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The Shine Overseas Marketing Limited Weight & Body Fat Monitoring Scale, Model BS0105 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass and bones mass using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults (from ages 18-80) who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.

The patient steps on the scale device, where two electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Shine Overseas Marketing Limited Weight and Body Fat Scale calculates the body fat percentage. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance. height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.

{
  "acceptance_criteria_and_performance_table": null,
  "study_details": {
    "sample_size_test_set": null,
    "data_provenance": null,
    "number_of_experts_ground_truth": null,
    "qualifications_of_experts": null,
    "adjudication_method": null,
    "mrmc_comparative_effectiveness_study": {
      "performed": false
    },
    "standalone_performance_study": {
      "performed": true,
      "details": "Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory."
    },
    "type_of_ground_truth": null,
    "sample_size_training_set": null,
    "ground_truth_establishment_training_set": null
  },
  "additional_information_from_document": "The document states that 'Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory.' However, it does not provide specific acceptance criteria values or detailed performance metrics from this clinical testing. It also doesn't specify the details of the clinical study such as sample size, ground truth, or expert involvement for the test data used to validate the device."
}

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