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The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner positions teeth by way of continuous gentle force.

The ClearPath clear aligner is 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. The aligners are provided non-sterile and are customized for each patient according to the dental clinician's prescription.

The dental health professional (dentist/orthodontist) takes provides physical or scanned impressions of the patient's teeth to ClearPath. A digital setup of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked.

The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.

The provided text describes the ClearPath Aligner, a series of clear plastic appliances for correcting dental malocclusion. The submission (K202857) seeks substantial equivalence to a predicate device (K162609). The key difference is the new device's use of software (Ortho Analyzer, 3Shape A/S, K180941) for treatment planning and 3D printing of models.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative (e.g., minimum accuracy, sensitivity, specificity) acceptance criteria for the device from a clinical performance standpoint for the software's functionality. Instead, the focus is on the manufacturing process and materials.

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

The document explicitly states that "Bench testing was performed to validate the manufacturing process: to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan."

• Sample Size for Test Set: The exact sample size for this bench testing is not specified in the provided text.
• Data Provenance: The nature of the bench testing suggests it would be prospective data generated specifically for this validation. The country of origin of the data is not specified, but the applicant's address is Lahore-Pakistan.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the bench testing. Given the type of testing (accuracy of thermoformed aligner vs. digital scan), ground truth would likely be established through precise metrological measurements, not expert clinical assessment in this context.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method, as the testing described is bench testing for manufacturing accuracy, not a clinical study involving human interpretation or consensus.

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

No, an MRMC comparative effectiveness study was not done or reported. The submission focuses on the substantial equivalence of the device, primarily through material and manufacturing process validation, and not on the comparative effectiveness of human readers with or without AI assistance. This device is not an AI diagnostic tool that assists human readers.

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

The document mentions that the software system (Ortho Analyzer) is used for "management of 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 orthodontic appliances based on 3D scanned orthodontic models."

However, a standalone performance study specifically for the algorithm's accuracy in these tasks, independent of the human-in-the-loop manufacturing process, is not explicitly described or quantified in terms of specific metrics (e.g., accuracy of tooth movement simulation). The bench testing described validates the manufacturing process based on the digital plan, rather than the intrinsic diagnostic or planning accuracy of the software itself in a standalone context.

7. The Type of Ground Truth Used

For the bench testing, the ground truth was the initial digital scan used as the reference against which the final thermoformed physical aligner was compared for accuracy. This implies a precise, measurable digital model.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. The device is an orthodontic aligner and the new part of the submission relates to the use of existing software in its manufacturing process. There's no indication that a new algorithm or AI model was developed by ClearPath Orthodontics that required a separate training set. The "Ortho Analyzer" software itself would have had its own development and validation, but that information is not part of this 510(k) submission for the ClearPath Aligner.

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

As no training set is discussed for the ClearPath Aligner device itself (other than potentially for the pre-existing Ortho Analyzer software), this information is not provided in the document.

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The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner is intended to position teeth by way of continuous gentle force.

ClearPath Orthodontics uses clear, thin, thermoformed plastic material for the manufacture of its ClearPath Aligner. The aligners are provided non-sterile and are customized for each patient according to the molds provided by the treating dentist or orthodontist. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each aligner is 14 days and it is to be worn except during meals.

This document is a 510(k) premarket notification for the ClearPath Aligner. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria, especially concerning artificial intelligence (AI) or an algorithm's performance. The document explicitly states:

• No in vitro or animal testing were required for this product.
• The reason for this 510(k) was to expand the indication from "minor anterior tooth movement" to "realignment of all permanent teeth."
• Clinical case reports were submitted to demonstrate that the aligners can effectively realign all permanent teeth as indicated. These are not described as a formal clinical study with acceptance criteria, sample sizes, or ground truth establishment in the way one would evaluate an AI/algorithm's performance. They appear to be observational case reports supporting the broader indication by showing positive outcomes.
• The focus of the submission is on substantial equivalence to an existing predicate device based on "the same intended use, the same design, identical materials, identical methods used for fabricating the aligners, and submission of clinical reports that demonstrate the device performs as intended."

Therefore, it is not possible to provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or an MRMC study for AI performance, as this document does not describe such a study. The device itself (ClearPath Aligner) is a physical, thermoformed plastic appliance, not an AI or algorithm.

The request details are relevant to the evaluation of AI/ML-driven medical devices, but the provided text describes a traditional medical device submission.

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The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner is intended for minor anterior tooth movement by way of continuous gentle force.

ClearPath Orthodontics uses clear, thin, thermoformed plastic material for the manufacture of its ClearPath Aligner. The aligners are provided non-sterile and are customized for each patient according to the molds provided by the treating dentist or orthodontist. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each aligner is 14 days and it is to be worn except during meals.

The provided text describes the ClearPath Aligner, a device for correcting dental malocclusion. However, it explicitly states that no performance testing was warranted for this product. Therefore, there is no study described that proves the device meets specific acceptance criteria.

The submission relies on a comparison to predicate devices and asserts substantial equivalence based on similarities in intended use, design, material composition, and mechanism of action.

Given this, I cannot provide a table of acceptance criteria and reported device performance or other details of a study that does not exist for this device.

Here's the information that can be extracted or inferred based on the provided text, along with clarifications for items that are not applicable:

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

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

• Not applicable. No test set was used as no performance testing was conducted.

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. No test set was used and therefore no ground truth was established by experts for a test set.

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

• Not applicable. No test set was used.

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

• No. This product is a physical dental aligner, not an AI-assisted diagnostic tool.

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

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

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

• Not applicable. No ground truth was established for a performance study. The submission relies on the established safety and efficacy of predicate devices (K073121 - NuBrace Invisible Removable Orthodontics and K981095 - Align System) and scientific literature for the materials used.

8. The sample size for the training set

• Not applicable. No training set was used as no algorithm was developed or tested.

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

• Not applicable. No training set was used.

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