(308 days)
The Panasonic wrist blood pressure meter, model EW 284, is intended to measure systolic and diastolic blood pressure using a pressurized cuff worn around the wrist.
The wrist blood pressure meter is a battery-charged non-invasive digital electronic blood pressure meter manufactured by Matsushita Electric Works, Ltd., (MEW) Osaka, Japan. The wrist blood pressure meter is intended to measure systolic and diastolic blood pressure using a pressurized cuff worn around the wrist.
Here's an analysis of the provided text regarding the Panasonic wrist blood pressure meter, model EW284, focusing on acceptance criteria and supporting studies:
I. Acceptance Criteria and Reported Device Performance
The document reports several performance specifications for the EW284 and notes changes from the predicate device (EW279). It does not explicitly state acceptance criteria in the sense of pass/fail thresholds for a study, but rather specifications of the device's design and operation. The study mentioned generally states that the device "passed all tests" to verify that changes haven't affected safety and effectiveness.
| Feature | Acceptance Criteria (as per specifications, for EW284) | Reported Device Performance (Implied from "passed all tests") |
|---|---|---|
| Measurement Range of Pressure | 0-300 mm Hg | Met (implied) |
| Noise Safety Specification | Less than 65 dB at 1 m from main unit | Met (implied) |
| Error Margin Performance | ± 5 beats per min | Met (implied) |
| Pressurization Performance | From 0 to 180 shall be less than 20 seconds | Met (implied) |
| Data Memory and Retention | Memory function for 60 readings | Met (implied) |
II. Sample Size Used for the Test Set and Data Provenance
The document states: "Hardware and software testing was conducted to verify that the changes made to model EW284 have not affected the safety and effectiveness of this device."
- Sample Size for Test Set: Not specified. The document does not provide details about the number of devices tested or the number of measurements taken.
- Data Provenance: Not specified, but the device is manufactured by Matsushita Electric Works, Ltd., Osaka, Japan, suggesting the testing likely occurred in Japan. The study is retrospective in the sense that it's performed on the completed device for regulatory submission, but the data itself could be prospectively collected during the testing phase.
III. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for blood pressure measurements in this context would typically be established by a reference method (e.g., a mercury sphygmomanometer calibrated against known standards) rather than by expert consensus. The document does not describe the specific methodology for establishing measurement accuracy (e.g., comparison to a trained observer using a stethoscope and sphygmomanometer).
- Qualifications of Experts: Not applicable, as expert consensus is not the stated method for determining ground truth in blood pressure device testing.
IV. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The document describes technical performance testing rather than studies involving human interpretation or subjective assessment that would require adjudication.
V. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human interpretation is a key component, not for an automated measurement device like a blood pressure monitor.
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study was performed and the device is not an AI-assisted diagnostic tool for human readers.
VI. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Yes, the described "Hardware and software testing" would inherently be a standalone performance evaluation of the device's ability to measure blood pressure according to its specifications. The document implies that the device operates independently to perform its measurement function.
VII. The Type of Ground Truth Used
- Type of Ground Truth: The document does not explicitly state the type of ground truth used. For blood pressure monitors, the ground truth for accuracy testing is typically obtained through a reference standard measurement, such as simultaneous measurement by a trained observer using a calibrated mercury sphygmomanometer or an oscillometric device that has been independently validated to a recognized standard (e.g., ISO 81060-2, AAMI, BHS). The "Error margin performance specification" of "± 5 beats per min" refers to pulse rate, not blood pressure accuracy directly, but it still implies comparison to a known standard.
VIII. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a hardware-based electronic blood pressure meter, not a machine learning or AI-based system that requires a "training set" in the computational sense. Its operation is based on predefined algorithms and physical principles, not learned patterns from a dataset.
IX. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the context of this device.
§ 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).