(291 days)
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"
}
}
}
§ 886.5300 Tear electrostimulation device.
(a)
Identification. A tear electrostimulation device is a non-implantable, electrostimulation device intended to increase tear production.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(2) Patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Physician and patient labeling must include:
(i) Summaries of electrical stimulation parameters;
(ii) Instructions on how to correctly use and maintain the device;
(iii) Instructions and explanations of all user-interface components;
(iv) Information related to electromagnetic compatibility classification; and
(v) Instructions on how to clean the device.