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The ARCEX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

The ARCES System is a medical device that delivers transcutaneous programmed. Carrier Frequency-enabled electrical spinal cord stimulation (ARCEN Therapy). The System is intended to be used in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals with cervical spinal cord injury (SCI). The stimulation is intended to be delivered transcutaneously and the active electrodes are intended to be placed in direct contact with intact skin, in appropriate locations along or near the spine to elicit desired outcomes. The ARCES System is intended to be used in a medical center setting by patients and their rehabilitation professionals. The primary components of the ARCEX System are: ARCEX Stimulator, ARCEX Stimulator Charger, ARCEX Splitter Box, ARCEX Extension Cables, ARCEX Programmer, Programmer Charger, and ARCEX Case. The ARCES System is intended to be used with the FDA-cleared Axelgaard PALS electrodes (K132422).

Here's a summary of the acceptance criteria and the study that proves the ARCEX System meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance for ARCEX System

The acceptance criteria for the ARCEX System are primarily derived from the special controls outlined by the FDA and the demonstrated clinical benefits. The clinical study aimed to demonstrate improvements in hand sensation and strength.

1. Table of Acceptance Criteria and Reported Device Performance

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The CP Relief Wand® CP-1000 is a TENS Device and is intended for use as an adjunctive therapy for pain management for medical purposes such as symptomatic relief of chronic intractable pain and relief of acute post-surgical and post-traumatic pain.

The CP Relief Wand® Model CP-1000 is a portable hand held TENS device with self-contained electrodes. The device is powered by a standard 9 volt alkaline battery. In operation, the electrode end of the CP-1000 is covered by a gel pad and positioned to touch the skin over the pain center. The electrical pulses travel from one electrode, through the skin, through the underlying nerve tissue, and back through the skin to the other electrode to desensitize the underlying nerves within the current path. Convenient controls on the unit are provided for power, intensity, pulse width, and pulse polarity. The materials comprising the gel pad and CP1000 electrodes are comparable to the materials comprising Axelgaard's PALS® Neurostimulation Electrodes cleared per K132422.

The provided 510(k) summary for the CP Relief Wand® Model CP-1000 describes performance testing for functional and design verification and validation, as well as side-by-side comparison with a predicate device. However, it does not present a typical clinical study with specific acceptance criteria that would include metrics often seen in AI/diagnostic device submissions, such as sensitivity, specificity, or AUC.

Instead, the submission focuses on demonstrating substantial equivalence through adherence to recognized consensus standards related to electrical safety and electromagnetic compatibility for medical devices, as well as by comparing waveforms to a predicate device.

Here's an breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a "test set" in the context of a clinical study involving patients or pathological samples. The testing described focuses on engineering and electrical performance. Therefore, typical sample size and data provenance information for a clinical test set are not applicable here. The testing appears to have been conducted on the device itself and possibly in a lab setting.

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

This information is not applicable. The device is a Transcutaneous Electrical Nerve Stimulator (TENS), and its substantial equivalence is primarily demonstrated through engineering standards compliance and performance characteristics, not through interpretation of diagnostic images or physiological signals that would require expert adjudication.

4. Adjudication Method for the Test Set

This information is not applicable, as there was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission is for a TENS device and relies on engineering standards and comparison to predicate devices, not on human interpretation or diagnostic accuracy where an MRMC study would be relevant. There is no mention of AI assistance in the context of improving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the device described. The CP Relief Wand® Model CP-1000 is a physical TENS device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness relies on:

• Compliance with recognized consensus standards: IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10.
• Comparison to predicate devices: Demonstration that its technological characteristics (including waveforms and materials) are substantially equivalent to the TENS 3000 Stimulator (K102014) and InterX5000 (K042912), and that any differences do not impact safety or effectiveness.

8. The Sample Size for the Training Set

This information is not applicable because the submission does not describe an AI or machine learning model that requires a training set.

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

This information is not applicable, as there was no training set.

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