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510(k) Data Aggregation

    K Number
    DEN220059

    Validate with FDA (Live)

    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
    Neurology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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, Alternative 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 < 0.0001.
    2. Mean reduction in IRLS (International Restless Legs Syndrome Study Group Rating Scale) score at Week 4 relative to Baseline and compared between study arms.NTX100: Mean reduction of 7.2 (SD 6.16, n=65); Sham: Mean reduction of 3.8 (SD 5.91, n=63); p = 0.0009.
    3. Mean reduction in MOS-II (Medical Outcomes Study Sleep Problems Index II) score at Week 4 relative to Baseline and compared between study arms.NTX100: Mean reduction of 13.7 (SD 14.94, n=65); Sham: Mean reduction of 4.0 (SD 14.75, n=63); p = 0.0002.
    4. Mean reduction in MOS-I (Medical Outcomes Study Sleep Problems Index I) score at Week 4 relative to Baseline and compared between study arms.NTX100: Mean reduction of 11.8 (SD 14.71, n=65); Sham: Mean reduction of 2.8 (SD 14.94, n=63); p = 0.0004.
    5. Mean CGI-I score at Week 4 relative to Baseline and compared between study arms.NTX100: Mean score of 2.6 (SD 1.05, n=65); Sham: Mean score of 3.5 (SD 0.86, n=63); p < 0.0001.
    6. Reduction in IRLS Question #7 score ("How often do you get RLS symptoms?") from Baseline to Week 8 (for subjects assigned to NTX100 in both Phases 1 and 2).NTX100: Mean reduction of 0.9 (SD 1.07, n=64); p < 0.0001. (Note: Sham comparison not applicable for Week 8 endpoint directly reported in this table, as this was specifically for NTX100 assigned subjects across both phases.) However, the statistically significant improvement in the NTX100 group from Baseline to Week 8 further supports the device's sustained benefit.

    Study Details

    1. Sample sizes used for the test set and the data provenance:

      • Test Set Sample Size: 133 participants (68 in NTX100 group, 65 in Sham group)
      • Data Provenance: The study was a multi-center, prospective, randomized, sham-controlled, double-blinded clinical trial. The text does not specify the country of origin of the data, but multi-center typically implies multiple locations within a country or region.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • The primary effectiveness outcome (CGI-I) and several secondary outcomes (e.g., PGI-I, IRLS, MOS-I, MOS-II) were based on patient-reported outcomes and clinician assessments (CGI-I).
      • The "experts" establishing the ground truth for the CGI-I were implicitly the investigators/clinicians at each study center who rated the patients' global improvement. The document does not specify the number of these clinicians beyond them being present at "multi-center" sites, nor their specific years of experience or precise qualifications beyond being "investigators" who made medical diagnoses and assessments of RLS.

    3. Adjudication method for the test set:

      • The document does not explicitly describe an adjudication method for the CGI-I or other outcomes, such as 2+1 or 3+1 consensus. The CGI-I was a direct assessment by the clinicians. It's typical for such studies that the assessing clinician's rating is considered the "ground truth" for that specific outcome measure.

    4. 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:

      • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is a clinical trial evaluating the effectiveness of a neuromodulation device (NTX100 ToMAc System®) for Restless Legs Syndrome, not an AI or imaging diagnostic or assistive device where human reader performance is typically assessed. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

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

      • No, a standalone (algorithm only) performance study was not done. The NTX100 ToMAc System® is a physical neuromodulation device used by patients, not an algorithm, and its effectiveness was assessed through patient use and clinician evaluation.

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

      • The "ground truth" for the primary and secondary effectiveness endpoints was primarily clinician assessments (CGI-I) and patient-reported outcomes (PROs), including PGI-I, IRLS scores, and MOS Sleep Problem Index scores. These are forms of outcomes data reflecting the direct experience and clinical evaluation of the condition.

    7. The sample size for the training set:

      • This was a clinical trial to evaluate the effectiveness of a medical device, not a machine learning model. Therefore, there was no separate "training set" in the context of algorithm development. The entire cohort of 133 study participants (68 active, 65 sham) serves as the dataset on which the device's performance was evaluated.

    8. How the ground truth for the training set was established:

      • As there was no "training set" in the machine learning sense, this question is not applicable. The device's "training" related to its design and pre-clinical verification/validation, rather than a data-driven model training process.
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