(93 days)
This product manages the pain in all types 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 and contamination. It provides the moist wound environment required for optimal wound healing. Examples of oral lesions include canker sores (aphthous ulcers), tooth extraction sites, oral mucositis, oral stomatic ulcers such is caused by braces and dentures, and irritation and pain following deep tooth scaling.
"Sock It!" Oral Pain Gel is a clear, viscous hydrogel wound dressing composed entirely of foodgrade ingredients including a food-grade preservative system. It is safe if swallowed, is designed to be physiologically compatible with both intact and compromised tissue in the mouth, and will manage the pain associated with all types of injuries to the mouth. The 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 that is similar to the natural mucosa. It also creates and maintains a moist wound environment, which is necessary for the natural healing process. The pH and osmotic pressure of the gel are adjusted to be compatible with saliva.
The provided 510(k) summary for "Sock It!" Oral Pain Gel does not present explicit acceptance criteria or a dedicated study demonstrating the device's performance against such criteria in the manner typically seen in AI/ML device submissions. This document is a premarket notification for a medical device that was submitted in 2006, prior to the widespread adoption of AI/ML in medical devices and the associated regulatory expectations for performance studies.
Instead, the submission relies on the concept of substantial equivalence to predicate devices. The primary assertion is that "Sock It!" Oral Pain Gel is substantially equivalent to existing legally marketed hydrogel oral wound dressings based on its intended use, technological characteristics, and safety profile.
Here's an analysis based on the information provided, formatted to address your questions where possible, and noting where information is not available due to the nature of this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as implied by substantial equivalence) |
|---|---|
| No explicit, quantitative acceptance criteria related to specific performance metrics (e.g., sensitivity, specificity, pain reduction score thresholds) are stated. | The device manages pain in various oral wounds, adheres to oral tissue, forms a protective barrier, and provides a moist wound environment. |
| Safe if swallowed (composed of food-grade ingredients). | |
| Physiologically compatible with intact and compromised tissue. | |
| pH and osmotic pressure adjusted to be compatible with saliva. | |
| Substantially equivalent in design and intended use to predicate devices: K933741, K953423, K964852, K983182, K012126. |
Explanation: The document does not define specific, measurable acceptance criteria in terms of clinical efficacy or quantitative performance metrics. Its acceptance by the FDA is based on demonstrating that it is substantially equivalent to predicate devices that are already on the market. This framework implies that if the new device has the same intended use and similar technological characteristics to a legally marketed device, and does not raise new questions of safety or effectiveness, it can be marketed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable / Not provided. This submission does not describe a clinical performance study with a distinct "test set" as understood in AI/ML evaluations. The equivalency claim is based on the device's formulation and mechanism of action being similar to predicate devices.
- Data Provenance: Not applicable. There is no specific data provenance described for a performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There was no explicit "ground truth" establishment for a test set in the context of a performance study described in this 510(k) summary. The "ground truth" for the predicate devices' effectiveness would have been established through their initial regulatory pathways and clinical use.
4. Adjudication Method for the Test Set
- Not applicable. No performance study with adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- Not applicable. This is not an AI/ML device, and no MRMC study is mentioned. The submission focuses on substantial equivalence, not on comparative effectiveness with human readers or AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is a physical hydrogel product, not an algorithm.
7. The Type of Ground Truth Used
- Type of "Ground Truth" (Implicit): The "ground truth" here is implicitly derived from the established safety and effectiveness of the existing predicate devices through their prior regulatory clearances and clinical experience. The claim is that "Sock It!" offers the same performance (pain management, protective barrier, moist environment) as these already approved devices due to its similar mechanism and composition.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set. The development likely involved formulation and in-vitro testing to ensure physical properties and safety, but not an AI-specific training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there's no AI/ML training set, there's no ground truth establishment for it.
Summary of the Study (or lack thereof) Proving Acceptance:
The submission for "Sock It!" Oral Pain Gel does not outline a specific study designed to meet quantitative acceptance criteria. Instead, the "proof" the device meets acceptance criteria ("intended use" and "technological characteristics") is established through the argument of substantial equivalence to already approved predicate devices.
The submission highlights:
- Intended Use: The indications for use are "the same as these for the predicate devices."
- Technological Characteristics: The device is a hydrogel wound dressing, similar to predicate devices, and its primary mode of action (adhering, forming a protective barrier, creating a moist environment) is the same. The only difference noted is the method of hydration (factory-hydrated vs. user-hydrated or saliva-hydrated). The submission argues this difference is "non-substantial" and does not alter the fundamental safety or effectiveness.
Therefore, the "study" demonstrating acceptance is essentially the comparison to predicate devices and the argument that the differences do not introduce new questions of safety or effectiveness. The FDA's issuance of the 510(k) clearance confirms their agreement that substantial equivalence was demonstrated.
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