Search Results

The BpTRU Vital Signs Monitor (Model BPM-300):

• Measures systolic and diastolic blood pressure and pulse rate in subjects 3 . years of age or older.
• Measure temperatures in subjects 3 years of age or older. ●
• Is intended for use in physicians' offices, nursing units, and patient care areas . of hospitals.

The BpTRU is intended to:

• measure systolic and diastolic blood pressure and pulse rate in subjects .
• measure systolic blood pressure in the range of 60 to 250 mmHg. ●
• measure diastolic blood pressure in the range of 40 to 160 mmHg. ●
• measure pulse rate in the range of 40 to 200 beats per minute. .
• measure temperature in the range of 28°C to 43°C (82.4°F to 109.4°F) for ● Continuous (Monitoring) Measurements and 35°C to 39°C (95.0 to 102.2°F) for Predictive (Single) Measurements.
• be operated by physicians, nurses, or other qualified medical personnel. ●
• be used in physicians' offices, nursing units, and patient care areas of . hospitals.
• . be pole-mounted, wall-mounted or used on a table top.
• be battery or mains operated. .
• be connected to a PC via a USB port for data interchange. .

The BPM-300 is an automated, non-invasive blood pressure and temperature monitor that measures the blood pressure and pulse rate of patients using an upper arm cuff and the oral, axillary and rectal temperature using thermometry probes. The device uses standard blood pressure cuffs normally used in auscultation to measure the blood pressure in the upper arm. The device also uses stainless steel temperature probes, which are similar to design to commercially available probes from YSI, to measure the temperature from the oral, axillary and rectal regions.

The BPM-300 has two blood pressure operational modes: Manual and Automatic, which are used with the oscillometric technique to calculate systolic and diastolic blood pressure. Manual Mode is designed to take a single blood pressure measurement. Automatic Mode takes six measurements, discards the first, and displays the average of the last five readings. The cycle time, or minutes between measurements (from the start of one measurement to the start of the next measurement), can be selected in Automatic Mode. Readings can be reviewed in both Manual and Automatic Modes.

The BPM-300 includes two temperature measurement modes: Predictive and Continuous. Continuous Mode is designed to be used for taking extended length, monitoring measurements from the oral, axillary or rectal regions of the body. Predictive Mode is designed to calculate a single, quick (15 second) and accurate temperature measurement from either the oral or axillary region. There are two different color-coded temperature probes available for the BPM-300: oral/axillary (blue probe) and rectal (red probe). These temperature probes, which are manufactured for VSM by Yellow Springs Inc., also include the additional safety of a disposable probe cover, manufactured for VSM by Banta Healthcare.

The BPM-300 incorporates a battery, which allows for portable operation, a polemounting feature and computer/interface connectivity feature, through a USB port.

The provided 510(k) summary (K023078) for the BpTRU Vital Signs Monitor (Model BPM-300) indicates that the device was tested against recognized standards for both blood pressure and temperature measurement. However, the document lacks detailed acceptance criteria and the comprehensive study information requested in the prompt.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

• Mean difference between test device and reference device for systolic blood pressure: ≤ ± 5 mmHg
• Standard deviation of the differences for systolic blood pressure: ≤ 8 mmHg
• Mean difference between test device and reference device for diastolic blood pressure: ≤ ± 5 mmHg
• Standard deviation of the differences for diastolic blood pressure: ≤ 8 mmHg
• Specific requirements for cuff size, subject population (e.g., adult, pediatric), number of subjects, and number of measurements per subject. | "The blood pressure feature of the BPM-300 was tested and meets the requirements of AAMI/ANSI SP10: 1992 (Electronic or automated sphygmomanometers)."
  Specific numerical performance values (mean difference, standard deviation) are not reported in the provided document. |
  | Continuous Temperature | | |
  | ASTM E1112-00 (Continuous Temperature) | As per ASTM E1112-00 standards:
• Accuracy requirements specifying maximum permissible error within certain temperature ranges (e.g., ± 0.1 °C for certain core body temperatures, ± 0.2 °C for others).
• Stability, response time, and other performance characteristics. | "The continuous temperature feature of the BPM-300 was tested and meets the requirements of ASTM E1112-00 (Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature)."
  Specific numerical performance values are not reported in the provided document. |
  | Predictive Temperature | Implied: Predictive measurements are "accurate as compared to the continuous temperature."
  Specific numerical criteria for this accuracy (e.g., mean difference, confidence intervals) are not provided. | "The predictive temperature feature of the BPM-300 was tested in a clinical validation study and the results demonstrate that the predictive measurements are accurate as compared to the continuous temperature."
  Specific numerical performance values are not reported in the provided document. |

2. Sample Size Used for the Test Set and Data Provenance

• Blood Pressure: The document states "The blood pressure feature of the BPM-300 was tested and meets the requirements of AAMI/ANSI SP10: 1992". While AAMI/ANSI SP10 specifies minimum sample sizes (e.g., typically at least 85 subjects for validation), the exact sample size used in the test set is not explicitly stated in the provided text.
• Continuous Temperature: The document states "The continuous temperature feature of the BPM-300 was tested and meets the requirements of ASTM E1112-00". ASTM E1112-00 has specific testing protocols, but the exact sample size used and data provenance are not reported. This standard is for the device itself, likely involving laboratory testing more than clinical patient data.
• Predictive Temperature: "The predictive temperature feature of the BPM-300 was tested in a clinical validation study." The sample size for this clinical study is not reported. The data provenance (country of origin, retrospective/prospective) is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Blood Pressure: For AAMI/ANSI SP10 testing, ground truth typically involves a reference method performed by trained observers (e.g., auscultatory method by two trained observers). The number and qualifications of experts are not specified in the provided text.
• Continuous Temperature: For ASTM E1112-00, the "ground truth" would be established by a primary reference thermometer instrument or known temperature baths in a lab setting, not typically by human experts.
• Predictive Temperature: The ground truth was "continuous temperature." This would likely involve the device's own continuous temperature measurement mode or another validated continuous temperature monitoring device. The use of human experts to establish this ground truth is not applicable in this context.

4. Adjudication Method for the Test Set

• Blood Pressure: For AAMI/ANSI SP10, if human observers were part of the reference method, an adjudication method (e.g., averaging two observers' readings or a third adjudicator if there's a discrepancy) would be standard. However, the specific adjudication method is not mentioned in the document.
• Temperature: Adjudication by human experts is not applicable for temperature measurement studies described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported. This type of study is more common for diagnostic imaging devices where human readers interpret images with and without AI assistance to assess changes in diagnostic accuracy.

6. Standalone Performance

Yes, standalone performance was assessed for both blood pressure and temperature functions.

• The blood pressure feature "was tested and meets the requirements of AAMI/ANSI SP10: 1992". This refers to the algorithm/device performance directly compared to a reference standard, without human intervention in the measurement process itself beyond initiating it.
• The continuous temperature feature "was tested and meets the requirements of ASTM E1112-00". This is a direct assessment of the device's accuracy.
• The predictive temperature feature "was tested in a clinical validation study and the results demonstrate that the predictive measurements are accurate as compared to the continuous temperature". This describes the standalone performance of the predictive algorithm against a reference (continuous temperature).

7. Type of Ground Truth Used

• Blood Pressure: Ground truth was based on the requirements of AAMI/ANSI SP10: 1992. This standard typically involves comparison to a reference sphygmomanometer reading, often obtained through the auscultatory method (manual stethoscope and cuff) by trained observers.
• Continuous Temperature: Ground truth was based on the requirements of ASTM E1112-00. This standard typically relies on calibrated temperature probes or reference thermometers in a controlled environment.
• Predictive Temperature: Ground truth was the device's "continuous temperature" measurement, implying a comparison of the rapid predictive reading to a several-minute continuous reading from the same device or a similar validated continuous temperature monitor.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This suggests that the device's underlying algorithms (oscillometric for BP, thermistor for temperature prediction) may be based on established physical principles and prior development, rather than a specific machine learning model that requires a distinct "training set" in the modern sense. If there was an internal algorithm for predictive temperature, the data used to develop that algorithm is not discussed.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, information on how its ground truth was established is not available.

Ask a specific question about this device