Search Results
Found 1 results
510(k) Data Aggregation
(279 days)
- Class I, III, V (non-stress area, minimally invasive restoration)
- Composite resin repair
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.
This document is a 510(k) summary for the medical device "Bright Low Flow", a light-cured flowable composite resin manufactured by GENOSS Co., Ltd. It declares that the device is substantially equivalent to a predicate device (K091388 G-aenial Universal Flo) and provides performance data to support this claim.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents two tables related to performance criteria: Biocompatibility and Performance Bench Testing.
Biocompatibility Acceptance Criteria and Performance:
| No. | Test | Method | Acceptance criteria | P/F (Result) |
|---|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5 | None cytotoxicity | Pass |
| 2 | Irritation | ISO 10993-10 | None oral irritation | Pass |
| 3 | Sensitization | ISO 10993-10 | None sensitization | Pass |
| 4 | Acute systemic toxicity | ISO 10993-11 | None systemic toxicity | Pass |
| 5 | Genotoxicity | ISO 10993-3 | None genotoxicity | Pass |
| 6 | Implantation | ISO 10993-6 | Biocompatible | Pass |
| 7 | Chronic toxicity | ISO 10993-11 | No chronic toxicity | Pass |
Performance Bench Testing Acceptance Criteria and Performance:
| No. | Items | Method | Acceptance Criteria | Result |
|---|---|---|---|---|
| 1 | Visual | ISO 4049 | No impurities and No specific changes | No impurities and No specific changes |
| 2 | Capacity | ISO 4049 | Capacity error of; Standard Capacity < ±5% | Size error of; Standard Size < ±5% H 0.43%, Ø 0.03% |
| 3 | Package | ISO 4049 | No damage | No damage |
| 4 | Sensitivity to Ambient Light | ISO 4049 | Must be physically uniform | Uniformity |
| 5 | Depth of Cure | ISO 4049 | More than 1.5 mm | Average: 2.9 mm |
| 6 | Shade | ISO 4049 | Must be shade uniform | Uniformity |
| 7 | Color Stability | ISO 4049 | Color should be stable | Stable |
| 8 | Flexural Strength | ISO 4049 | More than 80 MPa | Average: 142 MPa |
| 9 | Water Sorption | ISO 4049 | Less than 40 µg/mm3 | Average: 23 µg/mm3 |
| 10 | Solubility | ISO 4049 | Less than 7.5 µg/mm3 | Average: 0.9 µg/mm3 |
| 11 | Radio-opacity | ISO 4049 | More than Al | ≥ Al (1.81) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each of the biocompatibility and performance bench tests. However, the tests are identified by their ISO standard methods (e.g., ISO 10993-5, ISO 4049), implying that the testing was conducted according to these internationally recognized standards, which typically define appropriate sample sizes.
Data Provenance: The document indicates that the submitter is "GENOSS Co., Ltd." located in "Suwon-si, Gyeonggi-do, Korea." This suggests the data was generated in South Korea, or at least commissioned by a South Korean company. The tests are referred to as "Biocompatibility testing on the proposed Bright Low Flow has been completed" and "The proposed Bright Low Flow was evaluated using the following performance bench testing," implying these are prospective tests performed on the device itself for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests performed are laboratory-based physical and chemical property evaluations or biological assays (biocompatibility) rather than interpretations requiring human expert consensus on a test set.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are objective, laboratory-based measurements or biological assays, not interpretations requiring adjudication.
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
This information is not applicable. The device is a "light-cured flowable composite resin" (dental material), not an AI diagnostic or assistive tool.
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.
7. The Type of Ground Truth Used
For the biocompatibility tests, the "ground truth" is based on the biological response observed in the specific assays according to the ISO 10993 standards (e.g., cell viability for cytotoxicity, skin reaction for irritation, systemic effects for acute systemic toxicity).
For the performance bench tests, the "ground truth" is the quantitative measurement of the physical/chemical properties of the material (e.g., depth of cure in mm, flexural strength in MPa, water sorption in µg/mm3) as determined by the specified ISO 4049 standard methods. This represents direct measurement of inherent material properties.
8. The Sample Size for the Training Set
This information is not applicable. As a dental material, there is no "training set" in the context of machine learning or AI models. The device's properties are inherent to its formulation and manufacturing process, evaluated through scientific testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
Ask a specific question about this device
Page 1 of 1