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The Panasonic wrist blood pressure meter, model EW280, 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 510(k) summary regarding the Panasonic Wrist Blood Pressure Meter, Model EW280, focusing on acceptance criteria and the study conducted.

Acceptance Criteria and Device Performance for Panasonic Wrist Blood Pressure Meter, Model EW280

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance acceptance criteria for a novel device. The performance data presented primarily addresses verification that modifications to the new model (EW280) did not negatively impact the safety and effectiveness compared to the cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: For most features, the "acceptance criteria" for the EW280 appear to be the specifications of the predicate device (EW273), or in some cases, an explicit modification that is still deemed acceptable (e.g., simultaneous display as seen in EW279). The performance of the EW280 is implicitly stated as meeting these modified specifications, as the document concludes that "All devices passed all tests and are qualified for use."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the sample size used for the performance testing. It simply states that "Hardware and software testing was conducted".
• Data Provenance: The manufacturer is Matsushita Electric Works, Ltd., Osaka, Japan, implying the testing likely occurred in Japan. The type of study is a verification and validation (V&V) study, not a clinical trial. It is an internal study by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• This information is not applicable and not provided in the document. The testing described is component/device-level performance testing, not human-read clinical evaluation that would require expert ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving interpretation of data, not in hardware/software performance verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or similar devices where different human readers interpret cases. The document describes hardware and software performance verification.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

• The document describes standalone performance testing of the device (EW280). While it doesn't use the term "algorithm only," the testing focuses on the device's inherent functional performance (e.g., measurement range, accuracy of beats per minute, pressurization time, noise safety) without a human-in-the-loop component for interpretation. The device itself is an automated measurement system.

7. The Type of Ground Truth Used

• For the performance testing, the ground truth would be established through scientific measurement standards and calibrated equipment. For example, to verify the "Error margin performance specification" for pulse rate, a validated reference signal generator or a highly accurate reference device would be used. Similarly, a calibrated pressure gauge would be the ground truth for pressurization accuracy.

8. The Sample Size for the Training Set

• This information is not applicable and not provided. This device is an electronic blood pressure meter, not an AI/ML-driven device that requires a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

• This information is not applicable as there is no "training set" for this type of medical device as described in the 510(k) summary.

In summary, the 510(k) for the Panasonic Wrist Blood Pressure Meter, Model EW280, is a substantial equivalence submission. The "study" referenced is hardware and software testing designed to confirm that manufacturing changes and minor technical modifications to the EW280 do not adversely affect its safety and effectiveness when compared to previously cleared predicate devices. It is not a clinical study involving human subjects or AI/ML algorithms, and therefore many of the requested details related to those types of studies are not present in this document.

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