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Caphosol® is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the conditions are temporary or permanent. Caphosol® is also indicated as an adjunct to standard oral care in treating mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.

Caphosol® 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; inflammation of the mouth or throat; fever; emotional factors such as fear or anxiety; obstruction of the salivary ducts; Sjogren's syndrome; and Bell's Palsy.

Caphosol® 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.

It may be used as part of an oral hygiene program for patients with dry mouth. Caphosol® provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste and to relieve offensive nasal discharge and crusting.

Caphosol® is an electrolyte solution resembling human saliva, designed in part to replace the normal ionic and pH balance in the oral cavity. It is intended as a mouth rinse to moisten, lubricate, and clean the oral cavity including the mucosa of the mouth, tongue, and throat. Caphosol® 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. Patients having this condition are also prone to dental caries and candidal infections.

Caphosol® is a partial substitute for natural saliva. Caphosol® facilitates chewing and speaking; loosens tough mucus; prevent mucous membranes from sticking together, helps remove nasal crust and relieve nasal soreness; improves adherence of dentures, and also relieves bad taste. Caphosol® is an adjunct to standard oral care for treating mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration · of pain.

Caphosol® is a preparation comprising two separately packaged aqueous solutions, a phosphate solution (Caphosol® A) and a calcium solution (Caphosol® B) which when both sachet solutions are combined in equal volumes form a solution supersaturated with respect to both calcium and phosphate ions.

This document is a 510(k) Premarket Notification from the FDA regarding Caphosol® Artificial Saliva. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a performance study for new acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, specifically in the context of an AI/human comparative effectiveness study, standalone algorithm performance, or training set details, is not present in this document.

The document states: "No performance testing was conducted." This explicitly indicates that a study demonstrating device performance against acceptance criteria, as typically understood for medical device efficacy or AI performance, was not performed or submitted for this specific 510(k).

The "Substantial Equivalence" section details how the new device (Caphosol® in sachets) is compared to the predicate device (Caphosol® in vials). The core of the submission is that the new device has not changed its composition or indications for use, and the only difference is the packaging (sachets versus vials).

Here's the information that is available in the document, largely pertaining to the comparison with the predicate:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not present a table of new acceptance criteria and corresponding device performance data from a new study. Instead, it compares the characteristics of the subject device (Caphosol® in sachets) to the predicate device (Caphosol® in vials) to establish substantial equivalence.

   Feature	Caphosol® Artificial Saliva in sachets (Subject Device)	Caphosol® Artificial Saliva in vials (Predicate Device K030802)
   Product Code	LFD	LFD
   Indications for Use	Same as Predicate	Same as Subject
   Device Description	Same as Predicate (electrolyte solution resembling human saliva)	Same as Subject
   Composition (% w/w)	Dibasic Sodium Phosphate 0.032	Dibasic Sodium Phosphate 0.032
   	Monobasic Sodium Phosphate 0.009	Monobasic Sodium Phosphate 0.009
   	Calcium Chloride 0.052	Calcium Chloride 0.052
   	Sodium Chloride 0.569	Sodium Chloride 0.569
   	Purified Water 99.338	Purified Water 99.338
   Package	sachets	vials
   Shelf Life	3 years	3 years
   Shelf Life Testing	Yes (includes liquid and package testing)	Yes (includes liquid and package testing)

2. Sample size used for the test set and the data provenance: Not applicable. The document states "No performance testing was conducted." The "testing" mentioned refers to accelerated shelf-life testing, not clinical or performance efficacy trials with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth was used for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was used.

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 device is an artificial saliva solution, not an AI-powered diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established as "No performance testing was conducted."

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device; therefore, no training set was used.

9. How the ground truth for the training set was established: Not applicable. (See answer to #8).

In essence, this 510(k) submission leverages the substantial equivalence pathway, asserting that because the active ingredients, concentration, and intended use of the Caphosol® product remain identical to the previously cleared predicate, and only the packaging format has changed (from vials to sachets), no new performance data is required to establish safety and effectiveness. Shelf-life testing was conducted to ensure the integrity of the new packaging and the stability of the liquid over time, which is considered "similar" to the predicate's testing, with minor adjustments for the flexible package type.

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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:

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:

2. Sample size used for the test set and the data provenance: Not applicable as no clinical performance testing was done.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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, as this is not an AI/ML device.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. 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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