(161 days)
The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in out-of doors and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 15 monitor/defibrillator is not intended for use on pediatric patients less than eight years old.
Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST-elevation myocardial infarction (STEMI).
Pulse oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. SpO2 monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions.
Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance.
EtCO2 monitoring is used to detect trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.
Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diagnosis.
The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LIFEPAK 15 monitor/defibrillator product is a next generation product to the currently legally marketed LIFEPAK 12 defibrillator/ monitor product. The LIFEPAK 15 monitor/defibrillator design is significantly based upon the existing LIFEPAK 12 architecture and when compared to the LIFEPAK 12 predicate it has similar performance characteristics, features, and accessories.
The provided text from K082937 describes a 510(k) submission for the LIFEPAK® 15 Monitor/Defibrillator. It states that the device's features and functions are "substantially equivalent" to previously cleared predicate devices (specifically the LIFEPAK 12 defibrillator/monitor). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predecessor, rather than presenting new clinical study data with specific acceptance criteria and performance metrics for an AI algorithm.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert qualifications, and adjudication methods for a study proving an AI device meets acceptance criteria cannot be extracted from this document, as it outlines a substantial equivalence claim for a traditional medical device, not an AI/ML software.
The document highlights:
- Predicate Device Comparison: The core of the submission is the comparison to the LIFEPAK 12 for demonstrating substantial equivalence.
- Verification and Validation: It mentions "documentation related to the verification and validation of the LIFEPAK 15 monitor/defibrillator," which typically refers to engineering and system-level testing, not clinical studies in the context of AI performance.
- Intended Use and Indications/Contraindications: These are provided for the various monitoring and therapy functions of the device (e.g., manual defibrillation, AED, noninvasive pacing, 12-lead ECG, pulse oximetry, NIBP, EtCO2, invasive pressure monitoring).
In summary, this document does not contain the information needed to fill out the requested table and answer the specific questions related to the performance of an AI/ML algorithm. The regulatory pathway chosen (510(k) based on substantial equivalence to a predicate device) for this product typically does not require the extensive clinical efficacy studies with detailed acceptance criteria and performance metrics that would be associated with a novel AI-powered diagnostic or therapeutic device.
§ 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.