Search Results

The biotene Oral Balance Gel, biotene Dry Mouth Oral Rinse and biotene Moisturizing Mouth Spray intended use is to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.

Not Found

This document is a 510(k) clearance letter from the FDA for Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, and Biotene Moisturizing Mouth Spray. It states that these devices are substantially equivalent to legally marketed predicate devices.

The information requested in the prompt regarding acceptance criteria and a study proving the device meets these criteria is typically found in the 510(k) submission itself, or in supporting documentation attached to the submission. This FDA clearance letter and its attached "Indications for Use Statement" do not contain the detailed information necessary to answer the questions about acceptance criteria, device performance, study design, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The document confirms the device names and their intended use to relieve symptoms of dry mouth. However, it does not provide any specific quantitative performance metrics, study results, or details on how substantial equivalence was demonstrated beyond the general statement of equivalence to predicate devices.

Therefore, I cannot provide the requested table or answer the specific questions based solely on the provided text.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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.

Ask a specific question about this device