(86 days)
The BCI Mini-Torr Plus monitor is a portable noninvasive blood pressure (NIBP) monitor for spot checking or monitoring of a patient's systolic, diastolic, and mean arterial (MAP) blood pressures, and pulse rate. Optional oximeter, electronic thermometer and/or integral printer are available. The device will provide fast, reliable NIBP measurements on patients ranging form neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. The oximetry option works with all BCI oximetry probes, providing SpO2 and pulse rate on all patients from neonate to adult. The electronic thermometry option requires Welch Allyn thermometry probes and probe covers, and provides oral or rectal temperature information for neonate through adult patients.
The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals for the NIBP and oximetry functions.
The BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional oximeter, electronic thermometer, and printer has been updated to include a new neonatal NIBP mode which uses the same technology as existing legally marketed devices. This device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top NIBP monitor with a desk top charger. Features include an NIBP cuff hose connection, an optional SpO2 sensor interface, an optional temperature probe interface and holder, an optional internal printer, display of patient data via an LED display (systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature), display of patient NIBP mode via an LED, system status LEDs (battery, sensor, alarm silence, alarm, and alert), and the function keypad area consisting of eleven keys (power, start, cancel, stat, up and down arrows, interval, recall, manual/auto, alarm set, and alarm silence). The monitor has a serial port that is used for data communication.
Here's an analysis of the acceptance criteria and study details for the BCI Mini-Torr Plus (model 6004) with new neonate NIBP mode, based on the provided text:
Acceptance Criteria and Device Performance
The primary acceptance criteria for the new neonatal NIBP mode are derived from the ANSI/AAMI SP10-1992 standard and its 1996 amendment. These standards mandate specific limits for the difference between the device's measurements and a reference standard (arterial line pressure transducer) in terms of mean difference and standard deviation.
| Acceptance Criteria (ANSI/AAMI SP10) | Performance Metric | Reported Device Performance (Mean Difference vs. Arterial Line) | Reported Device Performance (Standard Deviation of Difference) |
|---|---|---|---|
| Mean difference ≤ ±5 mmHg | Systolic Pressure | -0.4 mmHg | 7.6 mmHg |
| Mean difference ≤ ±5 mmHg | Diastolic Pressure | -0.2 mmHg | 5.3 mmHg |
| Mean difference ≤ ±5 mmHg | Mean Arterial Pressure (MAP) | -0.6 mmHg | 5.1 mmHg |
| Std. deviation ≤ 8 mmHg | Systolic Pressure | N/A (criteria for mean difference) | 7.6 mmHg (meets criteria of ≤ 8 mmHg) |
| Std. deviation ≤ 8 mmHg | Diastolic Pressure | N/A (criteria for mean difference) | 5.3 mmHg (meets criteria of ≤ 8 mmHg) |
| Std. deviation ≤ 8 mmHg | Mean Arterial Pressure (MAP) | N/A (criteria for mean difference) | 5.1 mmHg (meets criteria of ≤ 8 mmHg) |
Summary of Device Performance against Acceptance Criteria: The device met all stated acceptance criteria from the ANSI/AAMI SP10 standard for the neonatal NIBP mode.
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The exact number of individual neonatal patients included in the clinical study is not specified, only that it was conducted on "neonates ranging in size from 0.52 to 8.60 kilograms."
- Data Provenance: The clinical testing was conducted at "two local hospitals." This indicates a prospective, multi-site clinical study. The country of origin is not explicitly stated, but given the submitter's address in Wisconsin, USA, and the referencing of American National Standards (ANSI/AAMI), it is highly probable the data is from the USA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for the NIBP measurements was established by "measurements made from an arterial line pressure transducer." This is an objective, direct physiological measurement. The document does not mention human expert involvement in establishing this specific ground truth for the NIBP readings.
- For the overall study conduct and ethical oversight, "Institutional Review Board (IRB) approvals" were received, indicating expert review of the study protocol.
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Adjudication method for the test set: Not applicable, as the ground truth for NIBP was a direct physiological measurement from an arterial line, rather than a subjective assessment requiring adjudication.
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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 study focuses on the accuracy of a physiological measurement device (NIBP monitor) and its algorithms, not on human reader performance with or without AI assistance for interpretation tasks.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, regarding the neonatal NIBP mode, the clinical testing involved comparing the "6004 monitor's algorithm" measurements to arterial line measurements. This represents standalone algorithm performance in the context of a medical device's automated function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The primary ground truth for the neonatal NIBP mode was invasive arterial line pressure transducer measurements. This is a highly accurate and direct physiological measurement often considered a gold standard for blood pressure.
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The sample size for the training set: Not applicable. This document describes a validation study for a medical device feature, not a machine learning model that would typically have a distinct training set. The device utilizes "currently available technology" and its design was updated with "only software...changed" for the neonatal NIBP mode. The development (training) of the underlying NIBP algorithm is not detailed here.
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How the ground truth for the training set was established: Not applicable, as this documentation pertains to a validation study rather than the development of an algorithm requiring a separate training set description.
§ 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).