(202 days)
PackFil RMGI Restorative Cement is indicated for filling and restoration of tooth of following typical applications:
- Primary teeth restorations;
- Class I restorations:
- Class III and V restorations:
- Transitional restorations;
- Base liners or laminated/sandwich restorations;
- Selective core build-ups (>50% coronal tooth intact);
PackFil Resin Modified Glass Ionomer (RMGI) Restorative Cement is used by dental professionals and intended for filling and restoration of teeth. The subject device possesses triple curing mechanisms of conventional acid-base glass ionomer reaction. methacrylate resin chemical curing and light curable on demand. It is a tooth colored, radiopaque (equivalent of 2.5 mm of aluminum), two-part paste/paste resin modified glass ionomer restorative cement material, with each part is packaged separately when not in use. PackFil RMGI provides the common benefits typical of conventional glass ionomer materials, with the feature of being packable after the two parts mixed together. The filler content of this system is primarily a combination of traditional silane treated barium-boro-silicate glass filler and radiopaque acid reactive fluoroaluminosilicate glass filler having a hybrid particle size range from about 0.01 up to about 5 micrometers while the resin system has a combination of aqueous polyacrylic acid copolymer, phosphate and other polymerizable methacrylate resins.
The provided text describes a 510(k) premarket notification for a dental product, "PackFil™ Resin Modified Glass Ionomer Restorative Cement." This document focuses on demonstrating the substantial equivalence of the new device to existing legally marketed predicate devices, rather than an AI-based device's performance against clinical acceptance criteria in the way a diagnostic AI would be evaluated.
Therefore, many of the requested categories for AI device evaluation (such as sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set size, etc.) are not applicable to this document as it pertains to a dental restorative cement, not an AI diagnostic tool.
However, I can extract information related to the device's technical specifications and the testing performed to demonstrate its performance against industry standards, which serves as its "acceptance criteria" in this context.
Here's an interpretation based on the given document:
1. A table of acceptance criteria and the reported device performance
For a dental material, the "acceptance criteria" are typically defined by recognized international standards (like ISO) and comparative performance to predicate devices. The document explicitly states that the performance data satisfies ISO 9917-2.
| Performance Metric | Acceptance Criteria (Satisfies ISO 9917-2) | Reported Device Performance (PackFil RMGI) |
|---|---|---|
| Bonding Strength to Resin composite | Defined by ISO 9917-2 (not explicitly stated here) | 18 MPa (Self-cured), 22 MPa (Light cured) |
| Flexural Strength | Defined by ISO 9917-2 (not explicitly stated here) | 41 MPa (Self-cured), 36 MPa (Light cured) |
| Compressive Strength | Defined by ISO 9917-2 (not explicitly stated here) | 245 MPa (Self-cured), 230 MPa (Light cured) |
| Radiopacity | Defined by ISO 9917-2 (not explicitly stated here) | 2.5 mm aluminum equivalent |
| Self-cure working time | Defined by ISO 9917-2 (not explicitly stated here) | 3 minutes |
| Self-cure setting time (from start) | Defined by ISO 9917-2 (not explicitly stated here) | 6 minutes |
| Depth of cure (VLC for 20'') | Defined by ISO 9917-2 (not explicitly stated here) | 3 mm |
| Sensitivity to Ambient Light | Defined by ISO 9917-2 (not explicitly stated here) | >60 seconds |
Biocompatibility Acceptance Criteria and Results:
The biocompatibility studies were selected according to ISO 10993-1:2009.
| ISO Test Method | Test Description | Acceptance Criteria (Implicit for safety) | Result Summary |
|---|---|---|---|
| 10993-5:2009 | Cytotoxicity - L929MEM Elution | No cytotoxic effect | No cytotoxic effect |
| 10993-10:2010, 3ed | Irritation - Intracutaneous Injection | Not more than control article | Not more than the control article |
| 10993-3:2003, 2ed | Genotoxicity - Mutation Study | Non-mutagenic | Non-mutagenic |
| 10993-10:2010, 3ed | Sensitization Maximization | No sensitization | No sensitization |
| 10993-6:2007 | Implantation - four weeks | Same as negative control | Same as the negative control |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document presents summary bench testing results and biocompatibility study results, but does not detail the sample sizes for these tests or the specific provenance of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the document describes a material for dental restoration, not an AI diagnostic device where 'ground truth' is established by human experts on clinical data. The performance metrics are measured through laboratory bench tests and standard biological assays.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as #3.
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 is not applicable as the document describes a dental material, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the document describes a dental material, not an AI algorithm. The performance presented ("reported device performance") is the standalone performance of the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance metrics, the "ground truth" (or reference standard) is established by objective measurements under controlled laboratory conditions following international standards (ISO 9917-2) for material properties and standard biological assays following ISO 10993-1:2009 for biocompatibility. There is no human interpretative "ground truth" in the clinical sense for this type of device.
8. The sample size for the training set
This is not applicable as the document describes a manufactured dental material, not a machine learning model that undergoes a "training set" phase.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.
§ 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.