(141 days)
The Biospace blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm. (BPBIO320n is the same device as the BPBIO320 and has same specifications except it has no printer module.)
BPBIO320/BPBIO320n is for use by medical professionals or at home and is a noninvasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff size is 545 × 120 (mm) and the arm circumference range is between to 17cm - 42cm. BPBIO320/BPBIO320n is designed and manufactured according to ANSI/AAMI SP10 manual, electronic or automated sphygmanometers. BPBIO320/BPBIO320n can measure systolic, diastolic pressure and pulse rate on the principle of oscillometric on inflation. The oscillometric method detects volume displacements within the artery and senses pressure variations within the blood pressure cuff during inflation.
Here's a breakdown of the acceptance criteria and study information for the BPBIO320 and BPBIO320n blood pressure monitors, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from ANSI/AAMI SP10) | Reported Device Performance |
|---|---|---|
| Accuracy | ||
| Pressure | ±3mmHg | ±3mmHg |
| Pulse rate | ±2% | ±2% |
| Measurement Range | ||
| Blood pressure | N/A (Compared to predicate) | 40~300mmHg |
| Pulse rate | N/A (Compared to predicate) | 30~240bpm |
Note: The document explicitly states that the device met "all applicable requirements of the standard" for ANSI/AAMI SP10. The table above focuses on the specific numerical performance metrics that are directly comparable to the predicate or listed as a specification for the proposed device.
Study Information
The document describes a clinical test conducted to demonstrate compliance with ANSI/AAMI SP10, especially given the difference in measurement methodology (inflation vs. deflation) compared to the predicate device.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The document only mentions "a new clinical test is done in accordance with ANSI/AAMI SP10." The ANSI/AAMI SP10 standard itself specifies minimum subject requirements for clinical validation (e.g., typically a minimum of 85 subjects with specific blood pressure ranges).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It simply refers to "a new clinical test."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. For blood pressure monitor validation, ground truth is typically established by trained human observers using a mercury sphygmomanometer or an equivalent reference device, not necessarily by "experts" in the sense of radiologists. The ANSI/AAMI SP10 standard details the requirements for these observers (e.g., blinded measurements, simultaneous readings, specific training).
4. Adjudication method for the test set:
- Not explicitly stated. The ANSI/AAMI SP10 standard outlines specific protocols for comparing the automated device's readings to reference measurements, which often involves multiple observers and statistical analysis, but the exact adjudication method (e.g., 2+1, 3+1) is not detailed in this summary.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No. This type of study (MRMC) is typically associated with imaging devices where multiple readers interpret cases. For a blood pressure monitor, the "effectiveness" is assessed by its accuracy against a reference measurement, not by human readers interpreting the device's output.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The clinical test described is a standalone performance evaluation of the device as it measures blood pressure and pulse rate directly. There isn't a human interpreting an "algorithm output" in the traditional sense; the device itself provides the final measurement.
7. The type of ground truth used:
- The ground truth would be reference blood pressure measurements obtained simultaneously by trained observers using a validated method (e.g., mercury sphygmomanometer) as mandated by the ANSI/AAMI SP10 standard.
8. The sample size for the training set:
- Not applicable/Not stated. Blood pressure monitors like the BPBIO320/BPBIO320n are hardware devices that use an oscillometric method. While there's an "arithmetic" (algorithm) involved, especially given the inflation detection method, the device is not typically "trained" on a dataset in the way a machine learning algorithm would be. The design and parameters of the oscillometric algorithm are established during development and then validated through clinical testing.
9. How the ground truth for the training set was established:
- Not applicable. See point 8. The "ground truth" for the development of the oscillometric algorithm would come from physiological principles and previous research relating cuff pressure oscillations to arterial blood pressure, rather than a specific "training set" with established ground truth in the context of supervised machine learning.
§ 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).