(32 days)
The Stabil-O-Graph Blood Pressure Monitor is intended to be used by adults at home to measure blood pressure (systolic and diastolic) and pulse rate from the upper arm.
The I.E.M. Stabil-O-Graph is intended to be used by adults at home to monitor Blood Pressure (systolic and diastolic) and pulse rate from the upper arm with arm circumference ranging from 9.4 inches to 16.5 inches (24 cm to 42 cm).
The Stabil-O-Graph Blood Pressure Monitor is a fully automatic table model device that measures blood pressure in a human being by means of an inflatable cuff on the upper arm. It employs the method of the "Oscillometric Principle".
This 510(k) summary for the Stabil-O-Graph Blood Pressure Monitor (K041313) does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested format.
The document primarily focuses on establishing substantial equivalence to a predicate device (OMRON, Model HEM-711 (773AC), K021862) based on similar intended use, design, technological characteristics, materials, and components.
Here's why the requested information cannot be extracted from the provided text:
- No specific acceptance criteria are listed. The document states the device has "the same general design and performance characteristics as the predicate devices" but doesn't quantify what those performance characteristics are or what statistical thresholds constitute "acceptance."
- No study details are provided. There is no mention of a clinical trial or performance study conducted for the Stabil-O-Graph. The submission relies on the substantial equivalence to the predicate, implying that the predicate's performance data is sufficient without new testing.
Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided document.
Summary of what can be inferred from the document:
- Device Type: Noninvasive Blood Pressure Measurement System.
- Intended Use: For adults at home to measure blood pressure (systolic and diastolic) and pulse rate from the upper arm.
- Method: Oscillometric Principle.
- Comparison: Substantially equivalent to OMRON, Model HEM-711 (773AC) (K021862).
To fulfill the request, a document that describes the actual performance testing and the specific criteria used to evaluate the Stabil-O-Graph Blood Pressure Monitor would be required. This typically involves comparison to a reference standard (e.g., auscultatory measurements) and predefined accuracy standards (like those from ISO, AAMI, or BHS).
§ 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).