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510(k) Data Aggregation
(89 days)
Sincera Technology (Changchun) Co., Ltd.
Light Cure Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures:
- Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives;
- Repair of dental restorations of ceramic, composites and/or metal alloys;
- Indirect dental restoration applications in combination with resin cement for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.
Not Found
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a "Light Cure Adhesive" device, which is a dental bonding agent. It discusses regulatory matters, such as substantial equivalence, general controls, and good manufacturing practices.
It does not include details about:
- Acceptance criteria table and reported device performance for a study proving the device meets the criteria.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or their effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
This document is a regulatory approval, not a clinical or performance study report for an AI/software-based medical device. Therefore, I cannot extract the requested information from the given text.
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(59 days)
Sincera Technology (Changchun) Co., Ltd.
Anterior restorations (Class III, IV) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Restorations in the posterior region (Class I and II) Veneering of discolored anterior teeth Splinting of mobile teeth Repair of composite and ceramic veneers
Light Cure Composite is a state-of-the-art light-curing, radiopaque, nano-hybrid composite for the restorative therapy. The device cures with light at the wavelength range of 400–500 nm (blue light). The device is paste contained in PP syringe.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Outward appearance-ISO 4049 | According to visual inspection, the product should be uniform in texture and should be a paste without visible impurities and foreign matter. | Meet the requirement |
| Sensitivity to ambient light-ISO 4049 | The material of sample remains physically homogeneous. | Meet the requirement |
| Depth of Cure-ISO 4049 | ≥1.5mm | ≥1.5mm |
| Flexural strength-ISO 4049 | ≥80Mpa | ≥80Mpa |
| Water sorption-ISO 4049 | ≤40µg/mm³ | ≤40µg/mm³ |
| solubility-ISO 4049 | ≤7.5µg/mm³ | ≤7.5µg/mm³ |
| Shade-ISO 4049 | Without the need for a magnifying glass to observe with the naked eye, the cured material should be evenly colored. | Meet the requirement |
| Color comparison for color stability-ISO 4049 | Only slight changes are allowed. | Meet the requirement |
| Appearance of container-ISO 4049 | Visually observe that the surface of the container should be smooth, without scratches, cracks, burrs, small notches or macroscopic defects caused by mechanical processing. | Meet the requirement |
| Delivery performance of container-ISO 4049 | Remove the syringe cap and turn the container push rod clockwise allowing resin to be smoothly squeezed out of the syringe without obstruction. | Meet the requirement |
| Compressive Strength | ≥ 200 Mpa | Meet the requirement (Mean: 286.5) |
| Elastic Modulus | ≥ 6 Gpa | Meet the requirement (Mean: 8.5) |
| Surface Hardness | ≥ 60 (HV) | Meet the requirement (Mean: 63.1) |
| Particle size | 0.4-2μm | (Value not explicitly stated as "meet requirement," but compared in section 6 as 0.4-2μm) |
| Radio-opacity | Mean: 2.27mm (This value is provided as a characteristic, not an acceptance criterion with a pass/fail. However, it is explicitly listed as a 'target' value.) | Mean: 2.27mm |
| Biocompatibility | Meet ISO 10993-1 - Biological evaluation of medical devices — Part 1: Evaluation and testing. | Meet ISO 10993-1 |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample sizes used for each specific test in the "Non-clinical performance Data" section. It lists performance results but not the number of units tested.
The data provenance is from non-clinical performance testing, likely conducted by the manufacturer, Sincera Technology (Changchun) Co., Ltd. The country of origin for the testing would be P.R. China, based on the submitter's address. The data is prospective in the sense that it was generated for the purpose of demonstrating the device's performance against established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This document describes a non-clinical performance study of a dental material, not a diagnostic device requiring human interpretation of images or clinical data. Therefore, there is no mention of "experts" or "ground truth" in the context of clinical interpretation for a test set. The "ground truth" for these tests is implicitly defined by the ISO standards themselves, which specify measurement methodologies and acceptance criteria.
4. Adjudication Method for the Test Set
As this is a non-clinical performance study against ISO standards, no adjudication method (like 2+1 or 3+1) is applicable or mentioned. The results are based on direct measurements and observations relative to the specified criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or is relevant to this type of device (Light Cure Composite). This is a material science and engineering performance evaluation, not a diagnostic imaging device requiring human reader input or comparison.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical dental material, not a software algorithm.
7. Type of Ground Truth Used
The ground truth used for this study is based on established international standards (ISO 4049 and ISO 10993-1). These standards define the test methodologies and the acceptable performance limits for the specific physical and chemical properties of the dental composite material.
8. Sample Size for the Training Set
Not applicable. This is a hardware/material device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, there's no ground truth to establish for it in this context.
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