(120 days)
The HEM-9000AI-X is intended to measure systolic and diastolic blood pressure and pulse rate in adults with an arm circumference of 17 - 50 cm (7-20 inches), and to calculate a radial augmentation index (AI) and central (aortic) blood pressure which is used on adult patients only.
The HEM-9000AI-X is intended for use in physicians' offices, hospitals, clinics and other medical facilities where non-invasive blood pressure and radial AI measurements/calculations are performed on patients and invasive measurement is contraindicated.
The Augmentation Index (AI) function of the HEM-9000AI-X has not been evaluated on patients who have intra-ventricular conduction delays (VCD).
The modified HEM-9000AI-X is an oscillometric NIBP mcasurcment device and tonometer Augmentation Index detection device. The HEM-9000AI utilizes both an oscillometric blood pressure detection technology via a cuff wrap at the upper arm as well as a tonomcter measurement technology using the radial artery at wrist. The HEM-9000AI-X detects Korotkov (K) sounds for NIBP mcasurement via oscillometric signal detection and processes the data through its CPU and algorithm within the device. It provides measurements of systolic, diastolic and pulse pressures, as well as pulse rate for adult patients with an upper arm circumference in the range of 7 - 20 inches (17 - 50 cm). AI information is collected via tonometry by the placement of a set of sensors over the radial artery at the wrist. The tonometer applies pressure and compresses the radial artery until sensors detect the pulse wave (PW). The signal is sent back to the central processor which separates the superimposed waveform into the ejected wave and the reflected wave components. The device is self-contained, single unit with both oscillometric and tonometer signal detection built in.
The modification is the addition of a new measured (calculated) parameter referred to as central svstolic blood pressure (cSBP) or central blood pressure (cSBP). This new reported measurement is calculated with the late systolic pressure of reflected waves recorded by the applanation tonometry applied to the radial artery.
The provided text describes the device HEM-9000AI-X, its intended use, and its substantial equivalence to predicate devices, focusing on the addition of central systolic blood pressure (cSBP) measurement. However, it does not include any specific acceptance criteria for performance, nor does it detail any study designed to prove the device meets such criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or details about training sets, as this information is not present in the provided document.
The document is a "Non-Confidential Summary of Safety and Effectiveness" for a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on presenting detailed performance study results against specific acceptance criteria.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).