(113 days)
The Welch Allyn Non-Invasive Blood Pressure device is intended to be used by clinicians and medically qualified personnel for the acquisition and attended monitoring of noninvasive blood pressure and pulse rate of neonatal through adult patients. The Welch Allyn Non-Invasive Blood Pressure device may be used for treatment and diagnostic spot NIBP measurements or attended NIBP monitoring in hospital general wards, clinics, and doctor's offices.
The Welch Allyn NIBP device consists of 1) a software program running on a laptop computer; 2) an NIBP module which measures and reports the patient's blood pressure and pulse rate readings. The device is intended to operate with a series of standard blood pressure cuffs and blood pressure tubing. The Welch Allyn NIBP device is designed to non-invasively measure systolic and diastolic blood pressure and pulse rate for adult, pediatric and neonatal patients using the oscillometric method. The Welch Allyn NIBP device will also calculate Mean Arterial Pressure (MAP). All blood pressure and pulse values are displayed on the large, easy-to-read LCD display of the laptop computer. The Welch Allyn NIBP device is intended for use in a wide variety of health care settings. This includes hospital departments; alternate care settings, such as physician offices, freestanding ambulatory care and surgery centers, health clinics and nursing homes.
The provided text describes the Welch Allyn Non-invasive Blood Pressure (NIBP) Device. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for performance metrics like accuracy for systolic, diastolic, or mean arterial pressure, or pulse rate. Instead, it refers to compliance with the ANSI/AAMI SP10: 2002 (R2008) standard for Manual, electronic or automated sphygmomanometers + Amendment 1 & 2 standards. This standard itself defines performance requirements for NIBP devices.
Therefore, the "acceptance criteria" are the performance requirements outlined in the ANSI/AAMI SP10 standard. The device "meets" these criteria by demonstrating compliance through its clinical performance data.
| Performance Metric | Acceptance Criteria (per ANSI/AAMI SP10: 2002) | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy | (Specific criteria for mean difference and standard deviation, as defined by ANSI/AAMI SP10 for systolic, diastolic, and MAP) | "Clinical safety and performance requirements were met based on the ANSI/AAMI SP10: 2002 (R2008) standard" |
| Pulse Rate Accuracy | (Specific criteria for heart rate accuracy, as defined by ANSI/AAMI SP10) | "Clinical safety and performance requirements were met based on the ANSI/AAMI SP10: 2002 (R2008) standard" |
Note: To get the exact numerical acceptance criteria, one would need to consult the ANSI/AAMI SP10: 2002 (R2008) standard directly, as the provided 510(k) summary only states compliance with it.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that clinical performance data was collected to meet the ANSI/AAMI SP10 standard. Typically, NIBP accuracy studies compliant with ANSI/AAMI SP10 involve a specific number of subjects across different blood pressure ranges and patient populations (adult, pediatric, neonatal).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. For NIBP studies, ground truth is typically established by trained observers using a reference method (e.g., auscultation with a mercury sphygmomanometer or direct arterial line measurement), but the document does not elaborate on this.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or is not mentioned. This type of study is more common for imaging devices where human readers interpret medical images. For NIBP devices, the focus is on the accuracy of the device's measurements compared to a reference method, not on human interpretation of data generated by the device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The clinical performance data described for the Welch Allyn NIBP device appears to be for its standalone performance (algorithm only), as it focuses on the device's ability to measure and report blood pressure and pulse rate accurately according to a recognized standard. The intended use indicates clinicians use the device, but the performance evaluation is centered on the device's measurements themselves, not on how humans interpret those measurements in an assisted workflow.
7. The Type of Ground Truth Used
Based on the reference to ANSI/AAMI SP10, the ground truth for an NIBP device study typically involves:
- Simultaneous comparison with a reference method: This usually means either:
- Auscultation by trained observers using a mercury sphygmomanometer (or an equivalent validated method), with specific protocols to minimize observer bias.
- Direct intra-arterial blood pressure measurement for studies involving more critical accuracies or specific patient populations.
The document does not explicitly state which specific ground truth method was used, but given the compliance with ANSI/AAMI SP10, it would be one of these validated reference methods.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size for a training set. The device utilizes an "Oscillometric BP Algorithm that is equivalent to the BP Algorithm in the Spot Ultra Vital Signs and Welch Allyn VSM 53000." This suggests the algorithm may have been trained or developed in previous iterations or products, but details of that training are not included in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
As no information about a training set or its sample size is provided, how the ground truth for the training set was established is not detailed in this document.
§ 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).