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510(k) Data Aggregation
(63 days)
ALOCLAIR ORAL RINSE
SINCLAIR ALOCLAIR™ ORAL RINSE Aloclair Oral Rinse with Aloe Vera extract, adheres to the mucosal surface and provides rapid pain relief from aphthous ulcers, canker sores, and minor oral lesions, including ulcers caused by braces and ill fitting dentures.
ALOCLAIR™ ORAL RINSE is a viscous gel formulation, which is presented for over-thecounter use premixed in containers of various sizes with plastic measuring cup. This combination of substances, when washed around the mouth, forms a protective layer over the oral mucosa.
The provided text describes the submission for a medical device (ALOCLAIR™ ORAL RINSE) for 510(k) clearance. The document focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not present in the provided text. The document states that "Functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL RINSE. All results are satisfactory," but it does not elaborate on what these tests entailed, what the acceptance criteria were, or what the reported device performance was.
Based on the provided information, I can only provide the following:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified in the document) | "All results are satisfactory." (No specific performance metrics or thresholds are provided.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide any information regarding a "test set" in the context of a clinical study or the sample size used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention any expert involvement in establishing ground truth for a test set. This type of information is typically part of a clinical trial, which is not detailed here.
4. Adjudication Method for the Test Set:
No information is provided regarding an adjudication method, as no test set requiring ground truth adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. The submission is focused on demonstrating substantial equivalence to predicate devices, not on comparing performance with human readers, or the effect of AI assistance.
6. Standalone (Algorithm Only) Performance:
This product is an oral rinse, not an algorithm or AI-based device. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. Type of Ground Truth Used:
No specific type of ground truth is mentioned, as the document states that functional and performance testing was conducted, but does not specify the nature of these tests or how results were validated against a "ground truth."
8. Sample Size for the Training Set:
This is an oral rinse, not an AI or machine learning device that requires a training set.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as this is not an AI/machine learning device.
Summary of Device and Basis for Clearance:
The ALOCLAIR™ ORAL RINSE is a viscous gel formulation intended for over-the-counter use to provide rapid pain relief from aphthous ulcers, canker sores, and minor oral lesions.
The basis for the 510(k) clearance is substantial equivalence to two predicate devices:
The submission highlights that ALOCLAIR™ ORAL RINSE has the "same intended/indications for use" as these predicate devices. A comparison table (Section 6) details the technological characteristics, showing similarities in claims, area of use, disease state, and presentation (non-sterile), with minor differences in method of use (pre-mixed vs. mix with water) and product type (oral rinse/mouthwash vs. concentrate for dilution).
The document states that "Functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL RINSE. All results are satisfactory." However, it does not provide specific details about these tests, the acceptance criteria, or the actual performance results in a quantifiable manner. The FDA's letter (Section 2, 3) confirms the determination of substantial equivalence, allowing the device to be marketed.
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