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LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healtheare professionals. It consists of a hosted web server, a hosted database server and two types of client interfaces - one that is provided by Windows client and one that is provided by a web client interface.

LifeStream software's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, dispensed medicine, ECG, peak flow, prothrombin time and retrospective PERS messages.

LifeStream retrospectively displays the data, user-defined data alerts for review and interpretation by a healthcare professional. LifeStream is not intended for emergency use or real-time monitoring.

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healthcare professionals. It consists of a hosted web server and two types of client interfaces, one that is provided by Windows client and one that is provided by a web client interface. LifeStream 5, like the predicate LifeStream 4.0, is configured to accept patient data that is acquired periodically and displayed retrospectively from Honeywell HomMed Patient Monitors (e.g. Genesis Touch). LifeStream 5 can also interface with 3nd party compatible medical device data systems (e.g. Govsphere TV). LifeStream 5 has the same intended use as the predicate, LifeStream 4.0. LifeStream 5, like LifeStream 4.0 is not intended for emergency use or real-time monitoring. Both are designed to retrospectively receive, display and store scheduled vital sign parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, ECG, peak flow, prothrombin time and retrospective PERS messages.

The Honeywell HomMed LifeStream™ 5 is a software program designed to retrospectively receive, display, and store monitored vital signs parameters and related data for review and interpretation by healthcare professionals. It is not intended for emergency use or real-time monitoring.

Here's an analysis of its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific quantitative acceptance criteria for performance. The "acceptance criteria" here are implied by the claim of substantial equivalence in intended use, users, use environment, technological characteristics, and safety to the predicate device, LifeStream™ 4.0.

The performance reported is qualitative, stating that LifeStream 5 is substantially equivalent to LifeStream 4.0 and that differences "do not affect the relative safety and/or effectiveness."

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

The document does not specify a "test set" in the context of clinical performance evaluation using patient data. This 510(k) submission primarily relies on demonstrating substantial equivalence through non-clinical performance testing (bench testing) and comparison of technological characteristics with a predicate device.

Therefore, there is:

• No specific sample size for a test set of patient data mentioned.
• No data provenance (country of origin, retrospective/prospective) related to a clinical test set.

The "validation testing of complete systems" and "black box testing" likely used simulated data or internal test cases, but no details on their size or origin are provided.

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

Since there is no mention of a clinical test set requiring expert ground truth, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

As there is no clinical test set with expert ground truth mentioned, no adjudication method is described.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technical and functional comparison to a predicate device and non-clinical testing, not on comparative effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a "standalone, prescription-based software program" for retrospective display and storage of vital signs, intended for use by healthcare professionals for review and interpretation. The "Performance / Bench Testing" section describes functional, validation, automated regression, black box, localization, and deployment testing, along with "External evaluation by Honeywell clinical team." This evaluation represents the standalone performance of the software in its intended function of receiving, displaying, and storing data correctly, as it is a device intended to assist human professionals, not to make diagnoses autonomously. However, these are engineering/software tests, not clinical performance studies measuring diagnostic accuracy of an algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance/bench testing, the "ground truth" would be established by the expected behavior and output defined in the software's functional specifications and requirements. For example:

• Functional Testing: The "ground truth" is that the software correctly performs its intended function (e.g., displaying specific vital sign data accurately, registering alerts based on defined thresholds).
• Validation Testing: The "ground truth" is that the complete system meets all specified requirements.
• Automated Regression Testing: The "ground truth" is that previously corrected defects remain fixed and new changes haven't introduced new errors.

There is no mention of pathology, outcomes data, or expert consensus serving as ground truth for a clinical dataset in this submission.

8. The Sample Size for the Training Set

Not applicable. This submission describes a medical device, LifeStream™ 5, which is a software system for managing vital signs data. It is not an AI/Machine Learning algorithm that typically requires a "training set" of data to learn patterns or make predictions. The software's functionality is pre-programmed based on defined rules and specifications.

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

Not applicable, as there is no training set for an AI/Machine Learning algorithm. The software's "ground truth" for its development would be its functional and system requirements.

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