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The Zoe Medical Nightingale Monitoring System is indicated for use in adult & pediatric patient populations.

The Zoe Medical Nightingale Monitoring System facilitates the monitoring of:

• ECG -
• Impedance respiration -
• Non-Invasive blood pressure -
• Invasive blood pressure -
• Body temperature "
• Functional arterial oxygen saturation (SpO2) -
• -End-tidal & inspired CO2

The Zoe Medical Nightingale Monitoring System is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

The Zoe Medical Nightingale Monitoring System (NMS) facilitates the monitoring of patient physiological parameters both at the bedside on the Nightingale PPM3 monitor and remotely on the Nightingale MPC central station. The physiological parameters monitored by the NMS include: ECG. impedance respiration, non-invasive blood pressure, invasive blood pressure, body temperature, functional arterial oxygen saturation (SpO2), and end-tidal & inspired CO2 (capnography). The Nightingale Monitoring System as described in this submission is a new device, and will be marketed as the next generation product superseding the original and previously cleared Zoe Medical NMS (K001775).

The part numbers for the four Nightingale PPM3 variants and their associated configurations are given below.

179-0003 NIGHTINGALE PPM3 (with NIBP, SPO2, ECG, and Temp)

179-1000 NIGHTINGALE PPM3 WITH IBP (with NIBP, SPO2, ECG, Temp, & IBP)

179-1001 NIGHTINGALE PPM3 WITH ETCO2 (with NIBP, SPO2, ECG, Temp, & Microstream ETCO2)

179-1002 NIGHTINGALE PPM3 (with NIBP, SPO2, ECG, Temp, IBP, & Microstream ETCO2)

The Nightingale MPC central station (171-0001) will be sold as an option available to all customers based on their needs.

The provided document describes the Zoe Medical Nightingale Monitoring System, a patient physiological monitor. Here's an analysis of its acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device (Spacelabs Healthcare Vital Signs Monitoring System, K090556) rather than detailing specific numerical acceptance criteria for each physiological parameter. The acceptance criteria are broadly defined by compliance with applicable standards and demonstration that the device's performance meets its predetermined specifications.

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

The document does not specify a separate "test set" in the context of device performance data beyond the compliance testing. The performance and safety validations were primarily based on engineering and laboratory testing against established standards and internal requirements. Therefore:

• Sample Size: Not applicable in terms of a clinical dataset for a test set. The samples would be the physical devices and components undergoing the various safety and performance tests.
• Data Provenance: The data comes from internal testing conducted by Zoe Medical, Inc., as part of their design and development processes. It is retrospective in the sense that the testing was completed before submission for clearance. The country of origin of this internal testing data is likely the USA (Topsfield, MA, where the company is located).

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

This information is not applicable. The device's performance is assessed against recognized industry standards and internal specifications, not against a "ground truth" established by experts in the typical sense of a clinical diagnostic study. The "ground truth" for electrical safety would be the requirements of the IEC 60601 series, and for EMC, the IEC 60601-1-2 standard. Internal engineering experts and certified testing laboratories would be involved in verifying compliance.

4. Adjudication Method for the Test Set

This is not applicable as there is no mention of a "test set" in the context of human interpretation or clinical data requiring adjudication. Compliance with standards is typically a pass/fail outcome based on measurements and observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission relies on demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards for a physiological monitor, not on assessing the improvement of human readers with this AI-assisted technology. This device is a monitor, not an AI diagnostic tool.

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

This is not applicable. The Zoe Medical Nightingale Monitoring System is a physiological patient monitor, a hardware device with embedded software. Its performance is inherent to the device itself and its sensors, not a standalone algorithm in the AI sense. Its intended use involves healthcare professionals continuously monitoring the patient via the device.

7. The Type of Ground Truth Used

The "ground truth" for the performance and safety testing is based on:

• Pre-determined specifications: Internal requirements established by Zoe Medical.
• International and National Standards: Compliance with recognized standards such as AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-XX series, ISO 80601-2-XX series, IEC 62366, and IEC 62304. These standards define acceptable levels of safety and performance for physiological monitors.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physiological monitor, not an AI/ML algorithm that requires a "training set" in the machine learning context. Its functionality is based on established engineering principles and signal processing, not on learning from a large dataset.

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

This information is not applicable, as there is no "training set."

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