(83 days)
(OTC): Neutrasal® is indicated for the dryness of the mouth (hyposalivation, xerostomia)
(OTC): Neutrasal® is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion.
(OTC): Neutrasal® may be used as part of an oral hygiene program for patients with dry mouth. Neutrasal® also provides intensive hygiene of the oral cavity.
(Rx): Neutrasal® is also indicated as an adjunct to standard oral care in relieving the discomfort associated with oral mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with amelioration of pain.
(Rx): Neutrasal® may be used for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy, infection or dysfunction of the salivary glands; fever; emotional factors such as fear or anxiety; obstruction of the salivary ducts; Sjögren's syndrome
Neutrasal® is a powder that when dissolved in normal tap water becomes a supersaturated calcium and phosphate rinse. Neutrasal® was designed in part to replace the normal ionic and pH balance in the oral cavity. Neutrasal® also maintains moistness in the oral cavity. It relieves diffuse dryness and fissuring of the oral mucosa, as well as painful tongue conditions due to hyposalivation.
Neutrasal® facilitates chewing and speaking; loosens tough mucus: prevents mucous membranes from sticking together; and improves adherence of dentures.
Additionally, Neutrasal® can be used as an adjunct to standard oral care for relieving the discomfort associated with oral mucositis that may be caused by high dose chemotherapy or radiation. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
Neutrasal® is a comprised of calcium chloride, sodium phosphate and sodium bicarbonate plus inactive ingredients. When Neutrasal® is dissolved in normal tap water, the water becomes supersaturated with both calcium and phosphate ions.
Syloid, an inactive ingredient in Neutrasal, is an amorphous silica that is recommended for free-flow and anti-caking for hydrogscopic food powders, industrial powders and other applications (pharmaceuticals) where humidity must be kept to a minimum.
The provided text describes a medical device, Neutrasal®, and its clearance based on substantial equivalence to a predicate device, Caphosol®. The document is a 510(k) summary submitted to the FDA.
However, the information provided does not contain acceptance criteria for a device algorithm, nor does it detail a study that proves the device meets specific performance acceptance criteria in the way typically expected for an AI/ML medical device. This is because Neutrasal® is a pharmaceutical product (a powder for an oral rinse) and not a software algorithm or AI device.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set size) are not applicable to the non-AI product described.
Here's an attempt to answer the questions based on the closest available information, acknowledging the limitations:
1. Table of Acceptance Criteria and the Reported Device Performance
This product is a pharmaceutical formulation, not an algorithm. Therefore, "acceptance criteria" for an algorithm's performance are not defined or reported. The "performance" assessment focuses on physical and chemical properties and achieving the intended use through bench testing.
| Acceptance Criterion (Proxy for Performance) | Reported Device Performance |
|---|---|
| Physical Properties | Bench testing performed |
| - pH | Bench testing performed |
| - Dissolution | Bench testing performed |
| - Activity Testing (Supersaturated State) | Bench testing performed |
| - Content Testing (Active Ingredients) | Bench testing performed |
| Biocompatibility | Technologically identical to 510(k)-approved predicate device |
| Manufacturing Compliance | Manufactured according to product specifications and cGMP guidelines; meets established specifications |
| Safety of Ingredients | All ingredients EAFUS approved (GRAS); Only USP-approved chemicals used |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. Performance testing was "bench testing" of the product's physical and chemical properties, not a clinical trial with a "test set" of patients or data.
- Data Provenance: Not applicable. Bench testing was performed by Scientech Laboratories, Inc. (an FDA-approved analytical laboratory testing service) and Bartor Pharmacal (internal testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As a pharmaceutical product, there is no "ground truth" to establish for a test set in the context of an algorithm's diagnostic or predictive performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. 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. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of an algorithm. The "truth" for this product lies in its chemical composition, physical properties, and safety, which are evaluated through analytical testing and regulatory review of ingredients and manufacturing.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable.
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