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510(k) Data Aggregation
(313 days)
- Base/liner
- Pit & Fissure sealant
Bright Flow is a light-cured flowable composite resin. It comprises two different types of flowability (Low Flow and High Flow) and 9 shades depending on the intended use, which enables aesthetic and durable outcomes for anterior and posterior composite restorations.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Name: Bright High Flow
Manufacturer: GENOSS Co., Ltd.
The provided document describes the performance bench testing and biocompatibility testing conducted to demonstrate that the Bright High Flow device meets its acceptance criteria. No clinical study or MRMC effectiveness study is mentioned, as this device appears to be a dental material.
1. Table of Acceptance Criteria and Reported Device Performance
Biocompatibility Testing
| No. | Test | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| 1 | Cytotoxicity | None cytotoxicity | Pass |
| 2 | Irritation | None oral irritation | Pass |
| 3 | Sensitization | None sensitization | Pass |
| 4 | Acute systemic | None systemic toxicity | Pass |
| 5 | Genotoxicity | None genotoxicity | Pass |
| 6 | Implantation | Biocompatible | Pass |
| 7 | Chronic toxicity | No chronic toxicity | Pass |
Performance Bench Testing
| No. | Items | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| 1 | Visual | No impurities and No specific changes | Pass |
| 2 | Capacity | Capacity error of; Standard Capacity < ± 5% | Pass |
| 3 | Package | No damage | Pass |
| 4 | Sensitivity to Ambient Light | Must be physically uniform | Pass |
| 5 | Depth of Cure | More than 1.5 mm | Pass |
| 6 | Shade | Must be shade uniform | Pass |
| 7 | Color Stability | Color should be stable | Pass |
| 8 | Flexural Strength | More than 80 MPa | Pass |
| 9 | Water Sorption | Less than 40 µg/mm³ | Pass |
| 10 | Solubility | Less than 7.5 µg/mm³ | Pass |
| 11 | Radio-opacity | More than the same thickness of aluminum (More than Al) | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each test. The tests are bench tests and biocompatibility tests, not studies involving human subjects or patient data. The provenance of the data (country of origin, retrospective/prospective) is not specified beyond the fact that the manufacturer is based in Korea and the testing was conducted according to international standards (ISO).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The evaluations are based on standardized laboratory tests (ISO standards) rather than expert interpretation of clinical data. There is no mention of experts establishing ground truth for a test set in the context of this device's evaluation.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments, which are not detailed for this device. The evaluation relies on objective measurements against defined standards.
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 MRMC comparative effectiveness study was done. This device is a dental material (flowable composite resin) and its evaluation is based on material properties and biocompatibility, not AI assistance for human readers.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This information is not applicable. The device is a dental material, not an algorithm, so "standalone performance" in the context of AI is irrelevant. Its performance is measured directly through physical and chemical property tests.
7. The type of ground truth used
The ground truth used for the performance evaluations are international consensus standards (ISO 10993 for biocompatibility and ISO 4049 for dental polymer-based restorative materials). These standards define the acceptable range or threshold for specific material properties.
8. The sample size for the training set
This information is not applicable. As the device is a material, there is no "training set" in the context of machine learning. The manufacturing process and material formulation are developed based on established dental material science principles.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this type of device. The "ground truth" for developing the material is derived from scientific knowledge, material engineering, and performance requirements for dental restorative materials, as codified in relevant ISO standards.
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