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Care Orchestrator Essence is intended for use by healthcare professionals (e.g., Physicians, Durable Medical Equipment providers) to gather, store, manage, and view compliance data for patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. The software also includes the ability to create new or updated prescriptions and/or performance settings, store them, and transmit them to compatible Respironics' non-life supporting therapy devices and Respironics Trilogy ventilator. Data and prescription settings are transferred between Care Orchestrator Essence and compatible devices via removable media. Care Orchestrator Essence is intended to be used in hospital, institutional, provider, and home care settings by healthcare representatives.

The software does not perform automatic scoring or diagnosis. The data it provides are only one of several elements to consider when making decisions about patient therapy.

Care Orchestrator Essence software is a desktop solution that allows healthcare representatives (e.g., physicians, clinicians, durable medical equipment providers) involved in a patient's therapy lifecycle the ability to manage patients and referrals; control access to patient information; view and interact with therapy and prescription data from Respironics devices; enhance the patient compliance management workflow; and gain efficiencies in the overall patient therapy workflow.

Care Orchestrator Essence supports patient data management and prescription updates for sleep therapy devices (BZD, MNS, MNT) and Trilogy respiratory devices (CBK, NOU) through an SD card.

I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) premarket notification for a medical device called "Care Orchestrator Essence," which is a software for managing patient compliance data and therapy settings for compatible Respironics devices.

While it mentions software verification and validation testing and non-clinical tests were conducted, it does not provide details on:

1. A table of acceptance criteria and reported device performance. It broadly states that "all product requirements have been met with acceptable test results," but no specific criteria or performance metrics are listed.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study. The device does not perform automatic scoring or diagnosis, so this type of study would not be applicable.
6. Standalone (algorithm-only) performance. The device is intended to be used by healthcare professionals.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document emphasizes that clinical tests were not required and that the effectiveness was demonstrated through non-clinical testing and comparison to predicate devices. It focuses on the functional similarities and differences between the new device and previously cleared predicate devices rather than providing detailed performance metrics from a study that fits the criteria of your request (e.g., studies involving ROC curves, sensitivity, specificity, etc., which are common for diagnostic or AI-driven systems).

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