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S-Line™ orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position

S-Line™ orthodontic ceramic bracket is used to treat malocclusion, the abnormal occlusion of the upper and the lower teeth. It is intended to be applied on the surface of teeth to restore dental esthetics and functionality and it is designed to be used jointly with orthodontic wire.

The applicant, BIO CETEC CO., LTD., submitted a 510(k) premarket notification for their device, S-Line™ Orthodontic Ceramic Bracket, claiming substantial equivalence to the C-Line™ Orthodontic Ceramic Bracket (K163467) as the primary predicate device and DAMON 4Clear (K081415) as a reference device. Transbond™ XT (K073697) was also used as a bonding agent for performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance tests conducted to demonstrate substantial equivalence by comparing the S-Line™ device to the reference device (DAMON 4Clear) and the primary predicate device (C-Line™). The reported "performance" is that the S-Line™ device's test results demonstrate substantial equivalence.

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

The document does not explicitly state the sample sizes used for the non-clinical performance tests. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The tests were conducted internally by the manufacturer or a contracted lab to meet ISO standards.

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

This information is not applicable as the study is a non-clinical performance study of a device (orthodontic bracket) and does not involve human subjects or expert assessment for ground truth in the context of clinical outcomes or imaging interpretation. Ground truth for these tests would be derived from the physical properties and measurements according to ISO standards.

4. Adjudication Method for the Test Set:

This information is not applicable for non-clinical performance testing. Adjudication methods are typically employed in clinical studies involving human readers/investigators.

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

An MRMC comparative effectiveness study was not done. The study described is a non-clinical performance study of a medical device, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance:

Standalone performance was done in the context of the device's physical and mechanical properties. The non-clinical performance tests (wire slot torque, shear bond, bracket removal, wire drag, door pull-out, adhesive strength, and biocompatibility) evaluate the device itself without human-in-the-loop interaction.

7. Type of Ground Truth Used:

The ground truth for the non-clinical performance tests was based on physical and mechanical measurements according to specified ISO standards. For example, bond strength would be a measured force, and biocompatibility would be assessed against the criteria of ISO 10993.

8. Sample Size for the Training Set:

This information is not applicable. The S-Line™ Orthodontic Ceramic Bracket is a physical medical device, not an AI/machine learning algorithm, and therefore does not have a "training set."

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

This information is not applicable for the same reason as above.

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3M™ Clarity™ Ultra Brackets and Adhesive Coated Appliance System are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.

3M™ Clarity™ Ultra Brackets and Adhesive Coated Appliance System are intended for use in orthodontic treatment. Clarity Ultra Bracket is an esthetic bracket with a sliding door. The brackets are composed of aluminum oxide, which gives them a clear appearance. A nickel titanium wire serves as part of the door mechanism and is attached to the bracket using a cured adhesive. The brackets incorporate a water-soluble color placement indicator system. The archwire slot, vertical slot, and door are marked to facilitate bracket positioning. Tie wing(s) and/or door are color coded with dots to facilitate bracket identification. The brackets are available with or without APC™ Flash-Free pre-coated adhesive. The pre-coated adhesive ensures a consistent amount of adhesive on the bracket.

The provided document is a 510(k) Summary for the 3M™ Clarity™ Ultra Self-Ligating Brackets and Adhesive Coated Appliance System. It details the device's technical specifications and a comparison to predicate devices, but it does not contain information typically found in a study proving a device meets acceptance criteria, particularly for AI/machine learning devices.

The document discusses "Performance Testing" which refers to bench testing of mechanical properties, not clinical performance or AI algorithm performance. Therefore, I cannot extract information related to AI acceptance criteria or studies from this document.

For completeness, I will extract what is available regarding the device's performance testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Bench testing consistent with the clinical application and intended use was used to evaluate the performance of Clarity™ Ultra Self-Ligating Brackets and Adhesive Coated Appliance System compared to the predicate devices, Clarity™ Advanced and Damon 4Clear. Properties evaluated include: rotation play angle, wire rotation strength, shear-peel bond strength, torque strength, and squeeze debond strength. 3M Health Care has tested Clarity™ Ultra Self-Ligating Brackets and Adhesive Coated Appliance System and has concluded that the performance tests results demonstrate substantial equivalence to the predicate devices."

However, specific numerical "acceptance criteria" values or "reported device performance" values for these properties are not provided in the document. It only states that the device was found to be "substantially equivalent" to the predicate devices.

2. Sample size used for the test set and the data provenance: Not applicable. This document describes bench testing on the device itself, not a test set of data for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant to this bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This device is not an AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to mechanical bench testing. The "ground truth" in this context would be the measured mechanical properties of the devices.

8. The sample size for the training set: Not applicable. This device is not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable.

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This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after Orthodontic treatment has been completed.

Symetri Clear, is a single-use orthodontic bracket made from polycrystalline alumina. This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after Orthodontic treatment has been completed. After following standard office protocols for tooth preparation, the brackets are bonded to the teeth with an orthodontic adhesive or cement. To aid with visual placement of the bracket to the tooth surface, the bracket has a removable, color coded, plastic axis indicator that is lifted away from the bracket following tooth placement or temporary color coded labial tie wings that are removed with a toothbrush and water. To identify tooth designation, the brackets include a temporary ink dot that is removed with a toothbrush and water after the brackets have been placed on the tooth. After the brackets are placed, an archwire is then inserted / threaded through the bracket's archwire slot and is held in place with a ligature tie. These ligatures are tightened, or ligated, around the 'wings' of the bracket and over the archwire. To aid in optimal teeth movement, the individual brackets can also be ligated to other brackets or other orthodontic devices. After the teeth have moved into their proper positions, the orthodontic / dental professional will remove the brackets with the Symetri Clear Debonding Instrument / Pliers. This step is also known as debonding.

The provided document is a 510(k) Pre-Market Notification for the Symetri Clear orthodontic bracket. This type of submission focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices, rather than comprehensive clinical performance studies typical for novel medical devices.

Therefore, the document does not contain information about acceptance criteria and the study that proves the device meets those criteria in the context of typical AI/ML device evaluations. Instead, it describes non-clinical performance data to demonstrate equivalence.

Here's an analysis of what is provided, and what is missing based on your requested information:

Key Takeaways from the document:

• Device Type: The Symetri Clear is an orthodontic bracket made from polycrystalline alumina, intended for the orthodontic movement of teeth. It is a physical medical device, not a software/AI device.
• Regulatory Pathway: 510(k) Pre-Market Notification, demonstrating substantial equivalence to predicate devices (3M Unitek Corporation's Clarity™ ADVANCED Ceramic Brackets (K102803) and Damon™ 4Clear (K081415)).
• Performance Data: The submission relies on non-clinical performance data and biocompatibility assessments to establish substantial equivalence. No clinical performance data was performed or submitted for Symetri Clear.
• No AI/ML Component: There is no indication that the Symetri Clear device itself or its use involves any Artificial Intelligence or Machine Learning component.

Addressing your specific questions based on the provided document:

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

   • Acceptance Criteria: Not explicitly stated as pass/fail numeric thresholds in the document. The general acceptance criterion implied is "perform comparably to the predicate devices" for various non-clinical tests.
   • Reported Device Performance: The document states: "The testing analysis shows that Symetri Clear brackets perform comparably to the predicate devices." Specific numerical results for each test (Torque Strength, Double Tie Wing Strength, Bond Strength Shear, Bond Strength Tensile, Wire Drag, Debonding Removal Fracture, Hook Strength, Staining) are not included in this summary.

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

   • Sample Size: Not specified in this document for the non-clinical tests.
   • Data Provenance: Not specified. It's non-clinical lab testing.

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. This is a physical device submission demonstrating mechanical and material properties. There is no "ground truth" in the diagnostic sense, nor is there a panel of experts evaluating diagnostic performance. The "ground truth" would be the standard scientific methods and measurements for the physical properties being tested.

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

   • Not Applicable. See point 3.

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 is not an AI-assisted device. No MRMC study was conducted or is relevant.

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

   • No. This is not an algorithm.

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

   • Not Applicable/Implied: For non-clinical tests, the "ground truth" is defined by the standardized measurement methodologies (e.g., ISO 27020 for dimensions) and the results obtained from those methodologies. It's not a diagnostic "ground truth."

8. The sample size for the training set

   • Not Applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not Applicable. See point 8.

In summary, the provided document is a regulatory submission for a traditional, physical medical device (an orthodontic bracket) and details non-clinical performance testing to demonstrate substantial equivalence to predicate devices, not an AI/ML device with associated acceptance criteria, ground truth, or clinical study designs typically associated with your questions.

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