(58 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
The device is an automatic non-invasive blood pressure system. The device is battery powered and can also be powered from an IEC 60601-1 compliant AC adaptor. The device inflates a cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During deflation the cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic pressure. The device is intended to be used with specified Omron cuffs in three sizes to encompass arms ranging from 9 to 17 inches in circumference. The device also detects the appearance of irregular heartbeats during measurement.
Here's a breakdown of the acceptance criteria and the study details for the Omron HEM-7200-Z (BP742) device, based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Device Performance (Reported) |
|---|---|
| Accuracy (Pressure) | +/- 3 mmHg or 2% of reading |
| Accuracy (Pulse Rate) | +/- 5% |
| Measurement Range (Pressure) | 0-299 mmHg |
| Measurement Range (Pulse Rate) | 40 to 180 bpm |
| Compliance with ANSI/AAMI/ISO 81060-2 | Met the standard in clinical accuracy testing |
Study Proving Device Meets Acceptance Criteria
The primary study mentioned to demonstrate clinical accuracy is:
- Clinical Accuracy Testing in accordance with ANSI/AAMI/ISO 81060-2.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 85 adults.
- Data Provenance: Not explicitly stated whether retrospective or prospective, or country of origin, but given it's a clinical accuracy study, it's typically prospective.
3. Number of Experts and Qualifications for Ground Truth
This information is not explicitly provided in the given text. For blood pressure clinical accuracy studies, "ground truth" (reference measurements) is usually established by trained observers using a certified sphygmomanometer and stethoscope, following specific protocols (e.g., European Society of Hypertension, British Hypertension Society, or AAMI standards). The expertise would relate to their training in blood pressure measurement, not necessarily a specific clinical specialty like "radiologist with 10 years of experience."
4. Adjudication Method for the Test Set
This information is not explicitly provided in the given text. In blood pressure accuracy studies, adjudication often involves multiple observers taking independent measurements and their readings being averaged or compared. It's not typically framed as a "2+1" or "3+1" like in image interpretation studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with AI in interpretation tasks (e.g., radiology) where human readers are assisted by AI. The device in question is a standalone blood pressure monitor, not an AI assistance tool for human interpretation.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done in the form of "clinical accuracy testing of the device in accordance with ANSI/AAMI/ISO 81060-2." This standard assesses the algorithm's performance against reference measurements, without human-in-the-loop interpretation or assistance.
7. Type of Ground Truth Used
- Expert Consensus / Reference Measurement: The "ground truth" for blood pressure accuracy testing according to ANSI/AAMI/ISO 81060-2 standards involves comparing the device's readings to those taken by trained observers using a validated reference method (e.g., auscultatory method with a mercury sphygmomanometer or an equivalent standard). This is analogous to an "expert consensus" on the true blood pressure.
8. Sample Size for the Training Set
- The text does not provide information regarding a separate "training set" sample size. The device uses an "oscillometric" technology with a "software algorithm" that is stated to be "identical to that used in the predicate Omron HEM-741CRELN 510(k) K052153." This implies that the algorithm was likely developed and "trained" (or validated during development) on prior data, but details of that specific dataset are not presented for this submission. The 85 adults refers to the test set for clinical validation.
9. How Ground Truth for the Training Set Was Established
- This information is not explicitly provided in the given text. As noted above, the algorithm is stated to be identical to a predicate device's algorithm, suggesting its development and "training" occurred prior to this submission, likely following similar clinical validation methodologies for its initial development.
§ 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).