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The Tulip condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip, nominal length 180mm, nominal width 52mm, and nominal thickness 0.05mm. It is lubricated with silicon, with cornstarch as a dressing material. The condom is offered in natural latex color and is designed to conform to established American and international voluntary standards including ASTM D3492-02 and ISO 4074-1-1996

{
  "acceptance_criteria_and_study_description": {
    "acceptance_criteria_table": [
      {
        "Feature": "Length (mm)",
        "Acceptance Criteria": null,
        "Reported Device Performance": "180"
      },
      {
        "Feature": "Width (mm)",
        "Acceptance Criteria": null,
        "Reported Device Performance": "52"
      },
      {
        "Feature": "Thickness (mm)",
        "Acceptance Criteria": null,
        "Reported Device Performance": "0.05"
      },
      {
        "Feature": "Air Burst Pressure(kPa)",
        "Acceptance Criteria": null,
        "Reported Device Performance": "2.3"
      },
      {
        "Feature": "Air Burst Volume (dm³)",
        "Acceptance Criteria": null,
        "Reported Device Performance": "38.5"
      },
      {
        "Feature": "Lubricant System",
        "Acceptance Criteria": null,
        "Reported Device Performance": "Silicone"
      },
      {
        "Feature": "Reservoir Tip",
        "Acceptance Criteria": null,
        "Reported Device Performance": "Yes"
      }
    ],
    "study_details": {
      "sample_size_test_set": "Not explicitly stated for a distinct test set. The document implies comparison to a predicate device's characteristics rather than a separate test of the 'Tulip Condom' against specific acceptance criteria with a defined sample size.",
      "data_provenance": "Not explicitly stated as a separate study with specific data provenance. The document compares the 'Tulip Condom' characteristics with those of a predicate device, which would imply the characteristics of the Tulip Condom were measured/derived, likely from manufacturing or internal testing. The manufacturer is Shanghai Latex Factory, China.",
      "number_of_experts_ground_truth_test_set": "Not applicable, as this is a comparison of physical device characteristics, not an expert-driven ground truth assessment.",
      "qualifications_experts_ground_truth_test_set": "Not applicable.",
      "adjudication_method_test_set": "Not applicable, as this is a comparison of physical device characteristics, not an expert-driven ground truth assessment.",
      "multireader_multicase_comparative_effectiveness_study": "No, this is not a multi-reader multi-case comparative effectiveness study. It's a comparison of technological characteristics for a medical device.",
      "effect_size_human_readers_ai_without_ai": "Not applicable.",
      "standalone_algorithm_only_performance": "Not applicable, as this device is a physical product (condom), not an algorithm or AI.",
      "type_of_ground_truth_used": "Device specifications/measurements, compared against a predicate device's specifications and established standards (ASTM D3492 and ISO 4074-1).",
      "sample_size_training_set": "Not applicable. This is not an AI/algorithm-based device requiring a training set.",
      "how_ground_truth_training_set_established": "Not applicable."
    },
    "acceptance_criteria_description": "The device (Tulip Condom) is presented as having the same technological characteristics as its predicate device (Latex Condom 510(k) #[K994118](https://510k.innolitics.com/search/K994118)). The acceptance criteria are implicitly met if the Tulip Condom's characteristics (Length, Width, Thickness, Air Burst Pressure, Air Burst Volume, Lubricant System, Reservoir Tip) are equivalent or within acceptable ranges of the predicate device's characteristics and conform to established American and international voluntary standards (ASTM D3492-02 and ISO 4074-1-1996)."
  }
}

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