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ENSEMBLE includes the essential features of a central station monitor for up to 12 patients. It can display vital signs information collected from bedside patient monitoring devices such as: ECG/Heart Rate, Arrhythmia (basic and extended alarms), ST Segment, Respiration, Temperature, Invasive Blood Pressure, Noninvasive Blood Pressure, Pulse Oximetry, and End Tidal carbon-dioxide. The ENSEMBLE may be used in system application in many different clinical specialties within the hospital.

The Ensemble Central Station is able to display the signals that are transmitted to it by the patient monitor to which it is connected via the communication network.

The document provided is a 510(k) premarket notification for the Mennen Medical ENSEMBLE Physiological Monitoring System, Central Station Display Terminal. It establishes substantial equivalence by comparing the new device to existing predicate devices (Mennen Medical ENVOY and HORIZON XL Patient monitors). This type of submission generally does not include performance studies with detailed acceptance criteria, sample sizes for test/training sets, expert adjudication, or MRMC comparative effectiveness studies in the same way a de novo or PMA submission might for novel AI/ML devices.

The information primarily focuses on demonstrating that the new Central Station performs similarly to previous versions in terms of displaying physiological parameters and alarm indications. The "equivalency statement" column acts as the "reported device performance" in this context, asserting that the new device performs identically or similarly in its function.

Given the nature of the document, many of your requested fields are not directly applicable or are not explicitly stated.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly that the ENSEMBLE Physiological Monitoring System, Central Station Display Terminal, when connected to the Mennen Medical ENVOY patient monitor, performs equivalently to when it is connected to the Mennen Medical HORIZON XL patient monitor across various functionalities.

Study Information:

1. Sample size used for the test set and the data provenance: Not explicitly stated. This type of submission relies on demonstrating functional equivalence through comparison to legally marketed predicate devices, rather than a clinical trial with a specific test set of patients or data. The "test" here is the comparison of features, not a performance evaluation on clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation (e.g., from expert annotations or pathology) is not discussed in this device's 510(k) submission.

3. Adjudication method for the test set: Not applicable.

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: Not applicable. This device is a central station display system, not an AI/ML diagnostic or assistive tool, and thus MRMC studies are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device's function is to display data from patient monitors; it does not contain a standalone algorithm for diagnosis or interpretation.

6. The type of ground truth used: Not explicitly defined in terms of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for this submission is implicitly the established and legally marketed functionality of the predicate devices. The claim is that the new configuration (ENSEMBLE with ENVOY) performs equivalently to the existing configuration (ENSEMBLE with HORIZON XL), where the existing configuration's performance is the reference.

7. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

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