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The LifeWindow™ LW8 Lite is a multi-parameter physiological patient monitor indicated for continuous measurement of the following parameters:

• · ECG waveforms from 3 or 5 lead measurements
• · Heart Rate (from ECG)

· Non-invasive blood pressure (NIBP) automatically measures systolic and diastolic pressure and pulse rate, while calculating mean arterial pressure (MAP). The equation used to calculate MAP provides an approximate value

• · End-tidal CO2 concentration (EtCO2) Mainstream or Sidestream
• · Inspired CO2 concentration (insCO2) Mainstream or Sidestream
• · Fractional Inspired Oxygen (FiO2)
• · Acoustic Respiration Rate (RRa)
• · Respiration Rate (from bioimpedance or EtCO2 measurement, or RRa)
• Two Temperature channels
• · Two Invasive Pressure channels (IP1, IP2)
• · Pulse Rate in BPM (from Pulse CO-Oximetry and/or NIBP)

· Pulse CO-Oximetry and pulse rate - the LifeWindow LW8 Lite Pulse CO-Oximeter functions and accessories incorporating Masimo technology are indicated for the continuous nomitoring of the following parameters during both no motion and motion conditions, and for patients who are well or poorly perfused:

• o Functional oxygen saturation of arterial hemoglobin (SpO2)
• o Carboxyhemoglobin saturation (SpCO)
• o Methemoglobin saturation (SpMet)
• o Total hemoglobin concentration (SpHb)

The defined patient population is adult through neonatal patients with appropriate accessories. The monitor displays a range of physiological waveforms and indices and provides alarms.

The LifeWindow™ LW8 Lite multi-parameter patient monitor may be used in hospital-type facilities, surgery centers, and emergency facilities. For professional use only. It is not intended for helicopter transport. hospital ambulance, or home use.

The LifeWindow™ LW8 Lite Multi-Parameter Monitor is designed for the measurement and monitoring of multiple physiological parameters simultaneously in a single patient.

LifeWindow™ LW8 Lite Multi-Parameter Monitor is constructed with the following features:

• I Compact monitor design in a rugged aluminum chassis
• Integration of cleared vital signs modules
• 트 Patients from neonates through adults
• I High Definition 8.4" TFT screen with touch screen operation
• 트 Multi-channel vital signs trace display with variable sweep speeds
• I Hardcopy printing via an integrated strip chart or compatible printer
• 트 Waveforms sweep speeds from 6.25mm/s up to 50mm/s
• . Mainstream and sidestream Capnography options
• I Specification of cleared third-party patient-applied accessories

This document describes the 510(k) premarket notification for the LifeWindow™ LW8 Lite multi-parameter patient monitor. The submission primarily relies on demonstrating substantial equivalence to predicate devices through non-clinical testing against recognized standards and guidance documents. No clinical studies were submitted.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from recognized national and international standards and guidance documents regarding medical device safety, electromagnetic compatibility, usability, alarms, and specific physiological parameter monitoring. The reported device performance indicates compliance with these standards.

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

The submission indicates reliance on non-clinical bench testing and simulations, not clinical studies with patient data. Therefore, there is no "test set" in the context of patient data, nor is there information on data provenance (country of origin, retrospective/prospective).

• For the Usability / Human Factors summative study, there were 15 representative professional users (USA) in a simulated critical care scenario with vital signs generation. This is a simulation study, not a clinical data study.

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

Not applicable. As described above, the studies conducted were non-clinical bench tests and a usability study. There were no "ground truth" experts in the traditional sense of medical image or diagnosis interpretation for patient data. For the usability study, "representative professional users" were involved, but their qualifications beyond being "professional users" are not further detailed.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was done. The device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool for interpretation of medical cases by human readers.

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

The device itself is a standalone monitor. The non-clinical tests assess the performance of the device's various physiological measurement algorithms against established standards and predicate device specifications. These tests essentially evaluate the "standalone" performance of the embedded algorithms for each parameter.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was established by:

• Reference standards and test equipment: Compliance with international and national standards (e.g., IEC 60601 series, ISO 80601 series, ANSI/AAMI SP10) typically involves testing the device against calibrated reference instruments and simulated physiological signals that represent known "ground truth" values.
• Predicate device specifications: Performance characteristics were compared directly to the specifications of the identified predicate devices, which serve as a reference for equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a physiological patient monitor and does not describe the use of machine learning algorithms that require a "training set" in the context of large datasets for model development. The software development lifecycle adheres to IEC 62304 standards for medical device software.

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

Not applicable, as there is no mention of a training set for machine learning.

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