(120 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 an Omron specified cuff to encompass arms ranging from 9 to 17 inches in circumference. The device also detects the appearance of irregular heartbeats during measurement. The device has provisions for selecting two users, measurements from these users are stored in memory. The memory stores up to 100 of the latest measurements. It can also display an average of the last three values.
Here's an analysis of the Omron HEM-7320's acceptance criteria and the study conducted, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Omron HEM-7320 are based on industry standards for non-invasive blood pressure monitors, specifically ANSI/AAMI/ISO 81060-2 (which replaced SP10). The reported device performance is that it met all requirements.
| Acceptance Criteria (Standard: ANSI/AAMI/ISO 81060-2) | Reported Device Performance |
|---|---|
| Clinical accuracy of blood pressure measurement | Met requirements |
Note: The document states the device "met all requirements specifications and standards requirements and were found to be equivalent in comparison to the predicate" and "Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2 as documented in Section 20." However, specific numerical results like mean difference and standard deviation of differences as per the standard (e.g., AAMI's ±5 mmHg mean difference and 8 mmHg standard deviation for validation) are not explicitly detailed in this summary. The table infers "Met requirements" based on the general statement provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Eighty-five patients (40 males and 45 females) were recruited for the clinical study.
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be prospective as patients were "recruited" for the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated, but the reference method was "Standard auscultation method." This implies human observers (clinicians/technicians) were performing the auscultation.
- Qualifications of Experts: Not explicitly stated, but they would be trained in performing standard auscultatory blood pressure measurements.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly mentioned. The "Standard auscultation method" was used as the reference.
- Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm. The sequence followed AAMI guidelines. This suggests a direct comparison method rather than an adjudication process between multiple experts for the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone accuracy of the device against a reference method (auscultation), not on how human readers' performance might improve with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Study: Yes, a standalone performance study was conducted. The clinical testing assessed the accuracy of the HEM-7320 device itself against the standard auscultation method, as per ANSI/AAMI/ISO 81060-2. This is a measure of the device's algorithmic performance.
7. Type of Ground Truth Used
- Type of Ground Truth: Expert consensus via "Standard auscultation method" was used as the reference blood pressure measurement.
8. Sample Size for the Training Set
- Sample Size: The document does not provide a sample size for a training set. This is a blood pressure monitor, and while it uses software and signal analysis, the typical development process for such a device (especially from 2014) would involve engineering development, calibration, and validation against a reference standard, rather than a "training set" in the machine learning sense. The clinical study described is a validation study.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable as a distinct training set (in the machine learning context) is not mentioned. The device's underlying algorithm is based on the oscillometric method, which is a well-established principle for blood pressure measurement, not typically "trained" on a dataset in the way an AI model would be. The clinical study serves to validate the device's accuracy against recognized standards.
§ 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).