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Intended for use in the creation of occlusal buildups (bite turbos) and as a retainer repair composite. It bonds to enamel, porcelain, acrylic and metal for duration of treatment externally communicating device that contacts tissue/bone/dentin.

TKO Composite Bite Turbo Gel is dispensed from a precision 3.5 gm LuerLoc syringe with tips.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a dental product called "TKO Composite Bite Turbo Gel." It outlines the device's characteristics, intended use, and a comparison with legally marketed predicate devices to establish substantial equivalence.

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

Important Note: This document pertains to a medical device (dental resin) and not an AI/ML enabled device. Therefore, many of the requested criteria related to AI/ML device performance (e.g., MRMC studies, training set details, expert ground truth adjudication) are not applicable and thus not present in the document. The study described focuses on non-clinical, physical, and chemical performance testing to demonstrate substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Test Method	Unit	Acceptance Criteria (Requirement)	Reported Device Performance (Test Result)
Shear Bond Strength (Enamel)	RD-022	MPa	5 sample average ≥ 8	Pass (16.47 ± 4.24)
Shear Bond Strength (Steel)	RD-022	MPa	5 sample average ≥ 8	Pass (36.157 ± 1.37)
Shear Bond Strength (Porcelain)	RD-022	MPa	5 sample average ≥ 8	Pass (21.54 ± 5.12)
Shear Bond Strength (Acrylic)	RD-022	MPa	5 sample average ≥ 8	Pass (24.28 ± 3.57)
Flexural Strength	ISO-4049:2019	MPa	4 of 5 samples ≥ 80	Pass (5 of 5 samples > 80)
Hardness after Cure	QC-006	N/mm²	> 69 Top, > 67 Bottom (After 20 s L/C)	Pass (>69 Top, > 67 Bottom)
Depth of Cure	ISO 4049:2019	mm	3 of 3 samples ≥ 1.5	Pass (3 of 3 samples > 1.5)
Sensitivity to Ambient Light	ISO 4049:2019	Homogeneous visual inspection	3 of 3 samples (homogenous)	Pass (3 of 3 samples homogenous)
Water Sorption	ISO 4049:2019	µg/mm³	4 of 5 < 40	Pass (5 of 5 < 40)
Water Solubility	ISO 4049:2019	µg/mm³	4 of 5 < 7.5	Pass (5 of 5 < 7.5)
Biocompatibility	ISO 10993-5, ISO 7405:2018	N/A	Passes Cytotoxicity or Oral Toxicity testing	Pass (14 day oral toxicity)
Storage and Shelf Life	Stability study for 3.7 months at 50 °C	N/A	SBS, Flexural Strength, and Hardness after cure pass after cure	Pass (24 month shelf life at room temperature)
Packaging	RD-037	N/A	Passes suitability testing	Pass

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

Sample Sizes: The sample sizes are specified for individual tests:
- Shear Bond Strength: 5 samples per test (for enamel, steel, porcelain, acrylic)
- Flexural Strength: 5 samples
- Hardness after Cure: Not explicitly stated, implied to be at least 2 (top/bottom)
- Depth of Cure: 3 samples
- Sensitivity to Ambient Light: 3 samples
- Water Sorption: 5 samples
- Water Solubility: 5 samples
- Biocompatibility: Not explicitly stated for number of samples, but mentions "14 day oral toxicity" which implies in vivo or in vitro testing.
- Storage and Shelf Life: Not explicitly stated for number of samples, but refers to a "stability study."
- Packaging: Not explicitly stated.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It describes "non-clinical data submitted" and "performance data provided in support of the substantial equivalence determination." These are likely lab-based experimental studies conducted by or for the manufacturer.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable to this type of device and study. The "ground truth" here is established by standardized test methods (e.g., ISO standards, internal RD and QC procedures) and the objective measurement of physical and chemical properties, not by expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes where there might be disagreement among evaluators. Here, the results are quantitative measurements from lab tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This information is not applicable. An MRMC study is relevant for evaluating the performance of AI/ML systems in conjunction with human readers, typically in image interpretation. This document describes a physical dental material, not an AI/ML device.

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

This information is not applicable. This question pertains to AI/ML algorithm performance. The device is a dental material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is defined by established physical and chemical standards and test methodologies. For example:
- Shear Bond Strength is measured according to method RD-022.
- Flexural Strength, Depth of Cure, Water Sorption, and Water Solubility are measured according to ISO 4049:2019.
- Hardness after Cure is measured according to QC-006.
- Biocompatibility is assessed against ISO 10993-5 and ISO 7405:2018.
The ground truth is not based on expert consensus, pathology, or outcomes data in the traditional sense, but rather on the quantitative results derived from these standardized tests, which are then compared to pre-defined acceptance criteria.

8. The Sample Size for the Training Set

This information is 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

This information is not applicable. As it's not an AI/ML device, there is no training set or ground truth established for it in that context.

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