(74 days)
A Refreshing Gel and Liquid that quickly diminishes dry discomfort, mouth odors, and other symptoms of a Dry Mouth.
Oral Balance is an artificial saliva substitute which contains moisturizers, amino acids, milk proteins that have lubricating and moistening properties, it also contains patented salivary enzymes. Product is supplied in 1.5 oz PI.T bottle and tube.
The provided text does not contain detailed information about specific acceptance criteria, device performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or the sample size and ground truth establishment for a training set in the context of a medical device study.
The document is a 510(k) summary for "Oral Balance Gel and Liquid," an artificial saliva substitute. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific performance metrics against acceptance criteria.
Here's a breakdown of what is available and what is missing:
Available Information (Limited to what's provided):
- Device Performance: The document states, "Oral Balance formulation has been shown in studies, including tests for acute oral toxicity, Oral Balance formulation has been shown to be effective and safe...to be safe and effective for its intended use." However, it does not provide specific quantitative performance metrics (e.g., success rates, percentage reduction in symptoms, specific scores) or a table of acceptance criteria.
- Study Details: It vaguely mentions "studies" and "tests for acute oral toxicity, eye irritation and preservative effectiveness." It does not specify:
- Sample sizes for these studies.
- Data provenance (country, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance (this is not an AI/algorithm-based device).
- Type of ground truth used (though implied to be clinical assessment for effectiveness given the intended use).
- Sample size for training set (not applicable for this type of device).
- How ground truth for training set was established (not applicable).
Missing Information (Required by the prompt):
- A table of acceptance criteria and the reported device performance: This is absent. The document only makes a general statement about safety and effectiveness.
- Sample sized used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method for the test set: Not specified.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-based device.
- The type of ground truth used: Indirectly implied to be clinical observation for effectiveness, but not explicitly stated or detailed.
- The sample size for the training set: Not applicable, as this is not a machine learning device.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
Based on the provided text, it is not possible to fill out the requested table and answer the detailed questions regarding acceptance criteria and study particulars. The document focuses on regulatory approval through substantial equivalence, and while it states the device is "safe and effective," it does not provide the granular study data needed for your request.
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