD/CAM software, the "device" itself is the physical aligner. The software's performance is not being evaluated as a standalone diagnostic tool, rather its output is a component of the manufacturing process of the physical device. The document mentions the 3Shape A/S Ortho System software has a 510(k) clearance (K180941) under the PNN product code, indicating its own prior regulatory evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Manufacturing Dimensional Accuracy: The "ground truth" was the target input value generated by the specialized orthodontic CAD/CAM software, representing the intended geometric specifications for the digital dentition models, 3D printed molds, and thermoformed aligners.
- Biocompatibility Testing: The "ground truth" was compliance with the pass/fail criteria defined by the relevant international standards (ISO 10993 series) for biological evaluation of medical devices.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set. The CAD/CAM software used for design and manufacturing is presumably a commercially available, previously validated tool.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device requiring a training set.
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(253 days)
Smylic Invisible Clear Aligners
The Smylio Invisible Clear Aligners is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.
The Smylio Invisible Clear Aligners are intraoral thermoformed plastic aligners that are worn 20 to 22 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligners are to be removed for eating and for cleaning.
Smylio Invisible Clear Aligners are fabricated using a three-step process.
The first step is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression. This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning.
The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, the doctor utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. A 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed.
The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission.
Here's an analysis of the provided text regarding the Smylio Invisible Clear Aligners' acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
| Measure | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional Accuracy | All translational measurements within 0.3 mm of the target input value. | All translational measurements were within 0.3 mm of the target input value. |
| All rotational measurements within 3° of the target input value. | All rotational measurements were within 3° of the target input value. | |
| Biocompatibility | Compliant with ISO 7405:2008 (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry). | Tested and shown to be compliant with ISO 7405:2008. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes a "manufacturing validation" study. While it states that "three critical aspects of the manufacturing process were assessed," it does not explicitly state the sample size (e.g., number of aligners, number of 3D models tested).
The data provenance is not specified regarding country of origin, nor whether it was retrospective or prospective. Given it's a manufacturing validation, it's inherently prospective in the sense of testing newly manufactured prototypes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the manufacturing validation. The ground truth was established by "target input values" or "predefined tolerance of the manufacturing process." An "independent 3rd party software and digital calipers" were used for measurements.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as experts were not used to establish ground truth. Measurements were taken using instrumentation and compared against predefined tolerances.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing was not conducted."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The manufacturing validation study appears to be a standalone performance assessment of the manufacturing process and resulting product (aligners). While software (3Shape®) is involved in the design and planning, the validation focuses on the physical accuracy of the manufactured components (digital models, 3D printed molds, thermoformed aligners) against their intended values, not on the performance of the software as a standalone diagnostic or treatment planning tool in comparison to a human. The independent 3rd party software and digital calipers act as the measurement tools, not as the AI algorithm itself being evaluated.
7. The Type of Ground Truth Used
The ground truth used for the manufacturing validation was based on pre-defined target input values for translational and rotational measurements. These targets represent the intended or desired dimensions and angles planned during the treatment design.
8. The Sample Size for the Training Set
No training set is mentioned or applicable here. The study described is a manufacturing validation, not an AI algorithm development study that would involve training data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there was no training set.
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