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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.

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.

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The Dental Pain Eraser DPE-T300 is intended to provide temporary dental anesthesia (pain relief). It is intended for prescriptive use only for the alleviation of oral pain for use by pediatric (10 years of age) and adult patients for treatment at home. Pediatric patients 10 through 12 years of age must be supervised by an adult.

The Dental Pain Eraser DPE-T300 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-T300 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 provided text describes the Synapse Dental Pain Eraser DPE-T300, a device intended for temporary dental anesthesia (pain relief) for at-home use. The document focuses on demonstrating its substantial equivalence to a predicate device (Dental Pain Eraser DPE-C300) through nonclinical and usability testing, rather than an effectiveness study proving specific acceptance criteria in terms of pain relief metrics.

Therefore, the acceptance criteria are primarily related to safety, essential performance, and usability for at-home use, ensuring it does not raise new issues of safety or effectiveness compared to the predicate.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission focused on substantial equivalence to a predicate device, the "acceptance criteria" are implied by the standards and testing performed to demonstrate that the new device (DPE-T300) is as safe and effective as the predicate (DPE-C300), particularly for a change in use environment (from professional facility to home use).

2. Sample Size Used for the Test Set and the Data Provenance

• Test Set Sample Size: Fifteen (15) Adult (18+ years of age) and fifteen (15) Pediatric patients (a mix of 8-11 years with parental supervision and 12-17 years with guardian involvement as at home). Total: 30 participants.
• Data Provenance: The document does not explicitly state the country of origin but implies the study was conducted for FDA submission, so likely within the US or a region adhering to similar regulatory standards. The study was prospective in nature, as participants actively performed tasks with the device under simulated conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The usability study did not involve establishing a diagnostic "ground truth" in the traditional sense, as it was a human factors study assessing the interaction of users with the device. Therefore, there were no experts establishing a "ground truth" for the device's diagnostic performance. Instead, the "ground truth" or reference for evaluating user performance was the expected safe and effective operation of the device and adherence to instructions. The assessment of user performance and risk was likely overseen by human factors experts or clinical professionals involved in the study design and evaluation, though their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set

Since the study was a human factors usability test, not an diagnostic efficacy study, an adjudication method for "ground truth" comparison is not directly applicable. User performance was observed and recorded based on predefined tasks and criteria for successful or erroneous completion. Task errors, close calls, or failures were identified and subsequently categorized for risk assessment.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The device is a Transcutaneous Electrical Nerve Stimulation (TENS) device for pain relief, not an AI-assisted diagnostic imaging tool, so such a study is not relevant to its function. The study was a human factors usability study, comparing user performance with the device against expected safe usage.

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

Yes, in a sense, the non-clinical bench testing (e.g., electrical safety, ingress protection, biocompatibility, compliance with standards like IEC 60601-1-11) represents a "standalone" performance evaluation of the device's physical and electrical characteristics as designed, independent of human interaction. These tests confirmed the intrinsic safety and performance attributes of the device itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the usability study, the "ground truth" was essentially the intended and safe operational procedures of the device as outlined in the Instructions for Use (IFU) and the successful completion of critical tasks by users without errors that could lead to harm. The "outcomes data" in this context refers to the observed user performance (task completion rates, types of errors, identification of use-related risks) during the simulated use conditions.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" for the usability study in the context of machine learning. The term "training set" is usually associated with AI/ML model development. In this human factors study, the participants themselves were the "test set." There might have been initial pilot testing or iterative design/testing, but a formal "training set" in the AI sense is not applicable or detailed here.

9. How the Ground Truth for the Training Set Was Established

As there was no "training set" in the context of an AI/ML model, the concept of establishing ground truth for it does not apply to this specific submission.

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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.

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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