(240 days)
Caphosol Dispersible is indicated for dryness of the mouth and throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the condition is temporary or permanent. Caphosol Dispersible is also indicated as an adjunct to standard oral care in the treatment of the 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.
Caphosol is a supersaturated calcium phosphate, electrolyte mouth rinse used as artificial saliva, designed in part to replace ionic and pH balance in the oral cavity, and formulated as a tablet to be dissolved in water prior to use.
The provided text is a 510(k) summary for a medical device called "Caphosol Artificial Saliva Tablets." It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or a study proving that the device meets such criteria in the context of an AI/ML device.
However, I can extract the information that is present and indicate what is not available for your specific request on AI/ML device acceptance criteria and study details.
Here's a breakdown based on the provided document and your request:
Device: Caphosol Artificial Saliva Tablets.
Device Type (relevance to AI/ML): This is a pharmaceutical-like product (artificial saliva) and not an AI/ML device. Therefore, the questions related to AI/ML specific performance, such as human reader improvement with AI assistance or standalone algorithm performance, are not applicable.
1. Table of acceptance criteria and the reported device performance
The document does not specify formal "acceptance criteria" for performance in the way an AI/ML device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Caphosol liquid artificial saliva) based on:
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (Caphosol Artificial Saliva Tablets) |
|---|---|
| Intended Use | Caphosol Dispersible is indicated for dryness of the mouth and throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the condition is temporary or permanent. Also indicated as an adjunct to standard oral care in the treatment of mucositis caused by radiation or high dose chemotherapy. Relief of dryness is associated with amelioration of pain. (Identical to predicate in core function, slight difference in specificity not raising concerns). |
| Technology/Operating Principle | Supersaturated calcium phosphate, electrolyte mouth rinse designed to replace ionic and pH balance in the oral cavity. Active chemical components (Calcium and Phosphate) are identical to the predicate. The final solution prepared after dissolution of a tablet or after mixing 2 ampules (predicate) are identical in quantity of the active ingredients. Substantially equivalent to predicate regarding operating principle and function. |
| Formulation (Active Ingredients) | Contains: Sodium phosphate dibasic anhydrous, Sodium phosphate monobasic anhydrous, Calcium chloride. (Identical active components to predicate). |
| Biocompatibility | Assessed in accordance with ISO - 10993-1. (Implies compliance with standard). |
| Safety (Adverse Effects) | "A literature search has not shown any clinically significant adverse effects being reported." |
Regarding the study that proves the device meets the acceptance criteria (as requested for an AI/ML device):
The document explicitly states: "Clinical performance testing was not conducted for the subject device."
Therefore, the following points which are highly relevant for AI/ML device studies are not applicable or not present in this document:
- Sample size used for the test set and the data provenance: Not applicable as no clinical performance testing was done.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary for this specific document:
This document describes a 510(k) submission for a non-AI/ML medical device. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a legally marketed predicate device, focusing on intended use, technological characteristics, active ingredients, and biocompatibility. No clinical performance study, in the typical sense of showing efficacy or safety for novel AI/ML devices, was reported to have been conducted for this submission, as it relied on the established safety and efficacy of the predicate and the similar nature of the product.
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