(81 days)
LED PRO SEAL® is intended to seal enamel surfaces around orthodontic brackets.
LED PRO SEAL® is a fluoride containing light cure filled surface sealant provided in a light impervious bottle dispenser. Upon delivery of one drop of LED PRO SEAL to a mixing pad, a thin coat of LED PRO SEAL is applied to a prepared enamel surface using a brush applicator and light cured for a minimum of 20 seconds with any halogen, plasma arc or cordless light capable of a 440-490 NM wavelength.
The provided document describes the 510(k) summary for the LED PRO SEAL® dental sealant. This submission seeks to demonstrate substantial equivalence to a predicate device, not through an AI/ML study, but through traditional laboratory testing of material properties. Therefore, many of the requested fields related to AI/ML specific studies will be marked as "Not Applicable".
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Predicate Device Performance - K021503) | Reported Device Performance (LED PRO SEAL®) |
|---|---|---|
| Mechanical/Physical: | ||
| Shear bond strength | Equivalent to original PRO SEAL® | Equivalent to original PRO SEAL® |
| Compressive strength | Equivalent to original PRO SEAL® | Equivalent to original PRO SEAL® |
| Flexural strength | Equivalent to original PRO SEAL® | Equivalent to original PRO SEAL® |
| Cumulative fluoride release | Equivalent to original PRO SEAL® | Equivalent to original PRO SEAL® |
| Depth of cure | Equivalent to original PRO SEAL® | Equivalent to original PRO SEAL® |
| Biocompatibility: | ||
| Cytotoxicity (ISO 10993-5) | Grade 2 material (mild reactivity) | Grade 2 material (mild cell lysis or toxicity) |
Study Proving Device Meets Acceptance Criteria:
A series of comparative tests were conducted between LED PRO SEAL® and the predicate device, original PRO SEAL® (K021503). These tests included:
- Shear bond strength
- Compressive strength
- Flexural strength
- Cumulative fluoride release
- Depth of cure
The document states that these comparisons "demonstrate that the applicant device is equivalent to the legally marketed device in terms of effectiveness."
Additionally, for biocompatibility, a Cytotoxicity Study using the ISO 10993-5 Agarose Overlay Method (Solid) was performed. The LED PRO SEAL® was found to cause "mild cell lysis or toxicity (generating grade 2 for mild reactivity)" and "met the requirements of ISO10993-5 for a grade 2 material showing evidence that the product is safe to use."
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated in the provided text for the material property tests.
- Data provenance: The tests were conducted internally by Reliance Orthodontic Products, Inc., comparing their new device to their own predicate device. The country of origin of the data is implied to be USA given the company's location. The study is prospective in nature as it tests the newly developed device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This type of medical device submission (dental sealant) relies on objective laboratory measurements of material properties and biological tests, not expert interpretation of images or clinical outcomes that would require a ground truth established by human experts in the context of an AI/ML study.
4. Adjudication method for the test set
- Not Applicable: See explanation for item 3.
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 not an AI/ML device requiring human reader assessment. It's a dental material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI/ML device.
7. The type of ground truth used
- Not Applicable: For material properties, the "ground truth" is established by the objective measurements obtained from standardized testing methods (e.g., measuring force for bond strength, chemical analysis for fluoride release, cell viability for cytotoxicity). For the purpose of regulatory submission, the performance of the predicate device acts as the benchmark ("ground truth" for comparison).
8. The sample size for the training set
- Not Applicable: This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable: This is not an AI/ML device, so there is no training set or associated ground truth.
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.