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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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