(134 days)
Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia)
The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillation mensuration. The subject devices will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; the time, date, blood pressure value and pulse value are included. The record maybe revisited.
Here's a breakdown of the acceptance criteria and study information for the Electronic Blood Pressure Monitor (models YE620B, YE620D, YE660E, YE660F, and YE680B), based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Reference) |
|---|---|
| Blood Pressure Accuracy: Mean difference (reference - device) and standard deviation for both systolic and diastolic blood pressure (ISO 81060-2:2018) | Systolic Blood Pressure: Mean difference ± Standard Deviation: Passed (Specific values not provided in the summary, but stated as conforming to ISO 81060-2). |
| Diastolic Blood Pressure: Mean difference ± Standard Deviation: Passed (Specific values not provided in the summary, but stated as conforming to ISO 81060-2). | |
| Pulse Accuracy: ±5% of reading value (device specification) | ±5% of reading value (device specification, confirmed in compliance to ISO 81060-2, which dictates this level of accuracy is met) |
| General Safety: Compliance with general requirements for basic safety and essential performance (ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1) | Passed |
| Electromagnetic Disturbances: Compliance with collateral standard for electromagnetic disturbances (ANSI AAMI IEC60601-1-2:2014) | Passed |
| Usability: Compliance with general requirements for basic safety and essential performance - Usability (IEC 60601-1-6 Edition 3.1 2013-10) | Passed |
| Home Healthcare Environment: Compliance with requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015) | Passed |
| Automated Noninvasive Sphygmomanometers Specific Requirements: Compliance with particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers (ANSI AAMI IEC80601-2-30:2009 & A1:2013 (R2016)) | Passed |
| Biocompatibility: ISO 10993-1, FDA Guidance, Tests included Cytotoxicity, Sensitization and Intracutaneous Reactivity | Passed |
| Electrical Safety: IEC60601-1 | Passed |
| EMC: IEC60601-1-2 | Passed |
| Usability (General): IEC 60601-1-6 | Passed |
| Home Use (General): IEC 60601-1-11 | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Validation (Test Set): 85 participants.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study. It is a prospective study as participants were "involved in the study" and "three valid blood pressure values are taken for each participant."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document states that "nurses" took the blood pressure values for the participants. The exact number of nurses is not specified, nor are their specific qualifications (e.g., years of experience in blood pressure measurement), beyond being "nurses."
- Ground Truth Establishment: The ground truth was established by these nurses using a reference device, a mercury sphygmomanometer.
4. Adjudication Method for the Test Set
- The document implies that the ground truth for each participant consisted of "three valid blood pressure values" taken by nurses. An explicit adjudication method (e.g., 2+1, 3+1 consensus) for these three values is not specified. It suggests these three values were directly used, perhaps averaged, or that "valid" implies some internal consistency checking.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The study described is a clinical validation against a reference standard (mercury sphygmomanometer), not a comparison of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance study was done. The clinical validation detailed is focused on the device's (algorithm's) accuracy in measuring blood pressure compared to a reference standard (mercury sphygmomanometer), without human intervention in the device's measurement process itself.
7. The Type of Ground Truth Used
- Expert Consensus / Reference Standard: The ground truth was established by "nurses" using a "mercury sphygmomanometer" as the reference device. This falls under the category of a reference standard established by human experts.
8. The Sample Size for the Training Set
- The document does not specify a training set sample size. This is typical for a 510(k) submission for a non-AI medical device like a blood pressure monitor, where the focus is on clinical validation against a standard, not machine learning model training. The device's underlying oscillometric algorithm would have been developed and validated internally by the manufacturer, but details of that process (including training sets for the algorithm itself) are not usually part of a 510(k) summary focused on clinical performance for regulatory clearance.
9. How the Ground Truth for the Training Set Was Established
- As no training set is explicitly mentioned or detailed in the document, how its ground truth was established is not provided.
§ 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).