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The Respire Pink Series - Herbst - EF is indicated to treat mild to moderate OSA.

The Respire Pink Series - Herbst - EF (Endurance Frameworks) - is available with a hard device fitting surface. The hard surface consists of Acrylic (side plates) and chrome - Wironit material ( upper / Palatal and lower / Lingual plates). Refer to Figure 1 Representative Drawing. The device is retained with ball and clasps which allows the device to be tightened if it becomes loose. The device is a mandibular advancement splint that holds the jaw in a forward position to help keep the tongue and supporting tissues in a position to help maintain an open airway, which helps in the treatment of snoring and mild to moderate obstructive sleep apnea. The Herbst hardware on the side of the device allows the patient to move forward and left and right, but not backwards. These movements give the patient some freedom to move which is important for their comfort and overall success of the device. The upper and lower components are connected by an adjustable hinge, thus patient can open and close while wearing the appliances.

{
  "acceptance_criteria_and_study": {
    "acceptance_criteria_table": [
      {
        "criterion": "Biocompatibility and cytotoxicity",
        "reported_performance": "Demonstrated via biocompatibility and cytotoxicity testing for Wironit material."
      },
      {
        "criterion": "Material integrity (specimen elongation and load bearing force to break)",
        "reported_performance": "Points of failure were identified at the same location for both Wironit/Acrylic and Acrylic-only (predicate) devices. The amount of energy to cause failure was less for Wironit/Acrylic but still far exceeded the amount of energy required by an oral cavity to create such a failure (average of 275.6 lbf)."
      }
    ],
    "sample_size_test_set": "Five (5) sample devices for material integrity testing.",
    "data_provenance": "Not specified (implied in-house testing by the submitter or a contracted lab).",
    "number_of_experts_ground_truth": "Not applicable, as the evaluation involves material testing rather than expert-derived ground truth for clinical outcomes.",
    "qualifications_experts": "Not applicable.",
    "adjudication_method": "Not applicable.",
    "mrmc_comparative_effectiveness_study": false,
    "standalone_performance_study": true,
    "type_of_ground_truth": "Laboratory testing data (biocompatibility, cytotoxicity, material integrity).",
    "sample_size_training_set": "Not applicable, as this is a device modification evaluation with laboratory testing, not an AI/algorithm study requiring a training set.",
    "ground_truth_training_set_establishment": "Not applicable."
  }
}

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