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510(k) Data Aggregation
(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.
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(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<0.0001 for mechanical-electrical stimulation vs. mechanical stimulation alone. |
| Long-term Patient-Reported Oral Moisture Improvement (Mechanical Mode) | 18% improvement in patient-reported degree of oral moisture. |
| Long-term Patient-Reported Oral Moisture Improvement (Mechanical-Electrical Mode) | 26% improvement in patient-reported degree of oral moisture. |
| Long-term Patient-Reported Xerostomia Frequency Decrease (Mechanical Mode) | 12% decrease in xerostomia frequency. |
| Long-term Patient-Reported Xerostomia Frequency Decrease (Mechanical-Electrical Mode) | 18% decrease in xerostomia frequency. |
| Statistical Significance for Long-term Xerostomia Severity | p<0.002 for the difference between mechanical-electrical and mechanical modes. |
| Statistical Significance for Long-term Xerostomia Frequency | p<0.05 for the difference between mechanical-electrical and mechanical modes. |
| Overall Improvement (End of Stage II for Oral Moisture) | 34% improvement (p<0.001) in self-perceived oral moisture. |
| Overall Improvement (End of Stage II for Xerostomia Frequency) | 17% improvement (p<0.002) in xerostomia frequency. |
| Increase in Resting Saliva Production (End of Stage II) | 25% increase (p<0.001) in collected saliva under resting conditions. |
| Increase in Masticatory Stimulated Saliva Production (End of Stage II) | 18% increase (p<0.02) in collected saliva under masticatory stimulation. |
| Restoration of Salivary Flow in Aptyalic Patients | Salivary flow could be collected on follow-up examinations in 7 out of 8 patients with no salivary flow at the start of the study. |
| Safety | No significant side-effects observed in short-term study. No severe or irreversible systemic or local adverse effects unequivocally attributed to GenNarino usage in long-term study. |
2. Sample Size and Data Provenance for Test Set (Clinical Studies)
- First Clinical Trial (Short-term):
- Sample Size: Not explicitly stated, but indicated as a "controlled, short-term usage, double-blinded study."
- Data Provenance: Multi-national; performed in three medical centers in Europe. Retrospective or prospective is not explicitly stated, but the description of "performed" suggests prospective.
- Second Clinical Trial (Long-term):
- Sample Size:
- Stage I: 96 patients completed.
- Stage II: 56 patients completed.
- Data Provenance: Multi-national; performed in 14 institutions in 13 countries, including the US and countries in Europe and the Americas. The description of "performed" suggests prospective.
- Sample Size:
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts or their qualifications used to establish ground truth for the clinical studies. The results rely on "patient-reported degree of oral moisture" and "xerostomia symptoms changes," as well as objective measurements such as "wetness sensors" and "amount of collected saliva."
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method. The studies were described as "double-blinded" for parts of their design, meaning neither the patients nor the clinicians administering the intervention knew whether the device was in mechanical-only or mechanical-electrical mode.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This device is an electrical salivary stimulator system, not an imaging or diagnostic device that typically employs MRMC studies to evaluate human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The GenNarino is a physical medical device (an electrical salivary stimulator system), not an AI algorithm or software-only device. Its performance is inherent to its physical function and electrical stimulation, not an algorithm running independently.
7. Type of Ground Truth Used
The ground truth used appears to be a combination of:
- Patient-reported outcomes: Subjective assessment of oral dryness, xerostomia symptoms, oral moisture, and xerostomia frequency.
- Objective physiological measurements: Wetness sensors and collected saliva volume.
- Observation of clinical effects: Restoration of salivary flow in previously aptyalic patients.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of an AI algorithm. The clinical trials described are for the evaluation of the device itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no AI algorithm training set is referenced.
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