(89 days)
Recommended for use in tooth extraction sites and management of alveolar osteitis (dry socket). The SaliCept Oral Patch is also intended for the management of all types of oral wounds, injuries and ulcers of the oral mucosa. The Salicept Oral Patch relieves pain by adhering to and protecting affected tissues from further irritation.
The SaliCept Oral Patch is a freeze-dried gel that contains Acemannan Hydrogel," a product obtained from the clear inner gel of Aloe vera L. Other ingredients include hydroxyethyl cellulose, polyvinylpyrrolidone, benzethonium chloride, simethicone. It is pliable, white to off-white, with a texture similar to that of finely woven cotton. The SaliCept Oral Patch is packaged in blister cards of six pledgets per card, two blister cards per carton, for a total of 12 pledgets per carton. Each pledget is approximately 1 cm in diameter and 0.5 cm thick.
This document describes the SaliCept Oral Patch and presents clinical data to support its intended use. However, it does not contain specific acceptance criteria for a device's performance in the typical sense of a regulatory submission (e.g., a specific sensitivity, specificity, or reduction percentage that must be met). Instead, the clinical studies cited demonstrate the patch's efficacy by showing statistically significant improvements in pain reduction and/or reduction in alveolar osteitis compared to control groups.
Therefore, I cannot directly fill in a table of "acceptance criteria" versus "reported device performance" as no explicit quantitative acceptance criteria are stated in the provided text for parameters like pain relief or AO incidence that would typically be seen in a device performance study for regulatory approval. The approval here is based on substantial equivalence and demonstration of safety and effectiveness through clinical trials.
Regarding the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
As explained above, explicit numerical acceptance criteria are not provided in the document. The "acceptance criteria" are implicitly met by demonstrating statistically significant positive outcomes in the clinical trials, rendering the device "substantially equivalent" to predicate devices. The "reported device performance" is the statistically significant clinical benefit observed.
| Outcome Measure | Reported Device Performance (SaliCept Oral Patch) |
|---|---|
| Pain Reduction (Aphthous Ulcers) | Significant reduction in pain within 20 minutes (lasting > 1 hour) vs. Orabase-Plain. |
| Significant reduction in pain within 2 minutes vs. Orabase-Plain. | |
| Significant reduction in pain vs. negative control (no difference vs. cyanoacrylate bioadhesive). | |
| Incidence of Alveolar Osteitis (AO) in Mandibular 3rd Molar Sites | 1.1% (11 of 958 sites) compared to 8.0% (78 of 975 sites) in the Gelfoam group. Difference was significant. |
| Incidence of Alveolar Osteitis (AO) in All Extraction Sites | 1.1% (12 of 1064 sites) compared to 7.6% (78 of 1031 sites) in the Gelfoam group. Difference was significant. |
2. Sample size used for the test set and the data provenance:
- Aphthous Ulcer Studies:
- Study 1: 37 patients (either Orabase-Plain or SaliCept Oral Patch).
- Study 2: 90 patients (Orabase-Plain, Carrington's Carrasyn Hydrogel Dressing, or SaliCept Oral Patch).
- Study 3: 155 patients (SaliCept Oral Patch, cyanoacrylate bioadhesive, or negative control).
- Alveolar Osteitis Study:
- Mandibular 3rd Molar Sites: 958 for SaliCept Oral Patch, 975 for Gelfoam.
- All Extraction Sites: 1064 for SaliCept Oral Patch, 1031 for Gelfoam.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies are referred to as "clinical data" and "clinical trials," indicating they are prospective in nature, as they involve actively administering treatments and observing outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
The document does not specify the number or qualifications of experts for establishing ground truth. For these clinical studies, the "ground truth" typically relies on patient-reported outcomes (pain scores) and clinical diagnosis/observation of conditions (aphthous ulcers, alveolar osteitis) by the treating clinicians involved in the trials. The studies cite publications from individuals such as "Plemons J, Rees T, Binnie W, Wright J," who are likely dental/oral health professionals, but their specific expert qualifications are not detailed in this summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not describe any specific adjudication method for the test set data. Clinical trials typically involve standardized protocols for assessment, but explicit multi-reader adjudication is not mentioned.
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:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes a medical device (oral patch) for direct patient application, not an AI diagnostic tool that assists human readers/clinicians. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical product (oral patch) intended for direct patient application, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used is primarily patient-reported outcomes data (pain relief) and clinical outcomes data (incidence of alveolar osteitis, presence/absence of aphthous ulcers), as assessed during the clinical trials.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
Not applicable. As a physical medical device, there is no "training set" or a need to establish ground truth for it.
N/A