(331 days)
GenNarino is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth), under prescription of a dental practitioner or physician.
GenNarino is an electrical salivary system device. It is comprised of two units: a mouthpiece shaped to the contour of the lower dental arch and an infra-red remote control to turn the stimulation On or Off. The mouthpiece comprises of two dental grade plastic sheets. GenNarino embed an electronic module hermetically sealed between both sheets and a power source of two 3V small coin batteries. Two electrodes made of biocompatible materials are connected to the electronic module, protrude from the plastic sheet and contact the mucosa of the lower dental arch, at the lingual side. The electronic circuit allows switching the stimulation "On" and "Off" by an external remote control. The user pushes the remote control's "ON" button to turn the electronic circuit on and afterwards places the device on his/her lower dental arch. Typically after up to five minutes of use, the user removes the device from his/her mouth and deactivates the stimulation by pushing the remote control's "OFF" button. The device is used on "as need" base (i.e. when the users feels oral dryness) but not more than 5 times per day. The device and replacement devices are allowed for a cumulative use of up to 50 months.
The provided text describes the GenNarino electrical salivary stimulator system and its clinical performance evaluation to demonstrate substantial equivalence to a predicate device, the Salitron System. However, it does not explicitly state specific acceptance criteria in a quantifiable manner for the device performance itself, nor does it present the data in a table format with "device performance" separate from "acceptance criteria" as requested. Instead, it presents clinical study results that show positive outcomes.
Therefore, I will extract relevant performance metrics from the clinical studies and present them as "reported device performance." Since explicit acceptance criteria are not provided, I will infer them as generally requiring a statistically significant improvement in the measured parameters.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Implied Acceptance Criteria) | Reported Device Performance (GenNarino) |
|---|---|
| Short-term Oral Dryness Relief | Significant decrease in oral dryness (measured by wetness sensors) with p |
§ 872.5560 Electrical salivary stimulatory system.
(a)
Identification. An electrical salivary stimulatory system is a prescription intraoral device that is intended to electrically stimulate a relative increase in saliva production.(b)
Classification —Class II (special controls). The special controls for this device are:(1) The design characteristics of the device must ensure that the device design, material composition, and electrical output characteristics are consistent with the intended use;
(2) Any element of the device that contacts the patient must be demonstrated to be biocompatible;
(3) Appropriate analysis and/or testing must validate electromagnetic compatibility and electrical safety, including the safety of any battery used in the device;
(4) Software validation, verification, and hazard testing must be performed; and
(5) Documented clinical experience must demonstrate safe and effective use for stimulating saliva production by addressing the risks of damage to intraoral tissue and of ineffective treatment and must capture any adverse events observed during clinical use.