(102 days)
The Shanghai Little Doctor LD-578 Fully Automatic Digital Blood Pressure Monitor, is a device intended to measure the systelic and diastolic blood pressure 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 LD-578 Fully Automatic Digital Blood Pressure Monitor, Model LD-578 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The provided text outlines the acceptance criteria and the study conducted for the LD-578 Fully Automatic Digital Blood Pressure Monitor.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Reference) |
|---|---|
| Clinical Performance: | |
| Clinical Data and Analysis ANSI/AAMI-SP-1000 Standard - Section 1-10 | All testing results met required parameters (Section 9) |
| Clinical Data and Analysis ANSI/AAMI-SP-10 Standard, Section 4.4.2 | All testing results met required parameters (Section 9) |
| Non-Clinical Performance: | |
| FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND (Electrical, Mechanical, Environmental Performance Requirements) | Met all relevant requirements; no safety hazards (Section 8) |
| General Functions Test | Met all relevant requirements (Section 8) |
| Reliability Test-Operation Conditions | Met all relevant requirements (Section 8) |
| Reliability Test-Drop Testing | Met all relevant requirements (Section 8) |
| Reliability Test-Storage | Met all relevant requirements (Section 8) |
| Reliability Test-Vibrating Testing | Met all relevant requirements (Section 8) |
| EMC Testing | Met all relevant requirements (Section 8) |
| IEC 60601-1 Safety Testing | Met all relevant requirements (Section 8) |
| FDA required Unit Intravariability Testing | Met all relevant requirements (Section 8) |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "We have performed clinical testing on the LD-578 Fully Automatic Digital Blood Pressure Monitor according to 'Clinical Data and Analysis ANSI/AAMI-SP-1000 Stondord -Section 1-1 0' - Alto 'Clinical Data and Analysis ANSI/AAMI-SP-10 Standard, Section 4.4.2'."
- Sample Size: The exact sample size used for the clinical test set is not explicitly mentioned in the provided text.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It only indicates that "clinical testing" was performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical testing. The clinical testing refers to adherence to the ANSI/AAMI-SP-10 standard, which typically outlines methods for validating blood pressure monitors against a reference method, often involving trained observers.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (such as 2+1 or 3+1) for the test set. Clinical validation of blood pressure devices against a standard often involves comparison to a reference standard (e.g., auscultation by multiple trained observers), but specific adjudication protocols are not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. The device is a "Fully Automatic Digital Blood Pressure Monitor," implying it autonomously measures blood pressure, and the focus is on its accuracy compared to established standards rather than human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, a standalone performance assessment was conducted. The device is described as "Fully Automatic Digital Blood Pressure Monitor" employing an "oscillometric method" to define systolic and diastolic blood pressure and calculate pulse rate. The clinical testing, according to ANSI/AAMI-SP-10, is a standalone validation of the device's accuracy without human interpretation of the device's output.
7. The Type of Ground Truth Used
The clinical testing was performed according to ANSI/AAMI-SP-10 standard. This standard typically requires the device's readings to be compared against a reference method, which is often auscultation performed by trained observers (expert consensus) using a mercury manometer or another validated reference sphygmomanometer. The document states, "Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer." This indicates that the ground truth for clinical validation would be established by the auscultatory method.
8. The Sample Size for the Training Set
The document does not provide information on a separate "training set" or its sample size. For blood pressure monitors, the "oscillometric method" is a well-known and established technique rather than a machine learning algorithm that requires a distinct training phase. The device's algorithm would have been developed and refined based on existing physiological knowledge and potentially pre-clinical data, but a formal "training set" in the context of supervised learning is not discussed.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" is mentioned in the context of developing a machine learning algorithm, there is no information on how its ground truth was established. The "oscillometric method" is a recognized technique, and its parameters would be defined through physiological research and engineering principles, not through a 'ground truthing' of a training 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).