(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: 1.5~8 min - For restoration: 1.5~6 min | 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.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.