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510(k) Data Aggregation
(224 days)
The Voutia™ system is indicated to provide relief of dry mouth by coating, and lubricating oral structures thereby relieving the symptoms of xerostomia (dry mouth).
Voutia™ is a non-sterile, single person use device for the treatment of xerostomia, consisting of a circuit board controlled pump, a fluid reservoir bottle, and tubing extension that goes from the pump, over a person's ear and transitions to a smaller tube that terminates in the user's oral cavity. The Voutia™ system delivers potable water to the mouth at nine (9) preprogrammed user selectable rates over a defined time, allowing stationary or portable hands free use.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
Device Name: Voutia™
K Number: K173808
Intended Use: The Voutia™ system is indicated to provide relief of dry mouth by coating, moistening, and lubricating oral structures, thereby relieving the symptoms of xerostomia (dry mouth).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state formal "acceptance criteria" in a quantitative, measurable format with specific thresholds (e.g., "flow rate must be within X% of target"). Instead, it describes general performance evaluations. I will infer the "acceptance criteria" based on the described performance testing.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Performance (Bench Testing): | |
| Reproducibility of water flow rate at selected levels. | Bench testing confirmed reproducibility of the water flow rate as intended on each selected level, meeting predetermined internal testing criteria. |
| Biocompatibility of fluid path components. | Biocompatibility assessment of fluid path components was conducted. Polyimide tubing meets USP Class VI testing evaluation and has established historical biocompatibility. |
| Clinical Performance (Proof of Concept & Functionality): | |
| Confirm proof of concept and functionality during use (waking and sleeping hours). | Performed using a volunteer beta testing population who utilized the system during waking and sleeping hours to confirm proof of concept and functionality. (No specific metrics provided, but implies successful operation). |
| Absence of adverse physiological events. | No adverse physiological events were reported by the participants over a 16-month period. |
| Safety - Battery: | |
| Lithium polymer battery safety. | The lithium polymer battery has been tested by Underwriters Laboratory and passed all safety testing consistent with a single cell power source. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "a volunteer beta testing population" is mentioned. The exact number of participants is not specified in the document.
- Data Provenance: The study was a "beta testing" conducted using volunteers, which implies a prospective study. The country of origin is not specified, but given the FDA submission, it implicitly refers to data relevant for the US market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This study does not involve establishing a ground truth through expert consensus in the typical sense (e.g., for diagnostic accuracy). Instead, it focuses on the functional performance, safety, and user experience for a device that delivers water.
- The "ground truth" for the non-clinical performance (reproducibility of flow rate, biocompatibility) would have been established by engineering and materials science standards/tests.
- For the clinical performance, the "ground truth" was likely the participants' self-reported experience regarding relief of dry mouth symptoms (confirming proof of concept and functionality) and the absence of reported adverse events. There is no mention of external "experts" establishing a ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
Given the nature of the device (water delivery for dry mouth relief) and the described "volunteer beta testing," there is no mention of an adjudication method (like 2+1 or 3+1 consensus). The evaluation of use was likely based on direct participant experience and reporting.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This device is a water delivery system for symptomatic relief of dry mouth, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this is not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device itself (the pump system) has standalone functional performance which was tested via bench testing.
7. The Type of Ground Truth Used
- Non-Clinical Performance: Engineering standards for flow rate reproducibility and recognized materials testing standards (e.g., USP Class VI for biocompatibility).
- Clinical Performance: User self-reporting of perceived symptom relief ("proof of concept and functionality") and adverse events. This aligns more with outcomes data in a general sense, focusing on user experience and safety outcomes rather than a diagnostic "ground truth."
8. The Sample Size for the Training Set
This document describes a medical device, not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The design and development of the device would have involved internal testing and iterations, but these are not referred to as a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
As per item 8, the concept of a "training set" for an AI algorithm is not applicable to this device.
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