(101 days)
Sinclair Gelclair® CONCENTRATED ORAL GEL, has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, and traumatic ulcers caused by braces or ill fitting dentures, or disease. Also indicated also for diffuse aphthous ulcers.
Sinclair Pharmaceuticals, Ltd. Gelclair® CONCENTRATED ORAL GEL is a viscous gel formulation, which is presented in a sachet of 15ml for mixing with 40ml of water. This combination of substances, when washed around the mouth, forms a protective layer over the oral mucosa.
The provided document is a 510(k) summary for a medical device (Gelclair® CONCENTRATED ORAL GEL), focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance is not available in the provided text.
Based on the available text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria or quantify device performance in terms of metrics like sensitivity, specificity, or improvement effect sizes. The submission focuses on demonstrating "substantial equivalence" to a predicate device, which inherently implies that if the new device has similar technological characteristics and intended use, its performance is considered acceptable.
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Implied) |
|---|---|
| Safety and Effectiveness | "Extensive functional and performance testing were conducted to assess the safety and effectiveness of Gelclair® CONCENTRATED ORAL GEL. All results are satisfactory." (This is a general statement, not specific performance metrics.) |
| Substantial Equivalence to Predicate Device | * Similar intended use (management and relief of pain for oral lesions).* Similar method of use (mix with water, take as needed).* Similar area of use (oral mucosa).* Similar disease state (Oral Mucositis/Stomatitis/Oral Lesions).* Similar product type (concentrate for dilution).* Similar presentation (non-sterile). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a specific "test set" in the context of an algorithm or AI. It refers to "Extensive functional and performance testing," but does not provide details on sample sizes or data provenance for these tests. There is no indication of retrospective or prospective data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This document does not describe a study involving human experts establishing ground truth for a test set, as it relates to an oral gel, not an AI or diagnostic device that requires expert interpretation.
4. Adjudication Method
Not applicable. There's no mention of adjudication for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a "CONCENTRATED ORAL GEL" for pain management, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only) Performance Study Was Done
No, a standalone (algorithm only) performance study was not done. This device is an oral gel, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of an AI device. For the oral gel, "ground truth" would relate to the clinical effectiveness of pain relief and mucosal adherence, likely assessed through clinical trials or user experience, which are not detailed in this 510(k) summary beyond the general statement of "satisfactory" results.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as the device is not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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