(90 days)
Rx: Under the supervision of a healthcare professional, BioXtra® Moisturizing Gel is indicated for relief from chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjögren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging. Relieves symptoms of dry mouth such as difficulties in swallowing, speech, and changes in taste and replaces missing saliva feel.
OTC: BioXtra® Moisturizing Gel is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth.
BioXtra® Moisturizing Gel contains a patented formulation of milk proteins and salivary enzymes which, with other ingredients in the product, temporarily substitute the feel of natural saliva to moisturize, lubricate, and refresh the mouth. The product is supplied in a 1.4 fl. oz aluminum tube.
The BioXtra® Moisturizing Gel is a device intended for the symptomatic relief of dry mouth (xerostomia). The provided 510(k) summary (K072306) indicates that the device met its acceptance criteria based on laboratory and human tests demonstrating safety and effectiveness for its intended use. However, the document does not provide specific quantitative acceptance criteria or detailed performance metrics from these studies.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for K072306 does not contain a table of explicit, quantitative acceptance criteria or specific reported device performance metrics (e.g., quantifiable relief duration, percentage of symptom reduction). The summary states:
"BioXtra® Moisturizing Gel has been shown in laboratory and human tests to be safe and effective for its intended use."
This is a general statement of conclusion rather than a presentation of specific performance data against predefined criteria.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary mentions "human tests," but it does not specify the sample size used for these tests.
Furthermore, the document does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature) for these human tests.
3. Number of Experts Used to Establish the Ground Truth and Their Qualifications
The 510(k) summary does not mention the number of experts used to establish a ground truth for the test set, nor does it detail their qualifications. For a device like BioXtra® Moisturizing Gel, ground truth might relate to patient-reported symptom relief or clinical assessment of dry mouth symptoms by healthcare professionals, but these details are not provided.
4. Adjudication Method for the Test Set
The 510(k) summary does not describe any adjudication method (e.g., 2+1, 3+1) used for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Because this is a Class I, unclassified medical device (artificial saliva) and not a diagnostic imaging AI algorithm, a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and therefore not mentioned in the submission. The device is a therapeutic product, not an interpretative aid.
6. Standalone (Algorithm Only) Performance
The device is a moisturizing gel for dry mouth relief, not a standalone algorithm. Therefore, standalone (i.e., algorithm only without human-in-the-loop performance) is not applicable and not evaluated in the context of this device.
7. Type of Ground Truth Used
The 510(k) summary generally refers to "human tests" to establish "safety and effectiveness." While not explicitly stated as "ground truth," for a product like a moisturizing gel, effectiveness would typically be assessed based on:
- Patient-reported outcomes: Symptom relief (e.g., difficulties in swallowing, speech, taste changes, mouth discomfort, mouth odors).
- Clinical assessment: Evaluation of oral dryness by healthcare professionals.
- Laboratory tests: Potentially, in-vitro or ex-vivo tests related to the formulation's properties or interaction with oral tissues.
The document does not specify which of these were used as primary indicators for "effectiveness."
8. Sample Size for the Training Set
As the BioXtra® Moisturizing Gel is a medical product (not an AI/ML algorithm), there is no concept of a "training set" in the typical machine learning sense. The product's development would involve formulation, in-vitro testing, and clinical studies for safety and efficacy. The sample sizes for formulation development or initial in-vitro tests are not described in the 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Similarly, since there is no "training set" for an AI/ML model, the concept of establishing ground truth for it is not applicable to this device.
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