(154 days)
The Dental Pain Eraser DPE-C300 is intended to provide temporary dental anesthesia (pain relief) and is indicated for use before, during, or after dental and orthodontic procedures, and other sources of oral pain. It is intended for use by dental/orthodontic professionals for the alleviation of oral pain.
The Dental Pain Eraser is a non-invasive electrical stimulation device that is used to numb the nerve pain associated with orthodontic procedures and to dull the pain of canker sores often developed inside the mouths of patients wearing braces or retainers. This method of treatment is referred to as Transcutaneous Electrical Nerve Stimulation (TENS). The Dental Pain Eraser has a shape and size similar to a common toothbrush, except that in place of the bristles are two metal electrodes. In operation, the device is turned on and for 30 seconds to 10 minutes the two electrodes are rubbed gently up and down the gums above the patient's aching tooth or on the intact skin around the canker sore. Current flowing between the electrodes through the gum anesthetizes the nearby nerves thus alleviating pain.
This document describes the regulatory submission for the "Dental Pain Eraser DPE-C300" (K182947), which is a non-invasive electrical stimulation device intended to provide temporary dental pain relief. The submission aims to demonstrate substantial equivalence to a predicate device, the "CEDETA Mk2" (K915717).
Based on the provided document, here's a breakdown of the acceptance criteria and the supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of pre-defined acceptance criteria with specific numerical targets. Instead, it demonstrates substantial equivalence by comparing the proposed device to a predicate device across various characteristics and stating that comprehensive testing confirmed its performance and safety are comparable. The "Acceptance Criteria" here are implicitly meeting the specifications and safety/effectiveness profile comparable to the predicate device.
However, we can infer some "performance" points from the clinical study summaries.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Pain Relief (General Dental/Orthodontic Pain) | Device performs as intended in relieving periodontal, mucosal, and dentinal pain related to orthodontic treatment. | CSP-TENS-002: Demonstrated that the device performs as intended at relieving periodontal, mucosal, and dentinal pain related to orthodontic treatment of adolescents and adults. |
| Pain Relief (Orthodontic Separator Pain) | Device effectively alleviates tooth pain after orthodontic separator placement, especially during the period of greatest pain. | CSP-TENS-003: Confirmed that the device relieves periodontal pain following separator placement during the first 3 days cumulatively when the greatest pain is normally experienced. |
| Pain Relief (Post-Orthodontic Adjustment Pain) | Device alleviates post-orthodontic appliance adjustment tooth pain. | CSP-TENS-001: Suggested that the device alleviates post-orthodontic appliance adjustment tooth pain. |
| Safety | No adverse device effects reported. | All three clinical studies (CSP-TENS-002, CSP-TENS-003, CSP-TENS-001): "No adverse device effects were reported." |
| Biocompatibility | Materials are biocompatible and meet relevant ISO standards. | Table 3: All tests for Cytotoxicity, Sensitization (Sodium Chloride & Sesame oil Extract), and Irritation (Sodium Chloride & Sesame oil Extract) Passed per ISO 10993-5 and ISO 10993-10 standards. |
| Electrica Safety & EMC | Compliant with applicable standards. | Nonclinical Testing Summary: "Electrical Safety and Electromagnetic Compatibility Testing" was performed and passed. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10. |
| Water Ingress | Device meets specified ingress protection rating. | Nonclinical Testing Summary: "Water Ingress Testing" was performed and passed. Ingress Protection Rating IP21. |
| Overall Performance | Meets established specifications and exhibits required mechanical and functional characteristics. | Conclusions: "The collective results confirm that the Dental Pain Eraser meets its specifications and exhibits the required mechanical and functional characteristics for its intended use..." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes for the clinical studies (CSP-TENS-001, CSP-TENS-002, CSP-TENS-003). It mentions "patients" in general terms.
- CSP-TENS-002: Patients selected during the leveling and aligning phase of orthodontic treatment with moderate to severe crowding experiencing immediate orthodontic pain.
- CSP-TENS-003: Patients randomly assigned to one of three treatment groups (Experimental, Sham, Control).
- CSP-TENS-001: Patients with periodontal pain associated with orthodontic appliance adjustment.
Data Provenance:
- The clinical studies were conducted by Synapse Dental, LLC.
- CSP-TENS-001 was a preliminary pilot study done by Doctor Cosmo Haralambidis at Cranston Orthodontics, Cranston, RI, United States.
- The document does not specify whether the studies were retrospective or prospective, but clinical trials are typically prospective. The mention of patient selection, randomization (for CSP-TENS-003), and pain assessment questionnaires strongly suggests prospective studies.
- The country of origin for the clinical data appears to be USA (Cranston, RI mentioned for CSP-TENS-001).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not discuss "ground truth" in the context of expert review for the clinical studies, as the device is for pain relief, which is a subjective patient experience. The "ground truth" for efficacy would be the reported pain levels by the patients themselves. Pain assessment questionnaires were used for CSP-TENS-003.
For the non-clinical testing, the "ground truth" is established by the specifications and standards (e.g., IEC, ISO, ANSI/AAMI) the device was tested against. The expertise lies in the certified laboratories and engineers performing these tests.
4. Adjudication Method for the Test Set
Not applicable in the context of this device and the clinical studies described. Pain relief is self-reported, not externally adjudicated by multiple experts viewing objective data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is typically performed for diagnostic imaging devices where human readers interpret images. This is not applicable to the "Dental Pain Eraser," which is a therapeutic electrical stimulation device for pain relief. The studies conducted compare the device's effect to a control/sham, not the improvement of human readers' performance with AI assistance.
6. Standalone Performance
The clinical studies describe the performance of the device itself (with a human operator, the dental/orthodontic professional, applying it), not an algorithm in isolation. The "performance" in this context is the alleviation of pain in patients when the device is used as intended. The studies assess the direct effect of the device on patient pain levels.
7. Type of Ground Truth Used
The primary "ground truth" for efficacy in the clinical studies is patient-reported pain levels validated via pain assessment questionnaires (explicitly mentioned for CSP-TENS-003). Safety "ground truth" is based on the absence of reported adverse device effects. For non-clinical tests, the ground truth is adherence to engineering specifications and international standards.
8. Sample Size for the Training Set
This product is a medical device for therapeutic use (pain relief), not an AI/ML model that requires a "training set" in the machine learning sense. Therefore, the concept of a training set sample size is not applicable here. The device's design is based on established principles of Transcutaneous Electrical Nerve Stimulation (TENS) and engineering.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device, there isn't a "training set" or "ground truth" for it in that context. The device's design and operating parameters (e.g., output voltage, current, waveform) are based on the intended physiological effects of TENS and are validated through the non-clinical and clinical performance data.
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