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The Aerotel MPM SYSTEM is indicated when patients use with home patient monitoring devices (blood pressure, digital scale, blood glucose level, respiratory peak flow, pulse oximetry) and wish to send the measured data to a central station via modem by telephone, where reports can be generated for the physician and reports can be received over the Internet by physicians and patients.

The system comprises a modem-like device that connects to various cleared measurement devices and a central station program that keeps the records of the patients, and makes the reports available ... the internet.

The Aerotel Medical Systems (1998) Ltd. MPM System functions as a device simplifying the transmission of patient health data from home monitoring devices to a central station for review by physicians and patients.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, error rates for data transmission). Instead, the acceptance is based on the system's ability to satisfactorily pass internal tests and its equivalence to predicate devices.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not mentioned. The document states, "The system has been tested with all of the compatible measuring units," but doesn't specify how many tests were run, the number of data points, or the number of patients/users involved in these "non-clinical tests."
• Data Provenance: The tests are described as "Non-clinical tests," implying laboratory or internal testing rather than real-world patient data. There is no information regarding the country of origin of this data, but given the company's location in Israel and the regulatory submission to the FDA in the US, it's likely conducted internally without external patient data. The study is retrospective in the sense that completed tests were reviewed for the submission.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned. The "satisfactorily passed the tests" statement implies internal review by the company's technical personnel, but no specifics are provided.

4. Adjudication Method for Test Set

• Adjudication Method: Not mentioned. The nature of the non-clinical tests suggests internal validation against pre-defined functional specifications rather than an external human adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "Clinical tests are not necessary because the device does not use new technology." The device's primary function is data transmission, not diagnostic interpretation by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device's intended use according to the submission.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the described "Non-clinical tests" and "software... extensively validated" can be considered a form of standalone performance evaluation for the system's data transmission and processing functions. The device is intended to operate automatically in transmitting data. However, specific metrics (e.g., data transmission error rates, uptime) are not provided, only the general statement that it "satisfactorily passed the tests."

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the non-clinical tests would likely be functional specifications and expected data output. For example, if a blood pressure reading of "120/80" was input from a compatible device, the ground truth would be that the system should accurately transmit and present "120/80" at the central station without corruption or error. There would be no "expert consensus," "pathology," or "outcomes data" in the traditional medical sense, as this device's role is data conduit.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. The MPM System, as described, is a data transmission system and not an AI/machine learning device that 'learns' from a training set of data to make predictions or classifications. Therefore, the concept of a "training set" in the context of AI development is not relevant here.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI/machine learning model.

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The Aerotel Medical Systems (1998) Ltd. MPM-Net system is intended to be used by patients to measure their blood pressure at home and transmit it to a central station by telephone. The system includes both the patient unit and a central computer program (to be used in a Personal Computer) which receives the blood pressure data, stores it in a patient's record, and prepares reports and charts showing the history of the systolic, diastolic pressures and the heart rate. The system is not intended for patients with defibrillators.

The MPM-Net is an option for a modem/dialer system adapted for the purpose of following patients' blood pressures. It operates in conjunction with a cleared home-use blood pressure device. The system includes the computer program at a central station used for receiving data and preparing reports. The option allows reports to be retrieved over the internet.

The provided K030825 document is a 510(k) summary for the "MPM-Net" device. It is essentially an administrative filing to demonstrate equivalence to a predicate device, not a report of a scientific study designed to establish new performance criteria. Therefore, the document explicitly states there were no clinical tests performed for this specific submission to demonstrate accuracy or performance.

Here's a breakdown based on the information provided and the absence of certain elements:

1. A table of acceptance criteria and the reported device performance

• Explanation: The document does not define specific performance acceptance criteria (e.g., accuracy, precision) for blood pressure measurement, nor does it report numerical device performance metrics for the MPM-Net itself. It relies on demonstrating equivalence to predicate devices which would have undergone such testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: 0 (No clinical tests were performed for this submission).
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable.

5. 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 study was not done. The device is a blood pressure monitor and transmission system, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance: Not applicable in the context of this 510(k) submission. The device is a system that includes a home blood pressure monitor and a transmission system, not a standalone algorithm for diagnostic interpretation. The emphasis is on the transmission and reporting capabilities.

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

• Type of Ground Truth: Not applicable for this submission as no clinical tests were performed. For the predicate blood pressure monitors, the ground truth would typically be established through comparison with a reference standard validated blood pressure measurement device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. The document does not describe a machine learning algorithm or a "training set" in the context of its development. The validation mentioned was for the system itself (software validation, electrical/mechanical characteristics), not the training of an AI model.

9. How the ground truth for the training set was established

• How Ground Truth was Established: Not applicable.

Summary of the Study (as described in K030825):

The document explicitly states: "No clinical tests were performed."

Instead, the study to demonstrate the device meets acceptance criteria (which are implicitly tied to the predicate devices) relied on:

• Non-clinical tests: "The modifications were validated by a validation test for the system." This likely refers to engineering, software, and functional testing to ensure the modifications (primarily the internet retrieval of reports) work as intended and do not negatively impact the core functionality, which is the transmission of blood pressure data.
• Comparison to Predicate Devices: The primary argument for safety and effectiveness is that the "MPM-Net is a modified version of the predicate device. It has basically the same electrical and mechanical characteristics, and the use of the two devices by the patient is equivalent. It permits the reports to be retrieved over the internet." The predicate devices (BP-Tel K983717 and TeleCliniQ K021447) would have undergone their own clinical testing to establish accuracy and performance. This 510(k) relies on the established safety and effectiveness of those predicates, asserting that the new modification (internet reporting) does not alter the fundamental performance or safety.

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