(80 days)
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.
Not Found
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.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.