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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.

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.

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AMPCARE 50709 Series of cutaneous electrodes are intended to be used to apply electrical stimulation current to the patient's skin. Example electrical stimulation current applications of these electrodes are: a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief, b) Electrical muscle stimulation (EMS) for neck muscle stimulation, c) Functional electrical stimulation (FES), d) Galvanic stimulation, e) Microcurrent electrical nerve stimulation (MENS), f) Interferential (IF) stimulation, and g) Neuromuscular electrical stimulation (NMES), including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

The new AMPCARE 50709 Series Electrodes device is a family of cutaneous electrodes with various shapes and sizes, which are similar in design and construction to several predicate cutaneous electrodes. AMPCARE electrodes are non-sterile, self-adhering, and are for multiple use by a single patient, available with either pin/socket or snap connections. The new AMPCARE device is designed in accordance with the general design approach of the predicate devices referenced above. Specifically, each electrode in the AMPCARE 50709 Series is constructed with a non-conductive top layer, conductive center layer and adhesive bottom layer. The plastic liner at the bottom of the electrode is peeled away just prior to placement on the patient, consistent with the four predicate devices. The pin/socket connector version of the new device will be provided with a lead wire that is 21 CFR 898 compatible, containing a female recessed socket for electrical connection.

The provided document is a 510(k) summary for the AMPCARE 50709 Series Electrodes, which are cutaneous electrodes. This device is a Class II medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a new clinical claim or performance. Therefore, the details requested in the prompt, which are typically associated with performance studies for algorithms or diagnostic devices, are not fully applicable to this type of submission.

However, I can extract the information relevant to the non-clinical testing performed to establish substantial equivalence.

Here's a breakdown based on the provided text, addressing the prompt's points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implied to be the performance demonstrated by the predicate devices. The "reported device performance" refers to the AMPCARE electrodes' performance in comparison to these predicates during non-clinical testing to demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance:
The document does not specify the sample size for the test set (number of AMPCARE electrodes tested) or the data provenance (country of origin, retrospective/prospective). It only mentions "AMPCARE electrodes" generally.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of non-clinical, substantial equivalence testing for a cutaneous electrode. There's no "ground truth" established by experts in the context of diagnostic or algorithmic performance. The testing involved physical and electrical properties of the electrodes.

4. Adjudication method for the test set:
This information is not applicable for the same reasons as point 3.

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:
This information is not applicable. MRMC studies are relevant for diagnostic devices or AI algorithms where human interpretation is involved. This submission is for a physical electrode.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:
For non-clinical testing of electrodes, the "ground truth" is typically defined by objective physical and electrical measurements (e.g., current distribution, impedance values) that meet established engineering standards or comparisons to legally marketed predicate devices. It is not expert consensus, pathology, or outcomes data in this context.

8. The sample size for the training set:
This information is not applicable. There is no "training set" as this is not an algorithmic or AI device requiring machine learning.

9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.

Summary of Non-Clinical Testing Performed (from the document):

• Dispersion testing: Demonstrated "uniform current distribution with no evidence of 'hot spots'." This testing included predicate devices (Columbia K080386 and Uni-Patch K915333) for comparison.
• Electrical impedance testing: Performed on AMPCARE electrodes and predicate devices to demonstrate substantial equivalence and suitability for various electrical stimulation applications.
• Electrical impedance uniformity testing: Performed on AMPCARE electrodes and predicate devices to demonstrate substantial equivalence.

The conclusion of the submission is that AMPCARE considers its electrodes to be "substantially equivalent" to the predicate devices based on similarities in primary intended use, principles of operation, functional design, nonclinical test results, and established medical use. The FDA's letter concurs with this substantial equivalence determination.

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