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The device is used to provide data to qualified medical personnel or trained users for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period. Measurements of systolic, diastolic, and heart rate are made and stored. The device can also be used to provide blood pressure and heart rate data in single measurement mode. The device is also intended to provide preliminary blood pressure data from ambulatory patients for non-time critical applications only. It is for use in hospitals, clinics or physicians offices by a qualified physician or trained staff member under the supervision of that physician. It is also intended for home care use by a trained patient with periodic health consultations from his or her physician.

Patient diagnosis is not to be performed solely based on the results of this device.

The Model PIESOMETER MK-1 Digital Blood Pressure Monitor measures systolic and diastolic blood pressure and heart rate using adaptive interference cancellation (signal processing) technologies. The system employs three acoustic sensors (i.e. microphones) in the electronic pressure cuff. During a blood pressurement, two acoustic sensors are placed in the traditional location on the patient's biceps. This set of sensors, operating much like a conventional stethoscope, senses the Korotkoff sounds. Unique to the PIESOMETER MK-1 is a second set of a sensor placed in the triceps area. This sensor serves to detect any interference signals that would normally compromise the reading. This allows reading to be taken even in noise and vibration intensive environment. This technology functions by identifying signals lying within the audio frequency and filtering out the interference signal. The CANAMET PIESOMETER is protected by U.S. Patent 6,520,918.

The provided text describes the PIESOMETER MK-1, a non-invasive automated blood pressure meter, and its FDA 510(k) summary for substantial equivalence. However, it does not contain explicit acceptance criteria or a detailed study description with specific performance metrics and statistical analyses to prove the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices (Spacelabs ABP and SunTech Accutracker DX) based on design and functional similarity. It broadly states that "The results of bench and user/clinical testing indicate that the new device is as safe and effective as the predicate devices," but does not provide the results of these tests in a quantifiable manner or against predefined acceptance criteria.

Therefore, much of the requested information cannot be extracted directly from the provided text. I will indicate where information is missing.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided text. The document refers to "bench and user/clinical testing" but does not provide details on the number of subjects or cases included in these tests.
   • Data Provenance: Not specified. It is unclear if the data was collected retrospectively or prospectively, or the country of origin.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts & Qualifications: Not specified. The document does not describe the methodology for establishing ground truth for any clinical testing that might have been performed.

3. Adjudication method for the test set:

   • Adjudication Method: Not specified. There is no information about how discrepancies or variations in "ground truth" measurements (if any were used) were resolved.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • MRMC Study: No, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or described. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Standalone Performance: The general claim of "safe and effective as the predicate devices" for the PIESOMETER MK-1 implies a standalone performance evaluation of the device's ability to measure blood pressure and heart rate. However, specific performance metrics are not provided. The device is an automated blood pressure meter, so its primary function is standalone measurement.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Type of Ground Truth: Not explicitly stated. For blood pressure devices, the typical ground truth involves comparison to a validated reference method, such as a mercury sphygmomanometer or an oscillometric device that has been independently validated, often with readings taken by trained clinicians. This detail is missing.

7. The sample size for the training set:

   • Sample Size for Training Set: Not specified. The document details the device's technology ("adaptive interference cancellation (signal processing) technologies") but does not provide information about a "training set" in the context of machine learning or AI. It's possible that the "signal processing" algorithms were developed using internal data, but no specifics are given.

8. How the ground truth for the training set was established:

   • Ground Truth for Training Set: Not specified. Given the lack of information on a "training set" and its methodology, how ground truth for such a set was established is also not present in the document.

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