(30 days)
The Steorra™ by SORBA is a noninvasive hemodynamic monitor based on the technology of impedance cardiography. The Steorra™ measures the following cardiac parameters: heart rate (HR); stroke volume (SV) and Cardiac Output (CO) The Steorra™ can be configured with optional noninvasive blood pressure (NIBP) technology. When blood pressure data are available (via the NIBP, analog input from an invasive monitor, or manual input), then systolic, diastolic and mean blood pressures are displayed with rate pressure product (RPP). If central venous pressure (CVP) is input as an analog signal from an invasive monitor, then CVP is displayed and systemic vascular resistance (SVR) is calculated and displayed.
SORBA Steorra Non-Invasive Impedance Cardiograph
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "SORBA Steorra Non-Invasive Impedance Cardiograph." This document does not contain the detailed technical specifications, acceptance criteria, or study results that would allow me to answer your request.
The letter explicitly states that it is a "premarket notification of intent to market the device" and that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. It does not elaborate on how that substantial equivalence was demonstrated in terms of specific performance metrics or clinical study data.
To answer your questions about acceptance criteria and study details, I would need a different type of document, such as:
- A Summary of Safety and Effectiveness (SSE) document: These are often publicly available for 510(k) clearances and contain the technical details, testing, and clinical data used to support the substantial equivalence claim.
- The original 510(k) submission: This would contain all the detailed information requested.
- A scientific publication or clinical trial report: If such a study was conducted and published separately.
Since this information is not present in the provided text, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Training set sample size.
- How training set ground truth was established.
§ 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.