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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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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.

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.

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