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The IntelliVue CL Respiration Pod is indicated for use by health care professionals whenever there is a need for intermittent or spot-check acquisition and monitoring of physiological patient parameters respiration rate and pulse rate wirelessly in specific hospital areas. The IntelliVue CL Respiration Pod is mainly indicated for use in general medical and surgery wards and in waiting areas of emergency rooms.

It is not indicated for use in hospital areas in which continuous patient monitoring is needed, such as intensive care units or operating rooms.

The intended use of the IntelliVue CL Respiration Pod when used together with a patient monitor is for intermittent or spot-check monitoring and recording of, and to generate alarms for, respiration rate and pulse rate of adult patients.

The IntelliVue CL Respiration Pod is also intended for acquisition of respiration rate and pulse rate data of adult patients for a clinical information management system.

The IntelliVue CL Respiration Pod is intended for use by health care professionals. It is not intended for home use. It is not a therapeutic device.

The IntelliVue CL Respiration Pod is not intended for use on patients with extremely high values for respiration rate (above 60 rpm).

The IntelliVue CL Respiration Pod is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias, e.g. very fast atrial fibrillation or ventricular tachycardia (rapid irregular pulse rate). For monitoring of these patients, a device for continuous ECG monitoring is necessary. The IntelliVue CL Respiration Pod is not a substitute for an ECG monitor.

Warning: Do not use the CL Respiration Pod on patients with rapid, irregular heart rates greater than 110 bpm. Use under these conditions has not been clinically validated.

Rx only: US Federal Law restricts these devices to sale by or on the order of a physician.

The IntelliVue CL Respiration Pod is a small body-worn, cableless, battery powered, respiration rate and pulse rate measuring and monitoring device. It uses specifically designed adhesive attachment (Mobile CL Resp Attachment, cleared with K122223), which holds the CL Respiration Pod at the patient chest.

The CL Respiration Pod provides and communicates measurements values and other information (e.g. battery state) wirelessly via Short Range Radio (SRR) to an assigned compatible IntelliVue Patient Monitor or IntelliVue GuardianSoftware. It can also provide information on basic posture (like supine, prone, upright etc.) and activity of the patient. The CL Respiration Pod can be controlled from the assigned IntelliVue Patient Monitor or IntelliVue GuardianSoftware.

The CL Respiration Pod is a small, battery powered, wireless, and body worn respiration and pulse rate measuring and monitoring device. It is attached to the patient's left costal arch using a specialized accessory, the adhesive Mobile CL Resp Attachment. The CL Respiration Pod has a multicolor LED and a single key to display states and allow basic operation locally. The CL Respiration Pod is connected during its use wirelessly via SRR a compatible IntelliVue Patient Monitor or IntelliVue to GuardianSoftware.

The CL Respiration Pod uses a measurement principle that is based the thoracic movements. Inclination changes of the on incorporated accelerometer sensor, caused by chest and abdomen movements during breathing and heart contraction, produce a voltage signal, from which respiration and pulse rate signals are derived. The modified Philips IntelliVue CL Respiration Pod uses the same measurement principle (respiratory effort and heart contraction/beating) to derive the respiration and pulse signal as the predicate Philips IntelliVue CL Respiration Pod.

With the means of the built-in accelerometer sensor, the modified CL Respiration Pod also detects activity and basic posture of the patient. This is the same technology as used by the legally marketed Philips IntelliVue CL Respiration Pod (K122223).

The Philips IntelliVue CL Respiration Pod aims to measure respiration rate and pulse rate. The study conducted for this 510(k) submission (K132320) is primarily focused on demonstrating substantial equivalence to a predicate device (IntelliVue CL Respiration Pod, K122223) rather than establishing new acceptance criteria or a comparative effectiveness of AI with human readers.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission describes verification and validation activities, but it doesn't explicitly state quantitative acceptance criteria in a table format that the device needed to meet for de novo clearance. Instead, the study aims to show substantive equivalence to a predicate device.

The reported device performance is described qualitatively as meeting defined specifications and demonstrating substantial equivalence. The document states:

• "The test results have shown that the respiration rate and pulse rate accuracy, resolution, and signal quality met in the whole measurement range the defined specifications."
• "The results of the statistical comparison demonstrate the substantial equivalency of of the modified IntelliVue CL Respiration Pod with the predicate IntelliVue CL Respiration Pod (K122223)."

Without specific numerical criteria for accuracy, resolution, and signal quality, a direct table of acceptance criteria vs. performance cannot be fully constructed from the provided text. The "acceptance criteria" appear to be implicit in the demonstration of substantial equivalence and meeting internal specifications.

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

• Sample Size: The additional clinical data set used for validating algorithm changes consisted of 26 patients (21 male, 5 female).
• Total Duration of Recording: 621 hours and 10 minutes.
• Data Points Used for Comparison: 2,276,855 ECG beats and 255,307 breaths.
• Data Provenance: The document does not explicitly state the country of origin. It mentions "clinical data," which implies real patient data. It is a prospective or, more accurately, retrospective analysis of a prospectively collected dataset, as it explicitly states, "An additional not yet used clinical data set with patient signals was used to validate the algorithm changes." This implies data were pre-existing before being used for this specific validation. It also notes that an "identical data set of K122223 has been reused for the development of the modifications," which would be retrospective for this new device.

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

The document does not mention the use of experts to establish ground truth for the test set. The comparison is statistical, between the modified device and the predicate device.

4. Adjudication Method for the Test Set

No adjudication method is mentioned or implied, as the comparison is statistical against a predicate device's measurements, not against a consensus-based ground truth established by experts.

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

No, an MRMC comparative effectiveness study was not done. The device is a physiological parameter monitor, and the study focuses on its measurement accuracy and equivalence to another device, not on how it impacts human reader performance or diagnostic tasks. The device itself is not an AI algorithm that assists human readers in interpretation.

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

Yes, the evaluations described are primarily standalone performance assessments of the device itself (or its underlying algorithms for respiration and pulse rate derivation) compared to a predicate device. The clinical performance tests involve a "Bland-Altman statistical comparison between respiration rate and pulse rate performance measured by the modified IntelliVue CL Respiration Pod and the predicate IntelliVue CL Respiration Pod." This is an assessment of the device's output.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurements obtained from the legally marketed predicate device (IntelliVue CL Respiration Pod, K122223). The study aimed to show that the modified device's measurements are substantially equivalent to those of the predicate device. This is a form of reference standard comparison rather than an independent gold standard like pathology or expert consensus. For bench testing, "simulated values" were used as the reference.

8. The Sample Size for the Training Set

The document states, "Two separate clinical data sets have been used. The identical data set of K122223 has been reused for the development of the modifications." The sample size for this reused dataset (presumably for training or development of the modifications) is not specified in the provided text.

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

The ground truth for the "training set" (the data from K122223 used for development) is implicitly linked to how the original predicate device (K122223) established its performance and potentially its own reference measurements. The current submission does not detail how the ground truth for this development dataset was established but indicates it was previously used for K122223.

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The IntelliVue CL Respiration Pod is indicated for use by health care professionals whenever there is a need for intermittent or spot-check acquisition and monitoring of physiological patient parameters respiration rate and pulse rate wirelessly in specific hospital areas. The IntelliVue CL Respiration Pod is mainly indicated for use in general medical and surgery wards and in waiting areas of emergency rooms. It is not indicated for use in hospital areas in which continuous patient monitoring is needed, such as intensive care units or operating rooms.

The intended use of the IntelliVue CL Respiration Pod when used together with a patient monitor is for intermittent or spot-check monitoring and recording of, and to generate alarms for, respiration rate and pulse rate of adult patients.

The IntelliVue CL Respiration Pod is also intended for acquisition of respiration rate and pulse rate data of adult patients for a clinical information management system.

The IntelliVue CL Respiration Pod is intended for use by health care professionals. It is not intended for home use. It is not a therapeutic device.

The IntelliVue CL Respiration Pod is not intended for use on patients with extremely high values for respiration rate (above 60 rpm).

The IntelliVue CL Respiration Pod is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias, e.g. very fast atrial fibrillation or ventricular tachycardia (rapid irregular pulse rate). For monitoring of these patients, a device for continuous ECG monitoring is necessary. The IntelliVue CL Respiration Pod is not a substitute for an ECG monitor.

Warning:
Do not use the CL Respiration Pod on patients with rapid, irregular heart rates greater than 110 bpm. Use under these conditions has not been clinically validated.

The new IntelliVue CL Respiration Pod is a small body-worn, cableless, battery powered, respiration rate and pulse rate measuring and intermittent monitoring device. It uses specifically designed adhesive attachment (Mobile CL Resp Attachment), which holds the CL Respiration Pod at the patient chest.

The CL Respiration Pod provides and communicates measurements values and other information (e.g. battery state) wirelessly via Short Range Radio (SRR) to an assigned compatible IntelliVue Patient Monitor or IntelliVue GuardianSoftware. It can also provide basic information on posture (like supine, prone, upright etc.) and, activity status of the patient. The CL Respiration Pod can be controlled from the assigned IntelliVue Patient Monitor or IntelliVue GuardianSoftware.

The modified IntelliVue Patient Monitor models MP2, X2, MP5, MP5T, and MP5SC consist of a display unit including built-in central processing unit (CPU) and multiple physiological measurements. All monitors share the same architecture of CPU units and exactly the same software is executed on each monitor. The monitors measure physiological parameters such as: Sp02, pulse, ECG, arrhythmia, ST, QT, respiration, invasive and non-invasive blood pressure, temperature, CO2, spirometry, C.O., CCO, and BIS. They generate alarms, record physiological signals, store derived data, and communicate derived data and alarms to the central station. These monitor models are robust, portable, lightweight, compact in size and modular in design, with interfaces to dedicated external measurement devices.

The modified IntelliVue GuardianSoftware is a Clinical Information Management System. It collects and manages vital signs data acquired from the IntelliVue Cableless Measurements and IntelliVue patient monitors. The IntelliVue GuardianSoftware provides trending, review, reporting, notification, clinical documentation, calculations, clinical advisories including EWS deterioration status, remote viewing and operating, interfacing, storage, and printing. The IntelliVue GuardianSoftware is software only product intended to be installed on a customer supplied PC or Server.

The Philips IntelliVue CL Respiration Pod device underwent verification and validation (V&V) activities that included clinical and bench performance tests, clinical usability, electrical safety, EMC, system level, functionality, and regression, environmental, mechanical, and radio tests. The tests aimed to establish the performance, safety, functionality, usability, effectiveness, and reliability characteristics of the new device and the modified compatible IntelliVue Patient Monitors and IntelliVue GuardianSoftware. The results of these tests demonstrated that the new Philips IntelliVue CL Respiration Pod and its accessories are as safe, effective, and perform as well as the predicate devices.

1. Acceptance Criteria and Reported Device Performance:

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

• Clinical Performance Test (First series): 39 patients (26 male and 13 female) aged between 16 and 86 years were evaluated. The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated but implies a prospective clinical study in a controlled environment.
• Clinical Performance Test (Second series): Eight 35-minute episodes showing irregularity in heart rate were selected from the AHA arrhythmia database. This indicates a retrospective analysis of existing, publicly available dataset.

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth during the clinical performance tests. However, the first series of clinical tests compared the device's readings with a "predicate device's respiration rate and heart rate," implying the predicate device (Philips IntelliVue Patient Monitor MP2) served as the reference standard. For the second series, "annotated ECG traces from the AHA arrhythmia database" were used, where annotations are established by cardiologists or other qualified medical professionals who are specialists in arrhythmia analysis.

4. Adjudication Method for the Test Set:

The document does not mention any specific adjudication method (e.g., 2+1, 3+1). For the first series of clinical tests, a "head to head comparison" was performed, and the Bland-Altman statistical method was used for analysis. For the second series, the "curve progression" of the pulse rate traces from the subject device was compared to the heart rate traces from the annotated ECGs of the predicate device. This suggests a direct comparison against a reference, rather than an adjudication process involving multiple human readers for ground truth establishment.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly stated or implied. The clinical testing focused on the device's performance against a predicate device and annotated databases, rather than assessing improvements in human reader performance with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance evaluation of the device's algorithms was conducted.

• The "Non-Clinical Performance Tests (bench testing)" verified the respiration rate and pulse rate range, accuracy, resolution, and signal quality by comparing reported values with "simulated values." This is a standalone assessment.
• The "second series of clinical tests" validated the "pulse rate calculation algorithm of the subject device" using "annotated ECG traces from the AHA arrhythmia database." This is a standalone evaluation of the algorithm's performance against a known ground truth.

7. The Type of Ground Truth Used:

• Clinical Performance Test (First series): The predicate device, the Philips IntelliVue Patient Monitor MP2, served as the ground truth/reference for respiration rate and heart rate.
• Clinical Performance Test (Second series): Expert-annotated ECG traces from the AHA arrhythmia database were used as the ground truth for validating the pulse rate calculation algorithm. This represents a form of expert consensus or established medical standard.
• Non-Clinical Performance Tests: "Simulated values" were used, suggesting a controlled, engineered ground truth for bench testing.

8. The Sample Size for the Training Set:

The document does not provide information about the sample size used for the training set. This summary focuses on the verification and validation of the device, implying that the training and development phases would have occurred prior to this submission.

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

The document does not provide information on how the ground truth for the training set was established.

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