(53 days)
CONTEC08C Electronic Sphygmomanometer is intended to measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult individuals.
The proposed device, CONTEC08C Electronic Sphygmomanometer is battery driven automatic non-invasive Blood Pressure Monitor. The device can automatically complete the inflation, deflation and BP measurement, which can measure systolic, diastolic and mean blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. It can be only used on adult individuals.
The device has the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure, mean blood pressure and pulse rate. These records can be uploaded to PC via USB and processed with the PC software.
The device has technical alarm function which will be triggered when the battery voltage is lower than 3.7V, and this alarm can not be cancelled unless being closed or the power replaced.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CONTEC08C Electronic Sphygmomanometer:
The provided document describes the clearance of a non-invasive blood pressure monitor (sphygmomanometer) through the 510(k) pathway, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This type of submission generally relies on performance testing against recognized standards rather than extensive clinical efficacy studies typically seen for novel devices.
Acceptance Criteria and Reported Device Performance
The device's performance is primarily assessed against the recognized standard ANSI/AAMI SP10: 2002 & A1: 2003 & A2: 2006. This standard outlines requirements for automatic sphygmomanometers, including accuracy specifications.
| Acceptance Criteria (from ANSI/AAMI SP10) | Reported Device Performance |
|---|---|
| Blood Pressure Accuracy | |
| - Mean difference: ≤ ±5 mmHg | Met standard requirements |
| - Standard deviation: ≤ 8 mmHg | Met standard requirements |
| Pulse Rate Accuracy | |
| (Not explicitly stated in provided text, but implied to be met per the standard.) | Met standard requirements |
| Other safety and performance standards | |
| - IEC 60601-1: 1988 +A1: 1991 +A2: 1995 (General safety) | Complies with standard |
| - IEC 60601-1-2: 2007 (EMC) | Complies with standard |
Note: The provided text states that "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ... ANSI/AAMI SP10: 2002 & A1: 2003 & A2: 2006." While it confirms compliance, specific numerical performance results (e.g., the exact mean difference and standard deviation achieved) are not detailed in this summary. However, meeting ANSI/AAMI SP10 implicitly means meeting its accuracy requirements for blood pressure (mean difference ≤ ±5 mmHg and standard deviation ≤ 8 mmHg).
Study Details
Given the nature of a 510(k) for a sphygmomanometer tested against ANSI/AAMI SP10, the "study" referred to is a specific blood pressure accuracy validation protocol as defined by that standard.
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Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the number of subjects (the sample size) used for the blood pressure accuracy testing according to ANSI/AAMI SP10. The standard itself specifies minimum subject requirements for various test phases (e.g., 85 subjects for the clinical validation of accuracy).
- Data Provenance: The document states that "Bench tests were conducted." The sponsor and submission correspondent are based in China (CONTEC MEDICAL SYSTEMS CO., LTD and Mid-Link Consulting Co., Ltd.), which suggests the testing was likely conducted in China. The data is prospective, meaning it was collected specifically for the purpose of validating the device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For blood pressure validation, the "ground truth" is typically established by trained observers (auscultators) using a mercury sphygmomanometer or validated reference device according to a standardized protocol. ANSI/AAMI SP10 requires at least two trained observers to simultaneously obtain reference blood pressure measurements.
- Qualifications of experts: These observers must be specifically trained and certified as competent in auscultatory blood pressure measurement. While the document doesn't detail their specific qualifications, compliance with ANSI/AAMI SP10 implies that appropriately qualified personnel were used.
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Adjudication method for the test set:
- ANSI/AAMI SP10 specifies an adjudication method for observer differences. Typically, if the two observers' readings differ by more than a predefined amount (e.g., 4 mmHg), a third observer or a re-measurement may be required, or the data point may be discarded. The exact protocol would follow the standard.
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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:
- No. This device is an automatic electronic sphygmomanometer and does not involve "human readers" interpreting images or data with or without AI assistance in the way an MRMC study would apply. Its function is to provide direct measurements. Therefore, an MRMC comparative effectiveness study was not performed and is not applicable here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the primary testing described is a standalone performance test of the device. The device's algorithm (oscillometric technique) measures blood pressure automatically without human input during the measurement phase. The "bench tests" and compliance with ANSI/AAMI SP10 are evaluations of this standalone performance.
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The type of ground truth used:
- For blood pressure devices, the ground truth is expert auscultatory measurements (or another validated reference method) conducted concurrently with the device measurements on human subjects, as dictated by the ANSI/AAMI SP10 standard.
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The sample size for the training set:
- The document does not refer to a distinct "training set" for an algorithm to be learned or optimized in the sense of machine learning. The device utilizes an oscillometric algorithm which is a well-established technique for blood pressure measurement. Any internal calibration or algorithm refinement by the manufacturer would have been part of the device's design and development, not typically described as a "training set" in a 510(k) summary for such a device. The testing described is validation of the final device.
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How the ground truth for the training set was established:
- As there is no "training set" explicitly mentioned or applicable in the context of an AI/machine learning model as typically discussed, this question is not relevant to the provided information. The device's underlying algorithm is based on established oscillometric principles rather than a data-driven "training" process from a ground truth 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).