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RexaStom™ Oral Ease has a mechanical barrier action indicated for the temporary relief of pain by adhering to the mucosal surface of the mouth, covering and soothing oral lesions of various etiologies. The lesions include oral mucositis resulting from chemo- or radiation therapy, stomatitis, irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, aphthous ulcers, or other diseases or conditions of the oral mucous surfaces.

RexaStom Oral Ease is a dry, wafer or matrix type material, similar to coarse blotting paper. For mucositis, it is supplied in a 2.5-cm curcular format, packaged in a vacuumsealed, foil packet. Its ingredients are either food grade or generally regarded as safe and therefore the wafer material is safe when swallowed. RexaStom is designed to be physiologically compatible with both intact and compromised tissue in the mouth, and provides temporary management of pain associated with various types of injuries to the mouth.

RexaStom's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contour of the wound, and protects the wound from contamination and irritation by forming a temporary protective barrier that is similar to the natural mucosa.

This document describes a 510(k) summary for a medical device called RexaStom™ Oral Ease. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device.

Therefore, the requested information elements (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are not applicable or not available in the provided text.

The document discusses the device's intended use, technological characteristics, and composition in comparison to existing predicate devices (Gelclair Concentrated Oral Gel and Aloclair Oral Rinse). The core argument is one of "substantial equivalence," meaning that the new device is as safe and effective as existing legally marketed devices.

Key points from the document regarding the device and its assessment:

• Acceptance Criteria and Reported Performance: No specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, or effect sizes) are mentioned. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices in terms of indications, composition, safety, and effectiveness.
• Study Type: This is not a study designed to evaluate performance against specific metrics but rather a submission to demonstrate substantial equivalence.
• Ground Truth: The concept of "ground truth" as typically used in AI/diagnostic studies does not apply here. The "truth" is established by showing similarity to legally marketed devices.
• Sample Size: No patient or data sample sizes are mentioned for a performance study. The document states, "Testing with more subjects may require addition of flavoring and possibly sweetener, which we assume will not require further approval," implying that if any testing with subjects occurred, it was for sensory aspects rather than clinical efficacy.
• Experts and Adjudication: Not applicable, as there's no clinical trial or diagnostic performance evaluation described that would require expert adjudication.
• MRMC or Standalone Studies: Not applicable.
• Training Set: Not applicable as this is not an AI/algorithm-based device requiring training data.

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