(196 days)
BPM64R automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's Arm. The intended use of this over-the-counter device is for adults aged 18 years and older with Arm circumference ranging 220 ~ 420 mm (approx. 9 ~ 17 inch) and for home use.
Blood Pressure Monitor is a device intended for use in automatically measures human's Systolic, Diastolic blood pressure and heart rate. The Blood Pressure Monitor, BPM64R uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.
Here's an analysis of the provided text regarding the acceptance criteria and study for the AViTA Arm Type Blood Pressure Monitor BPM64R:
Based on the provided 510(k) summary, the device is a non-invasive blood pressure monitor, and its performance is evaluated against the ISO 81060-2 standard for clinical validation of automated measurement type.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ISO 81060-2) | Reported Device Performance (AViTA Arm Type Blood Pressure Monitor BPM64R) |
|---|---|
| Required limits for mean difference | Fulfilled |
| Required limits for standard deviation | Fulfilled |
Note: The document states that the "results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device." However, specific numerical values for the mean difference and standard deviation are not provided in this summary. To get these exact values, one would typically need to refer to the full study report or the detailed submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the clinical validation. It mentions a "clinical investigation" and refers to "the subject device" fulfilling the required limits.
Regarding data provenance:
- Country of Origin: Not specified in the provided text for the clinical study.
- Retrospective or Prospective: Not specified. Clinical validations for devices like blood pressure monitors are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide details on the number of experts or their qualifications for establishing the ground truth. For blood pressure monitors, the "ground truth" (reference measurements) is usually established by highly trained technicians or physicians using a validated reference sphygmomanometer, often with protocols like auscultatory measurements by two independent observers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify the adjudication method. Clinical validation studies for blood pressure monitors following ISO 81060-2 typically involve multiple observers. For example, two observers taking sequential measurements, with a third if there's a significant discrepancy.
5. 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
This is not applicable to this device. The AViTA Arm Type Blood Pressure Monitor BPM64R is a standalone automated measurement device; it is not an AI-powered diagnostic tool requiring human readers for interpretation, nor does it provide "assistance" to human readers in the way an AI algorithm might in imaging diagnostics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The entire premise of this device is "automatically measures human's Systolic, Diastolic blood pressure and heart rate." The clinical investigation described is explicitly for the automated measurement type and demonstrates the device's ability to operate without human intervention for the measurement itself, though a human initiates the process and reads the display.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for blood pressure monitor validation studies, as per ISO 81060-2, typically involves simultaneous or near-simultaneous auscultatory measurements performed by trained observers using a calibrated mercury or an equivalent reference sphygmomanometer. This would fall under a form of expert reference measurement rather than pathology or outcomes data.
8. The sample size for the training set
This device is an automated measurement system, likely based on traditional oscillometric principles. It does not appear to employ a machine learning or AI model that requires a distinct "training set" in the conventional sense of AI development. Therefore, a sample size for a training set is not applicable in the context of this device as described.
9. How the ground truth for the training set was established
As there is no indication of a "training set" for a machine learning model, this question is not applicable. The device's underlying algorithms are likely based on established physiological models for oscillometric measurements, rather than being "trained" on a dataset in the AI sense.
§ 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).