(32 days)
MD-534 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive 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 circumference is limited to 22cm-48cm.
MD-534 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive 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 circumference is limited to 22cm-48cm. it is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers. The operational principle is based on oscillometric and silicon integrate pressure sensor technology. It can calculate the systolic and diast litegrac pressure, and display the result on the LCD. If any irregular heartbeat is detected, it can also be shown on the LCD. More over, it also has the function of averaging the last three measurements.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text states that the device, MD-534 Fully Automatic Electronic Blood Pressure Monitor, conforms to several standards, implying these standards contain the acceptance criteria for performance. The most relevant standard for blood pressure measurement accuracy is:
- AAMI SP10:2002, Manual, electronic or automated sphygmomanometers.
- AAMI / ANSI SP10:2002/A1:2003 --, Amendment 1 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.
- AAMI / ANSI SP10:2002/A2:2006 --, Amendment 2 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.
While the text states conformance, it does not explicitly list the specific numerical acceptance criteria from AAMI SP10 (e.g., mean difference and standard deviation between device and reference measurement), nor does it present specific device performance results in a table against those criteria. It only provides a general statement: "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." referring to differences between the new device and the predicate.
Therefore, a table cannot be fully completed with specific values from the provided text. However, we can infer the acceptance criteria are those outlined in AAMI SP10.
| Acceptance Criterion (from AAMI SP10) | Reported Device Performance (from submission) |
|---|---|
| Accuracy (Mean Difference) | Confirms to AAMI SP10; specific value not reported |
| Accuracy (Standard Deviation) | Confirms to AAMI SP10; specific value not reported |
| Mechanical Safety | Confirms to IEC 60601-1; "Identical" to predicate |
| Electrical Safety | Confirms to EN 60601-1-2; "Identical" to predicate |
| EMC | Confirms to EN 60601-1-2; "Identical" to predicate |
| Biocompatibility | "Identical" to predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only vaguely refers to "the test in this submission."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used to establish ground truth or their qualifications. For blood pressure monitors, ground truth is typically established by trained technicians or clinicians using a calibrated reference sphygmomanometer (mercury or aneroid).
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted or reported. This type of study is more common for diagnostic imaging AI systems where human interpretation is a key component. Blood pressure monitors are standalone measurement devices.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance assessment was done. The entire submission focuses on the performance of the MD-534 device itself, comparing it against the AAMI SP10 standard and demonstrating substantial equivalence to the predicate device. The performance claims (conformance to standards) refer to the device's inherent accuracy.
7. Type of Ground Truth Used
The type of ground truth used, though not explicitly detailed in its method, would be comparison against a reference standard blood pressure measurement device (e.g., a mercury sphygmomanometer) as mandated by the AAMI SP10 standard. This standard requires direct comparison of the device's measurements against those taken simultaneously by trained observers using a reference method.
8. Sample Size for the Training Set
The document does not mention a "training set" or its sample size. This device is a traditional electronic medical device (blood pressure monitor) and not an AI/ML-based system that typically requires a separate training set. Its design is based on oscillometric principles, not machine learning algorithms that learn from data.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device, there is no concept of a "training set" or its ground truth in this context.
§ 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).