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510(k) Data Aggregation
(131 days)
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).
| Acceptance Criteria (Implied) | Reported Device Performance (DPE-T300) |
|---|---|
| Safety and Essential Performance (Non-Clinical) | |
| Compliance with IEC 60601-1-11 (Home Healthcare Environment) | Compliant. Synapse performed safety testing in accordance with IEC 60601-1-11, Edition 2.0, 2015-01, demonstrating basic safety and essential performance for lay or trained healthcare personnel in the home healthcare environment. |
| Ingress Protection (IP) Rating appropriate for home use | IP24. Tested in accordance with IEC 60529, Edition 2.2, 2013-08. This rating is considered appropriate for home use and does not raise different safety/effectiveness questions compared to the predicate's IP21 rating. |
| Electrical Safety (Patient Leakage Current, Output Specs) | Compliant. Matches predicate (DC ~0 µA AC<10mA for normal and single fault conditions). Output specifications (Waveform, shape, max output voltage/current, phase duration, net charge, max phase charge, max current density, max average current, max average power density, burst mode parameters, ON/OFF time) are identical to the predicate device, indicating equivalent electrical performance. |
| Biocompatibility | Compliant. Biocompatibility testing was performed per ISO 10993-1 and FDA Guidance Document, ensuring patient-contacting materials (Lustran ABS, Clariant grey, 303 Stainless Steel) are safe. |
| Compliance with other applicable standards | Compliant with IEC 60529, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304, ANSI/AAMI NS4:2013, ISO 7405, ISO 10993-1, IEC 62366-1:2015, and ISO 14971:2012. Synapse verified compliance to the most current applicable standards. |
| Usability (Human Factors) | |
| Safe and Effective Use by Representative Users (Lay Users) | Achieved. Human factors usability testing conducted per FDA Guidance and IEC 62366-1:2015 demonstrated that representative users (pediatric 10-22 yrs and adults) could use the device safely and effectively under simulated use conditions without supervision, and without producing patterns of failures that could result in negative clinical impact or harm. Task completion rates were high for critical tasks. Use errors, while observed (e.g., clearing moisture, cleaning device, confirming indicator light), were categorized as not posing undesirable or intolerable risk. The study concluded that use-related safety issues were adequately mitigated, and no new risks identified, especially with pre-screening and training by dental/orthodontic professionals. The device's benefits were found to outweigh residual risks. |
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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