(86 days)
The Panasonic Wrist Blood Pressure Monitor, Models EW 3031 and EW 3032 are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
For the EW 3032, display of Normal (green), Prehypertensive (yellow) or Hypertensive (orange) are based on blood pressure values classified in the paper: "JNC Express, The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure" , U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Pressure Institute, National High Blood Pressure Education Program, NIH Publication No 03-5233, May 2003. The display values are generally known, but not proven, to be an indicator of your blood pressure.
The EW 3032 is not intended to be a diagnostic device. Contact your physician if prehypertensive or hypertensive values are indicated.
The Panasonic Wrist Blood Pressure Monitor, Models 3031/3032 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".
Here's an analysis of the acceptance criteria and study information for the Panasonic Wrist Blood Pressure Monitor, Models EW 3031/EW 3032, based on the provided text:
Acceptance Criteria and Device Performance
The provided 510(k) summary primarily focuses on the substantial equivalence of the new device to a predicate device and adherence to industry standards, rather than specific numerical acceptance criteria for blood pressure measurement accuracy.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in text) | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy | Met all relevant requirements of ANSI/AAMI SP10-1992 | Device met all relevant requirements of ANSI/AAMI SP10-1992 for electronic or automated sphygmomanometers. |
| Pulse Rate Measurement | Acceptable performance for pulse rate measurement | Evaluation of Pulse Rate Measurement was performed and deemed satisfactory. |
| Electrical Safety | Met all relevant requirements of IEC 60601-1 | Device met all relevant requirements of IEC 60601-1. |
| Mechanical Performance | Met requirements for reliability (drop, storage, vibrating) | Reliability tests (operation, drop, storage, vibration) were conducted and met relevant requirements. |
| Environmental Performance | Met requirements for EMC | EMC Test was conducted and met relevant requirements. |
| General Safety/Effectiveness | Met requirements of FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" | Device met all relevant requirements of the FDA Reviewer Guidance. |
Important Note: The document states that the devices met "all relevant requirements" of the ANSI/AAMI SP10-1992 standard. This standard provides specific limits for accuracy (e.g., mean difference and standard deviation between automated and reference measurements). However, the specific numerical results from the study (e.g., the actual mean difference and standard deviation) are not provided in this 510(k) summary. The summary only confirms compliance with the standard itself.
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified in the provided document.
- Data Provenance: Not specified. It's implied to be prospective as it's a clinical test performed on the device. No country of origin is mentioned for the clinical study participants.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not specified. ANSI/AAMI SP10-1992 typically requires comparison against trained observers using a reference method (e.g., auscultation with a mercury manometer), but the number of observers and their specific qualifications are not detailed in this summary.
- Qualifications of Experts: Not specified.
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Adjudication Method for the Test Set:
- Not specified. (For blood pressure measurements, ground truth is typically established by trained observers taking repeated measurements, which is then compared against the device. Any discrepancies or methods for resolving them are not detailed.)
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance changes human performance. The Panasonic device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, a standalone study was performed. The clinical testing performed according to ANSI/AAMI SP10-1992 assesses the accuracy of the device (algorithm + hardware) in measuring blood pressure directly against a reference standard, without human intervention in the measurement process itself. The document explicitly states, "Discussion of Clinical Tests Performed: ANSI/AAMI SP10-1992 'National Standard for Electronic or Automated Sphygmomanometers' testing was performed. All relevant sections were addressed and testing conducted. The EW 3031 and EW 3032 met all relevant requirements of this standard."
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Type of Ground Truth Used:
- Expert Consensus/Reference Standard: The ground truth for the clinical study (adhering to ANSI/AAMI SP10-1992) would typically be established by simultaneous or sequential measurements by trained human observers using a validated reference method, such as auscultation with a mercury manometer. The standard provides guidelines for this process.
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Sample Size for the Training Set:
- Not applicable/Not specified. This device uses the "oscillometric method," which is a well-established technique for blood pressure measurement. While internal development and calibration would involve data, the document does not mention a distinct "training set" in the context of a machine learning algorithm. The oscillometric method relies on analyzing pressure oscillations in the cuff, not on a machine learning model trained on a large dataset in the way modern AI is.
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How the Ground Truth for the Training Set Was Established:
- Not applicable/Not specified. As explained above, a dedicated "training set" for a machine learning algorithm is not relevant here. The oscillometric method's principles are based on known physiological responses and signal processing, not on a ground truth established for a neural network.
§ 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).