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510(k) Data Aggregation
(206 days)
BA Pit & Fissure Sealant is intended to seal pit and fissure depressions/faults in the biting surfaces of teeth. For dental professional use only.
Pit and Fissure sealants are used as a preventive measure to fill defects and prevent decay within crevices, voids or fissures on the surface of teeth. These voids are more challenging to keep free of substances that can lead to caries and eventual breakdown of tooth structure. BA Pit & Fissure Sealant is a material designed to fill these voids with a wear resistant material, ultimately preserving natural tooth structure.
BA Pit & Fissure Sealant is a light activated / photopolymerizable, glass filled, urethane dimethacrylate material that is placed onto an etched enamel surface and light activated for 20 seconds. The result after application is a tooth that has been sealed with a tough, wear resistant material.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for each test. Instead, it presents the results of various non-clinical performance tests for the subject device (BA Pit & Fissure Sealant) and then compares them to a predicate device (Pulpdent (Activa) Pit & Fissure Sealant with MCP) and sometimes a reference device (Prevent Seal) to establish substantial equivalence. The "acceptance criterion" in this context is generally that the subject device's performance is "similar" or "equivalent" to the predicate device, or that any differences do not raise additional concerns regarding safety or efficacy.
| Test | Acceptance Criteria (implied - "similar/equivalent to predicate/reference" or "no additional concerns") | Reported Device Performance (BA Pit & Fissure Sealant) |
|---|---|---|
| Compressive Strength | Similar to predicate and reference devices. | Exhibited very similar compressive strengths to the predicate device and reference device. |
| Diametral Tensile Strength | Similar to predicate device. | Exhibited similar diametral tensile strength compared to the predicate device. |
| Elastic Modulus | Level of flexibility that allows absorption of occlusal forces without damage, supporting efficacious use. | Material is flexible and will absorb significant forces without reaching permanent deformation; deformation limited by tooth structure allows absorption of occlusal forces without damage. |
| Working Time | Equivalent to predicate device. | Unlimited working time, equivalent to the predicate device. |
| Depth of Cure | Very similar to predicate device; minor differences acceptable for occlusal surface/thin layers and do not impact safety/efficacy. | Exhibited a very similar depth of cure to the predicate device. Minor difference not a concern for pit and fissure sealants. |
| Film Thickness | Nearly equivalent to reference device. | Nearly equivalent to the reference device. |
| Cytotoxicity | Same result as predicate device. | Provided the same result as the predicate device. |
| Accelerated Shelf-Life (interim) | "Passing" results at 18 months, supporting an 18-month shelf-life. | All test points to-date have yielded "passing" results, supporting an 18-month shelf-life (interim analysis). |
| Ion Release (Calcium, Phosphate, Fluoride) | Measurable ions released; minor differences to predicate acceptable as oral environment naturally fluctuates, and concentrations are very low. | Released measurable calcium, phosphate, and fluoride. Released more than predicate, but differences are low (ppm/ppb) and oral environment fluctuates, so no concerns. Substantial equivalence supported. |
2. Sample sizes used for the test set and the data provenance
The document describes non-clinical benchtop testing. For these types of tests, sample sizes are typically specified within the referenced ISO or ADA standards. However, the exact sample sizes for each specific test conducted for K190998 are not explicitly mentioned in the provided text.
The data provenance is retrospective, as the tests were conducted prior to the 510(k) submission to demonstrate substantial equivalence. The country of origin of the data is not specified, but given the applicant is Apex Dental Materials, Inc. with an address in Lake Zurich, Illinois, it is likely the studies were conducted in the USA or by contract labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the document describes non-clinical benchtop performance testing, not studies involving human interpretation or expert-established ground truth. The "ground truth" for these tests would be the measurement obtained from the laboratory instruments according to the specified standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable as the document describes non-clinical benchtop performance testing, not studies involving human reading or 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
This section is not applicable. The device is "BA Pit & Fissure Sealant," which is a material used for dental sealing, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study or AI component is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical material (dental sealant), not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is based on measurements obtained following standardized test methods (e.g., ISO, ADA standards). For example, for compressive strength, the ground truth is the force at which the material fractures, as measured by a testing machine according to the specified standard.
8. The sample size for the training set
This section is not applicable. The device is a physical material, not an AI model, and therefore does not have a "training set."
9. How the ground truth for the training set was established
This section is not applicable. The device is a physical material, not an AI model, and therefore does not have a "training set" or ground truth relevant to AI model training.
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