(87 days)
OraLube is a water-soluble, viscous liquid coating intended to be used an intraoral and perioral release agent for the following clinical situations:
- Taking an impression, in which OraLube is placed on the gums and inside the lip (areas not critical to the final outcome of the prosthesis) to facilitate the release of impression material and is applied to the lips and the skin around the mouth to prevent adherence of impression material;
- Using a dental cement or adhesive, in which OraLube is applied to adjacent hard and soft tissue and to the lips and skin around the mouth to prevent adherence of the cement or adhesive;
- Placement of a rubber dam, in which OraLube is brushed on the tooth to facilitate slipping the rubber dam over it.
- Long procedures, in which OraLube can be used to protect the lips from drying out and cracking.
Pulpdent OraLube is a water-soluble, viscous liquid coating intended to be used as an intraoral and perioral release agent, slip agent, lubricant, lip and skin protector.
The provided text describes a 510(k) summary for a dental device called "Pulpdent OraLube." The 510(k) process is for demonstrating substantial equivalence to a predicate device, rather than performing a de novo study with acceptance criteria and performance metrics.
Therefore, the input text does not contain the specific information required to answer the questions regarding acceptance criteria, device performance, study details, or ground truth establishment. It primarily focuses on comparing the new device to a predicate device ("Pulpdent Separating Medium K 896653") to establish "substantial equivalence" in performance, intended use, safety, and effectiveness.
Here's a breakdown of why this information is missing based on the provided text:
-
A table of acceptance criteria and the reported device performance: This information is not present. The submission relies on "substantial equivalence" to a predicate device that has been "on the market and used successfully by dental professionals for many years with no serious safety or effectiveness problems." This implies an existing track record for the predicate, not new performance data for OraLube against specific criteria.
-
Sample sizes used for the test set and the data provenance: Not applicable or provided. No specific test set or study data is mentioned.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. No ground truth establishment activity is described.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or provided.
-
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 device is a water-soluble lubricant; it is not an AI-assisted diagnostic tool or an imaging device, so MRMC studies are irrelevant.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a manual application product, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or provided.
-
The sample size for the training set: Not applicable or provided. No training set is mentioned as this device is not an AI/ML product.
-
How the ground truth for the training set was established: Not applicable or provided.
In summary, the provided document is a 510(k) summary for a Class I medical device, which typically relies on demonstrating equivalence to existing legally marketed devices rather than presenting extensive new performance study data against pre-defined acceptance criteria. Therefore, the information requested in your prompt related to clinical trials, expert review, training sets, and ground truth is not found in this type of submission.
§ 880.6375 Patient lubricant.
(a)
Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.