(292 days)
The device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patient (age 20-70) population with wrist circumference ranging from 13.5 cm to 21.5 cm and BMI
Accurate 24 Non-Invasive blood pressure monitor device is a small, lightweight, handheld device intended to measure and display blood pressure trending (Systolic and Diastolic) and spot-check of pulse rate. Measurement is performed on the wrist of the radial artery. This blood pressure monitor uses the pulse wave transit time with the hemodynamic method to measure the systolic and diastolic blood pressure and pulse rate. This device serves to measure the systolic and diastolic blood pressure and pulse rate of adults in a non-invasive manner.
The Accurate 24 Non-invasive blood pressure monitor was evaluated according to ISO 81060-2:2018 and IEEE 1708:2014 [Including: Amendment 1(2019)].
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (ISO 81060-2:2018) | Achieved SBP (mmHg) | Achieved DBP (mmHg) | Results SBP | Results DBP |
|---|---|---|---|---|---|
| Means (Bias) | ±5 mmHg | 1.67 | 1.01 | Pass | Pass |
| Standard Deviation (Criterion 1) | ≤ 8 mmHg | 4.04 | 5.32 | Pass | Pass |
| Standard Deviation (Criterion 2) | ≤ 6.76/6.87 mmHg | 2.73 | 3.55 | Pass | Pass |
2. Sample size used for the test set and data provenance:
- Total Subjects: 376 subjects were included in the clinical validation study.
- General Accuracy Study: 114 subjects (73 male, 41 female, aged 20-70 years) for the primary endpoint.
- Confounding Factors Study: 286 subjects were independently recruited across three groups:
- Fitzpatrick Scale Type 5 & Type 6
- Ages 51-70 years
- BMI Grade I & II
- Data Provenance: Not explicitly stated, but the study was conducted to meet international standards (ISO 81060-2:2018 and IEEE 1708:2014), suggesting a clinical trial setting. It is likely a prospective study as subjects were "included" and "recruited" for the validation.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
The ground truth was established by comparing the Accurate 24 BPM to a reference device, the "Welch Allyn DuraShock DS66 Trigger Aneroid." This is a commercially available and clinically accepted manual blood pressure device. The study design implies that trained medical professionals or technicians measured blood pressure using this reference device. The number of such "experts" is not specified, but standard clinical practice for such studies would involve multiple trained personnel. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed beyond their ability to accurately use the reference device.
4. Adjudication method:
The document does not explicitly describe an adjudication method for the test set, such as 2+1 or 3+1. The ground truth appears to be based on direct comparison to the Welch Allyn DuraShock DS66 Trigger Aneroid, which serves as the reference measurement. Discrepancies, if any, would likely be handled by repeated measurements or adherence to strict protocol for the reference device, rather than a separate expert adjudication panel.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone accuracy of the device against a reference standard, not its impact on human readers' performance with and without AI assistance.
6. Standalone performance (algorithm only without human-in-the-loop performance):
Yes, a standalone performance study was done. The entire clinical evaluation described focuses on the accuracy of the Accurate 24 BPM device itself, comparing its measurements to those obtained by a reference blood pressure monitor. There is no mention of human-in-the-loop assessment or AI assistance for human readers in this context.
7. Type of ground truth used:
The ground truth used was comparison to a clinically accepted reference device, specifically the "Welch Allyn DuraShock DS66 Trigger Aneroid." This is a form of clinical reference standard comparison for blood pressure measurements.
8. Sample size for the training set:
The document does not specify a separate training set or its sample size. The description of clinical performance data is related to the validation/test set. It is common for such devices to be developed and internally validated using proprietary datasets, but this information is not provided in a regulatory submission summary.
9. How the ground truth for the training set was established:
As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is not provided in this document.
§ 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).