(30 days)
Permanent cementation of pediatric crowns:
- Stainless Steel crowns
- Zirconia crowns
- 3M™ Pediatric Esthetic Crowns
3MTM RelyX™ Pediatric Resin Modified Glass Ionomer Cement is a radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement. RelyX Pediatric Cement is intended for the cementation of preformed pediatric crowns made of stainless steel, zirconia, and resin composite material.
RelyX Pediatric Cement consists of a base paste and a catalyst paste packaged in the Automix delivery system for direct delivery in consistent mix ratios. The mixing tip attachment offers convenience over traditional hand mixed cement systems and delivers consistent mix ratios. The cement is available in a white shade. The Automix syringe contains 8.5 g of cement material. The product provides both selfcuring and light curing mechanisms which makes it uniquely versatile for the cementation of different restorative materials.
Here's an analysis of the acceptance criteria and the study details for the 3M™ RelyX™ Pediatric Resin Modified Glass Ionomer Cement, based on the provided text:
Important Note: The provided document is a 510(k) summary for a dental cement. It does not describe an AI medical device, but rather a traditional medical device that undergoes physical and chemical performance testing to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested fields related to AI, such as sample sizes for test/training sets, data provenance, ground truth experts, adjudication methods, and MRMC studies, are not applicable and thus not present in this type of document.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implied by the demonstration of "equivalent or superior bonding" and other physical properties compared to predicate devices. The document does not explicitly list numerical acceptance criteria in a table format for each property, but rather states that the "results submitted in the 510(k) demonstrated equivalent or superior bonding."
Here's a table based on the reported performance relative to predicate devices:
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Adhesion to Dentin | Equivalent to or superior to predicate devices (K111185, K001730) | Demonstrated equivalent or superior bonding |
| Adhesion to Enamel | Equivalent to or superior to predicate devices (K111185, K001730) | Demonstrated equivalent or superior bonding |
| Adhesion to 3M Pediatric Esthetic Crown | Adequate performance for indicated use (specific to the new indication) | Demonstrated equivalent or superior bonding |
| Compressive Strength | Performance comparable to predicate devices | Data included in submission to evaluate performance for new indication |
| Flexural Strength | Performance comparable to predicate devices | Data included in submission to evaluate performance for new indication |
| Fluoride Release | Performance comparable to predicate devices | Data included in submission to evaluate performance for new indication |
| Linear Expansion | Performance comparable to predicate devices | Data included in submission to evaluate performance for new indication |
| Radiopacity | Performance comparable to predicate devices | Data included in submission to evaluate performance for new indication |
| Color Stability | Performance suitable for esthetic properties (specific to the new indication) | Data included in submission to evaluate performance for new indication |
| Biocompatibility | Meets biocompatibility requirements (ISO 10993-1:2018) | Confirmed to meet requirements; no additional testing needed due to identical formulation as predicate device |
| Shelf Life | 24 months at room temperature | Established as 24 months based on predicate device testing |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The document mentions "data from in vitro testing," which typically involves multiple samples for each test (e.g., several samples per group for adhesion tests, compressive strength, etc.), but the exact number is not provided.
- Data Provenance: The studies were in vitro testing. The country of origin of the data is not specified, but the submitter is 3M ESPE Dental Products, located in St. Paul, MN, USA. The testing was conducted to support a 510(k) submission to the U.S. FDA. The studies are by nature prospective in the sense that the manufacturer performed them to gain clearance for the device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this is not an AI/diagnostic device. The "ground truth" for material properties is established through standardized physical and chemical testing methods (e.g., ISO standards), not expert consensus.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for this type of in vitro material performance testing. Standardized test methods and measurements are used, not human adjudication.
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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 not an AI medical device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical and chemical properties (adhesion, strength, fluoride release, etc.), the "ground truth" is determined by the results obtained from standardized in vitro test methods (e.g., per FDA Guidance "Dental Cements - Premarket Notification" and ISO 9917-2:2017). For biocompatibility, the ground truth is established by meeting the requirements of ISO 10993-1:2018.
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The sample size for the training set:
- Not applicable. This is not an AI medical device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. This is not an AI medical device, so there is no "training set" or corresponding ground truth establishment process in that context.
§ 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.