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ExSpiron 1xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years old) patients.
ExSpiron 1xi is a non-invasive system that graphically displays lung volume against time and reports an approximate value of:
Tidal volume,
Respiratory rate, and
Minute ventilation
ExSpiron 1xi measurements are used as an adjunct to other clinical information sources.

The ExSpiron 1xi system consists of:
Bioimpedance measurement system: A stabilized high frequency current generator is connected to two outer electrodes. The inner four electrodes are connected to an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware performs signal acquisition and relays data to the panel PC.
Computer: A Windows 7 PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute volume, tidal volume, and respiratory rate.
Single Patient Use ExSpiron™ 1xi Electrode PadSet: An electrode assembly containing six electrodes to be placed on the torso. It delivers current and records impedance measurements. The electrode PadSet is also used to perform subsystem checks prior to patient measurements.

The ExSpiron™ 1xi respiratory monitor is indicated for use by healthcare professionals in healthcare facilities to monitor breathing in adult (at least 21 years old) patients. It is a non-invasive system that graphically displays lung volume against time and reports approximate values for Tidal Volume, Respiratory Rate, and Minute Ventilation. The measurements are used as an adjunct to other clinical information sources.

The provided documentation does not contain a table of acceptance criteria or reported device performance for this specific 510(k) submission (K130170). The submission is a Special 510(k) where the manufacturer states that "No clinical testing was performed for this 510(k). The measurement algorithm and software are unchanged from the predicate. Measurement performance statistics were determined by clinical trials reported in the predicate 510(k), K120087." This means that the device's performance relies on the data submitted for its predecessor, the ExSpiron Respiratory Monitor (K120087).

However, based on the information provided for K130170:

1. Table of Acceptance Criteria and Reported Device Performance:

As stated above, no specific acceptance criteria or reported performance for the ExSpiron™ 1xi is provided in this document as it references the predicate device. For the predicate device, K120087, the performance statistics would have been determined through clinical trials. Without access to K120087, these specific details cannot be provided here.

The document states that changes for K130170 were related to:

• Software Verification & Validation
• Safety Testing - IEC 60601-1 2nd Edition
• Electromagnetic Compatibility - IEC 60601-1-2
• ExSpiron 1Xi System Test Plan
• Patient Cable Design Verification (AAMI / ANSI EC53:1995/(R) 2008)
• Electrode PadSet Design Verification (AAMI / ANSI EC12:2000/(R)2010, AAMI / ANSI EC53:1995/(R) 2008)
• Electrode - Biocompatibility - ANSI/AAMI/ISO 10993-1

All performance testing for these modifications was reported as successful, raising no new safety or efficacy concerns and demonstrating substantial equivalence to the predicate device.

2. Sample Size for Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable for this specific 510(k) (K130170) as no new clinical testing was performed. The measurement performance statistics were determined by clinical trials reported in the predicate 510(k), K120087.
• Data Provenance: Not applicable for this specific 510(k). For the predicate device (K120087), this information would be detailed in its submission. It's likely that the data would be prospective, given the nature of clinical trials for device performance. Country of origin not specified in the current document.

3. Number of Experts and Qualifications for Ground Truth - Test Set:

• Not applicable for this specific 510(k) (K130170) as no new clinical testing was performed. The ground truth for the predicate device's clinical trials (K120087) would have been established through a reference standard method, but the number and qualifications of experts are not described in this document.

4. Adjudication Method for the Test Set:

• Not applicable for this specific 510(k) (K130170) as no new clinical testing was performed.

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

• No MRMC comparative effectiveness study was done for this specific 510(k) (K130170). The device is a monitor that reports values, not an AI for interpretation requiring human readers.

6. Standalone (Algorithm Only) Performance Study:

• Yes, implicitly. The statement that "The measurement algorithm and software are unchanged from the predicate" implies that the core algorithm's performance was evaluated in a standalone manner during the clinical trials for the predicate device (K120087). This 510(k) (K130170) focuses on modifications to hardware components and software updates that do not alter the fundamental measurement algorithm.

7. Type of Ground Truth Used:

• For the performance statistics referenced from the predicate K120087, the ground truth for respiratory measurements (Tidal Volume, Respiratory Rate, Minute Ventilation) would typically be established using a gold standard reference measurement system (e.g., highly accurate spirometry, capnography, or volumetric respirators) rather than expert consensus on images or pathology. The document does not specify the exact ground truth method used in the predicate study.

8. Sample Size for the Training Set:

• Not applicable for this 510(k) (K130170). The clinical trials for the predicate device (K120087) would have involved a patient sample. The document does not provide this information.

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

• Not applicable for this 510(k) (K130170). For the predicate device's clinical trials, the ground truth would have been established using a gold standard reference measurement system, as mentioned in point 7.

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ExSpiron is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years of age) patients.

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

• Tidal volume, .
• . Respiratory rate, and
• Minute ventilation. ●

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

The ExSpiron™ consists of:
Bioimpedance measurement system: A stabilized high frequency current generator is connected to two outer electrodes. The inner four electrodes are connected to an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware performs signal acquisition and relays data to the panel PC.
Panel PC: A Windows 7 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 volume, tidal volume, and respiratory rate.
Single Patient Use ExSpiron™ Electrode Lead Set: An electrode lead set containing six electrodes to be placed on the torso. It delivers current and records impedance measurements. The electrode lead set is also used to perform subsystem checks prior to patient measurements.

The provided 510(k) summary for the ExSpiron™ device includes information about its acceptance criteria and the study performed to demonstrate its performance.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the calculation of bias and accuracy. The specific pass/fail thresholds for these metrics are not explicitly stated as "acceptance criteria" but are presented as the device's performance against a reference.

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

• Sample Size for ExSpiron-Wright study: 20 subjects
• Sample Size for Wright-Morgan study: 20 subjects (a different set of subjects)
• Data Provenance: The document does not explicitly state the country of origin, but it is a 510(k) submission to the FDA, suggesting the study was conducted to support US market approval. The study design (clinical comparison) implies prospective data collection for the purpose of the submission.

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

Not applicable. This device is a measurement device, and its performance is compared directly against existing medical devices (Wright spirometer and Morgan SpiroAir LT diagnostic spirometer), which are considered the reference or "ground truth" for these measurements. There is no mention of human experts establishing ground truth for individual measurements.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth was established by direct measurement from predicate devices, not by expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The ExSpiron™ is a medical device for monitoring physiological parameters (tidal volume, minute ventilation, respiratory rate), not an AI-powered diagnostic tool for interpretation by human readers. Therefore, an MRMC study or AI assistance effect size is not relevant to this submission.

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

Yes, the clinical performance testing describes a standalone assessment of the ExSpiron™ device. Its measurements were compared directly and simultaneously with those from the predicate devices (Wright spirometer and, indirectly, Morgan diagnostic spirometer). The output of the ExSpiron (tidal volume, minute ventilation, respiratory rate) is generated solely by the device based on its bioimpedance measurements and internal algorithms, without human intervention in the measurement process itself.

7. The Type of Ground Truth Used

The ground truth used was measurement from predicate medical devices:

• Wright spirometer: for tidal volume, minute ventilation, and respiratory rate. Respiratory rate was calculated using a stopwatch in conjunction with the Wright spirometer.
• Morgan SpiroAir LT diagnostic spirometer: for tidal volume and minute ventilation in a separate comparative study with the Wright spirometer. This allowed for an indirect comparison between the ExSpiron and the Morgan device.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. The ExSpiron™ uses a "Bioimpedance measurement system" with "Firmware performs signal acquisition and relays data to the panel PC. Panel PC: A Windows 7 PC performs signal processing and calibration." It also states "the ExSpiron was calibrated to the individual" in the clinical study. This suggests a traditional signal processing approach with individual calibration, rather than a large dataset-based machine learning training paradigm. Therefore, a specific "training set sample size" as understood in AI development is not provided or likely applicable in the conventional sense for this device.

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

Similar to the point above, a traditional "training set ground truth" is not explicitly described. Instead, the device undergoes individual calibration for each subject against known physiological signals or reference measurements at the time of use. The clinical study details that "electrodes were applied, the ExSpiron was calibrated to the individual, and each subject performed ten 60-second breathing tests." This initial calibration likely establishes the individual's baseline and correlation for the bioimpedance measurements before subsequent monitoring.

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