(221 days)
SaliPen is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth), under prescription of a dental practitioner or physician.
SaliPen is an electrical salivary stimulatory system device. It is comprised of two units: an intraoral stimulating unit and an extra-oral command unit. The latter includes an electronic circuit, a compartment containing a 3V coin battery, and a bottom for switching the stimulation "On" and "Off".
The stimulating unit is made of silicone rubber and includes a stem and two flexible arms. The stem is used to hold SaliPen between the lips. The flexible arms are shaped to the inner contour of the lower dental arch. Each arm carries one pair of gold-plated stimulating electrodes. The device is designed in a manner that allows placing the electrodes on the linqual mucosa in the mandibular third molar region. The linqual nerve, which runs closely to this location, is the target of the stimulation due to its crucial role in the salivary reflex.
Electrical stimulation is achieved by the delivery of low-power, low voltage, biphasic electrical pulses. The selected stimulating parameters provide effective stimulation, yet are well below the sensation thresholds, and definitely below the pain threshold.
The user turns the device "On" and afterwards places the device in his/her mouth. After up to five minutes of use, the user removes the device from his/her mouth and deactivates the stimulation. 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.
Clinical trials showed that electrical stimulation to the lingual mucosa in the mandibular third molar region increases relative saliva production, resulting in more oral lubrication, due to the mechanical and electrical stimulation (both well-known techniques to increase salivary secretion and to relieve symptoms of dry mouth).
The provided text is a 510(k) summary for the SaliPen device, an electrical salivary stimulator. It focuses on demonstrating substantial equivalence to a predicate device (GenNarino, K160799) through comparison of technological characteristics and performance data.
However, the document does not contain the kind of detailed information typically found in a clinical study report that would allow for a precise filling out of the requested table and sections regarding acceptance criteria and a study proving those criteria.
Specifically, it lacks:
- A defined set of acceptance criteria for "device performance."
- Reported numerical performance metrics directly linked to specific acceptance criteria.
- Details about sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any clinical performance study.
- Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
The "Clinical performance evaluation" section only mentions "Usability testing was conducted in accordance to the standard IEC 60601-1-6:2013," which is about user interface and design, not clinical effectiveness in terms of salivary stimulation. The statement "Clinical trials showed that electrical stimulation to the lingual mucosa...increases relative saliva production..." is a general claim and not a detailed report of a specific study to prove acceptance criteria.
Therefore, I cannot fully complete the requested information based solely on the provided text.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|
| Clinical Performance: Increase relative saliva production | "Clinical trials showed that electrical stimulation to the lingual mucosa in the mandibular third molar region increases relative saliva production, resulting in more oral lubrication, due to the mechanical and electrical stimulation (both well-known techniques to increase salivary secretion and to relieve symptoms of dry mouth)." (Note: This is a general statement, not specific numerical performance data against a defined criterion in this submission document.) |
| Usability: In accordance with IEC 60601-1-6:2013 | "Usability testing was conducted in accordance to the standard IEC 60601-1-6:2013." (Implies compliance, but no specific performance metrics like task completion rates or error rates are provided). |
| Nonclinical Performance (Safety & EMC): Compliance with standards | "Testing (including electromagnetic compatibility, electrical safety, biocompatibility assessment, and risk analysis) was performed and found to be in compliance with the standards, such as ISO 10993-5, ISO 10993-12, EN ISO 14971:2012, EN 60601-1:2005, EN 60601-1-2:2007, IEC 60601-1-11:2010, ISO 15223-1:2016, EN 60529:1992+A2:2013, IEC 62304 1st edition 2006-05, EN ISO 13485:2003, and UL 1642." (Implies compliance, but no specific test results or metrics are provided). |
| Technological Characteristics' Equivalence to Predicate Device | The submission device (SaliPen) has similar mechanism of action, electrode placement, electronics, frequency of use, and external control as the predicate device (GenNarino). The difference in anatomical adaptation (flexibility vs. customization) does not raise safety/effectiveness concerns. |
Missing Information (Not Available in the Provided Text):
- Sample size used for the test set and the data provenance: Not specified for any clinical performance or efficacy studies. The general reference to "Clinical trials" does not provide these details.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified, as no rigorous "ground truth" establishment for assessing device performance is detailed in this summary.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not specified.
- 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 electrical stimulator, not an AI diagnostic/imaging device that would involve human readers or AI assistance in interpretation.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly defined for any performance claims regarding increased saliva. It seems to rely on the general physiological understanding of salivary stimulation.
- The sample size for the training set: Not applicable, as this is a physical medical device, not an AI/ML model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.