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SaliPen is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth).

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 stimulating electrodes. The device is designed in a manner that allows placing the electrodes on the linqual mucosa in the mandibular third molar region. Electrical stimulation is achieved by the delivery of low-power, low voltage, biphasic electrical pulses.

This document, K232063 for the SaliPen device, is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a clinical study with detailed acceptance criteria and performance data for a new, AI-powered diagnostic device. Therefore, it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of AI performance.

The document describes the SaliPen as an electrical salivary stimulator system, not an AI-powered diagnostic device. The "performance data" section refers to nonclinical evaluations (electromagnetic compatibility, electrical safety, biocompatibility, and risk analysis) and comparative testing of electrical output to the predicate device, not a human reader or standalone algorithm performance study.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria (as implied by the document's purpose): The primary acceptance criterion for this 510(k) submission is to demonstrate "substantial equivalence" to the predicate devices (SaliPen K180838 and K220618). This means showing that the device is as safe and effective as, and does not raise new questions of safety and effectiveness than, the legally marketed predicate.

  • Specific performance criteria mentioned relating to equivalence:
    • Mechanism of action is the same.
    • Placement of electrodes is the same.
    • Electronics are the same.
    • Anatomical adaptation is the same.
    • Frequency of use is the same.
    • External control is the same.
    • Electrical output is identical to the predicate (despite shortened electrodes).
    • Biocompatibility of shortened electrodes is demonstrated via cytotoxicity testing.
    • Risk assessment confirms no new/increased risks due to shortened electrodes.

• Reported Device Performance:

  • Nonclinical performance: "Testing (including electromagnetic compatibility, electrical safety, biocompatibility assessment, and risk analysis) was performed and found to be in compliance with the standards..." (listed standards such as ISO 10993-5, ISO 10993-12, EN ISO 14971:2012, EN 60601-1:2005, etc.)
  • Comparative Electrical Output: "comparative testing of the electrical output of the subject device was conducted to demonstrate that the output is identical to the predicate."
  • Biocompatibility: "Cytotoxicity testing per ISO 10993-5 was conducted on the shortened electrodes to demonstrate biocompatibility."
  • Risk Analysis: "a risk assessment of the brass was performance. A contraindication has been added to the labeling for persons who are allergic to brass."

  Note: Since this is not an AI diagnostic, there are no metrics like sensitivity, specificity, AUC, or reader improvement to report.

2. Sample size used for the test set and the data provenance:

• Not applicable for this document. The document describes nonclinical testing and comparative electrical output verification, not a clinical study on 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 expert review for ground truth associated with an AI algorithm's performance is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No clinical test set requiring adjudication is mentioned.

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 electrical stimulator, not an AI diagnostic algorithm that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This document describes a medical device, not a standalone AI algorithm. The performance evaluation focuses on the physical and electrical characteristics of the device itself and its biocompatibility, not its diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Implied "ground truth" for this device: The performance is benchmarked against established safety standards (e.g., ISO, EN standards for electrical safety, biocompatibility) and the electrical output of the predicate device. The "truth" is compliance with these standards and equivalence to the predicate.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not applicable. There is no training set mentioned.

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SaliPen is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth).

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 lingual mucosa in the mandibular third molar region. The lingual 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 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 does not describe a study that proves the device meets specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it outlines the substantial equivalence determination for a medical device (SaliPen) by the FDA. The "performance data" section primarily discusses non-clinical testing for safety and regulatory compliance, and a "Human Factors validation trial."

Therefore, I cannot fulfill most of the requested information regarding acceptance criteria and performance study details. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a detailed performance study like what would typically be conducted for a new diagnostic AI/ML device.

However, I can extract the following relevant information from the provided text:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The document does not specify quantitative performance acceptance criteria in terms of clinical outcomes (e.g., a certain percentage increase in salivary flow). The "acceptance" is centered on demonstrating substantial equivalence to a predicate device, and the "performance" described is about safety, compliance with standards, and usability.
• Reported Device Performance:
  • Nonclinical Performance: Compliance with various ISO, EN, IEC, and UL standards for electromagnetic compatibility, electrical safety, biocompatibility, and risk analysis. (Specific numerical results are not provided).
  • Clinical Performance (Human Factors Validation Trial):
    • Outcome 1: Study subjects (with and without xerostomia) were able to correctly decide eligibility for using the device based on the external label.
    • Outcome 2: Study subjects who used the device were able to follow the over-the-counter labeling instructions for use.
  • Mechanism of Action: Promote salivary function by mechanical and electrical stimulation of nerves involved in the salivary reflex.
  • Stimulation Parameters: Low-power, low voltage, biphasic electrical pulses, below sensation and pain thresholds.

Due to the nature of the document (510(k) summary for a substantial equivalence claim, not a detailed clinical performance study report), the following points cannot be answered from the provided text:

• 2. Sample sized used for the test set and the data provenance: Not specified for the human factors trial, other than "study subjects." Data provenance (country of origin, retrospective/prospective) is not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the "ground truth" was about user comprehension and ability to follow instructions, not clinical diagnosis by experts.
• 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. This device is a stimulator, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the human factors trial, the "ground truth" was whether subjects correctly understood eligibility and followed instructions, likely assessed by direct observation and questionnaires.
• 8. The sample size for the training set: Not applicable (no traditional "training set" for an AI model).
• 9. How the ground truth for the training set was established: Not applicable.

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