(99 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility | Satisfied: Testing of the plastic thermoformable material and ISO 10993-5 Cytotoxicity Testing of the finished thermoformed aligner were provided. |
| Manufacturing Process Accuracy (Digital vs. Physical) | Satisfied: Bench testing was performed to validate the manufacturing process to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan. |
| Material Equivalence | Satisfied: The thermoplastic materials used are the same as the predicate ClearPath Aligner. |
| Functional Equivalence (with predicate aligner) | Satisfied: The ClearPath Aligner has the same intended use as the predicate device. There are no fundamental technological differences between the Predicate and the modified device. The difference is the use of referenced software during specified manufacturing steps. |
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.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.