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Care Orchestrator is intended to support clinicians by tracking data on patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. Care Orchestrator provides remote patient data collection & viewing and is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in conjunction with compatible non-life support therapy devices to adjust prescription and/ or performance settings. Care Orchestrator allows read-only access to patients. Care Orchestrator is intended to be used in hospital, institutional, provider, and home care settings.

Care Orchestrator is a solution that will provide entities involved in a patient's therapy lifecycle with the ability to manage patients and referrals, control access to patient information and theract with billing information, enhance patient compliance management workflow, manage the resupply of medical equipment, and gain efficiencies in the overall Patient Therapy Workflow. Care Orchestrator will support patient data management for sleep therapy devices (BZD, MNS, MNT) and respiratory devices (CBK, NOU, CAW). Care Orchestrator will support prescription updates for sleep therapy devices. There are no input flows to the respiratory device interfaces (Bluetooth and SD Card). Device prescription and settings are read-only for these respiratory device types.

The provided text does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics typically associated with medical device studies (e.g., sensitivity, specificity, accuracy against a referent standard).

Instead, the document is a 510(k) Premarket Notification for a device called "Care Orchestrator," which is a data management system for therapy devices. The key focus of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (also named Care Orchestrator, K152356).

Here's a breakdown of what the document does state, and why it doesn't fit the requested criteria:

• Device Type: Care Orchestrator is a software-based data management system for tracking and managing patient data from therapy devices (e.g., sleep therapy, respiratory devices). It's not a diagnostic device or one that performs a specific measurement or medical interpretation that would require traditional performance metrics like sensitivity or specificity.
• Purpose: Its primary functions are remote patient data collection and viewing, managing patient and referral information, controlling access to patient data, handling billing information, managing medical equipment resupply, and allowing clinicians to adjust prescription/performance settings for compatible non-life support therapy devices.
• "Study" type: The relevant section is "VII. Performance Data: Software Verification and Validation Testing." This section describes non-clinical tests focused on verifying the software's functionality and ensuring it meets product requirements. It explicitly states, "Clinical tests were not required to demonstrate the safety and effectiveness of Care Orchestrator. Product functionality has been adequately assessed by non-clinical tests."

Therefore, I cannot provide the requested table or detailed information because the provided text does not include:

1. A table of acceptance criteria and reported device performance for specific medical metrics. The "performance data" refers to software verification and validation against product requirements, not medical diagnostic or treatment efficacy metrics.
2. Sample size for a test set in a medical performance study.
3. Data provenance (country of origin, retrospective/prospective).
4. Number of experts and their qualifications for ground truth.
5. Adjudication method.
6. Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
7. Standalone algorithm performance (as it's a data management system, not an AI for diagnosis/treatment).
8. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
9. Sample size for a training set.
10. How ground truth for a training set was established.

Summary of available information related to "performance":

The document focuses on demonstrating that the software functions as intended and is equivalent to the predicate device.

• Non-Clinical Tests: Software verification and validation testing was conducted.
  • Focus: Complete system testing to verify data transfer from therapy devices to Care Orchestrator (wireless and SD card), display of patient and device information, display of therapy data (including compliance and therapy reports), and the ability for a user to create/edit patient prescriptions for applicable therapy devices.
  • Outcome: "The testing of Care Orchestrator verified that all product requirements have been met with passing test results." And "The verification and validation testing demonstrated the overall substantial equivalence of the Care Orchestrator system."
• Clinical Tests: "Clinical tests were not required to demonstrate the safety and effectiveness of Care Orchestrator."

In essence, the "study" described is a software verification and validation process to ensure the data management system functions correctly and securely, rather than a clinical study evaluating diagnostic accuracy or therapeutic outcomes.

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