(10 days)
Bonding between dentin/enamel and composite filling materials.
Bonding between dentin/enamel and compomer filling materials.
Bonding mediator for fissure sealing
Bonding mediator for bracket attachment
Adper Prompt is classified as a Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer and composite restorative material).
Adper Prompt will be available in single dose applicators, "Adper Prompt L-Pop". Additionally, Adper Prompt will also be available in a two-vial version called "Adper Prompt". The resulting bonding agent, regardless if obtained from L-Pop application system or two-vial system, has the same chemical composition and material characteristics.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Adper Prompt device:
Acceptance Criteria and Device Performance for Adper Prompt
The provided 510(k) summary for Adper Prompt does not explicitly state numerical acceptance criteria tied to specific performance metrics (e.g., minimum bond strength in MPa). Instead, the acceptance philosophy hinges on demonstrating substantial equivalence to the predicate device, Prompt L-Pop. The core of the "study" described is a comparative performance study against this predicate.
Table 1: Acceptance Criteria (Implied) and Reported Device Performance
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility to be equivalent to predicate. | "Additionally, an independent research institute carried out biocompatibility testing. The results show that Adper Prompt is a safe device." (Implied to be comparable or superior to predicate, as it's deemed "safe"). |
| Effectiveness: Performance characteristics to be equivalent to predicate (Prompt L-Pop). | "To prove the effectiveness of Adper Prompt, the performance characteristics of Adper Prompt were compared to Prompt L-Pop." (Detailed results of this comparison are not provided in the summary, only the statement that the comparison was done and implied to meet equivalence for the device to be cleared.) The submission concludes that the device is "substantially equivalent to the predicate device" based on these comparisons, among other factors. |
| Chemical Composition: Minor changes, but basic design remains the same, leading to same final composition and material characteristics. | "The modifications of Prompt L-Pop concern minor changes of the chemical composition, however, the basic chemical design remains the same." "The resulting bonding agent, regardless if obtained from L-Pop application system or two-vial system, has the same chemical composition and material characteristics." "Adper Prompt incorporates the same basic chemical design." |
| Intended Use: Same as predicate. | "Adper Prompt has the same intended use." |
| Shelf Life: Same as predicate. | "Adper Prompt has the same shelf life." |
Missing Information: It's crucial to note that the provided 510(k) summary is very high-level regarding the actual efficacy data. It asserts a comparison was made and that equivalence was found, but it does not include any specific performance metrics (like bond strength values, leakage rates, etc.) or confidence intervals that would typically be associated with a robust clinical or bench study.
Study Details
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified in the provided summary.
- Data Provenance: The biocompatibility testing was carried out by "an independent research institute." The location/country of this institute, whether the studies were retrospective or prospective, or details about the "performance characteristics" comparison are not provided. Given the submitter is from Germany, it's possible the testing was also conducted in Germany or a European country.
-
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):
- Not Applicable. This device is a resin tooth bonding agent, not a diagnostic imaging device that typically uses human experts to establish ground truth from medical images. The "ground truth" for this device would be established through objective laboratory testing (e.g., tensile bond strength, microleakage, etc., and biocompatibility assays), not expert consensus on interpretations.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2. Adjudication methods are relevant for studies involving human interpretation where discrepancies need to be resolved. Performance of this device is assessed through laboratory methods.
-
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-assisted diagnostic device. Therefore, MRMC studies and AI-related effect sizes are irrelevant to this product submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or software device. Its performance is assessed as a standalone material.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for proving effectiveness and safety would be established through benchtop laboratory testing for material properties and performance (e.g., bond strength to dentin/enamel, microleakage studies, setting time, solubility) and in vitro/in vivo biocompatibility testing as per ISO standards. The summary only generally states "biocompatibility testing" and comparison of "performance characteristics."
-
The sample size for the training set:
- Not Applicable. This is a material-based device, not a machine learning or AI device that relies on a "training set."
-
How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.