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Indicated use- Measure of individual temperature
Measurements- Oral, Axillary -under arm, Rectal
Range of measurement- 90.0 degrees - 109.9 degrees F (32.0 degrees - 43 degrees C)
Accuracy- +/-0.2 degrees F
Targeted population- Individuals requiring temperature measurements
Environment of use- Hospital and home
Disposable / reusable- Reusable, clean with alcohol

The intended product is an electronic digital thermometer for measuring patient temperature.

{
  "acceptance_criteria_and_study": {
    "acceptance_criteria_table": {
      "headers": [
        "Parameter",
        "Acceptance Criteria",
        "Reported Device Performance"
      ],
      "rows": [
        [
          "Temperature range",
          "Not explicitly stated as an acceptance criterion for the subject device but compared to predicate device's 89.6-109.4° F",
          "90.0-109.9° F"
        ],
        [
          "Ambient temperature",
          "Not explicitly stated as an acceptance criterion for the subject device but compared to predicate device's 60.8-104° F",
          "60.8-104° F"
        ],
        [
          "Response time",
          "Not explicitly stated as an acceptance criterion for the subject device but compared to predicate device's ~1 minute",
          "About 20 seconds"
        ],
        [
          "Accuracy and Performance",
          "Meets ASTM E1112",
          "Meets ASTM E1112"
        ],
        [
          "Accuracy (for indications for use)",
          "+/- 0.2° F",
          "+/- 0.2° F (stated in Indications for Use, implies conformance)"
        ],
        [
          "Material safety",
          "Non-toxic and in compliance with EN ISO 10993",
          "All materials used are non-toxic and in compliance with EN ISO 10993"
        ]
      ]
    },
    "study_details": {
      "sample_size_test_set": "Not specified. The document states \"Performance testing,\" and notes that the device \"meets ASTM E1112,\" but does not detail the sample size for this testing.",
      "data_provenance": "Not specified. The testing was conducted to meet ASTM E1112 standards.",
      "number_of_experts_ground_truth": "Not applicable. The ground truth for performance and accuracy is based on compliance with a recognized standard (ASTM E1112) rather than expert interpretation of data.",
      "qualifications_experts": "Not applicable.",
      "adjudication_method": "Not applicable.",
      "mrmc_comparative_effectiveness_study": "No. This is a digital thermometer, not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.",
      "standalone_performance_study": "Yes, a standalone performance study was conducted to demonstrate compliance with ASTM E1112. The data provenance and sample size are not explicitly detailed beyond the standard reference.",
      "type_of_ground_truth": "Standard compliance (ASTM E1112) for accuracy and performance, and safety standard compliance (EN ISO 10993) for materials.",
      "sample_size_training_set": "Not applicable. This is a physical device, not an AI algorithm requiring a training set.",
      "ground_truth_training_set_established": "Not applicable."
    }
  }
}

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