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510(k) Data Aggregation
(120 days)
SalivaMAX
SalivaMAX™ is indicated for dryness of the mouth or throat (hyposalivation, xerostomia, mucositis), regardless of the cause and regardless of whether the condition is temporary or permanent. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
SalivaMAX™ is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy.
SalivaMAX™ may be used for the relief of dryness of the oral mucosa when hyposalivation results from the following: pre/post surgery, radiotherapy, chemotherapy, infection or dysfunction of the salivary glands, inflammation of the mouth or throat, fever, emotional factors such as fear or anxiety, obstruction of the salivary ducts, Bell's Palsy, and Sjogren's syndrome. SalivaMAX™ is also indicated for dryness of the oral mucosa due to drugs such as antihistamines, atropine, or other anticholinergeic agents that suppress salivary secretion.
SalivaMAX™ may be used as part of an oral hygiene program for patients with dry mouth. SalivaMAX™ provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste, relieve offensive nasal discharge, and crusting.
SalivaMAX™ is an artificial saliva that is provided in disposable packets.
SalivaMAX™ is comprised of powdered ingredients that when combined with 30 mL (1 oz.) of water, produces a supersaturated calcium phosphate solution. SalivaMAX™ is packaged in singleuse packets and will be provided non-sterile and is not intended to be sterilized before use.
Because SalivaMAX™ is to be administered several times per day it will primarily be used at home, office or other non-clinical settings. However, SalivaMAXTM may also be used in clinical or healthcare facility settings where patients are receiving inpatient services.
The goal of administering SalivaMAX™ is to relieve chronic and temporary xerostomia and mucositis. SalivaMAX™ is a partial substitute for natural saliva and intended to moisten, lubricate, and clean the oral cavity including the mucosa of the mouth, tongue, and throat. SalivaMAX™ facilitates chewing and speaking; and can relieve bad breath.
SalivaMAX™ is composed of US Pharmacopeia grade calcium, phosphate, bicarbonate, and chloride electrolytes. Each application of SalivaMAX™ is to swish half the solution for 1 minute, expectorate, then repeat for the remaining solution. Given that the rinse is topical with a maximum rinse time of 20 minutes per day (2 minutes per application x maximum 10 times per day), SalivaMAX™ is considered a surface contacting device with a limited duration of contact.
Key performance specifications of SalivaMAX™ are an in solution pH range of 6.25 - 7.5 and solubility in water.
The provided text describes the SalivaMAX™ device, its indications for use, and a comparison with predicate devices to establish substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria for performance.
Therefore, the requested information elements related to a study proving acceptance criteria cannot be fully extracted/answered from this document.
However, based on the Summary of Testing section (page 6), some information can be inferred or directly stated regarding "acceptance criteria" through the lens of establishing substantial equivalence to predicate devices.
Here's what can be extracted, and where information is missing or not applicable, it is noted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (inferred from comparative testing) | Reported Device Performance (SalivaMAX™) | Notes |
|---|---|---|
| Dissolution equivalent to NeutraSal | Equivalent to NeutraSal | The document states "The results were equivalent for SalivaMAX™ and the primary predicate, Neutrasal, providing further evidence of substantial equivalence." This implies that the dissolution profile of SalivaMAX™ met an "acceptance criterion" of being equivalent to NeutraSal. |
| pH between 6.25 - 7.5 (in solution) | 6.69 (in solution) | The "Key performance specifications" (page 4) state a target pH range. Table 1 (page 5) reports the actual pH of SalivaMAX™. The reported pH (6.69) falls within the specified range (6.25 - 7.5). |
| pH equivalent to NeutraSal | Equivalent to NeutraSal | The "Summary of Testing" states "pH evaluation" was conducted and "results were equivalent for SalivaMAX™ and the primary predicate, Neutrasal". The NeutraSal pH is reported as 6.72 in Table 1, very close to SalivaMAX™'s 6.69. |
| Solubility in water | Soluble in water | This is listed as a "Key performance specification" for SalivaMAX™ (page 4) and as a "Comparison Parameter" in Table 1 (page 5) where it is also stated as "Soluble in water" for the subject device and predicates. |
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 for Test Set: Not specified. The document refers to "bench testing" but does not provide details on the number of samples tested for dissolution or pH.
- Data Provenance: Not specified. It's bench testing, likely conducted internally or by a contract lab, but no country of origin or retrospective/prospective nature is mentioned.
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 document describes bench testing (dissolution, pH evaluation) for a liquid solution, not diagnostic performance or a scenario where human experts would establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, not for objective bench tests like dissolution and pH.
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 document is for a medical device (artificial saliva solution) that does not involve AI or human "readers" interpreting cases. The testing described is bench testing for physico-chemical properties.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a solution for oral rinse, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For pH and solubility:
- pH: The "ground truth" is established through standard laboratory measurement techniques using a pH meter, yielding an objective value.
- Solubility: The "ground truth" is whether the powder dissolves in water, an objective observation.
- For dissolution:
- The "ground truth" or acceptance standard was equivalence to the predicate device, NeutraSal, which itself would have established its dissolution profile through standard laboratory methods.
8. The sample size for the training set
- Not Applicable. This refers to bench testing of a medical device solution; there is no "training set" in the context of machine learning or algorithms.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for this type of device and testing.
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