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The Aerotel Medical Systems (1998) Ltd Tele-CliniQ Data Transmission 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 (purchased separaetly) 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. The Tele-CliniQ is not intended for patients with defibrillators.

The system includes a home blood-pressure measuring device that makes use of the oscillometric system (purchased separately), a means for sending the measurements over the telephone lines to a central station, and a computer program at the central station for receiving the measurements, storing them in a data base, and preparing reports.

The provided document does not contain information about specific acceptance criteria, a detailed study proving the device meets acceptance criteria, or most of the requested study parameters. The submission is a 510(k) summary for a Special 510(k), which typically relies on equivalence to a predicate device rather than extensive new clinical trials.

Here's a breakdown of the available information and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific numerical or qualitative acceptance criteria for clinical performance (e.g., accuracy against a gold standard for blood pressure measurement, data transmission success rate, software reliability metrics, user interface usability guidelines).

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

The document states: "Clinical tests: Not required." This indicates that a specific test set, in the sense of a clinical study cohort, was not used for this 510(k) submission. The FDA clearance is based on the device's technical specifications, validation of its software, and the prior clearance of its associated blood pressure measurement device (UA 767 PC), along with equivalence to a predicate device (Aerotel BP-Tel, K 983717).

Missing Information: Since clinical tests were not required, there is no information on sample size, country of origin, or retrospective/prospective nature of a test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Missing Information: As clinical tests were "not required," no experts were explicitly used to establish ground truth in a clinical study context for this submission.

4. Adjudication Method

Missing Information: No adjudication method is mentioned, as no clinical study with expert review was performed or required.

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

Missing Information: No MRMC study was done, as this refers to comparative studies involving human readers, which are not relevant for a blood pressure data transmission system that aims to digitize and transmit measurements from an already cleared device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is a "Clinical Data Transmission System for Blood Pressure." Its primary function is to transmit data. The "algorithm" here would largely pertain to the data transmission and storage functionalities.

• Non-clinical tests: The MPM (presumably "Medical Patient Monitoring" or similar) software "has undergone extensive validation testing." This would be the closest analogue to a standalone evaluation of the software's data handling capabilities. However, specific performance metrics or a detailed study of this validation are not provided.
• The FDA-cleared UA 767 PC blood pressure monitor itself would have undergone standalone performance evaluation for blood pressure accuracy prior to its clearance.

Missing Information: Specific details of the "extensive validation testing" for the MPM software, including metrics, methodologies, and results that would demonstrate standalone performance.

7. Type of Ground Truth Used

• For the electrical safety and EMC testing, the "ground truth" would be compliance with the respective EN 60950 and electromagnetic compatibility standards.
• For the MPM software validation, the "ground truth" would likely involve software engineering best practices, data integrity tests, and functional requirements to ensure accurate data transmission, storage, and reporting.
• For the blood pressure measurements themselves, the "ground truth" would have been established during the clearance of the UA 767 PC device, likely against invasively measured blood pressure or highly accurate reference non-invasive devices.

Missing Information: Specific details on how ground truth was established for the software validation in terms of what constitutes "accurate" data transmission and storage.

8. Sample Size for the Training Set

Missing Information: The document does not mention a training set, as this type of device (a data transmission system) does not typically involve machine learning or AI models that require a "training set" in the conventional sense. The "training" here would be the development and testing of robust software code.

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

Missing Information: Not applicable, as there is no mention of a training set.

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