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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 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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