(422 days)
The HeartStart XL+ is a defibrillator/monitor. The device is for use by qualified medical personnel trained in the operation of the device and certified by training in basic life support, advanced life support or defibrillation. It must be used by or on the order of a physician.
AED Therapy: AED mode is used in the presence of suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless.
Manual Defribillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation (cardioversion) is indicated for termination of certain atrial and ventricular arrhythmias.
Non-Invasive External Pacing: The pacing option is indicated for treating patients with symptomatic bradycardia.
Pulse Oximetry: The SpO2 option is indicated for use when it is beneficial to assess the patient's oxygen saturation level.
Non-Invasive Blood Pressure Monitoring: The NBP option is indicated for non-invasive 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.
ECG Monitoring: ECG monitoring is indicated to be used for monitoring, alarming and recording of the patient's heart rate and morphology.
The Philips HeartStart XL+ with End-Tidal Carbon Dioxide Monitoring Defibrillator/Monitor is a modification of the FDA cleared HeartStart XL+ Defibrillator/Monitor. This function of the XL+ modification is to measure the partial pressure of carbon dioxide in a sample of the patient's exhaled breath. The HeartStart XL+ may be used to monitor carbon dioxide in both intubated and non-intubated patients.
The partial pressure of carbon dioxide is derived by multiplying the measured carbon dioxide concentration with the ambient pressure. From the partial pressure measurement, the end-tidal carbon dioxide (EtCO2) is derived.
EtCO2 is the peak CO2 value measured during expiration. It is used to monitor the patient's respiratory status. The EtCO2 measurement uses a technique based on the absorption of infrared radiation by some gases. It indicates the change in:
· The elimination of CO2.
• The delivery of O2 to the lungs.
The CO2 monitoring function of the HeartStart XL+ provides an EtCO2 value, a CO2 waveform (Capnogram), and an airway respiration rate (AwRR). The AwRR relies on CO2 functionality to identify valid breaths for numeric display and alarm conditions such as Apnea.
The provided document is a 510(k) summary for the Philips HeartStart XL+ Defibrillator/Monitor with End-Tidal CO2 Monitoring. It describes the device and its intended uses, but it does not contain a study or acceptance criteria related to a specific AI algorithm's performance in a diagnostic or predictive capacity.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards for the overall defibrillator/monitor device, not a specific AI component or a study proving its AI components meet acceptance criteria.
Therefore, many of the requested elements about an AI study cannot be extracted from this document, as it doesn't describe such a study.
Here's what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document lists various IEC and EN ISO standards that the device was tested against. The "reported device performance" is a general statement that "The non-clinical testing was completed with passing results according to its Pass/Fail criteria." Specific numerical performance metrics against acceptance criteria for each standard are not detailed in this summary.
| Acceptance Criteria (Relevant Standards) | Reported Device Performance |
|---|---|
| IEC 60601-1 Medical Electrical Equipment- Part 1: General Requirements for basic safety and essential performance | "Completed with passing results according to its Pass/Fail criteria." |
| IEC 60601-1-2 Medical Electrical Equipment- General Requirements for safety- Collateral standard: Electromagnetic compatibility | "Completed with passing results according to its Pass/Fail criteria." |
| IEC 60601-2-4 Medical Electrical Equipment- Part 2-4: Particular requirements for basic safety of cardiac defibrillators | "Completed with passing results according to its Pass/Fail criteria." |
| IEC 60601-1-8 Medical electrical equipment: General requirements tests and guidance for alarm systems | "Completed with passing results according to its Pass/Fail criteria." |
| IEC 60601-2-30 Medical electrical equipment: Particular requirements for the safety, automatic cycling non-invasive blood pressure monitoring equipment | "Completed with passing results according to its Pass/Fail criteria." |
| IEC 60601-2-27 Medical electrical equipment: Particular requirements for the safety, specification for electrocardiographic monitoring equipment | "Completed with passing results according to its Pass/Fail criteria." |
| EN ISO 9919 Medical electrical equipment Part 2-27: Particular requirements for the basic safety of pulse Oximeter equipment. | "Completed with passing results according to its Pass/Fail criteria." |
| EN ISO 21647 Medical electrical equipment - Particular requirements for the basic safety and essential of respiratory gas monitors | "Completed with passing results according to its Pass/Fail criteria." |
Regarding the device's End-Tidal CO2 function, the document describes its mechanism rather than performance metrics:
- "The partial pressure of carbon dioxide is derived by multiplying the measured carbon dioxide concentration with the ambient pressure. From the partial pressure measurement, the end-tidal carbon dioxide (EtCO2) is derived."
- "EtCO2 is the peak CO2 value measured during expiration. It is used to monitor the patient's respiratory status."
- "The EtCO2 measurement uses a technique based on the absorption of infrared radiation by some gases."
- "The CO2 monitoring function of the HeartStart XL+ provides an EtCO2 value, a CO2 waveform (Capnogram), and an airway respiration rate (AwRR)."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document states, "No clinical studies were necessary to demonstrate substantial equivalence." The testing mentioned is non-clinical (bench testing) against standards. There is no test set of patient data described for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No clinical studies or ground truth establishment by experts are described for an AI component.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
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
- No. The document explicitly states: "No clinical studies were necessary to demonstrate substantial equivalence." There is no mention of an MRMC study or AI assistance for human readers. The device itself (HeartStart XL+ Defibrillator/Monitor) is the subject, not an AI component assisting human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. The device is a "Defibrillator/Monitor" intended for use by "qualified medical personnel." It's an integrated medical device, not a standalone AI algorithm being evaluated for human-in-the-loop or standalone performance. The document describes the technical function of CO2 monitoring, which is a physical measurement, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided.
8. The sample size for the training set
- Not applicable / Not provided.
9. How the ground truth for the training set was established
- Not applicable / Not provided.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.