(149 days)
The Lubricity® Moisturizing Mouth Spray's intended use is to relieve the symptoms of dry mouth, refresh, moisturize, soothe oral irritation and lubricate dryness in and around the oral cavity.
Lubricity® is an oral saliva substitute containing gel film forming polysaccharides, Sodium Hyaluronate, which has lubricating and moisturizing properties in the buccal cavity. The product is formulated, preserved and packed in blow molded polyethylene terephthalate bottles with a closure system comprising a metered dose liquid spray fitting manufactured from polypropylene, high density polyethylene, polymethoxylene copolymer and stainless steel (spring). All container closure components have appropriate status under FDA food contact or GRAS regulations.
The document provided is a 510(k) summary for the device "Lubricity®", an artificial saliva product. It aims to demonstrate substantial equivalence to a predicate device, Salinum®/Oraclair (K024148). The summary includes information on performance testing, but it does not detail specific acceptance criteria or provide a full study report with quantitative results needed to populate all the requested fields.
Here's the information that can be extracted or inferred from the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric/Objective | Acceptance Criteria (Not explicitly stated as numerical criteria) | Reported Device Performance |
|---|---|---|
| Oral lubrication improvement | Implied: Demonstrate improved oral lubrication. | Met primary study objective of improved oral lubrication. |
| Serious Adverse Events (SAEs) | Implied: No serious adverse events. | No serious adverse events were reported. |
| Biocompatibility: Cytotoxicity | Not explicitly stated. | Tested and implied to be acceptable (no specific results provided). |
| Biocompatibility: Delayed Hypersensitivity | Not explicitly stated. | Tested and implied to be acceptable (no specific results provided). |
| Biocompatibility: Oral Mucosal Irritation | Not explicitly stated. | Tested and implied to be acceptable (no specific results provided). |
| Biocompatibility: LD50 Short Term Toxicity | Not explicitly stated. | Tested and implied to be acceptable (no specific results provided). |
| Stability Testing | Not explicitly stated. | Tested and implied to be acceptable (no specific results provided). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "In clinical evaluation, Lubricity® met the primary study objective...", but does not provide the number of participants in this clinical evaluation.
- Data Provenance: Not explicitly stated, but it is a premarket notification for a US FDA clearance, so the data is presumed to be submitted to the FDA for review. It's not specified if the clinical evaluation was retrospective or prospective, nor the country of origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. For a dry mouth product, "ground truth" might refer to expert assessment of symptoms or patient-reported outcomes, but the document does not specify.
4. Adjudication method for the test set
- This information is not provided in the document.
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
- This information is not applicable as the device is an artificial saliva product, not an AI-powered diagnostic or imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable as the device is an artificial saliva product, not an algorithm.
7. The type of ground truth used
- The document states "Lubricity® met the primary study objective of improved oral lubrication". This suggests the ground truth was based on clinical evaluation outcomes, likely involving patient-reported symptoms and/or clinician assessments of oral lubrication and dry mouth symptoms. It does not mention pathology or other objective outcomes data in detail.
8. The sample size for the training set
- This information is not applicable as the device is an artificial saliva product, not an algorithm that requires a training set in the typical machine learning sense.
9. How the ground truth for the training set was established
- This information is not applicable for the reasons stated in point 8.
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