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The ASCEND Electrode is intended for use as disposable, conductive, adhesive interface between the user's skin and a transcutaneous electrical nerve stimulator.

The ASCEND Electrode provides an electrically conductive interface between a transcutaneous electrical nerve stimulator and a user's skin. It is intended to be disposable and for single person use. It is provided non-sterile.

This document is a 510(k) Pre-Market Notification for a Class II medical device, the ASCEND Electrode. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study that establishes acceptance criteria and proves the device meets them in the way a clinical trial or performance study would for a more complex device.

Based on the provided text, the following information can be extracted, but with significant limitations due to the nature of the document being a substantial equivalence submission for an electrode:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a table of acceptance criteria for the ASCEND Electrode's performance. Instead, it states:
"Verification and performance testing demonstrated that the electrode met user needs as reflected in the functional specification." and "The ASCEND Electrode has the same technological characteristics as the predicate SENSUS Electrode that was validated with electrical and mechanical tests to show that the electrode met its target specifications over a range of operating and storage conditions."

However, no specific performance metrics or their acceptable ranges are listed. The focus is on demonstrating that it performs similarly to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "electrical and mechanical tests" and "verification and performance testing" but does not specify the sample size used for these tests. It also does not explicitly state the data provenance (country of origin, retrospective or prospective). Given that it's a 510(k) for an electrode, these tests would typically be laboratory-based rather than involving human subjects for performance evaluation in the way a clinical study would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the information provided. For an electrode, "ground truth" would typically relate to objective physical or electrical measurements, not expert interpretation of diagnostic images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically used in studies where multiple human readers interpret data, which is not the case for the described testing of an electrode's physical properties.

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 is not applicable. The device is an electrode, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This is not applicable as the device is an electrode, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing mentioned, the "ground truth" would be established through objective electrical and mechanical standards and specifications (e.g., conductivity measurements, adhesive strength tests, impedance measurements, biocompatibility standards). The document references "functional specification" directly.

8. The sample size for the training set

This is not applicable as the device is an electrode and does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

This is not applicable as there is no training set for this device.

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