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The BioCare vTrust 701DH NIBP monitor is a compact, battery-powered monitor which measures noninvasive blood pressure (systolic and mean arterial pressure) and pulse rate based on the principle of plethysmography (oscillometric on inflation). This equipment is intended for use only by qualified medical providers in conjunction with established medical protocols. It is not intended for use in an MRU environment, or in an air transport environment.

Device Description

The BioCare vTrust 701DH NIBP monitor is a compact, battery-powered monitor which measures noninvasive blood pressure (systolic, diastolic and mean arterial pressure) and pulse rate based on the principle of plethysmography (oscillometric on inflation). The oscillometric method detects volume displacements within the artery and senses pressure variations within the blood pressure cuff during inflation. The measurement is more quickly and with less patient discomfort than with monitors which measure NIBP during cuff deflation. Cycle time function enables you to pre-set measurement intervals. User can set alarm limits by selectable for high or low range.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Clause	Performance Characteristics	Max. permissible error or acceptance criteria	Reported Device Performance (Max. deviation)	Passed/Failed
4.2.1	Storage conditions: [23°F(-5°C)] for 24 hrs; [122°F(50°C)] for 24 hrs; RH: 90% (noncondensing)	≤± 3 mmHg (±0.4 kPa) ≤± 4 mmHg for in use	-3.4 mmHg	Passed
4.2.2	Operating conditions: Temp: 50°F (10°C)~~104°F(40℃); RH: 15~~90% (noncondensing); Bar. 105kPa~~80kPa (790mmHg~~600mmHg)	≤± 3 mmHg (±0.4 kPa) ≤±4 mmHg for in use	± 3 mmHg	Passed
4.2.3	Vibration and shock: ISTA-standard drop and vibration test IEC 60601-1, sections 21.5 & 21.6	ISTA-1A: 14,200 vibratory impacts; drop test-10 drops; before and after transportation test within ±5 mmHg of the average reading.	no visible damage; SD ≤8 mmHg	Passed
4.2.4.1	Voltage range: Battery-powered devices-indication of battery condition	Red light: low battery; Blue light: batteries are charging; Green light: fully charged	<8.2VDC; 8.2~8.4VDC	Passed
4.2.4.2	Life: Maintain the safety and performance characteristics for 10,000 full-scale cycles. Adult mode: 150 mmHg; Neo. mode: 75 mmHg	≤ 3 mmHg (±0.4 kPa)	2 mmHg	Passed
4.2.5	Electromagnetic compatibility	complied with EC 60601-1-2 (EMC)	N/A	Passed
4.3.1.1	Maximum cuff pressure: Adult: 300mmHg; neonate: 150 mmHg	NIBP pressure calibration: <310 mmHg; Safety test: Release pressure before <320 mmHg	N/A	Passed
4.3.1.2	Release rate: Rapid exhaust: 260~~15 mmHg ≤10s; 150~~5 mmHg ≤5s	NIBP pressure calibration: deflate at 25 mmHg/sec; Speed test: Deflation >25 mmHg/sec	mmHg/sec	Passed
4.3.2	Electrical safety:	IEC 60601-1, 1988; Amendment 1, 1991; & Amendment 2, 1995.	N/A	Passed
4.4.3.1.A	Range: 0 mmHg to at least 260 mmHg by visual inspection	NIBP pressure calibration	0~300 mmHg	Passed
4.4.3.2.A	Resolution: 1 mmHg by visual inspection	NIBP pressure calibration	1 mmHg	Passed
4.4.3.3.A	Accuracy of pressure measurement: Ambient temp 10°C~40°C; RH: 15%~90%; Pressure stages: 50, 100, 150, 200, 250, 300 mmHg	≤±3 mmHg (±0.4 kPa) or 2% of the reading; ≤±4 mmHg for in use	±3 mmHg	Passed
4.4.3.4.A	Repeatability Cuff-Link simulator test for stability and reproduction of performance Adult: SYS120/DIA80/MAP90 mmHg, 80 BPM Neo: SYS80/DIA50/MAP62 mmHg, 120 BPM	Average difference ≤± 5 mmHg	5 mmHg	Passed
4.4.3.6.A	Leakage: Ambient temp 15°C~~25°C; RH: 20~~85%; Pressure stages: 50, 100, 150, 200, 250 mmHg, wait at least 60 s before reading the values.	≤6 mmHg/min	1.2 mmHg/min	Passed
4.4.4.B	Pressure transducer accuracy: Ambient temp 10℃~40℃; RH: 15%~90%; Pressure stages: 50, 100, 150, 200, 250, 300 mmHg	≤±3 mmHg (±0.4 kPa) or 2% of the reading; ≤±4 mmHg for in use	±3 mmHg	Passed
4.4.5.B	Overall system efficacy-clinical testing (auscultatory method as the reference Std.) no fewer than 85 subjects with a minimum of 255(=3*85) observations	For systolic and diastolic: mean≤±5 mmHg; SD ≤8 mmHg	Mean: Sys/Dia 3.4/-4.5; SD: Sys/Dia 5.23/4.64 mmHg	Passed
4.5.1	Inflation source: pressure~300mmHg≤10s	NIBP pressure calibration: inflate at 5 mmHg/sec; Speed test: Inflation > 5 mmHg/sec	N/A	Passed
4.5.4.3.B	Automated valves-Release rate: rapid exhaust with fully-opened valve	260mmHg → 15mmHg ≤10 sec or 150mmHg → 5mmHg ≤5 sec	deflate at 25 mmHg/sec	Passed
IEC 60601-2-30	Automatic cycling function 1. In long term automatic mode (normal condition) Adult 120/80(90)[SYS/DIA(MAP)]--long term Neonate 80/50(62)[SYS/DIA(MAP)]--long term 2. In long term automatic mode (single fault condition) 3. In short term automatic mode (stat mode)	1. deflated time ≥30 sec; mean≤± 5 mmHg; 2. deflated time ≤30 sec; release cuff pressure to below 15mmHg(adult)/ 5mmHg(neo.); 3. deflated time≥2sec. after each determination	1. average for adults 34 sec / for neonates 42 sec; -4mmHg; 2. <15sec, safety activates; 3. average for adults 3 sec / for neonates 8 sec; --4mmHg	Passed

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Clinical Testing (Test Set): No fewer than 85 subjects with a minimum of 255 observations (3 observations per subject).
Data Provenance: Not explicitly stated, but the submission is from BioCare Corporation (Taiwan), suggesting the study may have been conducted in Taiwan or a related region. The document does not specify if the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The ground truth for the clinical testing was established using the auscultatory method as the reference standard. This method typically involves trained medical professionals (e.g., nurses, doctors) taking manual blood pressure measurements using a stethoscope and sphygmomanometer. The document does not specify the exact number or precise qualifications (e.g., years of experience) of the experts performing the auscultatory measurements for this study.

4. Adjudication Method for the Test Set:

The document implies that the auscultatory measurements served as the direct reference standard. There is no mention of a separate adjudication process involving multiple experts for the clinical ground truth.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study focused on assessing the standalone performance of the device against a known reference standard (auscultatory method), not on the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone performance study was done. The entire set of performance tests, including bench and clinical results, are for the BioCare vTrust 701DH Noninvasive Blood Pressure Monitor operating as a standalone device, without human-in-the-loop intervention beyond the initial application of the cuff and initiation of measurement. The clinical testing specifically compared the device's readings against the auscultatory method.

7. Type of Ground Truth Used:

For the clinical study, the ground truth was established using the auscultatory method (a recognized clinical reference standard for blood pressure measurement). For other performance characteristics, the "acceptance criteria" themselves served as the ground truth, derived from the ANSI/AAMI SP-10: 2002 standard.

8. Sample Size for the Training Set:

The document does not specify a separate training set or its sample size. Blood pressure monitors like this typically operate based on established oscillometric algorithms rather than being "trained" in the machine learning sense with a distinct training dataset that is then validated on a separate test set. The validation here refers to the device's overall performance against the ANSI/AAMI SP-10: 2002 standard and clinical reference.

9. How the Ground Truth for the Training Set Was Established:

As a training set is not explicitly mentioned or implied in the context of the device's validation, the method for establishing its ground truth is not applicable or provided in this document. The device's underlying oscillometric principle is based on known physiological responses and engineering principles, not typically on machine learning model training.

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