(297 days)
The Parkell Pit and Fissure Sealant is indicated for prophylactic sealing of pits and fissures as well as for micro-restorative procedures for composite restorations.
The Device is a light-cured, flowable, resin-based sealant for prophylactic sealing of pits and fissures as well as for micro-restorative procedures. The Device is light-curable under standard power (600 mW/cm²) and contains filling agents which cause the Device to release and recharge beneficial ions (fluoride and calcium).
The provided text describes the 510(k) clearance for the "Parkell Pit and Fissure Sealant." However, the clearance letter and accompanying 510(k) summary pertain to a physical dental device (a sealant), not an AI/software medical device.
Therefore, many of the requested criteria regarding AI/software performance studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable and are not mentioned in this document.
The document focuses on the physical and chemical properties of the sealant and compares them to a predicate device. The performance data is based on non-clinical, in-vitro testing of these physical properties.
Below is the information that can be extracted from the provided text, adapted as best as possible to the requested format, with clear indications where information is not applicable (N/A) due to the nature of the device.
Acceptance Criteria and Device Performance for Parkell Pit and Fissure Sealant
This device is a physical dental sealant, not an AI/software medical device. Therefore, the performance evaluation focuses on physical and chemical properties and biocompatibility, not algorithmic performance on image data.
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Pass/Fail) | Reported Device Performance (Parkell Pit and Fissure Sealant) |
|---|---|---|
| Bond Strength to Dry Enamel | ≥10 MPa | ≥10 MPa |
| Compressive Strength | ≥200 MPa | ≥200 MPa |
| Flexural Strength | ≥90 MPa | ≥90 MPa |
| Depth of Cure | 1.5-2.5 mm | 1.5-2.5 mm |
| Shrinkage | ≤8% | ≤8% |
| Viscosity (initial) | 1-5 Pa.s | 1-5 Pa.s |
| Shelf Life | Not explicitly stated | 2 years (established by testing) |
| Material Biocompatibility | Substantially equivalent to predicate device | Substantially equivalent to predicate device |
| Beneficial Ion Release | Fluoride & Calcium | Fluoride & Calcium (vs. Predicate's Fluoride, Calcium, Phosphate) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document. The testing was non-clinical (in-vitro).
- Data Provenance: Non-clinical physical property testing. Not applicable for geographical or retrospective/prospective distinctions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This is a physical dental material. "Ground truth" in this context typically refers to objective measurements from laboratory testing equipment (e.g., universal testing machines for strength, viscometers for viscosity, etc.), not expert interpretation of data like in AI/imaging studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. As above, this is laboratory-based physical property testing, not subjective assessment requiring adjudication.
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
- N/A. This is not an AI-assisted device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is not an algorithm. Standalone performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Laboratory Standard Measurements / In-vitro physical property testing. The performance criteria (e.g., strength in MPa, shrinkage in %, viscosity in Pa.s) are based on standardized tests for dental materials.
8. The sample size for the training set
- N/A. This is not an AI/machine learning device. No training set was used.
9. How the ground truth for the training set was established
- N/A. As above, no training set was used.
§ 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.