(73 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.
Environments of Use: Home Patient Population: Adult
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 a breakdown of the acceptance criteria and study details for the Omron HEM-7311, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy of pressure indicator | Within ± 3 mmHg or 2 % of reading | Within ± 3 mmHg or 2 % of reading (Identical to predicate) |
| Accuracy of pulse rate | Within ± 5% of reading | Within ± 5% of reading (Identical to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 85 patients (39 males, 46 females)
- Data Provenance: Not explicitly stated, but the study was conducted to demonstrate clinical accuracy based on ANSI/AAMI/ISO 81060-2. This standard is an international standard for non-invasive sphygmomanometers, suggesting the study adheres to globally recognized clinical validation protocols. The document is from Omron Healthcare, Inc., located in Lake Forest, IL, USA, but this doesn't definitively indicate the country of origin for the clinical data itself.
- Retrospective or Prospective: The description "Eighty five patients... were recruited for the study" indicates a prospective study design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document states that the "Standard auscultation method was used as the reference blood pressure (BP) measuring." This implies that trained medical professionals, such as physicians or nurses, performed the auscultatory measurements and served as the 'experts' in establishing the ground truth. However, the specific number of experts and their qualifications (e.g., number of years of experience, specific certifications) are not detailed in the provided summary.
4. Adjudication Method for the Test Set
The study followed a protocol where "BP measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in AAMI." This description suggests a direct comparison method rather than a multi-reader adjudication process typically seen in image-based diagnostics. For blood pressure measurements, the auscultatory method itself is considered the "ground truth" reference, and the device's readings are compared against it. Therefore, a formal adjudication method like "2+1" or "3+1" that resolves discrepancies between multiple readers is not applicable in this context, as the reference is a clinical measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging devices where human readers interpret images with and without AI assistance. The Omron HEM-7311 is a blood pressure monitor, and its accuracy is validated directly against a reference measurement method (auscultation), not against human interpretation of an output that could be assisted by AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the clinical accuracy testing described in "Clinical Testing Summary" is a standalone evaluation of the device's algorithm performance. The device takes measurements, and its reported values are compared directly against the auscultatory reference. There is no human involved in interpreting the device's output to make a diagnosis; the device itself provides the numerical blood pressure and pulse rate readings.
7. The Type of Ground Truth Used
The ground truth used was expert clinical measurement (auscultation). The summary states: "Standard auscultation method was used as the reference blood pressure (BP) measuring in the left upper arm."
8. The Sample Size for the Training Set
The provided text does not specify a separate "training set" sample size or details about a training process for the device's algorithm. The available information describes the clinical validation study (test set). For a blood pressure monitor based on oscillometric methods, the core algorithm is typically developed and refined during the product development phase using engineering data and potentially internal, non-clinical datasets, rather than reporting a specific "training set" in the context of a 510(k) summary for clinical accuracy.
9. How the Ground Truth for the Training Set Was Established
Since no specific "training set" or its ground truth establishment is mentioned in the provided 510(k) summary, this information is not available in the given text.
§ 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).