(272 days)
OraMoist" Patches for Dry Mouth promotes lubrication of the oral mucosa that may be dry due to side effects of medication, chemo or radiation therapy, or as a symptom of Sjogren's syndrome, or because of oral inflammation. OraMoist Patches for Dry Mouth provides temporary relief for dry mouth.
OraMoist® Patches for Dry Mouth is formulated as an oral tablet that adheres to soft tissues of the mouth and dissolves slowly moisturizing the buccal cavity for hours. The tablets are packaged individually in low density polyethylene foil. Each tablet consists of a mixture of electrolytes, natural lubricants, flavoring agents, and enzymes, and an adherent polymer.
The provided text describes a 510(k) submission for the OraMoist® Patches for Dry Mouth, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria through a formalized study.
Therefore, many of the requested sections (e.g., acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to the information provided in a 510(k) summary for this type of device.
Below is an attempt to address the applicable parts of your request based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission of this nature, explicit "acceptance criteria" for clinical performance are not typically presented in a quantifiable manner as they would be for a novel device requiring extensive clinical trials. Instead, substantial equivalence is demonstrated by comparing the new device to a legally marketed predicate device. The "performance" is implicitly tied to demonstrating similar safety and effectiveness to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device must be safe for its intended use. | Not explicitly detailed in quantifiable metrics. Implied by substantial equivalence to a predicate and the nature of the device components. |
| Effectiveness: Provides temporary relief for dry mouth. | "Clinical investigations in patients with xerostomia have been conducted with OraMoist® Patches for Dry Mouth." (Specific results not detailed beyond supporting equivalence.) |
| Adhesion/Dissolution: Achieves slow dissolution and adheres to oral mucosa. | "In Vitro erosion time (standard USP dissolution test) and clinical investigations...have been conducted." "OraMoist® Patch for Dry Mouth dissolves slowly moisturizing the buccal cavity for hours." |
| Substantial Equivalence: Similar intended use, claims, and mechanism of action to predicate. | "OraMoist® Patches for Dry Mouth is substantially equivalent to the predicate device based on components, claims, and intended use with the mechanism of action (adherence device based on components, and differentiating OraMoist® Patches for Dry Mouth from the predicate device lozenge form." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "clinical investigations in patients with xerostomia have been conducted with OraMoist® Patches for Dry Mouth." However, it does not provide details on:
- The sample size of these clinical investigations.
- The country of origin of the data.
- Whether the study was retrospective or prospective.
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)
This information is not provided in the submission. The "ground truth" for a device like artificial saliva is typically patient-reported efficacy (symptomatic relief) rather than expert interpretation of images or other objective measurements that require expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable to the documentation for this type of device when demonstrating substantial equivalence. Adjudication methods are typically used in studies involving expert interpretation, often for diagnostic devices.
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
An MRMC comparative effectiveness study was not performed, nor would it be relevant for this type of medical device (artificial saliva patch). MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance to measure performance improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a physical device like an artificial saliva patch. "Standalone performance" refers to the performance of an algorithm or AI system operating entirely independently, without human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a device addressing symptomatic relief of dry mouth would primarily be patient-reported outcomes data, specifically regarding the reduction of dry mouth symptoms (xerostomia). The document states "clinical investigations in patients with xerostomia have been conducted," implying that patient feedback on symptom relief would form the basis of effectiveness assessment.
8. The sample size for the training set
This is not applicable. This device is a physical product (a patch), not an AI algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set" for this device.
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