(156 days)
FDBP A series Upper Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse and children at least 12 years of age, at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia). with the cuff around the left upper arm according to the instruction in the user's guide manual.
FDBP A series Upper Arm Blood Pressure Monitor (Model:FDBP-A8,FDBP-A11,FDBP-A12,FDBP-A14 )includes utilize modular design method, It consists of nine main modules: power-on self-test module, system initialization module,sampling data processing and pressure, pulse rate calculation module, display processing module, power detection processing module, data storage module, key scanning processing module, sampling processing module, voice broadcast processing module, and each module communicates through a message queue. The blood pressure monitor controls the pneumatic flow control module through singlechipped microcomputer to pressurize the cuff module in order to exceed the lower pressure of patients, the blood being pushed against the artery walls; Pneumatic Flow Control Module being directed to release the pressure, while the pressure detection module collect pulse pressure signal and amplify filter; amplified filtersignal being read by single-chipped microcomputer for pressure and pulse signal,through unique algorithm to obtain the systolic and diastolic pressure with pulse; Single-chipped microcomputer will control the inflation module to release the pressure after receive measurements; in the meanwhile, display the measurements results then stored the values with memory module.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Level (from Predicate Device/Standards) | Reported Device Performance (FDBP A Series) | Met? |
|---|---|---|---|
| Measuring Range | Pressure: 0~280 mmHg | Pressure: 0~280 mmHg | Yes |
| Pulse: 40~199 beats/minute | Pulse: 40~200 beats/minute | Yes | |
| SYS (systolic pressure): 60-255 mmHg | SYS (systolic pressure): 60-255 mmHg | Yes | |
| DIA (diastolic pressure): 40-200 mmHg | DIA (diastolic pressure): 40-200 mmHg | Yes | |
| Pressure Resolution | 1 mmHg or 0.1 kPa | 1 mmHg or 0.1 kPa | Yes |
| Accuracy | Pressure: ±3 mmHg (±0.4 kPa) | Pressure: ±3 mmHg (±0.4 kPa) | Yes |
| Pulse: ±5 % | Pulse: ±5 % | Yes | |
| Performance Standard | ANSI/AAMI/ISO 81060-2 | Complies with ANSI/AAMI/ISO 81060-2 | Yes |
| Electrical Safety Standard | IEC 60601-1 | Complies with IEC 60601-1 | Yes |
| EMC Standard | IEC 60601-1-2 | Complies with IEC 60601-1-2 | Yes |
| Home Use Standard | IEC 60601-1-11 | Complies with IEC 60601-1-11 | Yes |
| Performance Standard | IEC 80601-2-30 | Complies with IEC 80601-2-30 | Yes |
| Biocompatibility Standard | ISO 10993-5, -10 | Complies with ISO 10993-5, -10 | Yes |
Study Proving Acceptance Criteria:
The studies conducted for the FDBP A Series Upper Arm Blood Pressure Monitor are divided into "Non-Clinical Data" and "Clinical Data."
2. Sample Size Used for the Test Set and Data Provenance:
- Non-Clinical Data:
- The document does not explicitly state the sample size for individual biocompatibility, electrical safety, EMC, or bench testing. However, it indicates these tests were conducted on "all the modules and accessories in the system" and "all the patient contracting materials."
- Data Provenance: Not specified, but given the manufacturer is Famidoc Technology Company Limited (China), it's highly probable the testing was conducted in China or by labs contracted by the Chinese manufacturer. The document doesn't specify if it's retrospective or prospective for non-clinical testing.
- Clinical Data:
- The document states: "Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers -Part 2: Clinical validation of automated measurement type."
- ISO 81060-2: 2013 typically requires a specific number of subjects for clinical validation. While the exact number is not provided in this document, the standard generally mandates a minimum of 85 subjects for validation in a mixed population.
- Data Provenance: Not explicitly stated, but likely from a clinical study conducted either within China or a region where compliance with ISO 81060-2 is standard. The document doesn't specify if it's retrospective or prospective, but clinical validation studies are inherently prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- For the clinical validation (per ISO 81060-2):
- ISO 81060-2 requires that the reference blood pressure measurements (the "ground truth") be obtained by at least two trained observers using a mercury sphygmomanometer or an equivalent validated reference device.
- Qualifications of Experts: These observers must be specifically trained and certified to perform accurate auscultatory blood pressure measurements, adhering to strict protocols outlined in the standard. The document does not provide specific details on the individual qualifications of the "two trained observers" used in this particular study, but it is a prerequisite of the standard cited.
4. Adjudication Method for the Test Set:
- For the clinical validation (per ISO 81060-2):
- The standard dictates a specific methodology where simultaneous (or near-simultaneous) measurements are taken by the device under test and the two trained observers. The average of the two observers' measurements typically serves as the reference (ground truth). Discrepancies between the observers' measurements might trigger re-measurements or specific rules for reconciliation, but a formal "adjudication" in the sense of a third expert resolving disagreements is not always explicitly a primary step unless the initial agreement criteria are not met. The document does not specify the exact adjudication method (e.g., 2+1, 3+1) beyond compliance with ISO 81060-2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance:
- Not applicable. This device is an automated blood pressure monitor for direct blood pressure measurement, not an AI-assisted diagnostic imaging device or an interpretation tool involving human "readers." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this type of medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, this is a standalone device. The FDBP A Series Upper Arm Blood Pressure Monitor is an automated device designed to measure blood pressure without human intervention in the measurement process (once the cuff is applied and the device activated). The "algorithm only" performance is the core function of such a device. The clinical validation conducted under ISO 81060-2 is precisely a standalone performance evaluation against a human-read auscultatory reference.
7. The Type of Ground Truth Used:
- Expert Consensus (Auscultatory Reference): For the clinical validation, the ground truth for blood pressure measurements is established by trained human observers using the auscultatory method (typically with a mercury sphygmomanometer or a validated equivalent), following the protocols defined in ISO 81060-2. This is considered an "expert consensus" in the context of blood pressure measurement.
8. The Sample Size for the Training Set:
- Not applicable/Not explicitly stated. As an automated blood pressure monitor, the device's core functionality relies on a pre-defined oscillometric algorithm rather than a "training set" in the context of machine learning or AI models. While the algorithm itself would have been developed and refined using data (which could be loosely considered "training"), the document does not provide details on such a training dataset or its size. The primary validation focuses on its clinical performance against expert-derived ground truth.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not explicitly stated. Similar to point 8, the document does not detail a "training set" for an AI algorithm. If an algorithm development process involved data, the ground truth for that development would likely have been established through a combination of simulated data, data from calibration devices, and potentially earlier validation studies against auscultatory measurements. However, the document does not provide these specifics.
§ 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).