(59 days)
Pulpdent RMG/ Fill is a resin-modified glass ionomer preparation used by dental professionals as filling material in dental restorations.
Pulpdent RMG/ Fill is a resin-modified glass ionomer preparation with both a bioactive resin matrix and bioactive glass fillers. In this context 'bioactive' refers to the release of beneficial ions from the resin and glass fillers into the oral environment. As a resin-modified glass ionomer, Pulpdent RMG/ Fill has three setting mechanisms: light cure, self-cure resin chemistry, and acid-base glass ionomer reaction. It contains no Bisphenol A, no BisGMA and no BPA derivatives. Pulpdent RMG/ Fill is a paste-paste formulation provided in an automix syringe that is used by dental professionals as filling material in dental restorations.
The provided document describes the "Pulpdent RMGI Fill" device, a resin-modified glass ionomer preparation used as a restorative filling material in dentistry. The submission aims to demonstrate substantial equivalence to predicate devices, primarily through bench testing of physical properties.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for each performance metric. Instead, it presents the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence. For this table, I will use the reported performance values for "Pulpdent RMGI Fill" as the "reported device performance." The "acceptance criteria" can be inferred as being at least comparable to or better than the predicate devices to demonstrate substantial equivalence, though specific numerical targets beyond the observed values are not given.
| Performance Metric | Acceptance Criteria (Inferred: Comparable to Predicate) | Reported Device Performance (Pulpdent RMGI Fill) | Notes (from predicate comparisons) |
|---|---|---|---|
| Bench Testing | |||
| Flexural Strength | Comparable to predicate devices | 102.0 MPa | Higher than all listed predicates (Pulpdent RMGI Low Viscosity: 88 MPa; 3M ESPE Ketac Nano: 35 MPa; GC Fuji Filling LC: 28 MPa). |
| Flexural Modulus | Comparable to predicate devices | 4.3 GPa | Lower than 3M ESPE Ketac Nano (5.4 GPa) and GC Fuji Filling LC (12.3 GPa), but comparable to, or potentially better than, Pulpdent RMGI Low Viscosity (value not provided, but generally being "lower viscosity" might imply a lower modulus for that predicate depending on formulation). The document concludes overall equivalence despite individual differences. |
| Compressive Strength | Comparable to predicate devices | 280.0 MPa | Higher than all listed predicates (Pulpdent RMGI Low Viscosity: 239 MPa; 3M ESPE Ketac Nano: 236 MPa; GC Fuji Filling LC: 165 MPa). |
| Diametral Tensile Strength | Comparable to predicate devices | 42.0 MPa | Higher than all listed predicates (Pulpdent RMGI Low Viscosity: 36 MPa; 3M ESPE Ketac Nano: 32 MPa; GC Fuji Filling LC: 15 MPa). |
| Light cure set time | Not explicitly stated/compared | 20 seconds | Not directly compared to predicates in the provided tables. |
| Self-cure set time (intraoral) | Not explicitly stated/compared | 2 minutes, 20 seconds at 37°C | Not directly compared to predicates in the provided tables. |
| Self-cure set time (extra-oral) | Not explicitly stated/compared | 3 minutes, 30 seconds from beginning of mix at 20°C | Not directly compared to predicates in the provided tables. |
| Shear bond strength | Not explicitly stated/compared | 28 MPa (RMGI Fill to composite) | Not directly compared to predicates in the provided tables. |
| Radiopacity | Not explicitly stated/compared | Equivalent to 2 mm aluminum | Not directly compared to predicates in the provided tables. |
| Polymerization shrinkage | Not explicitly stated/compared | 1.7% | Not directly compared to predicates in the provided tables. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "bench testing" for the physical properties. Details regarding the exact sample sizes (e.g., number of specimens tested for flexural strength) for each test are not provided. The data provenance is not explicitly stated beyond "Pulpdent Corporation" as the owner/manufacturer, implying the testing was conducted or sponsored by them. There is no information to indicate if the data is retrospective or prospective; it is bench test data conducted for this submission.
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 inquiry is not applicable to this submission. The device is a dental restorative material, and the performance evaluation relies on objective physical and chemical bench tests, not on expert interpretation of images or clinical outcomes that typically require "ground truth" establishment by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This inquiry is not applicable to this submission. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints that require consensus or independent review. The reported data are from objective bench 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 inquiry is not applicable to this submission. An MRMC study is relevant for evaluating the impact of AI on human performance in diagnostic tasks. The "Pulpdent RMGI Fill" is a material, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This inquiry is not applicable to this submission. This refers to the performance of an AI algorithm alone, which is irrelevant for a dental material product. The "standalone" performance here refers to the material's properties as measured in a laboratory setting. The presented data is essentially a standalone performance evaluation of the material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the reported performance metrics (flexural strength, compressive strength, etc.) are the objective measurements derived from standardized material testing methods (implied by the nature of such tests for dental materials). There is no "expert consensus," "pathology," or "outcomes data" specifically mentioned as ground truth for these physical properties. The values obtained from the bench tests are considered the factual measurements of the material's properties.
8. The sample size for the training set
This inquiry is not applicable to this submission. The "Pulpdent RMGI Fill" is a material, not an algorithm that requires a training set. The term "training set" is used in the context of machine learning and AI development.
9. How the ground truth for the training set was established
This inquiry is not applicable to this submission, as there is no "training set" for this material.
§ 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.