Search Results

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

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."

Ask a specific question about this device

The Krystal Klear Aligners System is intended to correct minor discrepancies in the alignment of maloccluded anterior teeth on patients with permanent dentition (second molars) by moving the teeth with a progressive series of clear thin, thermoformed plastic aligners, fabricated in stages to gradually align teeth over a period of several months. The aligners are completely removeable by the patient and may be discontinued at any time.

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

The Krystal Klear Aligners System's acceptance criteria and the study proving it meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state a specific sample size for a "test set" in the context of a clinical trial or a machine learning evaluation. The performance testing section describes "bench testing" which was performed to ensure accuracy and consistency. This likely refers to in-house engineering and quality control tests on manufactured aligners and processes, rather than a clinical dataset for performance evaluation against a diagnostic algorithm.

The data provenance for these bench tests is internal to the manufacturer ("internal acceptance criteria derived by considering all sources of variation"). There is no mention of country of origin for the data or whether it was retrospective or prospective.

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

The document mentions that the "Fit of the aligner against the treatment plan" was "as determined by dental health professional". It does not specify the number of experts, their specific qualifications (e.g., years of experience, specialization), or how ground truth was established for the "test set."

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

No adjudication method is mentioned for the 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:

The document does not describe an MRMC comparative effectiveness study or any study involving human readers or AI assistance. The Krystal Klear Aligner System is a physical medical device (aligners) for orthodontic treatment, not an AI-powered diagnostic or assistive tool.

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

This question is not applicable as the device is not an algorithm for standalone performance. The "Software Consideration" section refers to software used in the ordering and treatment planning process, implying human oversight and input, rather than a standalone algorithm with diagnostic capabilities.

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

For the physical attributes (Density, Flexural Modulus, etc.), the ground truth was based on ASTM standards and achieving "acceptance criteria" defined by these standardized methods.

For the "Fit of the aligner against the treatment plan" and "Process consistency," the ground truth was based on "pre-established specifications and acceptance criteria" and likely involves expert assessment by dental health professionals in the context of verification and validation testing.

For biocompatibility, the ground truth was based on standardized biological evaluation tests (cytotoxicity, sensitization, irritation) according to ISO 10993-1 guidance, with results being "non-cytotoxic, non-sensitizing, and is not an intracutaneous irritant."

8. The sample size for the training set:

The document does not mention a "training set" or a machine learning model that would require one. The product is a physical orthodontic device manufactured through a process that includes software for treatment planning but does not describe the use of a machine learning model that would be "trained."

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

As no training set is mentioned or implied for a machine learning model, this question is not applicable.

Ask a specific question about this device

MTM® Clear Aligner In-Office is indicated for the treatment of anterior tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental minor tooth movements (torque, tipping, rotation and bodily movement), MTM® Clear Aligner sequentially positions teeth by way of continuous gentle force.

MTM® Clear Aligner In-Office is a system of plastic aligners fabricated in the dental professional's office that are modified with thermoplier accessories to create force points and spaces necessary for tooth movement by way of continuous gentle force. Commercially available auxiliaries such as hooks and orthodontic elastics may also be used in order to create the desired tooth movement. As the aligner is positioned on any particular tooth, the presence of the force points loads the polymeric shell material. The stored energy thus imparted into the elastomeric material of the aligner slowly dissipates over time as the bone underlying the tooth physiologically responds to the forces. After each desired incremental tooth movement has occurred, the aligner can be modified to increase the size of the force points or a new aligner may be fabricated. Each aligner moves the patient's teeth in small increments from their original state.

This document describes the acceptance criteria and the study conducted to prove that the MTM® Clear Aligner In-Office device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MTM® Clear Aligner In-Office were based on its ability to achieve incremental minor tooth movements, as stated in its Indications for Use. The clinical study aimed to demonstrate this capability.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document lists the number of cases successfully treated for each type of tooth movement: 5 for Torque, 7 for Tipping, 14 for Rotation, and 11 for Bodily Movement. The total number of unique patients or overall cases included in the study is not explicitly stated but is implicitly the sum of cases across all movement types if each case represented a unique patient with a primary movement type, or possibly a smaller number if a single patient experienced multiple types of movements. Without further detail, it's difficult to ascertain the exact total number of individuals.
• Data Provenance: The study was a "prospective open-label safety and effectiveness study." The country of origin for the data is not specified.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Number of Experts: The document does not specify the number of experts explicitly. However, it mentions that the study included a "pretreatment period for establishing baseline root integrity and tooth position and to develop a treatment plan." This implies that dental professionals (likely orthodontists or dentists) were involved in assessing the initial state and planning the treatment for each patient.
• Qualifications of Experts: The specific qualifications of these experts are not detailed, but it can be inferred that they were dental practitioners responsible for treatment planning and monitoring.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing the ground truth or evaluating the outcomes of the test set. The study design focused on documenting "progression of the case" and establishing "final tooth position and root integrity," which suggests that the clinical outcomes were assessed directly by the participating practitioners as part of the prospective study.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study focused on the performance of the device itself rather than comparing human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only)

This device is an in-office system of physical aligners and accessories, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The device inherently requires human intervention (dental professional's fabrication, modification, and patient's wear).

7. Type of Ground Truth Used

The ground truth used was based on clinical outcomes assessed by dental professionals. This included:

• Pre-treatment establishment of "baseline root integrity and tooth position."
• Documentation of "progression of the case" during treatment.
• Post-treatment establishment of "final tooth position and root integrity" to determine the "magnitude of total tooth movement."
• Monitoring for "adverse events, including root resorption."

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. The MTM® Clear Aligner In-Office system is a physical medical device, not a software algorithm that requires a training dataset.

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

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable.

Ask a specific question about this device