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The higi Station is intended to be used by the general public to measure blood pressure, pulse, body weight, percent lean body mass, percent body fat, total body water and calculate Body Mass Index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can also choose to store or send the data to a personal physician or healthcare professional.

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I'm sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a device called "higi Station." It primarily discusses the regulatory approval, classification, and general information about the device's intended use and compliance requirements.

However, the text does not contain any information regarding:

• Acceptance criteria for device performance.
• Details of a study proving the device meets acceptance criteria.
• Sample sizes used for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC studies or effect sizes.
• Stand-alone algorithm performance.
• Type of ground truth used.
• How ground truth for training data was established.

The document states the device name and its "Indications for Use," which describe what the device is intended for (measuring blood pressure, pulse, body weight, etc.) and specifies that it is "not a diagnostic device." It confirms substantial equivalence to predicate devices, but this approval doesn't detail performance testing.

Therefore, I lack the necessary information to construct the table or answer the specific questions about device performance studies and acceptance criteria.

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The higi Station is intended to be used by the general public to measure blood pressure, pulse, body weight, and calculate Body Mass Index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can also choose to store or send the data to a personal physician or healthcare professional. The user has to be at least 13 years old.

Not Found

This document is a FDA 510(k) clearance letter for the higi Station, a device intended for general public use to measure blood pressure, pulse, body weight, and calculate Body Mass Index. It does not contain the detailed acceptance criteria or a study summary that proves the device meets specific performance criteria.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it is considered as safe and effective as a device that was on the market before the 1976 Medical Device Amendments or has been reclassified. However, the 510(k) clearance process itself often relies on submission of performance data, but the details of those studies and specific acceptance criteria are not included in this FDA clearance letter.

Therefore, I cannot provide the requested information from this document. The document only specifies the device name, K-number, regulation number, product code, and its intended use, along with general regulatory requirements.

Ask a specific question about this device