(23 days)
Use UltraSeal XT® hydro™ for prophylactic sealing of pits and fissures.
UltraSeal XT® hydro is a 53% filled, light cure, radiopaque, methacrylatebased, thixotropic resin sealant. It is hydrophyllic and has a self-adhesive quality. UltraSeal XT® hydro™ chemistry provides the option of a visual verification for marginal retention with the use of a UV light, upon placement and at recall visits. The UV light is not included in the Ultra Seal XT® hydro™ kit.
The provided text describes a Special 510(k) premarket summary for a dental device called UltraSeal XT® hydro™. The document focuses on establishing substantial equivalence to predicate devices and detailing the technological characteristics and performance testing of the new device. However, it does not contain the kind of information typically found in a study proving a device meets acceptance criteria, particularly in the context of AI/ML-based medical devices as implied by your request.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance in the format you requested, nor does it specify numerical performance targets.
- Mention of a "test set" with sample size, data provenance, or ground truth establishment.
- Information about experts, adjudication methods, or multi-reader multi-case (MRMC) comparative effectiveness studies.
- Details on standalone algorithm performance or training set characteristics (sample size, ground truth).
The text describes various physical and chemical property tests performed on the dental sealant to demonstrate its performance and establish an 18-month shelf life. These are standard tests for material science and dental products, not for AI/ML algorithms.
Here's a breakdown of what is available in the document, framed against your request, while highlighting what's missing:
Acceptance Criteria and Study to Prove Device Meets Criteria:
1. A table of acceptance criteria and the reported device performance
The document lists several tests performed, implying that certain performance thresholds were met for each, but it does not provide numerical acceptance criteria or specific reported performance values in a table for UltraSeal XT® hydro™. Instead, it gives qualitative statements about the desired outcomes of the tests in comparison to predicate devices.
Qualitative Performance Claims (Implied Acceptance):
| Test | Acceptance Criteria (Implied) | Reported Device Performance (Qualitative) |
|---|---|---|
| Shear Bond | High MPa value (adhesion to tooth) | "This is the most impressive test to show that UltraSeal XT® hydro™ provides the highest adhesion to the tooth compared to both of our predicates. This adhesion is accomplished without the use of a drying agent... This test shows that UltraSeal XT® hydro™ will bond well to the tooth creating a very successful pit and fissure sealant." |
| Flexural Strength | Higher than competitors, more "give" (elasticity) | "This test will show the strength of the bond during stress. A higher number than our competitors is good. The modulus side of this test shows the strength at which flexing the bond occurs. Our testing shows more 'give' to it as our competitor's product tends to be 'stiffer.' We prefer the elasticity as it allows the product to remain on the teeth longer and 'gives' with movement." |
| Hardness | Higher than competitors | "This test shows the resiliency of the material to resist deformation. It is acceptable for us to remain higher than our competitors." |
| Ambient Light Working Time | Product sets up quickly for reduced chair time | "This test shows the time that the product will cure in ambient light. It shows working time with the product and curing time of the product. We prefer the product to set up quickly to reduce chair time for the dentist and patient." |
| Sorption | Low readings (resin absorbs less water) | "This test shows how much water the resin absorbs. We want low readings on this test." |
| Uncured Film thickness | Defined thickness (implies successful bonding) | Tested (no qualitative performance stated, just that the test was done for bond strength) |
| Solubility | Low number (product does not degrade in solutions/saliva) | "Look for a low g. number on this test." |
| Compressive Strength | Higher number (material resists breaking under compression) | "Measures the material's ability to not break apart under a compressive load. Prefer a higher number." |
| Shrinkage Stress | High strength adhesion (implies low shrinkage stress) | "This test determines shrinkage over a specified period of time. This value shows the high strength adhesion of the product." |
| Shrinkage % | Low value | "This test determines how much shrinkage will occur when the product has fully cured. We prefer a low value on shrinkage." |
| Depth of Cure | Shows light cure ability | "This test shows the light cure ability of the product." |
| Joules Test - Setting Time | Cures in 3 seconds time (specific joules) | "This test shows actual joules to cure the product in 3 seconds time." |
| Shelf Life | 18 months | "Stability testing was conducted on UltraSeal XT® hydro™ and the results show that the product has an 18 month shelf life based on accelerated stability studies conducted in R & D." (Accelerated study equiv. to 19.5 months real time) |
2. Sample size 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 tests described are laboratory-based material property tests, not clinical performance studies with patient 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 information is not provided as the device is a physical dental sealant, not an AI/ML algorithm requiring expert interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Not applicable for physical material 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
Such a study was not performed or mentioned. This is a material science product, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical pit and fissure sealant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
"Ground truth" as understood in AI/ML is not applicable here. The "truth" for material properties is established through standardized physical and chemical testing methods (e.g., measuring shear bond strength in MPa).
8. The sample size for the training set
This is not applicable as the device does not employ a training set (it is not an AI/ML device).
9. How the ground truth for the training set was established
This is not applicable.
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.