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ExSpiron 2Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in patients at least 1 - year of age.

ExSpiron 2Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of:

• Minute Ventilation (MV)

• Tidal volume (TV)

• Respiratory Rate (RR)

ExSpiron 2Xi measurements are used as an adjunct to other clinical information.

The ExSpiron 2Xi Respiratory Monitor System consists of:
Monitor: The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure.
Bioimpedance measurement system: The Monitor incorporates a stabilized high frequency current generator and an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware within the Monitor performs signal acquisition and relays data to the tablet PC.
Computer: A tablet PC performs signal processing and calibration and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate.
Patient Cables and Electrode Padsets that are also included in the system but were cleared in previous 510(k)s: K130170, K162131, K173181
ExSpiron Patient Cable: A reusable cable that connects the ExSpiron 2Xi Monitor to the Electrode PadSet.
Single patient use ExSpiron Electrode PadSet: A Single-Patient Use Electrode PadSet is placed on the skin of the patient's torso. It delivers current to, and records impedance measurements from, the skin.

The provided document describes the ExSpiron 2Xi Respiratory Monitor System, focusing on its substantial equivalence to a predicate device (ExSpiron 1Xi).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ExSpiron 2Xi are based on demonstrating substantial equivalence to its predicate (ExSpiron 1Xi). The key performance metric highlighted is Bench Accuracy for Minute Ventilation (MV), Tidal Volume (TV), and Respiratory Rate (RR), which serves as a surrogate for demonstrating equivalent performance.

The document states, "The accuracy of the proposed device is substantially equivalent to the predicate." This implies that the ExSpiron 2Xi's performance falling within a comparable range to the predicate's established performance fulfills the accuracy acceptance criterion.

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

The document does not specify a sample size for a particular "test set" in the context of clinical data for accuracy. Instead, it refers to "Bench Accuracy" testing. This suggests the primary testing for equivalence was done in a controlled, non-human, benchtop environment, rather than a clinical dataset of patients.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, as the clinical testing was deemed "not required" for this Special 510(k). The "large historical cohort" mentioned for algorithm training is not further detailed.

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

This information is not provided as the primary performance evaluation relied on "Bench Accuracy" testing, not clinical studies requiring expert ground truth for medical imaging/diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation did not involve human readers interpreting a test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted for this submission. The submission is a "Special 510(k)" which typically relies on design control changes and verification/validation testing to demonstrate substantial equivalence, rather than new clinical trials or comparative effectiveness studies with human readers. The document explicitly states, "Clinical testing was not required."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The accuracy values provided for MV, TV, and RR are implied to be standalone performance metrics of the device itself, as they are derived from "Bench Accuracy" testing. There is no mention of human interaction influencing these reported accuracy percentages in the context of the device's output.

7. Type of Ground Truth Used

For the "Bench Accuracy" testing, the ground truth would likely be established through controlled measurements using calibrated testing equipment or simulated physiological models, where the true values of Minute Ventilation, Tidal Volume, and Respiratory Rate are known or precisely controlled. The document does not specify the exact nature of this "ground truth" for bench accuracy, but it would not be expert consensus, pathology, or outcomes data in this context.

8. Sample Size for the Training Set

The document states that the software algorithm was trained with "a dataset containing respiratory data from a large historical cohort." A specific sample size for this training cohort is not provided.

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

The document mentions that the algorithm uses a "proprietary, non-linear, regressive model trained with a dataset containing respiratory data from a large historical cohort." It does not explicitly state how the ground truth for this training data was established. It can be inferred that for the "respiratory data," ground truth would likely involve highly accurate reference measurements from other established monitoring methods (e.g., spirometry, capnography, or other gold standard methods) when the historical data was collected. However, this is conjecture based on typical medical device development, and not explicitly stated in the document.

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