(28 days)
ZSBP-003/004/005/006/007/008 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the patient of the age over 18 years old.
ZSBP-102/103/104/105/106/107 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the patient of the age over 18 years old.
All measurement values can be read out and keep memory on the LCD panel for home care use.
Basically the measuring system were composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at wrist or upper arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software... and so on.
The main operation for the blood pressure measurement is carried out in such a way that the measuring cuff at wrist or upper arm is inflated to the estimated pressure level, then deflated to zero automatically. During the inflation, the pressure change with respective of time were recorded as the data base of measurement. Then the following measuring results will be calculated against the measurement data base:
- Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method)
- Heart beat rate.
The provided text describes a 510(k) submission for a blood pressure monitor and does not contain detailed information about a specific study proving the device meets acceptance criteria. Instead, it refers to compliance with voluntary standards and verification/validation tests.
Here's a breakdown of what can be inferred and what is not present in the provided document, based on the requested categories:
1. A table of acceptance criteria and the reported device performance
The document states "Compliance to applicable voluntary standards includes ANSI/AAMI, SP 10," which is the standard for non-invasive sphygmomanometers. This standard dictates specific accuracy requirements for blood pressure measurements.
| Acceptance Criteria (Based on ANSI/AAMI SP 10, inferred) | Reported Device Performance |
|---|---|
| Blood Pressure Measurement Accuracy | |
| Mean difference between device and reference measurement: ≤ ±5 mmHg | Not explicitly stated. The submission states that V&V tests demonstrate the device "maintain the same safety and effectiveness as that of cleared devices" which comply with ANSI/AAMI SP 10. |
| Standard deviation of difference between device and reference measurement: ≤ 8 mmHg | Not explicitly stated. |
| Heart Rate Measurement Accuracy | Not explicitly stated. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission mentions "verification and validation tests" but does not detail the methodology, sample size, or data provenance of these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For blood pressure monitors, ground truth is typically established by trained technicians using a reference sphygmomanometer (e.g., mercurial manometer) in a clinical setting.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is not applicable to this device. Blood pressure monitors are standalone measurement devices and do not involve "human readers" or AI assistance in their primary function of measuring blood pressure from a patient.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, this is the primary mode of operation for a blood pressure monitor. The device is intended to automatically measure blood pressure and heart rate using an oscillometric method. The "verification and validation tests" would assess this standalone performance against reference measurements. However, the details of these tests (e.g., specific metrics, results) are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implicitly refers to reference blood pressure measurements as the ground truth. For accuracy testing of blood pressure monitors, the established practice (as per ANSI/AAMI SP 10) involves comparing the device's readings to those obtained simultaneously from a validated reference method (e.g., a mercury sphygmomanometer) by trained observers.
8. The sample size for the training set
This information is not provided in the document. Blood pressure monitors using the oscillometric method rely on algorithms that are typically developed and refined using extensive physiological data. The size of this underlying development/training data set is not specified.
9. How the ground truth for the training set was established
This information is not provided in the document. For an oscillometric blood pressure monitor, the ground truth for algorithm development would generally involve simultaneous recordings of cuff oscillations and invasive arterial pressure (or highly accurate non-invasive reference measurements) across a diverse population.
Summary of what the document does indicate regarding acceptance criteria and study:
The submission implies that the device meets acceptance criteria by:
- Stating "Compliance to applicable voluntary standards includes ANSI/AAMI, SP 10." This standard itself contains detailed acceptance criteria for non-invasive sphygmomanometers.
- Reporting that "verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared devices [ZSBP-001, ZSBP-002, and ZSBP-101 (K070473)]."
- The FDA's clearance (K090027) indicates that these tests were sufficient to demonstrate substantial equivalence to predicate devices, which were themselves compliant with relevant standards.
However, the document does not provide the specific numerical results of the performance tests, the sample sizes, expert qualifications, or detailed methodology of the studies conducted for this specific device (ZSBP-003/004/005/006/007/008 and ZSBP-102/103/104/105/106/107). It relies on the assertion of compliance with standards and equivalence to previously cleared devices.
§ 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).