(25 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 DPE-C300 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 DPE-C300 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 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. The Dental Pain Eraser is intended for the alleviation of oral pain for pediatric (10 years through 22 years of age) and adult patients. The modified Dental Pain Eraser DPE-C300 is a multi-use device to be used in a dental/orthodontic facility.
This document describes a 510(k) premarket notification for the "Dental Pain Eraser DPE-C300," which is a non-invasive electrical stimulation device for temporary dental anesthesia. The primary purpose of this submission is to demonstrate that a modified version of the device, intended for multi-use, is substantially equivalent to a predicate single-use device (K182947). Therefore, the study focuses on validating the reprocessing (cleaning and disinfection) and durability for multi-use, rather than clinical efficacy studies of the pain relief itself.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantifiable manner for the overall "performance" of the device in terms of pain relief. Instead, it focuses on demonstrating substantial equivalence to a predicate device, particularly regarding its new multi-use characteristic. The "reported device performance" in this context refers to the successful outcomes of the nonclinical tests designed to support the multi-use claim.
| Acceptance Criteria Category | Specific Criteria/Focus | Reported Device Performance |
|---|---|---|
| Cleaning and Disinfection Validation | Adherence to standards for reprocessing medical devices. | "The results of the collective testing demonstrate that differences between the modified Dental Pain Eraser DPE-C300 as a multi-use device and the predicate as a single-use device do not raise different questions of safety or effectiveness." |
| Residual Cytotoxicity Testing | Ensuring no harmful residues remain after disinfection. | Implied to be met as part of "Disinfecting Validation/Residual Cytotoxicity Testing" and the overall conclusion of no new safety/effectiveness questions. |
| Cycle Testing | Durability and consistent performance over multiple uses. | "meet the established specifications necessary for consistent performance during its intended use." (Specific quantitative cycles not provided in summary). |
| Tip Assembly Pull Testing | Mechanical integrity of the tip assembly. | "meet the established specifications necessary for consistent performance during its intended use." (Specific quantitative force not provided in summary). |
| Biocompatibility | Compliance with relevant ISO standards and FDA guidance. | "Biocompatibility testing was performed per ISO 10993-1 and FDA Guidance Document... issued June 16, 2016." (No specific results provided in summary, but implied compliance). |
| Electrical Safety & EMC | Compliance with IEC 60601 series and ANSI/AAMI NS4:2013 | "Compliant with applicable requirements of: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304, ANSI/AAMI NS4:2013." (General statement of compliance without specific test results in summary). |
| Risk Management & Usability | Compliance with ISO 14971 and IEC 62366-1 | "Compliant with applicable requirements of: IEC 62366-1:2015, Medical devices. Part 1: Application of usability engineering to medical devices ISO 14971:2012, Medical Devices. Application of Risk Management to Medical Devices." (General statement of compliance without specific details). |
| Output Specifications (Voltage, Current, etc.) | Identical to predicate device. | All output specifications (patient leakage current, output modes, waveform, shape, voltage, current, pulse duration, frequency, charge, power density, burst mode, on/off time) for the proposed device are listed as identical to the predicate device. |
| General Physical Characteristics | Identical to predicate device (except multi-use capability). | Indications for Use, Intended User/Patient Population, Use Environment, Product Code, Classification, Manufacturer, Power Source, Method of Line Current Isolation, Indicator Display, Therapy Range, Weight, Unit Body Dimensions, Materials and Construction, Ingress Protection Rating are all stated as "N/A (same)" as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical testing was not required to establish substantial equivalence."
Therefore, there is no "test set" in the context of clinical performance data. The "tests" performed were nonclinical (bench testing) for cleaning, disinfection, cycle testing, and pull testing. The sample sizes for these specific bench tests are not provided in the summary. Data provenance is implied to be from Synapse Dental's internal testing as part of their 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test set was used to establish ground truth for clinical efficacy. The evaluation was based on nonclinical bench testing and comparison to a predicate device.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication was used.
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 direct-use electrical stimulation device, not an AI-powered diagnostic tool requiring human reader interpretation. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable, as the device is not an algorithm or AI system. It is a physical medical device.
7. The Type of Ground Truth Used
For the nonclinical tests (cleaning, disinfection, cycle, pull), the "ground truth" was established by compliance with regulatory standards and pre-established specifications for those specific engineering and microbiological tests. For example, for cleaning and disinfection, it would be the absence of detectable bioburden or remaining residues, meeting the criteria outlined in AAMI TIR standards. For cycle and pull testing, it would be the structural integrity and continued function after a specified number of cycles or under a specified load.
For the substantial equivalence claim, the overarching "ground truth" is that the modified multi-use device performs equivalently to the predicate single-use device without raising new safety or effectiveness concerns, justified by the nonclinical testing results.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
N/A