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The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.

The device is for use by qualified medical personnel trained in the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.

Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is indicated for the termination of certain atrial and ventricular arrhythmias.

Noninvasive External Pacing Therapy: The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.

Pulse Oximetry: The SpO2 option is intended for use when it is beneficial to assess the patient's oxygen saturation level.

Noninvasive Blood Pressure Monitoring: The NBP option is intended for noninvasive measurement of a patient's arterial blood pressure.

End-Tidal CO2: The EtCO2 option is intended for noninvasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.

12-Lead ECG: The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead-ECG report, which may include measurement and interpretative statements.

Q-CPR: The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

Invasive Pressures: The Invasive Pressures option is indicated for measuring arterial, venous, intracranial, and other physiological pressures on patients.

Temperature: The Temperature option is indicated for measure temperature in patients.

The Philips HeartStart MRx with Airway Confirmation Assist (ACA) Defibrillator/Monitor is a modification of the FDA cleared HeartStart MRx Defibrillator/Monitor. This function of the MRx used to verify airway placement and aid in assessing ventilatory status when an adult or pediatric patient is being ventilated using an endotracheal or supraglottic airway and the airway is being monitored using capnography.

Based on predetermined criteria, Airway Confirmation Assist continuously analyzes the CO2 waveform coming from the capnography monitor to decide if the waveform represents a valid breath. If the Airway Confirmation Assist is enabled in the MRx, and based on characteristics of the valid breaths, ACA will decide if the airway is established. It will then report a Pass/Fail decision to the MRx. The defibrillator/monitor will display the result to the user in the configured format (graphic and text). As an adjunct to clinical examination, ACA provides additional information along with capnography to help in verifying airway placement and aiding in assessment of ventilation status.

This 510(k) summary (K130153) describes the Philips HeartStart MRx with Airway Confirmation Assist (ACA) Defibrillator/Monitor, a modification of the previously cleared HeartStart MRx. The ACA function is designed to verify airway placement and aid in assessing ventilatory status by continuously analyzing the CO2 waveform from a capnography monitor.

It is important to note that the provided document does not contain a detailed study report with specific acceptance criteria, reported performance, or information regarding sample sizes, ground truth establishment, or expert involvement for the Airway Confirmation Assist feature. The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the general intended uses of the overall HeartStart MRx device and its various options beyond the ACA.

However, based on the available information, we can infer some aspects and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does NOT explicitly state an acceptance criterion or specific reported performance metrics for the Airway Confirmation Assist (ACA) feature. It generally states:

"Based on predetermined criteria, Airway Confirmation Assist continuously analyzes the CO2 waveform coming from the capnography monitor to decide if the waveform represents a valid breath. If the Airway Confirmation Assist is enabled in the MRx, and based on characteristics of the valid breaths, ACA will decide if the airway is established. It will then report a Pass/Fail decision to the MRx."

And:

"...it has been determined that the HeartStart MRx with Advanced Airway Confirmation Defibrillator/Monitor is suitable for its intended use."

Without a specific study report for the ACA feature, a table of acceptance criteria and reported device performance cannot be accurately generated from this document. If this were a full study report, we would expect to see metrics like sensitivity, specificity, accuracy, or a pass/fail rate against a specified threshold for correct airway placement detection.

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

The document does not provide information on the sample size used for testing the Airway Confirmation Assist (ACA) feature, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). The summary mentions "performance and usability testing" but gives no details about these tests for the ACA.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the Airway Confirmation Assist (ACA) feature's test set. For a device assessing airway placement, one would typically expect highly qualified medical professionals (e.g., intensivists, emergency physicians, anesthesi paramedics with specific training in intubation and capnography) to serve as the ground truth.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set of the Airway Confirmation Assist (ACA) feature.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study for the Airway Confirmation Assist (ACA) feature. It does not provide an effect size of how much human readers (medical personnel) improve with AI vs. without AI assistance. The ACA is described as providing "additional information along with capnography to help in verifying airway placement and aiding in assessment of ventilation status," suggesting it's an adjunct rather than a complete replacement for human assessment, but no specific study comparing human performance with and without ACA is detailed.

6. Standalone Performance Study

While the device's ACA function "continuously analyzes the CO2 waveform... to decide if the waveform represents a valid breath" and "decide if the airway is established," the document does not explicitly describe a standalone (algorithm only without human-in-the-loop performance) study with specific metrics for the ACA feature. The description points to an algorithmic function ("Based on predetermined criteria," "continuously analyzes... to decide if the waveform represents a valid breath," "ACA will decide if the airway is established"), but performance data from such a study is absent.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for evaluating the Airway Confirmation Assist (ACA) feature. For airway placement, ground truth could involve direct visualization by an expert, fiberoptic bronchosopy, chest X-ray, or clinical assessment combined with continuous capnography waveform analysis by experienced clinicians.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set for the Airway Confirmation Assist (ACA) feature.

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 for the Airway Confirmation Assist (ACA) feature.

In conclusion, this 510(k) summary primarily focuses on regulatory approval based on substantial equivalence and general safety/performance. It lacks the detailed study information typically found in a clinical validation report for a specific algorithmic feature like the Airway Confirmation Assist. To answer most of these questions thoroughly, a more in-depth technical or clinical study report for the ACA feature would be required. The document indicates that "HeartStart MRx with Airway Confirmation Assist Defibrillator/Monitor has been subjected to performance and usability testing," but the specifics of this testing for the ACA component are not detailed here.

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The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital transport and home environments.

The Capnostream20 monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

The Capnostream20 bedside monitor is a two parameter monitor consisting of a CO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed. The device is classified as CCK Class II according to 21 CFR § 868.1400 - Carbon Dioxide Analyzer with DQA 21 CFR § 870.2700 Pulse Oximeter listed as an additional or alternate classification.

This device has two modules that are classified as follows:

• 21 CFR 868.1400, Carbon Dioxide Analyzer (Classification CCK) .
• 21 CFR 870.2700 Pulse Oximeter (Classification DQA) .

Each module is controlled by dedicated software that is an integral part of the respective module.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a SPECIAL 510(k) submission, indicating that the device (Capnostream20 with microMediCO2 CO2 module) is being submitted for substantial equivalence to a previously cleared predicate device (Capnostream20 with miniMediCO2 CO2 module). In such submissions, the primary "study" is often a demonstration of equivalence to the predicate device, rather than a de novo clinical trial with novel acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the "acceptance criteria" are essentially demonstrating substantial equivalence to the predicate device's established performance and meeting relevant regulatory standards. The device performance is generally stated as being equivalent to or meeting the same standards as the predicate.

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

• Sample Size for Test Set: The document does not provide a specific sample size for a "test set" in the context of clinical data for the new microMediCO2 CO2 module. The submission focuses on design and performance verification/validation against existing predicate standards, rather than new clinical trials with patient data. The "test set" here refers to engineering and bench testing to demonstrate compliance with standards and equivalence.
• Data Provenance: Not applicable in the context of clinical patient data. The provenance of the validation data would be from Oridion's internal testing and compliance activities.

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

• Number of Experts: Not specified or applicable in the context of expert-adjudicated ground truth for a clinical dataset. The "ground truth" for this engineering-focused submission is derived from established international standards (ISO, IEC, UL) and a comparison to the predicate device's performance. Performance testing would likely involve engineers and technicians.
• Qualifications of Experts: Not specified, as it's not a clinical study requiring expert adjudication of patient cases.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This submission doesn't describe a clinical study requiring adjudication of expert interpretations. The verification and validation activities would follow standard engineering and quality assurance protocols, where measurements are compared against specifications and standards, not through expert consensus on medical findings.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done, and it is not relevant to this submission. The device is a monitor providing physiological parameters, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance: Not explicitly termed "standalone algorithm performance" as it would be for AI. However, the document states: "Verification and validation of the new module as a standalone and when integrated in the monitor were successfully completed." This indicates that the microMediCO2 CO2 module's performance was evaluated independently before integration into the Capnostream20 monitor. This is essentially demonstrating the technical performance of the module itself.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device, in terms of its performance, is based on:
  • Reference measurements/standards: For CO2 and SpO2 accuracy, this would involve comparing the device's readings against highly accurate reference instruments or calibrated gas mixtures as dictated by ISO standards (ISO 21647, ISO 9919).
  • Predicate device's performance: The fundamental "ground truth" for this 510(k) is that the new module performs equivalently to the previously cleared predicate device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physiological monitor, not a machine learning model that requires a "training set" in the AI sense. Its calibration and operational parameters are determined through engineering design and testing, not by learning from a dataset.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" in this context.

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