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An orthodontic archwire used to provide force to the teeth to effect movement in orthodontic treatment.

The SimpliClear Rectangular Orthodontic Wire is a translucent archwire comprised of glass fibers, a polymer composite resin, and a polymer coating. The embedded glass fibers function as the reinforcement, providing the necessary force to straighten teeth. The translucent polymer composite resin serves as the matrix, binding together the individual glass fibers. The outer coating, made of a USP Class VI polycrystalline and amorphous linear polymer, increases the abrasion resistance properties of the wire.

Here's a breakdown of the acceptance criteria and the study details for the SimpliClear Rectangular Orthodontic Wire, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

The document does not specify a separate "test set" in the context of clinical data for algorithmic performance. Instead, the "testing" described is bench testing of physical properties of the orthodontic wires.

• Sample Size for Bench Testing: Not explicitly stated in terms of the number of wires or samples tested for each metric (Elastic Modulus, Tensile Strength, Flexural Strength, Flexural Modulus). The text indicates "At similar wire dimensions" for comparisons, implying various dimensions were tested.
• Data Provenance: The data comes from in-vitro bench testing performed according to specific ASTM standards (ASTM D3916-02 and ASTM D790-03). This is therefore not patient data, nor is it retrospective or prospective in the clinical sense.

3. Number of Experts and Qualifications for Ground Truth for the Test Set

Not applicable. The ground truth for the "test set" (bench testing) is derived from objective physical measurements and adherence to recognized ASTM standards, not expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "test set" consists of physical property measurements against established ASTM standards, not interpretive data requiring adjudication.

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

No. This document describes the substantial equivalence of a physical medical device (orthodontic wire) based on its material composition and mechanical properties, compared to predicate devices. It does not involve AI or human readers evaluating cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is not an AI/algorithm-based device.

7. Type of Ground Truth Used

The ground truth for the device's performance is based on objective physical measurements obtained through standardized laboratory tests (ASTM D3916-02 for Elastic Modulus and Tensile Strength, ASTM D790-03 for Flexural Strength and Flexural Modulus) and compliance with biocompatibility standards (ISO10993). Comparisons are then made to the performance ranges of legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-based device that requires a training set.

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

Not applicable.

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The Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

The Translucent Orthodontic Bracket is comprised of single crystal alumina. The translucent properties of the bracket make the bracket less visible than polycrystalline ceramic and metal brackets. The bracket consists of three distinct parts: (1) arch wire slot, (2) four tie wings, and (3) base. The arch wire slot allows the placement of an arch wire which applies the necessary force to effect tooth movement. The tie wings allow the placement of an elastic o-ring, which holds the arch wire in place. The base is adhered to a patient's tooth using adhesive, thereby anchoring the bracket to the tooth.

The provided submission focuses on the substantial equivalence of the BioMers Translucent Orthodontic Bracket to predicate devices, primarily through comparison of technical characteristics and existing standards for dental materials. It does not contain information typically found in an AI/ML device submission regarding acceptance criteria for algorithm performance or detailed study designs for proving such criteria.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered from the provided text as they pertain to AI/ML device testing methodologies not present here.

However, I can extract the acceptance criteria and performance data related to the device's material properties, which are relevant to its substantial equivalence claim.

Here's the available information based on the provided text:

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

The submission uses "Bond Strength" as a key performance metric for the BioMers Translucent Orthodontic Bracket, tested according to ISO 11405-2003(E). While explicit "acceptance criteria" in terms of a minimum or range for bond strength are not directly stated as a pass/fail threshold, the device's performance is compared against its predicates. The implication is that performance comparable to or better than predicate devices, within a clinically acceptable range, demonstrates safety and effectiveness.

Note: Units for bond strength are not explicitly stated in the table but are typically in MPa for this type of test.

Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):

The study primarily supporting the device's claims is a bench test and functional testing study conducted according to ISO 11405:2003 - Dental materials -- Testing of adhesion to tooth structure. This standard guides the methodology for evaluating the bond strength of dental materials to tooth structure.

Key Findings from the "Study":

• The BioMers Translucent Orthodontic Bracket demonstrated a bond strength of 11.73 ± 3.04 (units not specified, but likely MPa).
• This performance falls within the range observed for the predicate devices, being higher than one predicate (Absolute: 5.51 ± 1.65) though lower than the other (PURE Sapphire: 19.41 ± 5.08). The submission implicitly argues that this performance, combined with similar technological characteristics and adherence to safety standards (ISO 10993 for biocompatibility, ISO 14971 for risk analysis), establishes substantial equivalence.

Regarding AI/ML-specific questions (2-9):

The provided text does not contain any information related to AI/ML device performance, ground truth establishment, expert review, sample sizes for AI/ML models, or MRMC studies. The device in question is a physical orthodontic bracket, and the submission focuses on its material properties and comparison to existing physical devices, not an AI/ML algorithm. Therefore, the following sections cannot be populated:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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