(211 days)
Parkell® Desensitizer Gel is indicated for reduction of tooth hypersensitivity by the following treatments:
- · treatment of dentin exposed by toothbrush abrasion, periodontal disease, and/or acid erosion;
- · treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning;
- · treatment of tooth hypersensitivity associated with bleaching: and
- · treatment of prepared dentin for fillings and/or prosthetic restorations.
Parkell® Desensitizer Gel alleviates dental hypersensitivity at treatment sites. It is a gel which requires no mixing prior to use and which is applied to treatment sites using a standard applicator brush. Parkell® Desensitizer releases calcium and phosphate ions at the treatment site and stimulates hydroxyapatite formation on the surface of treated dentin and in dentinal tubules. In this manner, the Device hardens following application and forms a layer of mineral hydroxyapatite as well as hydroxyapatite plugs which occlude dentinal tubules, which results in the treatment of dental hypersensitivity.
Parkell® Desensitizer Gel is packaged in any standard single-chamber syringe. The syringe is accompanied by standard snap-in tips and standard applicator brushes.
This document is a 510(k) Summary for the Parkell® Desensitizer Gel, which is a medical device. This type of regulatory submission in the US focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study results that explicitly define and prove acceptance criteria in the format requested.
Therefore, the requested information categories related to acceptance criteria, specific studies proving them, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and training set details are not applicable (N/A) in the context of this 510(k) summary for a desensitizer gel.
Here's the relevant information that can be extracted:
Acceptance Criteria and Device Performance (from "6. Comparison of Technological Characteristics" and "Table 5-A")
The acceptance criteria for the Parkell® Desensitizer Gel are predominantly comparative, demonstrating that its performance is equivalent to or better than the predicate device (Teethmate Desensitizer). The key performance criteria evaluated are:
| Acceptance Criteria Category | Specific Criteria | Parkell® Desensitizer Gel Reported Performance | Predicate Device (Teethmate Desensitizer) |
|---|---|---|---|
| Material Form | Equivalent desensitizing function despite different material form. | Gel | Powder/Liquid |
| Chemical Composition | Water; calcium phosphate-based filler(s) | Water; calcium phosphate-based filler(s) | Water; calcium phosphate-based filler(s) |
| Surface Coverage | Ability to provide surface coverage of treated dentin. | Yes | Yes |
| Dentinal Tubule Occlusion | Ability to occlude dentinal tubules. | Yes | Yes |
| Microshear Bond Strength | Bond strength to dentin of resin-based bonding agents (self-etch mode for agent #1 and #2, total-etch mode for agent #1) | ≥15MPa | ≥15MPa |
The document states that the "technological differences do not raise issues with respect to substantial equivalence and are addressed by comparative performance data provided within this submission." This indicates that the reported performance for Parkell® Desensitizer Gel met or exceeded the performance of the predicate device for these comparative criteria.
The following questions are not applicable or cannot be determined from the provided 510(k) summary, as it describes a non-AI medical device submission based on substantial equivalence, not a study evaluating AI performance with detailed statistical rigor as implied by the questions:
2. Sample size used for the test set and the data provenance
N/A. This document describes in vitro (bench) testing, not a clinical "test set" in the context of an AI/algorithm study. The specific sample sizes for the bench tests (e.g., number of samples for microshear bond strength) are not provided. Data provenance is not described for a biological context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. Ground truth in the context of expert consensus is not relevant for this type of device and testing. The "ground truth" for the performance criteria listed (like chemical composition or bond strength) would be established by validated analytical and mechanical testing methods, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Adjudication methods like 2+1 or 3+1 are used for human reader studies, typically in diagnostic imaging or similar fields where interpretation is subjective and consensus is needed. This is not applicable to the bench testing described for a dental desensitizer.
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. No MRMC study was conducted. This device is a treatment product, not an AI diagnostic tool, and involves no human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. Not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the bench data (e.g., chemical composition, surface coverage, dentinal tubule occlusion, microshear bond strength) is established through objective, validated laboratory testing methods following relevant ISO standards and material science principles, not expert consensus or pathology in a clinical sense.
8. The sample size for the training set
N/A. Not an AI algorithm.
9. How the ground truth for the training set was established
N/A. Not an AI algorithm.
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.