(122 days)
The Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate by using the oscillometric method during inflation. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults at medical facilities or at home. The intended upper arm circumference is 22-40cm (8.7" - 15.7"). Not suitable for neonatal and infants.
The blood pressure monitor model C02 and F01 are sphygmomanometers with electronic manometer intended to be used for the indirect (non-invasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults during inflation. The inflatable cuff is wrapped around the upper arm of an individual. The systolic and diastolic blood pressures are transmitted via air pressure and determined by the transducer integrated on the monitor with the oscillometric method. The systolic and diastolic blood pressure values and pulse rate per minute are displayed on the LED panel. The monitors C02 and F01 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device: Blood Pressure Monitor (Models C02 and F01)
Manufacturer: Shenzhen Jamr Technology Co., Ltd.
Predicate Device: Full Automatic (NIBP) Blood Pressure Monitor HL858CL (K190507)
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criteria for the clinical performance of the blood pressure monitor are derived from the ISO 81060-2 standard.
| Acceptance Criteria (from ISO 81060-2) | Reported Device Performance (Blood Pressure Monitor C02) |
|---|---|
| Mean error and standard deviation within required limits | "The results of this clinical investigation show that the required limits for mean error and standard deviation are fulfilled by the subject device C02." |
| BP Accuracy: ±3mmHg (±0.4kPa) | ±3mmHg (±0.4kPa) |
| PR Accuracy: ±5% of reading | ±5% of reading |
| BP Measurement Range: 60-255mmHg (SYS); 40-200mmHg (DIA) | 60-255mmHg (SYS); 40-200mmHg (DIA) |
| PR Measurement Range: 40-170 pulses/min | 40-170 pulses/min |
Note: The document explicitly states that the device passes various other non-clinical standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-11, IEC 80601-2-30, ISO 81060-1, IEC 62304, ISO 14971, IEC 62366-1) which imply acceptance criteria for electrical safety, EMC, performance, software, usability, and risk management, but specific quantitative acceptance values for these are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 90 patients (42 males and 48 females)
- Data Provenance: Not explicitly stated, but the submission is from a Chinese company (Shenzhen Jamr Technology Co., Ltd.) and refers to a "Clinical Test report" and "clinical investigation," implying this data was collected during a clinical study to support this particular device. It is most likely prospective data collected for the purpose of regulatory submission. The location of the actual clinical trial is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document states that the "Standard auscultation method was used as the reference blood pressure monitor measuring in the arm according to the sequence in ISO 81060-2."
- Number of Experts: Not explicitly stated. The ISO 81060-2 standard typically requires measurements by multiple trained observers (usually at least two trained observers taking simultaneous or sequential measurements) to establish the reference values using the auscultatory method. However, the specific number of experts involved in this particular study is not detailed in the provided summary.
- Qualifications of Experts: Not explicitly stated, but implies individuals trained in the auscultatory method of blood pressure measurement, as per the ISO 81060-2 standard.
4. Adjudication Method for the Test Set
The adjudication method is implicitly that of the ISO 81060-2 standard for assessing blood pressure devices using the auscultatory method. This standard typically involves comparisons between the automated device and a reference measurement obtained by trained observers using a sphygmomanometer and stethoscope. While the document doesn't explicitly state an "adjudication method" in terms of resolving discrepancies between multiple expert readings, the ISO 81060-2 protocol itself serves as the framework for establishing the reference values against which the device is compared. It generally involves the average of readings from multiple observers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study is a standalone clinical validation of the device's accuracy against a standard reference method (auscultation), not a comparison of human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone clinical validation (algorithm only) was done. The study evaluated the accuracy of the Blood Pressure Monitor (an automated device) against the reference auscultation method. This evaluates the device's inherent performance.
7. The Type of Ground Truth Used
The type of ground truth used is expert consensus/clinical reference measurement established by the standard auscultation method. This is considered the gold standard for non-invasive blood pressure measurement in such validation studies.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set. This is a clinical validation study for a medical device's accuracy, not a machine learning algorithm that typically requires a distinct training set. The device itself (Blood Pressure Monitor) is a hardware device with an embedded algorithm; the summary focuses on the validation of the device rather than the development of the algorithm.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this type of device validation, this information is not applicable.
§ 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).