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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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OnyxCeph3™ software is intended to be used for the medical purpose of managing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph3™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data.

OnyxCeph3™ dental aligner software device is designed for the simulation and planning of orthodontic and maxillofacial surgical combination treatments, based on virtual models and CT / DVT volume data. OnyxCeph3™ is a software device that includes both 3D and 2D versions both suitable for dental facilities to use for orthodontic treatments.

The provided text is a K213263 510(k) summary for the OnyxCeph3™ device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document states that "Clinical testing has not been included and is not required to demonstrate substantial equivalence."

Therefore, I cannot provide the requested information from the given text.

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

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

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

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

Here's what can be extracted and inferred:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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The Clear Image Aligners are indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.

The Clear Image Aligners are a sequential set of removable aligners prescribed by an orthodontist or dentist, used to gradually move a patient's teeth in order to treat misalignment and malocclusion. Each aligner in the sequential set is created by a trained technician utilizing 3Shape orthodontic software (K171634/K152086) and tooth movement recommendations from the prescribing orthodontist/dentist. Aligners are then fabricated from plastic. Corrective force to progressively reposition the teeth is delivered via minor changes from one aligner to the next within the series.

Each aligner set is patient specific and can only be used for an individual patient for whom it is prescribed. Clear Image Aligners are provided non-sterile and are completely removable by the patient and treatment/use may be discontinued at any time.

The provided text describes a 510(k) premarket notification for "Clear Image Aligners" by Specialty Appliance Works, Inc. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, many of the requested details about acceptance criteria and study design are not applicable or not provided in this regulatory submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This submission does not define specific acceptance criteria (e.g., accuracy, sensitivity, specificity) for device performance. Instead, it aims to demonstrate substantial equivalence to a legally marketed predicate device.

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

Not applicable. No "test set" in the context of performance evaluation (e.g., for AI algorithm metrics) is described. The submission states that clinical testing was not necessary due to the established performance of sequential aligners.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. No ground truth establishment by experts for a performance study is described.

4. Adjudication Method

Not applicable. No adjudication method for a test set is described.

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

Not applicable. No MRMC study is mentioned. This device is an aligner, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical orthodontic aligner, not an algorithm. The manufacturing process uses 3Shape orthodontic software, but the submission doesn't describe a standalone performance study of this software or the aligner.

7. Type of Ground Truth Used

Not applicable. No performance study with ground truth is described.

8. Sample Size for the Training Set

Not applicable. No training set for an AI algorithm is described.

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

Not applicable. No training set or ground truth establishment process is described.

Summary of the Study and Substantial Equivalence Claim:

The submission asserts that clinical testing was not necessary because:

• Established Performance: "The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998."
• Substantial Equivalence: The Clear Image Aligners are deemed substantially equivalent to the predicate device (Derby Dental Laboratory Custom Clear Aligner System, K173785) in terms of:
  • Indications for Use
  • Design and Technology
  • Device Classification Name (Orthodontic Plastic Bracket)
  • Product Code (NXC)
  • Classification (Class II)
  • Mode of Action (alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays)
  • Method of Use
  • Prescription Status (Prescription)
  • Software Used during manufacturing (3Shape Ortho System)
  • Sterility (Provided Non-Sterile)
  • Material (Essix Ace plastic - K062828, described as a thin thermoformed polyurethane). The mechanical properties of this plastic were previously demonstrated by the manufacturer.

In essence, the "study" demonstrating the device meets the acceptance criteria (of being safe and effective) is the history of successful use of similar predicate devices and the demonstration that the proposed device shares the same fundamental technological characteristics and intended use as the predicate. This is a common approach for 510(k) clearances when a novel technology is not being introduced.

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Ortho System™ for dental retainers and dental cast for sequential aligners is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3D models of the patient's dentition before the start of an orthodontic treatment.

The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

3Shape's Ortho System™ for dental retainers and dental cast for sequential aligners is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analysing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of orthodontic appliances based on 3D scanned orthodontic models.

The realization of the orthodontic appliances are done using appliance workflows templates which either supports

• . (Retainers and dental casts for sequential aligners) Thermoforming FDA cleared or listed material on a dental cast. The cast is designed and produced by machines and materials included in the appliance workflow template
• (Retainers) Direct production using 3D printer or milling machines with FDA . cleared or listed materials included in the appliance workflow template.

The Ortho System™ appliance workflow templates with approved machines is available through a dedicated download centre by the software. The instruction for use contains instructions for configuration of additive printers.

The actual production of appliances/casts and any thermoforming is done by the user and is under their control and responsibility – only materials specified in the manual must be used to produce the final appliance.

The Ortho System™ has no patient contact being a software.

The provided text is a 510(k) summary for a medical device called "Ortho System™" from 3Shape A/S. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance data for a new AI/algorithm-based device.

Therefore, the document does not contain the information required to answer the questions regarding acceptance criteria, study details, expert involvement, and ground truth establishment.

Here's why and what's missing:

• No Acceptance Criteria or Performance Table: The document states that "All test results have been reviewed and approved, showing the Ortho System™ to be substantially equivalent to the reference devices," but it does not provide a table of acceptance criteria or actual performance metrics (e.g., accuracy, sensitivity, specificity, AUC) like one would expect for an AI/algorithm-based device clearance.
• No Mention of AI/Algorithm Study: The "Ortho System™" is described as a "medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options..." It's a software system, but not explicitly stated as an AI/ML algorithm that predicts or classifies. The review is based on "software, hardware, and integration verification and validation testing," and a comparison of features with a predicate device.
• No ML Specifics: There is no mention of training sets, test sets, ground truth establishment, expert adjudication, or MRMC studies, which are typical for AI/ML device submissions. The "Clinical Testing" section explicitly states, "Clinical testing is not a requirement and has not been performed."

In summary, the provided FDA 510(k) clearance document for Ortho System™ does not contain the detailed study information, acceptance criteria, or performance data that would be relevant for an AI/ML powered device, as it seems to be cleared based on substantial equivalence to an existing software device with similar functionalities and technical characteristics, rather than a novel AI algorithm requiring specific performance validation metrics.

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