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The Intranasal Tear Neurostimulator provides a temporary increase in tear production during neurostimulation in adult patients.

The Intranasal Tear Neurostimulator is a non-surgical, non-implantable device intended for the application of low level electrical stimulation to sensory neurons of the nasal cavities to acutely increase tear production in adult patients. The device consists of four distinct non-sterile subassemblies: Disposable Tips, a reusable Base, a reusable Charging Station, and a reusable Cover.

{
  "acceptance_criteria": [
    {
      "criterion": "Acute increase in tear production during neurostimulation.",
      "reported_performance": "OCUN-009: Average Schirmer score of 25.3 mm ± 10.7 during active electrostimulation, compared with 9.2 mm ± 7.3 for Sham control (p < 0.0001) and 9.5 mm ± 8.2 for extranasal control (p < 0.0001).",
      "study_met_criteria": true
    },
    {
      "criterion": "Increased tear production during neurostimulation over time (6 months).",
      "reported_performance": "OCUN-010: Statistically significant increases in stimulated tear production were seen at all study visits. Mean difference between stimulated and unstimulated tear production: Day 0: 18.0 mm; Day 7: 13.1 mm; Day 30: 8.1 mm; Day 90: 8.3 mm; Day 180: 9.4 mm. Trend of decreased effectiveness over time, but still an increase compared to baseline.",
      "study_met_criteria": true
    },
    {
      "criterion": "No significant clinical safety changes from device use.",
      "reported_performance": "OCUN-009: No device-related serious adverse events (AEs). 4 AEs reported (1 corneal abrasion not device-related, 3 non-ocular AEs related/possibly related: nasal itching, transient lightheadedness, exacerbation of hypertension). All resolved without sequelae. HR and BP slightly increased during stimulation, returned to pre-stimulation levels post-stimulation. OCUN-010: No device-related SAEs. Most frequently related AEs were nasal (e.g., pain/discomfort, nosebleed, congestion), headaches, and others (e.g., sore eye, sinus pain). All non-serious.",
      "study_met_criteria": true
    },
    {
      "criterion": "Device can be used properly by patients without harmful use-errors.",
      "reported_performance": "OCUN-012: No safety-related use-errors reported. Participants did not require assistance, encountered no safety-related close calls, or experienced safety-related difficulties. All participants used the device correctly and understood labeling, and considered it safe.",
      "study_met_criteria": true
    }
  ],
  "study_details": {
    "OCUN-009": {
      "sample_size_test_set": "48 subjects (>22 years of age)",
      "data_provenance": "United States, retrospective",
      "number_of_experts_ground_truth": "Not applicable (direct measurement of tear production)",
      "qualifications_of_experts": "Not applicable",
      "adjudication_method": "Not applicable",
      "multi_reader_multi_case_study": "No",
      "standalone_performance_done": "Yes (device performance measured directly via Schirmer test)",
      "type_of_ground_truth": "Direct physiological measurement (Schirmer test)",
      "sample_size_training_set": "Not applicable (pivotal clinical trial, not an AI model requiring a training set)",
      "ground_truth_training_set_established": "Not applicable"
    },
    "OCUN-010": {
      "sample_size_test_set": "97 subjects",
      "data_provenance": "United States, prospective",
      "number_of_experts_ground_truth": "Not applicable (direct measurement of tear production)",
      "qualifications_of_experts": "Not applicable",
      "adjudication_method": "Not applicable",
      "multi_reader_multi_case_study": "No",
      "standalone_performance_done": "Yes (device performance measured directly via Schirmer test over time)",
      "type_of_ground_truth": "Direct physiological measurement (Schirmer test)",
      "sample_size_training_set": "Not applicable (pivotal clinical trial, not an AI model requiring a training set)",
      "ground_truth_training_set_established": "Not applicable"
    },
    "OCUN-012": {
      "sample_size_test_set": "16 laypeople",
      "data_provenance": "Not specified, presumably United States, prospective (human factors study)",
      "number_of_experts_ground_truth": "Not applicable (assessment of user interactions and safety-related errors)",
      "qualifications_of_experts": "Not applicable",
      "adjudication_method": "Not applicable",
      "multi_reader_multi_case_study": "No",
      "standalone_performance_done": "Not applicable (human factors study)",
      "type_of_ground_truth": "Observation of user interactions and self-reported perceptions of safety and understanding",
      "sample_size_training_set": "Not applicable",
      "ground_truth_training_set_established": "Not applicable"
    }
  }
}

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