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K Number
DEN240014
Device Name
ARC-EX System
Manufacturer
Onward Medical Inc.
Date Cleared
2024-12-19

(266 days)

Product Code
SDO
Regulation Number
890.5851
Type
Direct
Panel
NE
Reference & Predicate Devices
K132422
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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).

Device Description

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).

AI/ML Overview

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

Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device Performance and Evidence
Clinical Effectiveness: Hand Sensation ImprovementDemonstrate improvement in hand sensation.ISNCSCI-UESS: Mean improvement of 2.9 (SD 4.8, 90% CI 1.8, 3.9) in the device use phase (p

N/A