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The Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrode is intended for use in defibrillation procedures, cardioversion, pacing, and ECG monitoring.

The Ludlow Gradient Edge Adult Multifunctional Electrode is for use on adults (an adult is defined as a patient weighing over 10 Kg). The Ludlow Gradient Edge Adult Multifunctional Electrode is not intended for use on children or infants. The device is non-sterile and single-use only.

The Ludlow Gradient Edge Pediatric Multifunctional Electrode is for use on pediatrics (a pediatric is defined as a patient weighing less than 10 Kg). The device is non-sterile and single-use only.

Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes

This document (K012218) is an FDA 510(k) clearance letter for the Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about specific acceptance criteria or details of a study (clinical or otherwise) that proves the device meets such criteria.

The letter focuses on the regulatory determination of substantial equivalence based on the device's indications for use and classification. It does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
• Information about multi-reader multi-case comparative effectiveness studies, standalone algorithm performance, or ground truth types.
• Details on training sets or how their ground truth was established.

Therefore, I cannot fulfill your request for these specifics based solely on the provided document. The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a predicate device, which may involve referencing performance data or design specifications of the predicate, but the details of such assessments are typically found in the full 510(k) submission, not in the clearance letter itself.

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The Katecho external electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). The Katecho KDP-85 Defib/Pace Electrodes are designed for, and to be used, with Agilent Technologies defibrillation devices.

Katecho KDP-85 Adult Defib/Pace Multifunction Electrode. The Katecho external electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the Katecho KDP-85 Adult Defib/Pace Electrodes. The document is a 510(k) clearance letter from the FDA, which primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing it. It does not contain details about performance studies, sample sizes, ground truth establishment, or expert reviews.

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TZ Medical adult disposable electrodes are used by trained professionals in hospitals, doctors offices and Emergency medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.

PadTac Adult Defibrillate/Cardiovert/Pace Pad Fac Addit Dollahilator - TZ Medical Inc.

The provided text is a 510(k) premarket notification approval letter for the "PADTAK Adult Defib/Cardiovert/Pace/Monitoring Electrodes." This document primarily indicates the FDA's finding of substantial equivalence to a predicate device and permits the marketing of the device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information regarding performance, sample size, ground truth, or study details from the provided text.

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PadTac Pediatric disposable electrodes are used by trained professionals in hospitals, doctors offices and Emergency Medical Services for pediatric low-energy defibrillation, cardioversion, pacing and monitoring.

PadTac Pediatric Defibrillate/Cardiovert/Pace/Monitoring Electrodes

This document is an FDA 510(k) clearance letter for the "PadTac Pediatric Defib/Cardiovert/Pace/Monitoring Electrodes." It does not contain information about acceptance criteria or a study proving device performance in the manner requested. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than the results of a specific performance study against defined acceptance criteria.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory clearance based on substantial equivalence, not on a detailed scientific study with performance metrics and ground truth establishment.

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The PIC is intended primarily for use by trained emergency responders, trained in advanced life support, cardiac care techniques, interpretation of ECG waveforms, and the use of the PIC. The usage may be in an ambulance or at the scene of an emergency. The PIC is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. It is also intended to be used during the transport of patients between any of the locations mentioned above. The patient population will consist of adults and children (described below), and will consist of patients both with and without heart dysfunction. The PIC will be used primarily on patients experiencing symptoms of cardiac arrest or in a post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. Indications for each of the specific functions are discussed below:

DEFIBRILLATOR FUNCTION: The defibrillator function of the PIC is used to treat: ventricular fibrillation and pulseless ventricular tachycardia. Patients may range from neo-natal to adult.

DEFIBRILLATOR (INTERNAL PADDLE) FUNCTION: With internal paddles, the defibrillator function of the PIC is used for the termination of ventricular fibrillation during cardiac surgery, with the paddles applied directly to the heart. Patients may range from neo-natal to adult.

ECG MONITOR FUNCTION: The ECG monitor function of the PIC is used to monitor and/or record ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The PIC also provides output signals for the purpose of sending ECG waveforms to a remote monitor via direct connection, telephone, or radio transmission. Patients may range from neo-natal to adult.

EXTERNAL TRANSCUTANEOUS PACEMAKER FUNCTION: The external transcutaneous pacing function of the PIC is used for the emergency treatment of hemodynamically compromising bradycardia, bradycardia with escape rhythms that are unresponsive to pharmacologic therapy, refractory tachycardia (supraventricular or ventricular), and bradyasystolic cardiac arrest. Patients may range from pediatric to adult.

NON-INVASIVE BLOOD PRESSURE FUNCTION: The non-invasive blood pressure function of the PIC is used to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or (occasionally) leg. Patients may range from pediatric to adult.

TEMPERATURE MONITOR FUNCTION: The temperature monitor function of the PIC is used to make continuous measurements of rectal, esophageal, or surface temperature, and to alarm if the temperature is outside of the limits set by the user. It is used on patients ranging from neo-natal to adult.

PULSE OXIMETER FUNCTION: The pulse oximeter function of the PIC is used to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user. It is used on patients ranging from neo-natal to adult. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc. It is used on patients ranging from neo-natal to adult.

RESPIRATION RATE MONITOR FUNCTION: The respiration rate monitor function of the PIC is used to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. The patients range from neo-natal to adult. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. It is used on patients ranging from neo-natal to adult.

The PIC is intended primarily for use by trained emergency responders, trained in advanced life support, cardiac care techniques, interpretation of ECG waveforms, and the use of the PIC. The usage may be in an ambulance or at the scene of an emergency. The PIC is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. It is also intended to be used during the transport of patients between any of the locations mentioned above. The patient population will consist of adults and children (described below), and will consist of patients both with and without heart dysfunction. The PIC will be used primarily on patients experiencing symptoms of cardiac arrest or in a post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. Indications for each of the specific functions are discussed below:

DEFIBRILLATOR FUNCTION: The defibrillator function of the PIC is used to treat: ventricular fibrillation and pulseless ventricular tachycardia. Patients may range from neo-natal to adult.

DEFIBRILLATOR (INTERNAL PADDLE) FUNCTION: With internal paddles, the defibrillator function of the PIC is used for the termination of ventricular fibrillation during cardiac surgery, with the paddles applied directly to the heart. Patients may range from neo-natal to adult.

ECG MONITOR FUNCTION: The ECG monitor function of the PIC is used to monitor and/or record ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The PIC also provides output signals for the purpose of sending ECG waveforms to a remote monitor via direct connection, telephone, or radio transmission. Patients may range from neo-natal to adult.

EXTERNAL TRANSCUTANEOUS PACEMAKER FUNCTION: The external transcutaneous pacing function of the PIC is used for the emergency treatment of hemodynamically compromising bradycardia, bradycardia with escape rhythms that are unresponsive to pharmacologic therapy, refractory tachycardia (supraventricular or ventricular), and bradyasystolic cardiac arrest. Patients may range from pediatric to adult.

NON-INVASIVE BLOOD PRESSURE FUNCTION: The non-invasive blood pressure function of the PIC is used to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or (occasionally) leg. Patients may range from pediatric to adult.

TEMPERATURE MONITOR FUNCTION: The temperature monitor function of the PIC is used to make continuous measurements of rectal, esophageal, or surface temperature, and to alarm if the temperature is outside of the limits set by the user. It is used on patients ranging from neo-natal to adult.

PULSE OXIMETER FUNCTION: The pulse oximeter function of the PIC is used to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user. It is used on patients ranging from neo-natal to adult. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc. It is used on patients ranging from neo-natal to adult.

RESPIRATION RATE MONITOR FUNCTION: The respiration rate monitor function of the PIC is used to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. The patients range from neo-natal to adult. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. It is used on patients ranging from neo-natal to adult.

I am sorry, but based on the provided text, I cannot extract the acceptance criteria and the study details as requested. The document is an FDA 510(k) clearance letter for a "Portable Intensive Care Unit" (PIC), which outlines regulatory information and indications for use. It does not contain details about specific performance acceptance criteria or a study proving those criteria were met.

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CardioServ is intended to be used for the emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia.
CardioServ is intended to be used by trained operators
CardioServ is designed for external and internal defibrillation (including cardioversion)
CardioServ is capable of monitoring the heart rate with adjustable alarm limits.
CardioServ is designed for external pacing with adjustable current and frequency.
The intended use of CardioServ is identical to the intended use of the predicate devices.

CardioServ is a portable defibrillator with ECG monitor, built-in recorder, and the capability of external pacing with adjustable current and frequency.

The provided text describes a medical device, the CardioServ P, and its equivalence to predicate devices, but it does not contain the specific information requested about acceptance criteria and a study proving those criteria are met for AI/algorithm performance.

The document is a 510(k) summary from 1997, focusing on the safety and effectiveness of a defibrillator/pacemaker. The "Technology" section mentions compliance with voluntary standards (e.g., ANSI/AAMI, IEC) and quality assurance measures like "software and hardware testing," "safety testing," and "final validation testing by an independent test group." However, these are general development and testing processes for a hardware medical device, not a study evaluating an AI algorithm's performance against specific acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on the equivalence of the CardioServ P to predicate devices based on its intended use, technological similarity, and adherence to established electrical and medical device standards. There is no mention of an AI component, performance metrics like sensitivity/specificity, or a study design suitable for evaluating such a component.

To fulfill your request, I would need a document detailing the performance evaluation of an AI or algorithm, including specific acceptance criteria and the results of a study designed to demonstrate compliance.

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Responder 2500 is intended to be used in a hospital environment by emergency personnel in evaluating and treating life-threatening arrhythmias.
♦ Responder 2500 is intended to be used by trained operators
♦ Responder 2500 is designed for external and internal defibrillation (including cardioversion)
♦ Responder 2500 is capable of monitoring the heart rate with adjustable alarm limits.
♦ Responder 2500 is designed for external pacing with adjustable current and rate.

Responder 2500 and Cardiac Care System is an emergency cardiac monitor/defibrillator with an external pacing option.

This 510(k) submission for the Marquette Electronics Responder 2500 Defibrillator and Cardiac Care System focuses on demonstrating substantial equivalence to predicate devices (Marquette Series 900 and Marquette Series 1500 Responder) rather than providing detailed acceptance criteria and a study proving device performance against those criteria in a typical AI/ML medical device context.

Therefore, many of the requested details regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment, which are standard for AI/ML device evaluations, are not present in this document. The submission relies on compliance with voluntary standards and general performance equivalency to predicate devices.

Here's an attempt to extract and interpret the available information according to your requested format, along with explicit statements about what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Study Description:

The document describes the "development" of the Responder 2500, which involved various testing and quality assurance measures to confirm compliance with listed voluntary standards and establish equivalence to predicate devices. These measures are:

• Requirements specification reviews
• Code inspections
• Software and hardware testing
• Safety testing
• Environmental testing
• Field tests on the monitor function
• Animal studies on the defibrillation and pacing functions
• Final validation

The results of these measurements "demonstrated that Responder 2500 is as safe, as effective, and performs as well as the predicate devices Marquette Series 900 and Marquette Series 1500 Responder."

Missing Information (Relative to AI/ML Device Evaluation):

Specific quantitative acceptance criteria (e.g., sensitivity, specificity, AUC thresholds) are not provided, as this is a traditional medical device submission focused on performance standards and predicate equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document mentions "field tests on the monitor function" and "animal studies on the defibrillation and pacing functions," but provides no numbers for test subjects (human or animal) or the duration/scope of these tests.
• Data Provenance: Not specified. No mention of country of origin or whether data was retrospective or prospective.

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 specified. The evaluation relies on compliance with established engineering standards and functional performance, not on expert adjudication of diagnostic outcomes like an AI/ML algorithm might.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified. (See point 3)

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. This is not an AI/ML device and therefore no MRMC study, or impact on human readers, was conducted or reported.

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

• The device itself is a standalone functional unit. Performance was assessed based on its functional capabilities (monitoring, defibrillation, pacing) and compliance with standards. There isn't an "algorithm only" performance concept in the way it applies to AI/ML devices, as the device's function is inherently a standalone "performance."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Functional Ground Truth: The "ground truth" for this device's performance would be defined by the technical specifications outlined in the voluntary standards referenced (e.g., ANSI/AAMI DF2-1996 for defibrillator performance, IEC 601-2-27 for ECG performance). For animal studies, the "ground truth" would be established by physiological measurements and successful or unsuccessful defibrillation/pacing events as determined by veterinarians or other qualified personnel. It is not expert consensus for image interpretation or pathology.

8. The sample size for the training set

• Not applicable. This device is a hardware/software system, not a machine learning model that undergoes a "training" phase with a dataset in the AI/ML sense. Its development involved traditional engineering, software development, and quality assurance processes.

9. How the ground truth for the training set was established

• Not applicable. (See point 8)

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