(125 days)
Orapeutic™ Oral Pain Gel manages the pain of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation & contamination. Orapeutic™ Oral Pain Gel also maintains a moist wound environment.
Orapeutic™ Oral Pain Gel is a viscous hydrogel wound dressing composed entirely of food grade ingredients including a food grade preservative system. It is designed to be physiologically compatible with both intact and compromised tissue in the mouth to manage the pain associated with injuries to the mouth.
Orapeutic Oral Pain Gel's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a protective barrier. It also maintains a moist wound environment.
Orapeutic Oral Pain Gel is provided in 10mL syringes.
Here's a breakdown of the acceptance criteria and study information for the Orapeutic™ Oral Pain Gel device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (Orapeutic™ Oral Pain Gel) | Conclusion Regarding Acceptance |
|---|---|---|---|
| Material Properties | pH | The pH was tested and results were "substantially equivalent" to the predicate device (Sock It! Oral Pain Gel). | Met |
| Barrier Function | Hydrogel Barrier Testing | The hydrogel barrier function was tested and results were "substantially equivalent" to the predicate device. | Met |
| Microbial Safety | Microbial Testing | Microbial testing was performed, and results were "substantially equivalent" to the predicate device. | Met |
| Chemical Safety | Formulation (all food-grade ingredients) | Device is "composed entirely of food grade ingredients including a food grade preservative system" with "established safety profiles." This addresses safety by design. | Met |
| Efficacy | Manage oral pain, adhere to oral tissue, form protective barrier, provide moist wound environment | The device's primary mode of action and intended use are consistent with the predicate, and non-clinical testing demonstrated comparable performance. | Met (via substantial equivalence to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each non-clinical test. The document mentions "Bench testing comparing Oral Pain Gel and Sock It! were performed," implying comparative tests, but does not provide specific numbers of samples or replicates used for pH, Hydrogel Barrier Testing, or Microbial Testing.
- Data Provenance: The studies were non-clinical performance testing (bench testing). The country of origin is not specified, but the submission is to the U.S. FDA, implying the data would be expected to originate from, or be acceptable to, a U.S. regulatory context. These were likely prospective bench tests designed to compare the new device to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable as there was no clinical study involving human patients, and therefore no "ground truth" established by clinical experts or readings of patient data. The "ground truth" for the non-clinical tests was likely established by standard laboratory methods and equipment, and the comparison was to the performance of the legally marketed predicate device.
4. Adjudication Method for the Test Set
- This is not applicable as there were no human readers or subjective interpretations in the non-clinical bench testing that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical performance testing was conducted."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a hydrogel wound dressing, not an algorithm or AI-based product. Therefore, no standalone algorithm performance testing was performed.
7. The Type of Ground Truth Used
- For the non-clinical performance testing, the "ground truth" was established by objective laboratory measurements of physical and chemical properties (pH) and functional characteristics (hydrogel barrier, microbial presence). The primary form of "ground truth" for demonstrating equivalence was the performance of the legally marketed predicate device (Sock It! Oral Pain Gel) as measured by these objective tests.
8. The Sample Size for the Training Set
- This is not applicable as there is no AI/algorithm involved in this device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable as there is no AI/algorithm involved in this device, and thus no training set or associated ground truth.
N/A