(35 days)
Bioland Blood Pressure Monitor Model 2001, Model 2003, Model 2004, Model 2005, model 3000, Model 3001 and Model 3002, are Sphygmomanometer with Electronic Manometer ntended to be used for the indirect (non-invasive) measurement of diastohc, systolic blood pressure and pulse rate for adults only.
Bioland Blood Pressure Monitor Model 2001, Model 2003, Model 2005, model 3000, Model 3001 and Model 3002, are Sphygmomanometers with Electronic Manometer intended to be used for the indirect (non-mvasive) measurement of diastohe, systolic blood pressure and pulse rate for adults only.
Bioland Blood Pressure Montor Model 2001 and Model 2004 respectively use an inflation cuff wrapped around the upper arm The cuff is inflated by a manual air pump
Bloland Blood Pressure Monitor Model 2003 and Model 2005 respectively use an inflation cuff wrapped around the upper arm. The cuff is inflated by an electrical air pump
Bioland Blood Pressure Montor Model 3000, Model 3002, respectively uses inflation cuffs wrapped around the wrists. The cuff is inflated automatically by an electrical arr pump
The systolic, diastolic blood pressures and heart beats are transmitted via air pressure in the mflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by arr pump The deflation rate is controlled and released by a preset mechanical valve at a constant rate beginning at the pressure peak during the measurement results including dastolic. systolic pressures and heart pulse rate are displayed on the LCD
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the Bioland Blood Pressure Monitor models:
Acceptance Criteria and Device Performance for Bioland Blood Pressure Monitors
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Bioland Blood Pressure Monitors are primarily based on the ANSI/AAMI SP-10 standard and FDA guidance "Non-invasive Blood Pressure (NIBP) Monitor Guidance". The clinical performance is evaluated against the accuracy of a mercury-type sphygmomanometer.
| Acceptance Criteria (from ANSI/AAMI SP-10 & Clinical Study) | Reported Device Performance (Models 2001, 2003, 2004, 2005, 3000, 3001, 3002) |
|---|---|
| ANSI/AAMI SP-10 Standard Conformance: | Conformed for all applicable sections: |
| - General requirements | Conformed |
| - Device labeling | Conformed |
| - Outer container | Conformed |
| - Information manual | Conformed |
| - Component replacement | Conformed |
| - Power system labeling | Conformed |
| - Labeling for battery-powered devices | Conformed |
| - Storage conditions | Conformed |
| - Operating conditions | Conformed |
| - Vibration and shock | Conformed |
| - Voltage range | Conformed |
| - Life | Conformed |
| - Maximum cuff pressure | Conformed |
| - Cuff deflation | Conformed |
| - Electrical safety | Conformed (also complies with EN 60601-1 1990 and EN 60601-1-2/2001) |
| - Conductive components | Conformed |
| - Pressure indicator accuracy | Conformed |
| - Overall system efficacy (referenced to Auscultatory method) | Conformed |
| - Intra-arterial method as reference | Not applicable |
| - Battery-powered devices | Conformed |
| - Requirements for devices with manual inflation systems | Conformed (for Model 2001/2004) |
| Clinical Accuracy (compared to mercury sphygmomanometer): | Reported Performance: |
| - Within +/- 3 mmHg | Model 2001/2003: 89.7% (78/87) |
| Model 2004/2005: 90.8% (79/87) | |
| Model 3000/3001/3002: 90.8% (79/87) | |
| - Within +/- 5 mmHg | Model 2001/2003: 96.6% (84/87) |
| Model 2004/2005: 96.6% (84/87) | |
| Model 3000/3001/3002: 94.3% (82/87) | |
| - Within +/- 8 mmHg | Model 2001/2003: 100% (87/87) |
| Model 2004/2005: 100% (87/87) | |
| Model 3000/3001/3002: 100% (87/87) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The clinical test involved 87 patients for each group of models (Model 2001/2003, Model 2004/2005, Model 3000/3001/3002). It is not explicitly stated if these are unique patients across all model groups or if the same 87 patients were tested with different models. Assuming 87 unique patients for each grouped model as presented.
- Data Provenance: The study was conducted in Feng Gang Overseas Chinese Hospital. The type of study (retrospective or prospective) is not explicitly stated, but clinical tests are typically prospective. The country of origin is implicitly China, given the hospital's name and location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The ground truth was established by "normal mercury-type sphygmomanometers." This implies that the measurements were taken by healthcare professionals trained in using these devices. The document does not specify the number of experts, their qualifications (e.g., specific medical titles, years of experience), or if multiple experts were involved in taking reference measurements for the same patient.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (like 2+1, 3+1, or none) for establishing ground truth measurements from the mercury sphygmomanometers. It simply refers to "comparing to normal mercury-type sphygmomanometers," which suggests that the direct readings from these reference devices were used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the device's measurements against a reference standard (mercury sphygmomanometer), not against human readers' performance with and without AI assistance. This device is a standalone measurement system, not an AI-assisted diagnostic tool for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The Bioland Blood Pressure Monitors are automatic devices that measure blood pressure using an oscillometric method. The clinical tests evaluate the accuracy of these devices' measurements (algorithm only) compared to the ground truth established by mercury sphygmomanometers, without human intervention in operating the device or interpreting its output.
7. The Type of Ground Truth Used
The ground truth used was "normal mercury-type sphygmomanometers." This is an accepted and common reference standard for non-invasive blood pressure measurement devices.
8. The Sample Size for the Training Set
The document does not provide information regarding a separate training set or its sample size. This is a medical device clearance, and the focus is on the validation/test set performance against established clinical and engineering standards. For such devices, manufacturers typically use proprietary algorithms developed with internal data, and the submission primarily demonstrates performance on a separate, independent test set.
9. How the Ground Truth for the Training Set was Established
Since information about a specific training set is not provided, the method for establishing its ground truth is also not detailed in this summary.
§ 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).