(202 days)
The Synapse Transcutaneous Electrical Stimulation Device is intended for use for the symptomatic relief and managemt of chronic intractable pain. The Synapse Transcutaneous Electrical Stimulation Device may be used during sleep.
The function of the Synapse Transcutaneous Electrical Stimulation Device is to apply a series of pre-programmed micro-currents of varying frequency, amplitude and duration to the patient via electrode pads. A micro-controller is used to set the current demands to a linear current controller implemented solely in hardware.
The Synapse Transcutaneous Electrical Stimulation Device is oval shaped and measures approximately 7 cm wide by 4 cm high by 2 cm deep. It is activated by pressing the On/Off button. There is single set program which runs in specific sequence for 48 hours after which time the unit will turn itself off and should be replaced with another unit until the end of the prescribed course of treatment. The devices are packaged in quantities of 6 so that the total treatment duration is 12 days.
The Synapse Transcutaneous Electrical Stimulation Device has an LED light which indicates operational status: unit off, treatment active, treatment dormant (waiting for next active session), or current too low (e.g., interruption during treatment due to poor skin contact of the electrodes)
Only Covidien's Uni-Patch electrode series are recommended for use with the Synapse Transcutaneous Electrical Nerve Stimulator. These electrodes are cleared for marketing by the FDA and are provided with stimulating electrode hydrogel (K915333); Synapse Order Code EP84910)
This document is a 510(k) premarket notification for the Synapse Transcutaneous Electrical Stimulation Device. It focuses on demonstrating substantial equivalence to a predicate device, not on clinical performance or acceptance criteria in the context of diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth is not applicable.
Here's a breakdown of what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria for clinical performance in terms of diagnostic accuracy metrics. Instead, "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device and compliance with electrical safety and electromagnetic compatibility standards.
| Acceptance Criteria (Implied by Equivalence & Standards) | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1) | Conforms with IEC 60601-1 Medical electrical equipment - part 1: General requirements for basic safety and essential performance 2005 (3rd edition) plus Amendments 1:2006 and 2:2007. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Conforms with IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (edition 2007). |
| Functional Equivalence to Predicate | "The Synapse Transcutaneous Electrical Stimulation Device has similar characteristics to the predicate device." Differences (non-reusable vs. rechargeable, minor size/weight/material differences) "do not raise any new types of safety or effectiveness questions." |
| Indicated Use Equivalence | Shares the same indications for use as the predicate: "symptomatic relief and management of chronic intractable pain. The Synapse Transcutaneous Electrical Nerve Stimulator may be used during sleep." |
2. Sample size used for the test set and the data provenance
- Not applicable. This submission focuses on non-clinical testing (electrical safety, EMC) and demonstrating hardware/software equivalence to a predicate device for safety and effectiveness, rather than a clinical performance study with a "test set" and "data provenance" in the context of diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. See point 2.
4. Adjudication method for the test set
- Not applicable. See point 2.
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 Transcutaneous Electrical Nerve Stimulator, not a diagnostic AI tool, and therefore MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device for electrical stimulation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical testing, the "ground truth" would be established by the standards themselves (e.g., IEC 60601-1 specifies acceptable leakage current limits, EMC standards specify acceptable emissions and immunity levels). The device's performance is measured against these established standard limits.
8. The sample size for the training set
- Not applicable. This submission is for a physical medical device, not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).