(353 days)
Parkell Self-Adhesive Cement is intended for the cementation of indirect restoratives including ceramic, zirconia, composite, and metal-based inlays, onlays, crowns, bridges, and posts.
Parkell Self-Adhesive Cement is a two-component, dual-cured, self-adhesive resin cement. It is designed for luting of indirect restorations (inlays, onlays, crowns, bridges, and endodontic posts) made of metal alloys, composite resins, porcelain, lithium disilicate or zirconia. The material also exhibits high bond strength and is radiopaque to allow visibility of excess in sub-gingival areas. Parkell Self-Adhesive Cement will cure in 10 seconds with a dental curing light emitting blue light at 430 - 480 nm and a minimum intensity of 600 mW/cm². The product will self-cure in 3-4 minutes at mouth temperature. Parkell Self-Adhesive Cement will be provided in 5 mL auto-mix syringes. The device comprises catalyst and base components, which are combined just prior to use via a static (1:1) mixing tip which is affixed to the dual chamber syringe.
The provided document is a 510(k) summary for a dental cement (Parkell Self-Adhesive Cement). It aims to demonstrate substantial equivalence to a predicate device. This type of submission relies heavily on bench testing and biocompatibility studies, rather than clinical performance (human trials) for its primary evidence.
Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context pertains to the non-clinical performance and physical properties of the dental cement, as well as its biocompatibility, when compared to the established standards and the predicate device.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:
The document implicitly defines acceptance criteria by comparing the subject device's performance to the predicate device's performance, or to generally accepted values for dental cements (e.g., "Pass/Fail Criteria"). The performance listed is for the standalone (algorithm only without human-in-the-loop performance) of the material itself.
| Property | Predicate Device Performance / Acceptance Criteria (Pass/Fail Criteria) | Parkell Self-Adhesive Cement Performance |
|---|---|---|
| Physical Properties | ||
| Film Thickness (Microns) | ≤ 50 microns | ≤ 50 microns |
| Working time (seconds) @ 35 C | ≤ 60 seconds | ≤ 60 seconds |
| Setting time (minutes) @ 35 C | ≤ 10 minutes | ≤ 10 minutes |
| Flexural strength LC (MPa) | ≥ 50 MPa | ≥ 50 MPa |
| Flexural Strength SC (MPa) | ≥ 50 MPa | ≥ 50 MPa |
| Compressive Strength LC (MPa) | ≥ 200 MPa | ≥ 200 MPa |
| Water Sorption (ug/mm³) | ≤ 40 ug/mm³ | ≤ 40 ug/mm³ |
| Water Solubility (ug/mm³) | ≤ 7.5 u/mm³ | ≤ 7.5 u/mm³ |
| Radiopacity (% Al) | ≥ 100 %Al | ≥ 100 %Al |
| Depth of Cure (mm) | ≥ 1mm | ≥ 1mm |
| Diametral Tensile Strength (MPa) | ≥ 30 MPa | ≥ 30 MPa |
| Barcol Hardness after 20 minutes @35c (MPa) | > 50 MPa | > 50 MPa |
| Barcol Hardness after 20 secs Light Cure each surface (MPa) | > 60 MPa | > 60 MPa |
| Bond Strength (MPa) to Substrates (LC = Light Cure, SC = Self-Cure, Treatment indicated where applicable) | ||
| Dentin LC (None) | ≥ 6 MPa | ≥ 6 MPa |
| Dentin LC (PBA) | ≥ 10 MPa | ≥ 10 MPa |
| Dentin SC (None) | ≥ 3 MPa | ≥ 3 MPa |
| Enamel LC (None) | ≥ 10 MPa | ≥ 10 MPa |
| Enamel LC (H3PO4) | ≥ 10 MPa | ≥ 10 MPa |
| Enamel SC (None) | ≥ 3 MPa | ≥ 3 MPa |
| Lithium Disilicate LC (Silane) | ≥ 5 MPa | ≥ 5 MPa |
| Lithium Disilicate LC (HF) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Zirconia LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Zirconia LC (PBA) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Zirconia LC (HF) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Zirconia SC (SB) | ≥ 5 MPa | ≥ 5 MPa |
| Porcelain LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Porcelain LC (Silane) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Porcelain LC (HF) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Porcelain SC (HF) | N/A (Predicate did not have this indication) | ≥ 5 MPa |
| Palladium LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Titanium LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Titanium SC (SB) | ≥ 5 MPa | ≥ 5 MPa |
| Cobalt LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Cobalt SC (SB) | ≥ 5 MPa | ≥ 5 MPa |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the numerical sample size (e.g., number of specimens tested for each property). It only indicates that "Performance and Physical Properties" tests were performed.
- Data Provenance: The data is generated from non-clinical (bench) testing. The country of origin of the data is not specified, but the submission is to the U.S. FDA by a company based in New York. The testing would be considered prospective in the sense that it was conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: This is not applicable to this type of submission. The "ground truth" for the performance and physical properties of the dental cement is established through standardized laboratory test methods (e.g., ISO standards like ISO 4049, ISO 11405, etc.) and direct object measurement, not expert consensus or interpretation.
- Qualifications of Experts: Not applicable, as expert interpretation is not the primary means of establishing "ground truth" for material properties.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic studies involving human readers/interpreters to resolve discrepancies. For bench testing of material properties, the results are quantitative measurements against defined criteria.
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 submission for a medical device (dental cement), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Quantitative measurements against established international standards and defined criteria. For physical properties, the ground truth is derived from the reproducible results of standardized laboratory tests. For biocompatibility, the ground truth is assessed against the requirements of ISO 10993 series of standards.
8. The Sample Size for the Training Set:
- Not applicable. This is a medical device submission based on bench testing of material properties, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of device.
§ 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.