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K Number
DEN220059
Device Name
NTX100 Tonic Motor Activation (NTX100 ToMAc) System
Manufacturer
Noctrix Health, Inc.
Date Cleared
2023-04-17

(208 days)

Product Code
QWD,OWD
Regulation Number
882.5887
Type
Direct
Panel
NE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The NTX100 Tonic Motor Activation (ToMAc) System® is intended to reduce symptoms of primary moderate-severe Restless Legs Syndrome (RLS) and to improve sleep quality in adults refractory to medications.

Device Description

The NTX100 Tonic Motor Activation (ToMAc) System® is a non-surgical, non-implantable prescription device intended for the application of low-amplitude electrical stimulation to the common peroneal nerve at lateral side of the knees to reduce symptoms of moderate-severe Restless Legs Syndrome (RLS). Patients will be instructed to use the NTX100 ToMAc System® as needed for symptom relief for up to 120 minutes per 24-hour period.

The primary components of the NTX100 ToMAc System® include:

  • . Therapy Unit
  • Charge Dispersing Interface (CDI) .
  • . Charging accessories
  • Clinician App (for clinician use only) .
  • . Clinician Computer (for clinician use only)
AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Primary Effectiveness)Reported Device Performance (NTX100 ToMAc System®)
Primary Outcome: Responder rate on the CGI-I (Clinical Global Impressions-Improvement) scale at Week 4 of Phase 1 relative to Baseline and compared between the study arms, defined as the proportion of responses of "Much Improved" or "Very Much Improved." (Null Hypothesis: RRT RRs, where RRT and RRs are true responder rates for treatment and sham groups respectively, tested at alpha = 0.025 level).The NTX100 Cohort had a CGI-I Responder Rate at 4 weeks that was significantly greater than that of the Sham cohort (44.6% vs. 16.2%, p = 0.0002; 95% CI: [32.5, 56.8] vs. [7.1, 25.2]). This statistically significant result indicates the device met its primary effectiveness outcome.

Key Secondary Effectiveness Measures (all tested as statistically significant):

Acceptance Criteria (Secondary Effectiveness)Reported Device Performance (NTX100 ToMAc System®)
1. PGI-I (Patient Global Impressions-Improvement) responder rate (defined as for CGI-I) at Week 4 relative to Baseline and compared between study arms.NTX100: 50.8% (n=33) PGI-I Responders; Sham: 19.0% (n=12) PGI-I Responders; **p

N/A