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The iSirona Magellan software solution provides healthcare professionals with supplemental information about patient alarms and other medical-related events. The product can route all or subsets of this information to selective remote devices such as centralized computer stations and mobile communication devices. Receipt of alarm messages or events by the centralized computer stations and/or mobile communication devices is not confirmed and delivery to the end device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.

iSirona Magellan, is an on-site messaging integration solution which forwards information about patient alarms and other medical-related events obtained from information sources such as patient monitors, ventilators, infusion pumps, etc. to the user. The user receives the information via selective remote devices such as centralized computer stations and mobile communication devices provided by third-party companies. iSirona Magellan utilizes the existing hospital network to process data and relay secondary notifications. It is not to be considered a primary alarming device.

iSirona Magellan connects to the information sources through wired ethernet connections which are part of the customer's infrastructure. The user configures iSirona Magellan to determine which information, including alarm notifications, is delivered to which users, iSirona Magellan then formats the data for wireless delivery to the centralized computer stations and mobile communication devices.

Here's a breakdown of the acceptance criteria and study information for the iSirona Magellan device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for iSirona Magellan does not specify quantifiable acceptance criteria in the traditional sense of performance metrics (e.g., sensitivity, specificity, accuracy, latency targets). Instead, the performance testing focuses on verifying the software's adherence to its design specifications and relevant regulatory guidelines.

Here's a table summarizing the reported device performance and the general criteria used:

"Test results indicate that iSirona Magellan complies with its predetermined specifications, and applicable standards and guidance documents." |
| Functional Performance Compliance: Meets predetermined specifications for its intended function (forwarding patient alarms and medical events to users via remote devices). | "iSirona Magellan was tested for performance in accordance with internal requirements."

"Test results indicate that iSirona Magellan complies with its predetermined specifications and the applicable standards." |
| Safety and Effectiveness: Demonstrates safety and effectiveness when used as intended. | "Verification and validation activities were conducted to establish the performance and safety characteristics of iSirona Magellan. The results of these activities demonstrate that iSirona Magellan is safe and effective when used in accordance with its intended use and labeling."

"Therefore, iSirona Magellan is considered substantially equivalent to the predicate device." |

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

The 510(k) summary does not provide any details about the sample size used for a specific "test set" in the context of clinical or diagnostic performance evaluation. The testing described is primarily focused on software verification and validation, and internal performance testing, rather than a clinical study with patient data.

Therefore, information on:

• Sample size for the test set: Not provided.
• Data provenance (country of origin, retrospective/prospective): Not applicable/not provided for this type of software and performance testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided. The iSirona Magellan is a communication and notification system; its performance testing described here is focused on the reliability and accuracy of message routing and software functionality, not on diagnostic accuracy requiring expert interpretation of medical images or data. Therefore, there's no "ground truth" in the clinical diagnostic sense established by medical experts for a test set.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As there's no mention of a test set requiring expert interpretation or a "ground truth" established by experts, there's no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The iSirona Magellan's function as a communication system does not involve human interpretation for diagnostic purposes.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance testing described is essentially a "standalone" or algorithm-only evaluation of the software's ability to correctly route and format information based on its predetermined specifications. The device itself is an automated system for message delivery. However, it's important to note that the device's role is to supplement human vigilance; it's explicitly stated that the "primary alarm notification is the device producing the alarm or event" and "this product is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices." So while the algorithm operates standalone in its function, its intended use is ancillary to human monitoring, not as a standalone diagnostic or primary alarming device.

7. The Type of Ground Truth Used

The "ground truth" for iSirona Magellan's performance testing is its predetermined specifications and the applicable standards and guidance documents. The tests verified that the software functions as designed, routing the correct information to the correct recipients based on its internal logic and configuration. It is not about clinical ground truth derived from pathology, outcomes, or expert consensus on patient conditions.

8. The Sample Size for the Training Set

This information is not provided. The iSirona Magellan is an integration and communication software solution; it is not described as utilizing machine learning or AI models that require a "training set" in the typical sense for image analysis or predictive algorithms. Its "training" would involve configuring its rules and connections based on a hospital's existing infrastructure and desired notification logic.

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

This information is not applicable/not provided. As mentioned above, the device doesn't appear to use a "training set" in the context of developing a machine learning model for which a ground truth would need to be established by experts or other data sources. Its "ground truth" for operational setup would be the validated configuration settings defined by the hospital and the software's adherence to its design specifications.

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