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This device is intended for bonding brackets to teeth for orthodontic treatment.

Reli-On is a one step orthodontic adhesive. It comprises of two major components, i.e., a viscous polymeric resin paste and a watery component called. Activator. The paste is delivered from a syringe, while the activator is dispensed from a squeeze bottle. Besides the paste & the activator, the product kit contains a preloaded syringe of etchant (35% phosphoric acid solution), brushes to apply the activator on the tooth and a stack of mixing pads for easy transfer of the activator.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Justification:
The document states that "no established performance criteria are published by eminent standards bodies (i.e., ASTM, ANSI, etc.)". Therefore, the two criteria – set time and shear bond strength – were selected based on "actual product use" and for "equivalency comparison" to a predicate device.

• Set Time: The acceptance criterion for set time is derived from the "typically" observed range for one-step adhesives (20-25 seconds). The Reli-On's 29 seconds is slightly outside this "typical" range but is very close to the predicate's 28 seconds, suggesting it's acceptable for equivalency. The study procedure confirms it's important not to be too short or too long.
• Shear Bond Strength: The acceptance criterion for shear bond strength is based on published data (ref. 1) indicating mastication-induced forces of "around 6 to 8 MPa." The device is considered to "pass" if it exceeds 8 MPa.

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

• Set-Time: 5 different samples were tested for Reli-On and the entire procedure was repeated for Right-On (predicate device).
• Shear Bond Strength: 5 different brackets for both candidate adhesives (Reli-On and Right-On) were tested.
• Data Provenance: The data appears to be prospective experimental data generated specifically for this 510(k) submission. The methods and materials are detailed, indicating controlled laboratory testing. The country of origin is not explicitly stated, but the submission is from Class One Orthodontics, Lubbock, TX, USA.

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

• Not Applicable: For this type of device (material properties of an adhesive), the "ground truth" is established by direct physical measurements (set time, shear bond strength) using standardized or defined experimental procedures, not by expert interpretation or consensus on a dataset. Therefore, no experts were used to establish ground truth in the way one might for diagnostic imaging or clinical outcomes. The "ground truth" is the measured physical property.

4. Adjudication Method for the Test Set

• None: As the "ground truth" is derived from direct physical measurements rather than expert assessment of subjective data, an adjudication method (like 2+1, 3+1) is not applicable or necessary. The measurements are objective.

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

• No: This is not an MRMC study. MRMC studies are typically used for diagnostic or screening devices where human readers interpret medical images or data, and the study assesses how AI assistance impacts their performance. This submission focuses on the physical properties of a dental adhesive.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Yes, in essence: The performance data presented (set time, shear bond strength) represents the standalone performance of the device itself (the adhesive) under controlled laboratory conditions, without human intervention in the measurement process beyond conducting the experiment according to the defined protocol. There is no AI algorithm involved.

7. The Type of Ground Truth Used

• Experimental Measurement / Physical Properties: The ground truth for both set time and shear bond strength is based on direct experimental measurements of the material properties of the adhesive. For shear bond strength, the performance is also tied to a specific clinical requirement (withstanding 6-8 MPa mastication force) derived from a published reference (Reynolds I.R., 1975).

8. The Sample Size for the Training Set

• Not Applicable: This submission does not describe a dataset used for training a machine learning model or algorithm. It pertains to the physical performance characteristics of a medical device (an orthodontic adhesive).

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

• Not Applicable: As there is no training set for an algorithm, there is no ground truth to be established for it.

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