(39 days)
The TERUMO digital blood pressure monitor ES-H55A is a non-invasive device to measure blood pressure at upper arm for pediatric(age 3 and above ) except for neonate and infant, and adult, using an appropriate sized cuff. It measures systolic and diastolic blood pressures and pulse rate using oscillometric method, also it serves as a manual sphygmomanometer using a stethoscope. It is intended for professional use.
The Terumo Digital Blood Pressure Monitor ES-H55A is a non-invasive device to measure patient's blood pressure by electrically detecting and amplifying the pulse wave and pressure signal obtained from the inside of the cuff. As an automated Blood Pressure Monitor, it measures the systolic and diastolic blood pressure and pulse rate using Oscillometric method. Also as a manual sphygmomanometer (pressure gauge), it displays the pressure values.
This document pertains to the Terumo Digital Blood Pressure Monitor ES-H55A (K071075) and its conformity to the ANSI/AAMI Standard SP10-2002 for Electronic or Automated Sphygmomanometers.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood pressure monitors are defined by the ANSI/AAMI SP10-2002 standard. This standard sets limits for the difference between the device's readings and a reference measurement (auscultation).
| Acceptance Criteria (ANSI/AAMI SP10-2002) | Reported Device Performance | Comments |
|---|---|---|
| Mean difference (± SD) between device and reference measurement: | Not explicitly provided in the document. | The document states that the device was evaluated "in accordance with ANSI/AAMI Standard SP10:2002," implying compliance. However, specific values for mean difference and standard deviation are not detailed in this summary. |
| - Mean difference ≤ ±5 mmHg | ||
| - Standard deviation (SD) ≤ 8 mmHg |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the exact sample size for the clinical evaluation. However, it indicates that the study included "pediatric patients" in addition to adults. The ANSI/AAMI SP10 standard typically requires a minimum of 85 subjects for accuracy validation. Given the inclusion of pediatric patients, the sample would likely be structured to represent both age groups adequately.
- Data Provenance: The study was a "clinical evaluation" conducted to comply with the ANSI/AAMI SP10:2002 standard. The document does not specify the country of origin for the data or whether it was retrospective or prospective. Clinical evaluations for medical devices are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide details on the number or qualifications of experts used to establish the ground truth. For clinical accuracy studies of blood pressure monitors following ANSI/AAMI SP10, the ground truth (reference measurements) is typically established by trained observers (technicians or clinical personnel) using auscultation with a mercury sphygmomanometer or validated equivalent. These observers are trained to recognize Korotkoff sounds accurately.
4. Adjudication Method for the Test Set
The document does not explicitly mention an adjudication method. In clinical accuracy studies for blood pressure monitors, if multiple observers are used for reference measurements, their readings might be averaged, or discrepancies might be resolved through a pre-defined protocol. However, these specific details are not provided in this summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. An MRMC study is typically used to assess the effectiveness of an AI-powered diagnostic tool by comparing the performance of multiple human readers with and without AI assistance. This device is a standalone blood pressure monitor, not an AI diagnostic tool designed to assist human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The clinical evaluation "in accordance with ANSI/AAMI Standard SP10:2002" assesses the device's accuracy (algorithm only, as it's an automated device) against a reference measurement (human-read auscultation). The device operates independently to measure blood pressure without human interpretation of its internal signals.
7. Type of Ground Truth Used
The ground truth used for calibration and validation of automated blood pressure monitors, as per ANSI/AAMI SP10, is expert auscultation (manual blood pressure measurement using a stethoscope and sphygmomanometer). This is considered the clinical gold standard for non-invasive blood pressure measurement.
8. Sample Size for the Training Set
The document does not provide the sample size for a training set. This is because the device, while automated, is likely based on established oscillometric principles and calibrated using standard methods rather than a deep learning approach that requires a distinct "training set" in the AI sense. The clinical evaluation mentioned serves as a validation set.
9. How the Ground Truth for the Training Set Was Established
Since the device does not employ a deep learning or similar AI algorithm that typically requires a training set, the concept of establishing ground truth for a training set in this context is not directly applicable. The device's underlying oscillometric algorithm would have been developed and refined using physiological principles and potentially smaller, internal datasets for initial calibration, with the clinical evaluation serving as the primary validation against a recognized standard (expert auscultation).
§ 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).