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Pearl Clear Aligner is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to align teeth during the orthodontic treatment of malocclusions. They are made of biocompatible thermoplastic polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides a digital file (scan) of the patient's teeth to Pearl Digital. Based on the dental health professional's treatment plan, Pearl Digital develops a digital plan using commercially available treatment planning software. Upon approval by the dental health professional, molds are created with 3D-printing technology and the clear aligners are vacuum formed on the molds. The finished, customized aligners are provided to the dental health care professional who delivers the aligners to the patients in sequential stages checking for fit and function.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Pearl Clear Aligner. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics and acceptance criteria for the new device.

Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth for a performance study is not available within this document. The document mainly discusses the technical characteristics and biocompatibility testing of the Pearl Clear Aligner and compares them to the predicate device.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, specific quantitative acceptance criteria for the device's performance (e.g., accuracy of tooth movement, treatment success rates) are not detailed. The performance aspects highlighted are related to the manufacturing process validation and the general concept of applying forces for tooth alignment.

Acceptance Criteria (Implied/General)	Reported Device Performance (Summary)
Biocompatibility	Met requirements for ISO 10993 (Cytotoxicity, Oral Mucosal Irritation, Skin Sensitization, Acute Systemic Toxicity, Implantation, Subacute Systemic Toxicity, Subchronic Toxicity). Pyrogen Testing performed according to USP 45/NF40 .
Manufacturing Process Accuracy	Bench testing performed to validate the manufacturing process to ensure the accuracy of the final aligners compared to the initial digital scans. A final report was part of the 510(k) package. (No specific metrics provided in this document)
Intended Use	"The Pearl Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by continuous gentle forces." (This is a statement of intended use, not a performance metric.)
Mode of Action	"The removable appliance applies continuous gentle forces on teeth according to the plan prescribed by the doctor." (Description of how it works, not a performance metric.)

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

The document mentions "Bench testing was performed to validate the manufacturing process to ensure the accuracy of the final aligners compared to the initial digital scans." However, the sample size for this test set is not specified.
Data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The manufacturing process validation likely involved internal technical experts, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set:

This information is not provided in the document.

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 comparative effectiveness study is not mentioned for this device. The device itself (Pearl Clear Aligner) is an orthodontic appliance, not a diagnostic AI system with human-in-the-loop interaction for interpretation. The "treatment planning software" is mentioned as a reference device, but no MRMC study involving it is described here.

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

This information is not applicable in the context of an orthodontic aligner device. While an algorithm is used for treatment planning (referencing PlaniMax Orthodontic Software, K201036), this document is for the aligner itself, and no standalone algorithm performance study for the aligner's effectiveness is detailed. The closest would be the "bench testing" to ensure manufacturing accuracy, which is a validation of the physical product, not a standalone algorithm performance.

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

For the "bench testing" of manufacturing accuracy, the "initial digital scans" (likely of the patient's teeth or desired final positions) served as the reference or ground truth against which the final aligners were compared.

8. The sample size for the training set:

The document implies that "commercially available treatment planning software is used" (referencing PlaniMax Orthodontic Software, K201036). If this software utilized a training set (as AI/ML software often does), its sample size is not specified in this document, as the document focuses on the aligner device.

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

As the document references an already cleared "commercially available treatment planning software," how its training set's ground truth was established is not detailed in this 510(k) submission for the Pearl Clear Aligner. That information would typically be part of the 510(k) for the software itself (K201036).

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