(123 days)
Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness.
Biotène Dry Mouth Oral Rinse is a specially formulated artificial saliva substitute which contain moisturizers, humectants, a protein, and patented salivary enzymes, that collectively have lubricating, moisturizing, soothing, and refreshing properties to relieve & treat the symptoms of Dry Mouth. The liquid products are supplied in PET bottles of various sizes, including an 8 oz., 16 oz., and 33.8 oz., and also 15 ml. multilayer laminated foil pouches.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in a quantitative manner.
The document is a 510(k) summary for a medical device (Biotène Dry Mouth Oral Rinse) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with acceptance criteria and performance metrics.
Here's a breakdown of what is and is not available in the provided text regarding your request:
Information Present in the Document:
- Device Description: Biotène Dry Mouth Oral Rinse is an artificial saliva substitute containing moisturizers, humectants, a protein, and salivary enzymes to relieve and treat dry mouth symptoms.
- Intended Use/Indications for Use: Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness.
- Predicate Devices: Laclede, Inc. Oral Balance Gel (K061331) and Oral Balance Liquid (K061331).
- Nonclinical Tests: The document states that "Biotène Dry Mouth Oral Rinse has been shown in non-clinical studies to be safe (Toxicology Assessments), and stable (Stability Studies) for its intended use."
- Clinical Tests: It states, "It has also been shown in clinical studies to be effective (Use Studies)." It then specifies, "No other clinical tests were performed other than a Use Study for this submission."
Information NOT Present in the Document (and therefore cannot be provided by me):
- A table of acceptance criteria and reported device performance: This is completely absent. The document only states it was shown to be "effective" in "Use Studies" but provides no quantitative results, metrics, or comparison to specific acceptance thresholds.
- Sample sized used for the test set and the data provenance: While a "Use Study" is mentioned, no details about its design, sample size, or data provenance are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not mentioned, as no specific ground truth or expert consensus method for a test set is described.
- Adjudication method for the test set: Not applicable or not mentioned.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. This type of study is more common for imaging diagnostics, not typically for oral rinse effectiveness.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical product, not an algorithm.
- The type of ground truth used: Not explicitly stated. For a "Use Study," it would likely be patient-reported outcomes or clinical assessment of dry mouth symptoms, but no specifics are given.
- The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device requiring a training set in that context.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text serves as a regulatory submission (510(k) summary) focused on demonstrating substantial equivalence, not a detailed scientific report on a specific study with acceptance criteria and quantitative performance metrics. While it mentions "Use Studies" proving effectiveness, it does not elaborate on the methodology, results, or specific criteria met.
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