(41 days)
The Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) is intended to measure the blood pressure (systolic and diastolic) and pulse rate by oscillometric method. The measurements are conducted by using an cuff which is wrapped around the upper arm. The device is designed for adult patient population.
The Quanta Blood Pressure Meter, Model no.: Cardiac Elite 1000 (or QH200) is designed to measure the systolic and diastolic blood pressure, and pulse rate (heart of an individual). The device uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by an electrical air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff. The measurement results are displayed on the LCD.
No acceptance criteria related to device performance (e.g., accuracy, precision) were explicitly stated or reported in the provided text. The document primarily focuses on regulatory approval and substantial equivalence to predicate devices based on intended use, technological characteristics, and conformance to general safety and EMC standards.
Therefore, the requested tables and specific details about a study proving the device meets acceptance criteria are not available in the given text.
Based on the provided information:
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Table of acceptance criteria and the reported device performance: Not available. The document mentions conformance to technical standards but does not provide specific performance metrics or acceptance criteria for blood pressure accuracy.
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Sample sized used for the test set and the data provenance: Not available. The document mentions "bench testing" but does not detail the sample size, specifics of the test set, or data provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set or ground truth establishment by experts for performance evaluation is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no specific test set or adjudication process is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a non-invasive blood pressure monitor, not an AI-assisted diagnostic imaging device or similar system where human reader performance would be a relevant metric.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a standalone blood pressure monitor, and its performance is inherently standalone. However, no specific performance study results are provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no specific ground truth for performance evaluation is described. For blood pressure monitors, the "ground truth" typically involves comparison against a reference standard (e.g., auscultatory method by trained observers). This information is not present.
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The sample size for the training set: Not applicable. This document does not describe the development or training of an algorithm in the context of machine learning or AI.
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How the ground truth for the training set was established: Not applicable.
§ 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).