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(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.

Silica gel, 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.

This document is a 510(k) summary for the medical device Neutrasal®, a powder for supersaturated calcium phosphate rinse. It does not include information about a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested categories of information are not applicable or cannot be extracted from this document, as they pertain to a performance study that was not conducted or reported for this submission.

Here's a breakdown based on the provided text, indicating where information is present and where it is not:

1. A table of acceptance criteria and the reported device performance

• Note: The document states that the performance testing "included the assessment of the physical properties of Neutrasal® and its ability to achieve its intended use." The listed bench tests (pH, dissolution, activity, content) were performed. However, specific numerical acceptance criteria for these properties are not explicitly stated in the document, nor are the specific numerical results of these tests reported. The implicit acceptance criterion is that these properties are equivalent to the predicate device, which is implied by the "Substantial Equivalence Conclusion."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. No clinical test set data is provided in this submission for substantial equivalence. The "test set" here refers to the physical properties tested in bench studies.
• Data Provenance: Bench testing was completed by Scientech Laboratories, Inc., an FDA-approved analytical laboratory testing service, as well as internal testing. No country of origin for data is specified beyond the laboratory location. The nature of these tests makes them "prospective" in the sense that they were conducted for this submission, but not on human subjects.

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. This device is not an AI/diagnostic device that relies on expert interpretation of images or clinical data. Ground truth in this context refers to the chemical and physical properties of the formulation, established through laboratory testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are typically for clinical study endpoints or diagnostic interpretations, neither of which are present in this submission.

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

• No. This is a medical device (oral rinse), not an AI-assisted diagnostic tool. An MRMC study is completely irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the device's performance relies on objective laboratory measurements of its physical and chemical properties (pH, dissolution, supersaturated state activity, content of active ingredients) and established regulatory frameworks for ingredient safety (GRAS listing) and manufacturing (cGMP). The ground truth for biocompatibility is its identity to a previously approved predicate device.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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(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.

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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