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SeLECT Defense Dental Pit and Fissure Sealant is a BisGMA based light cured resin for the sealing of deciduous teeth and the filling of fissures in primary tooth structure.

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The provided document is an FDA 510(k) clearance letter for a dental pit and fissure sealant. It does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

The document primarily focuses on:

• The FDA's determination of substantial equivalence for a physical dental device (SeLECT Defense Dental Pit and Fissure Sealant) to predicate devices.
• Regulatory information, including product codes, regulation numbers, and compliance requirements.
• Indications for Use for the dental sealant.

Therefore, I cannot extract any of the requested information regarding acceptance criteria and a study proving device performance for an AI/ML device from this text.

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

Lion Se 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 formulation of Lion Se adhesive is identical to the predicate adhesive, except that the Lion Se paste contains 2% of a Selenium compound . This is a modified acrylic monomer which polymerizes & becomes an integral part of the final cured adhesive. 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 provided text, focusing on the acceptance criteria and the study used to prove the device meets them:

Acceptance Criteria and Device Performance

Note: The acceptance criteria for "Set-Time" and "Shear Bond Strength" are inferred from the description of typical values for one-step adhesives and the reference to clinical survival standards (Ref. 1). For physical characteristics, substantial equivalence to the predicate device is the implicit criterion.

Study Details

The study presented focuses on demonstrating substantial equivalence to Classone Orthodontics' own predicate device, "Reli-On One Step Adhesive F700," for orthodontic bracket bonding.

2. Sample Size and Data Provenance

• Set Time: 5 different samples were tested for both the Lion Se and Reli-On adhesives.
• Shear Bond Strength: 5 different brackets for both the Lion Se and Reli-On adhesives were tested.
• Data Provenance: The data is prospective and generated in-house by Class One Orthodontics in Lubbock, TX, USA. The experiments were conducted specifically for this submission.

3. Number of Experts and Qualifications

• Not applicable. The ground truth for these performance tests is based on objective, quantifiable physical measurements rather than expert human interpretation.

4. Adjudication Method

• Not applicable. The tests involve direct physical measurements and pass/fail criteria, not subjective human assessment requiring adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or clinical assessment devices where human interpretation plays a significant role. The device in question is an adhesive.

6. Standalone Performance (Algorithm Only)

• This concept is not applicable as the device is a physical adhesive, not a software algorithm or AI-driven system. The performance presented is the standalone performance of the adhesive itself.

7. Type of Ground Truth Used

• The ground truth used for both Set Time and Shear Bond Strength is objective physical measurement based on established standardized (or internally standardized) experimental procedures.
  • Set Time: Measured directly by stop-watch until the bracket becomes difficult to manipulate.
  • Shear Bond Strength: Determined by applying a static load equivalent to 10 MPa and observing if the bond withstands this load, referencing published clinical survival standards (6-8 MPa mastication force). Reference 1 (Reynolds I.R.) serves as the basis for the clinical relevance and acceptance criteria for shear bond strength.

8. Sample Size for the Training Set

• Not applicable. This device is an adhesive, not a machine learning model. Therefore, there is no "training set" in the context of AI. The development of the adhesive would involve formulation and testing, but these are not considered "training" in the AI sense.

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

• Not applicable, as there is no training set for this type of device. The formulation and properties of the adhesive were likely established through iterative chemical and materials engineering processes, guided by desired performance characteristics rather than a formal "ground truth" for a training set.

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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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