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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.

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The BpTRU BPM-200:

• Measures systolic and diastolic blood pressure and pulse rate 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 Portable Automated Non-Invasive Blood Pressure Monitor (Model BPM-200) is a portable automated, non-invasive blood pressure monitor designed to measure the blood pressure and pulse rate of patients using an upper arm cuff. The device uses a standard blood pressure cuff to measure the blood pressure in the upper arm. The device automatically inflates and deflates the cuff, and uses the oscillometric technique to calculate systolic and diastolic blood pressure.
The BPM-200 has two blood pressure operational modes: Manual and Automatic. 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. Individual readings are stored and can be reviewed in both Manual and Automatic Modes.
The BPM-200 can be operated while mounted to a wall, attached to a roll-stand or self-standing on the tabletop. The new device includes an internal rechargeable battery and features USB connectivity.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BpTRU™ Portable Automated Non-Invasive Blood Pressure Monitor (Model BPM-200):

Unfortunately, the provided document does not contain the specific acceptance criteria or details of a study proving the device meets those criteria. The document is a 510(k) summary and approval letter, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

However, based on the context of a non-invasive blood pressure monitor and typical regulatory requirements, we can infer what would likely be required for such a device, and what information is explicitly missing from this document.

Here's a breakdown of the requested information, highlighting what can be extracted and what information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document does not mention any specific clinical study sample sizes for testing the BPM-200's primary performance.
• Data Provenance: Not specified. There is no mention of the country of origin of any data, nor is it stated whether any study was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No. This type of study is typically relevant for interpretative devices (e.g., imaging AI) where human readers are part of the diagnostic process. A standalone blood pressure monitor like the BpTRU BPM-200 does not involve human interpretation in the same way, so an MRMC study would not be applicable or expected for its primary performance evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: Implicitly, yes, for a device of this type. For a medical device like an automated blood pressure monitor, the primary performance evaluation is a standalone assessment of its accuracy and reliability against a reference standard. However, the details of such a study (sample size, methodology, results) are not provided in this document. The summary states it uses the "oscillometric technique to calculate systolic and diastolic blood pressure," which is the algorithm it uses.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not specified. For a blood pressure monitor, the ground truth would typically be established by a reference standard, often:
  • Simultaneous auscultation by trained observers using a mercury sphygmomanometer (following a standard protocol like AAMI or BHS).
  • Invasive arterial pressure monitoring (though less common for routine NIBP validation due to invasiveness).
    The document does not detail which method, if any, was used.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. Automated oscillometric blood pressure monitors typically rely on established algorithms and mathematical models based on extensive physiological and engineering research over decades, rather than a "training set" in the context of modern machine learning. While the development of the algorithm itself might have involved data, there isn't a "training set" in the sense of a dataset used to train a neural network for a specific task.

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

• Ground Truth for Training Set: Not applicable/Not specified. See point 8.

Summary of Document Contents Regarding Performance Information:

The provided 510(k) summary is primarily concerned with demonstrating substantial equivalence to existing predicate devices (BpTRU™ Automated Non-Invasive Blood Pressure Monitor Model BPM-100). The modifications described (battery operation, USB connectivity, pole/self-standing operation) are largely related to form factor and connectivity, not the core blood pressure measurement algorithm itself.

The document claims the device "uses the oscillometric technique to calculate systolic and diastolic blood pressure," implying that the underlying measurement technology is similar or identical to the cleared predicate devices. Therefore, the FDA's approval for this device (K023055) is based on the premise that its performance characteristics are substantially equivalent to the previously cleared devices (K994423, K002046, K012636), for which relevant performance data would have been submitted at the time of their clearance. This current document does not re-iterate or provide new clinical performance data for the BPM-200 specifically.

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The BPM-100:

• Measures systolic and diastolic blood pressure and pulse rate in adults greater than 18 years of age.
• Is intended for use in physicians' offices, nursing units, and patient care areas of hospitals.

Automated Non-Invasive Blood Pressure Monitor, Model BPM-100

The provided text is an FDA 510(k) clearance letter for an "Automated Non-Invasive Blood Pressure Monitor, Model BPM-100". It merely states that the device is substantially equivalent to legally marketed predicate devices and is approved for market.

Crucially, the document does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes (for test or training sets), expert qualifications, ground truth establishment, or any comparative effectiveness studies.

Therefore, I cannot provide the requested information. To answer your questions, I would need access to the actual 510(k) submission summary or detailed study reports for the BPM-100 device.

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