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The BioZ System was designed to monitor a patients hemodynamic parameters. These include ECG, HR, PEP, LVET, STR, SV, SI, CO, CI, SVR. SVRI, EDV, EDI, IC, ACI, LCW and TFC.

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I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called the "BioZ System." It indicates that the device has been found substantially equivalent to predicate devices, allowing it to be marketed.

The document lists:

• The device name (BioZ System, Models BZ-100, 101, 102, and BioZ Portable Model BZ-125).
• Its regulatory class (Class II).
• Its product code (74 DSB).
• Indications for Use (monitoring hemodynamic parameters such as ECG, HR, PEP, LVET, etc.).
• A list of abbreviations for the hemodynamic parameters.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training data information).

Therefore, I cannot fulfill your request based on the provided text.

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