Search Results
Found 2 results
510(k) Data Aggregation
(389 days)
Self-curing glass ionomer based radiopaque filling cement, for dental use only. Recommended Indications:
(1) Restoration of primary teeth.
(2) Restorations of Class III, V and limited Class I cavities.
(3) Base linings under composite and amalgam.
(4) Core build-up.
Glass Ionomer Cement (Filling) has two types: Filling II. It is a device composed of various materials including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as a permanent or temporary tooth filling or as base linings. It's a powder liquid system. The basic operation principle of Glass Ionomer Cement (Filling) is acid-base reaction.
The provided document describes the acceptance criteria and the study (physical and chemical properties tests) for the "Glass Ionomer Cement (Filling)" device (K160345).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria (Standard Requirement - ISO 9917-1:2007) | Reported Device Performance (Conclusion) |
|---|---|---|
| Components | Liquid: Free from deposits or filaments, no visible signs of gelation. Powder: Free from extraneous material, uniformly dispersed pigment (if colored). Unset cement: Homogeneous and smooth consistency. | Within spec set by standard |
| Net setting time | For restoration: 1.5~6 min | Within spec set by standard |
| Compressive strength | For restoration: ≥100 MPa | Within spec set by standard |
| Acid erosion | ≤0.17 mm | Within spec set by standard |
| Acid-soluble Lead content | ≤100 mg/kg | Within spec set by standard |
| Radio-opacity | At least equivalent to that for the same thickness of aluminum. | Within spec set by standard |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for each physical and chemical properties test. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that it refers to ISO standards and a submission by a Chinese company, it's highly probable the testing was conducted in a laboratory in China following international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the study described is a series of laboratory-based physical and chemical properties tests against predefined ISO standards, not a clinical study involving human assessment or interpretation requiring expert ground truth establishment.
4. Adjudication method for the test set
This section is not applicable as the study described is a series of laboratory-based physical and chemical properties tests against predefined ISO standards. There is no mention of adjudication for these types of tests.
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 section is not applicable. The document describes a traditional device clearance for a dental material (Glass Ionomer Cement), not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical dental material, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance criteria in this context is established by the ISO 9917-1:2007 standard for Dentistry — Water-based cements - Part 1: Powder/liquid acid-base cements. The reported performance is a direct measurement against these internationally recognized physical and chemical property specifications.
8. The sample size for the training set
This section is not applicable as the device is a physical dental material and not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
Ask a specific question about this device
(117 days)
Self-curing glass ionomer based radiopaque luting cement, for dental use only. Recommended indications:
(1) Cementation of metal-based inlays, onlays, crowns and bridges;
- (2) Cementation of high strength (zirconia based) all ceramic crowns and bridges;
- (3) Cementation of posts and screws made of metal or high-strength ceramic;
- (4) Cementation of orthodontic bands;
- (5) Restoration of caries in unstressed area (Luting II only).
Glass Ionomer Cement (Luting) has two models: Luting II. It is a device composed of various materials mainly including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as luting to affix dental devices such as metal-based inlays, onlays, crowns, bridges, and orthodontic bands. It's a powder liquid system, with each part is packaged separately when not in use. The basic operation principle of Glass Ionomer Cement (Luting) is acid-base reaction.
The provided document is a 510(k) summary for a "Glass Ionomer Cement (Luting)" device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on algorithm-driven performance. Therefore, most of the requested information about AI/algorithm-related studies (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not applicable to this document.
However, the document does contain a table of acceptance criteria and reported performance for physical and chemical properties based on the ISO 9917-1:2007 standard.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Item per ISO 9917-1:2007 | Acceptance Criteria (Pass/fail criteria) | Reported Device Performance (Conclusion) |
|---|---|---|
| 5.2 Components | - Liquid: Free from deposits or filaments on the inside of its container. No visible signs of gelation.- Powder: Free from extraneous material.- Unset cement: Homogeneous and of a smooth consistency. | Within spec set by standard |
| 8.1 Net setting time | - For luting: 1.5 | Within spec set by standard |
| 8.2 Film thickness | - For luting: ≤25 µm- For restoration: N/A | Within spec set by standard |
| 8.3 Compressive strength | - For luting: ≥50 MPa- For restoration: ≥100 MPa | Within spec set by standard |
| 8.4 Acid erosion | - For luting: ≤0.17 mm- For restoration: ≤0.17 mm | Within spec set by standard |
| 8.6.2 Acid-soluble Lead content | - For luting: ≤100 mg/kg- For restoration: ≤100 mg/kg | Within spec set by standard |
| 8.7 Radio-opacity | The radio-opacity shall be at least equivalent to that for the same thickness of aluminium. | Within spec set by standard |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each physical/chemical property test. It mentions that "Biocompatibility tests were performed to satisfied the ISO 10993 standards," but does not detail the specific sample counts for those tests. The data provenance is internal testing conducted by SHANDONG HUGE DENTAL MATERIAL CORPORATION, presumably prospective testing for this specific device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests are for physical and chemical properties, measured objectively according to ISO standards, not interpreted by human experts.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements, not subject to 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
Not applicable. This is a dental cement, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental cement, not an algorithm.
7. The type of ground truth used
The "ground truth" for the physical and chemical property tests is defined by the specific measurement methodologies and acceptable ranges stipulated in the ISO 9917-1:2007 standard. For biocompatibility, the ground truth would be the thresholds and methodologies defined by ISO 10993 standards.
8. The sample size for the training set
Not applicable. There is no AI algorithm being trained.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm being trained.
Ask a specific question about this device
Page 1 of 1