(209 days)
Relieves and treats the symptoms of dry mouth; refreshes mouth odors, soothes oral irritations, moisturizes, lubricates, and diminishes dry discomfort. Indication for Use: Relieves the symptoms of dry mouth; refreshes, moisturizes, soothes oral irritation, and lubricates oral dryness.
Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief is a specially formulated artificial saliva substitute which contains 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 spray is supplied in a 1.5 oz. non-pressurized pump action spray bottle fitted with cap.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief:
First, it's critical to note that the provided documents are a 510(k) Summary and an FDA clearance letter. A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through rigorous clinical trials like a PMA would. Therefore, the information typically requested in your prompt (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC studies, standalone performance metrics) is usually not extensively detailed or even present in a 510(k) summary for a device like this.
The "studies" mentioned are non-clinical assessments to demonstrate safety and stability, and a "use study" for effectiveness. These are typically not analogous to the algorithm performance studies one would see for AI/ML medical devices.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are not quantitative metrics typical for an AI device (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria for this device appear to be qualitative demonstrations of safety, stability, and effectiveness in relieving dry mouth symptoms, benchmarked against legally marketed predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Safety | Device is safe for its intended use. | "Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief has been shown in nonclinical studies to be safe (Toxicology Assessment) for its intended use." (Section 7) |
| Stability | Device maintains its properties over time for its intended use. | "Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief has been shown in nonclinical studies to be [...] stable (Stability Study) for its intended use." (Section 7) |
| Effectiveness | Device relieves and treats the symptoms of dry mouth. | "Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief has been shown in [...] to be effective (Use Study)." (Section 7) |
The FDA's clearance letter states "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." implying it meets the effectiveness profile of the predicates. |
| Substantial Equivalence | Device is as safe and effective as a legally marketed predicate device. | The entire 510(k) submission and FDA clearance are based on demonstrating substantial equivalence to "Oral Balance Gel cleared in (K061331)" and "Oral Balance Liquid cleared in (K061331)". The "Substantial Equivalence Comparison Chart" (Section 6) details similar intended use, method of use, applications per day, disease state, area of use, and product type. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an AI/ML algorithm evaluation. The studies mentioned ("Toxicology Assessment," "Stability Study," "Use Study") are non-clinical or general product performance evaluations. Therefore, sample sizes for these are not provided in this summary, and data provenance (country, retrospective/prospective) is also not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. The studies conducted (toxicology, stability, use study) for this type of device do not typically involve experts establishing "ground truth" in the way an AI algorithm for diagnostic imaging would.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable, as no "test set" for an AI algorithm's performance is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned or implied. This device is an artificial saliva substitute, not an AI-assisted diagnostic tool that would typically undergo such studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an AI algorithm; it's a topical medical device.
7. Type of Ground Truth Used
The concept of "ground truth" as applied to AI/ML algorithms is not relevant here. The "effectiveness" of the device was likely assessed through a "Use Study" where subjects used the product and reported symptomatic relief, or through objective measures relevant to dry mouth. Its safety was assessed via toxicology.
8. Sample Size for the Training Set
Not applicable, as there is no AI algorithm and therefore no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI algorithm and no "training set."
Summary of Device and Approval Context:
This document describes the 510(k) clearance for "Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief." The approval is based on demonstrating substantial equivalence to existing predicate devices (Biotene Oral Balance Gel and Liquid). The "studies" mentioned are:
- Toxicology Assessment: To demonstrate safety.
- Stability Study: To demonstrate product shelf-life and consistency over time.
- Use Study: To demonstrate effectiveness in relieving dry mouth symptoms.
These are common types of non-clinical and basic clinical/user studies for medical devices like artificial saliva substitutes, and do not involve the kind of rigorous performance metrics or AI-specific evaluation criteria found in AI/ML device clearances.
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