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The LIFEPAK 35 AC power adapter is an optional accessory intended to connect to the LIFEPAK 35 monitor/defibrillator to provide auxiliary power. The bracket and screws provided are intended to attach the power adapter to a wall or shelf.

The LIFEPAK 35 AC power adapter is intended for indoor environments and for fixed installation in ground transportation vehicles.

The LIFEPAK 35 AC Power Adapter is an optional accessory for use with only the LIFEPAK 35 monitor/defibrillator. This accessory contains: AC power adapter with output cable, mounting bracket, bracket screws, region-specific AC power cord (packed separately). The power adapter:

• Provides operating power to the monitor/defibrillator without batteries installed.
• Provides power to charge batteries installed in the monitor/ defibrillator.

The LIFEPAK 35 AC Power Adapter operates on 100 to 240 VAC line power. Installed batteries are charged whenever the power adapter is connected to the LIFEPAK 35 monitor/defibrillator. To help manage and maintain battery charge, the power adapter should be kept plugged into the defibrillator whenever possible.

This document is a 510(k) premarket notification for a medical device: the LIFEPAK® 35 AC Power Adapter. It does not describe a study involving an algorithm or AI.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be found in this document. This document pertains to a physical hardware accessory for a defibrillator.

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The Switched Internal Paddles are intended for use with HeartStart defibrillators to defibrillate the heart during open-chest surgical procedures.

The Switched Internal Paddles are used for defibrillation during open-chest (intrathoracic) procedures. These paddles have a shock button located on the right-hand paddle shown in Figure 5-1. This shock button allows the user to deliver a defibrillation shock holding the paddles to discharge the defibrillator remotely. The reusable switched internal paddles are shipped non-sterilized by the health care provider prior to each patient use. These switched internal paddles are accessories to compatible Philips HeartStart Defibrillators as detailed in Table 5-1, and are identified by the M47xxA series model numbers (where "xx" is a variable integer), as listed below in Table 5-1. These paddles can be used on adult and pediatric populations per the indications for use of the compatible defibrillators.

The information provided describes the acceptance criteria and study proving the device meets those criteria for the Philips Switched Internal Paddles.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Usability Testing: 15 participants (11 sterile processing technicians and 4 surgical technicians).
• Biocompatibility Testing: "Extra Large Switched Internal Paddles with the largest surface area (Model No. M4741A)" were used to simulate a worst-case scenario. The exact number of units tested is not specified, but it implies a single model for testing.
• Other Bench Testing (Hardware, Electrical Safety, Cleaning/Sterilization Validation, Labeling Verification): The sample sizes for these tests are not explicitly stated in the provided text.
• Data Provenance: Not specified, but likely proprietary internal testing given the nature of the submission for product modifications. It's not explicitly stated as retrospective or prospective, but performance testing is inherently prospective for the modified product. No country of origin is mentioned for the data itself, but the submission is to the U.S. FDA.

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

• Usability Testing: The "experts" in this context are the 15 participants in the usability study: 11 sterile processing technicians and 4 surgical technicians. Their qualifications are implied by their roles in a hospital setting (operating room and central processing/sterilization room). No further detail on their specific years of experience or board certification is provided.
• Other Testing: The ground truth for bench tests (biocompatibility, electrical safety, cleaning/sterilization, hardware) is established by adherence to recognized international and national standards (e.g., ISO 10993, IEC 60601, ISO 17665, ANSI AAMI HE75). The "experts" are the engineers and scientists conducting these tests and interpreting results against these standards. Specific numbers or qualifications are not detailed.

4. Adjudication Method for the Test Set:

• Not applicable in the traditional sense for this type of submission. The tests performed are objective measurements against established engineering and biological standards, or observations of user interaction with predefined tasks in usability. There is no mention of a human expert panel adjudicating test results or ground truth in the way it might be done for an AI diagnostic algorithm.

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 MRMC comparative effectiveness study was done. This document describes a K203231 510(k) submission for "Switched Internal Paddles," which is a physical device (defibrillation electrodes) and not an AI diagnostic algorithm or a system requiring human-reader interpretation.

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

• Not applicable. The device is a physical medical device (defibrillation paddles). There is no "algorithm only" component or AI involved. The document explicitly states: "The modified Switched Internal Paddles do not use software for its function nor required any software modifications for compatibility with the HeartStart Defibrillators; therefore, software testing is not applicable for this submission."

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

• Biocompatibility: Ground truth is established by the results of standardized biological tests (e.g., cytotoxicity, sensitization, irritation) against predefined acceptable limits specified in ISO 10993 standards.
• Electrical Safety & Hardware Performance: Ground truth is established by objective measurements verifying compliance with specified engineering requirements and international safety standards (e.g., IEC 60601 series).
• Cleaning & Sterilization Validation: Ground truth is established by verifying the effectiveness of the reprocessing methods through standardized microbiological and chemical tests to ensure sterility and material integrity after reprocessing, as per ISO 17665-1 and other relevant standards.
• Usability: Ground truth is established by observing user interaction with the device following the modified instructions, assessing their ability to safely and effectively use the device, and identifying any potential use errors, against human factors engineering principles (ANSI AAMI HE75) and FDA guidance.

8. The sample size for the training set:

• Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable, as there is no training set for this device.

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The TEMPUS LS - MANUAL is a multi-function, portable of providing defibrillation therapy, noninvasive external pacing, displaying ECG, and CPR feedback in hospital settings. It is to be used by qualified medical health care professionals trained in the use and operation of the device and qualified by training in advanced cardiovascular life (ACLS) support.

Manual Defibrillation: In Manual Defibrillation mode, the TEMPUS LS - MANUAL is indicated for victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions: Unconsciousness, Absence of breathing, and Absence of pulse. This product should be used only by qualified medical personnel for terminating ventricular fibrillation and ventricular tachycardia. Defibrillation is indicated for adult and pediatic patients. When a victim is less than 8 years of age, or weighs less than 55 lbs. (25kg), the TEMPUS LS - MANUAL should be used with the Tempus Pediatric Electrodes or in the device's pediatic mode with the Tempus Adult Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

Cardioversion: The TEMPUS LS - MANUAL may be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardia (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified user trained in the operation of the device must decide when synchronized cardioversion is appropriate. Cardioversion is indicated for adult and pediatric patients.

External Pacing: The TEMPUS LS - MANUAL is indicated for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology. As a standby when standstill or bradycardia might be expected. External pacing is indicated for adult and pediatric patients.

ECG Display: The TEMPUS LS - MANUAL is intended to display a patient's ECG from a 3- or 4- lead wire ECG patient cable. It is indicated for use in adult or pediatric for attended monitoring of the patient's ECG signal (e.g., before starting demand pacing or after successful defibrillation).

CPR Feedback: The TEMPUS LS - MANUAL may be supplied with an optional CPR feedback sensor, which is intended to provide visual and audio feedback to encourage rescuers to perform CPR in accordance with AHA/ERC guidelines for chest compression rate and depth. It is indicated for use on adult and pediatric patients ≥ 8 years of age or weighing ≥ 25 kg / 55 lbs. CPR Feedback is not indicated for use on neonatal and pediatric patients under 8 years of age or weighing less than 25 kg/55 lbs.

The TEMPUS LS – MANUAL is a compact, lightweight, portable electromedical device that contains a direct current (DC) defibrillator capable of delivering up to 200 joules of electrical energy to a patient through selfadhesive external electrode pads. The device is intended for use by advanced cardiac life support (ACLS) trained health care professionals in hospital settings to provide defibrillation therapy, non-invasive external pacing, cardiopulmonary resuscitation (CPR) feedback, and non-alarming electrocardiograph (ECG) monitoring. The device is intended for prescription-use only. The unit is powered by a rechargeable lithium-ion battery which is recharged when connected to a mains power supply. The unit incorporates a color LCD display that displays information related to a clinical intervention. The trained user may select an energy level between 1 - 200 ioules and deliver a shock in either an asynchronous mode of delivery or through synchronized cardioversion using the patient's R-wave as a timing reference for the shock. The device provides non-invasive transcutaneous pacing in either fixed or demand modes of operation through the same self-adhesive pads used in manual defibrillation. In addition, the device incorporates an audible metronome to quide a user as to the correct rate at which chest compressions should be administered in accordance with current American Heart Association (AHA) resuscitation guidelines. The device may be supplied with an optional cardiopulmonary resuscitation (CPR) feedback sensor which assists caregivers during CPR in delivering chest compressions at a rate and depth in compliance with current AHA guidelines. The device may also be paired to a compatible external device via a secure wireless communications protocol called Tempus Data Link (TDL) to export event data (without patient identifiers) at the convenience of the user.

This is a 510(k) summary for the TEMPUS LS - MANUAL, a multi-function defibrillator. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological comparisons and non-clinical performance testing. It does not contain information about a clinical study with acceptance criteria in the typical sense of metrics like sensitivity or specificity for an AI algorithm.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document describes "pre-established acceptance criteria" but does not explicitly list them or quantify performance metrics in a table. Instead, it states that various tests "met requirements" or "met the requirements of the standard," implying that the acceptance criteria were compliance with specific industry standards and successful operation in bench testing.

2. Sample size used for the test set and the data provenance

The document does not detail a "test set" in the context of an AI algorithm's performance. The closest analogous information is for the Human Factors validation testing:

• Sample size: 15 participants
• Data provenance: Not specified, but given the manufacturer is UK-based and the test was for usability, it's likely the participants were located in a similar context. It was a prospective study to evaluate usability.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as the document describes non-clinical testing and human factors usability, not a clinical study requiring expert-established ground truth for diagnostic accuracy.

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

This information is not provided as the document does not describe a process that would involve expert adjudication of a test set for diagnostic performance.

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, a MRMC comparative effectiveness study was not done with human readers and AI assistance. This document describes a medical device (defibrillator) primarily relying on hardware and embedded software functionality, not an AI-powered diagnostic tool that assists human readers.

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

This concept is not directly applicable to the device described. The "algorithm" here refers to the device's operational functions (defibrillation waveform generation, pacing parameters, CPR metronome, etc.) rather than a diagnostic algorithm generating an output for review. Bench testing was performed for these functionalities, which could be considered "standalone" in the sense that the device's technical specifications were verified against standards.

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

For the non-clinical performance testing, the "ground truth" was the pre-established acceptance criteria derived from recognized consensus standards (e.g., IEC 60601-1, IEC 60601-2-4). For the human factors study, the ground truth was the successful and safe use of the device by participants, evaluated against predefined usability metrics.

8. The sample size for the training set

The document does not mention a "training set" as it is not for an AI/ML algorithm that undergoes a training phase with a dataset.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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The Sterilizable Internal Defibrillation Paddles are intended for use with LIFEPAK defibrillators to internally detect ECG rhythm and provide defibrillation or synchronized cardioversion directly to the surgically exposed heart within a sterile use environment.

Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.

The Sterilizable Internal Defibrillation Paddles is an accessory designed to be used with biphasic LIFEPAK defibrillator/monitors during open heart cardiac surgery. The Sterilizable Internal Defibrillation Paddles are intended for use by highly-trained medical professionals to internally detect electrocardiogram (ECG) rhythm and deliver internal defibrillation and synchronized cardioversion therapy directly to the surgically exposed heart. This accessory consists of metal paddle electrodes, and molded plastic handles with discharge control (located on the right handle) which connects directly to the defibrillator.

The Sterilizable Internal Defibrillation Paddles accessory requires sterilization before initial use and after each use, per the Sterilizable Internal Defibrillation Paddles Instructions for Use.

The provided text describes a 510(k) premarket notification for Sterilizable Internal Defibrillation Paddles. It's important to clarify that this document is for a medical device (hardware), not an AI/ML algorithm. Therefore, many of the typical questions for AI/ML device acceptance criteria and study design (like ground truth, expert adjudication, MRMC studies, training/test set sizes) are not directly applicable in the same way.

Instead, the acceptance criteria for such a device typically revolve around demonstrating substantial equivalence to a predicate device, as well as meeting established safety and performance standards through design verification and validation.

However, I will extract the information that is comparable or relevant to your questions, and specify where the requested information is not applicable for this type of device.

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device and meeting design specifications related to safety and performance.

1. A table of acceptance criteria and the reported device performance:

Non-Applicable / General Information for Hardware Devices

The following questions are primarily relevant to AI/ML software performance studies and are not directly applicable to this hardware device's 510(k) submission as described.

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a hardware device in the context of AI/ML test sets. Performance testing for hardware involves laboratory, animal, and simulated use testing, not "test sets" of data in the AI/ML sense. Data sources for such tests are internal (e.g., test benches, animal studies).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML test set is not a concept used for this type of hardware device's testing.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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: Not applicable. This is a hardware device, not an AI assistance tool for human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an accessory to a defibrillator and requires a highly-trained medical professional for use. It is a human-operated device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a hardware device means meeting its engineering and safety specifications, and performing its intended function.
• 8. The sample size for the training set: Not applicable for hardware.
• 9. How the ground truth for the training set was established: Not applicable for hardware.

Summary of Device-Specific Study Information (Performance Data)

The submission highlights that no human clinical studies were submitted as part of this 510(k) Premarket Notification. This is typical for devices seeking substantial equivalence where predicate device experience or non-clinical data is deemed sufficient.

The performance data that supports the acceptance criteria for this hardware device includes:

• Design Verification Testing: To ensure the device meets established design specifications.
• Biocompatibility Testing: To ensure materials are safe for biological contact.
• Electrical Safety and Electromagnetic Compatibility Testing: To ensure the device operates safely within electrical and electromagnetic parameters.
• Design Validation Testing: Which encompassed:
  • Animal Testing: To evaluate performance in a living biological system.
  • Simulated Use Testing: To assess performance under conditions mimicking clinical use.

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To remove excessive hair prior to placement of defibrillator electrodes.

The Rapid Hair Removal Pads ("RHRP") are intended to be used by medical professionals prior to the placement of DC-Defibrillator, Low Energy electrodes to remove excessive chest and side torso hair from a victim of sudden cardiac arrest. This hair can significantly impede the defibrillator's performance in analyzing the heart's rhythm and delivering an appropriate shock. The primary mechanism of the RHRP is a high-tack adhesive that removes hair from the sites on the chest and side torso on which these electrodes are to be placed, prepping the site for optimal electrode-to-skin contact. RHRP is a single-use product and can be disposed of with other emergency single-use equipment.

To use the RHRP, the user removes the pads from the outer packaging, peels the pads sequentially off the non-stick PET liner backing, and places the adhesive side of the pad at two sites—on the chest and side torso-where the defibrillator electrodes will be placed. The user presses the pads on firmly to adhere them to the hair and skin at those sites. The user then pulls the pads quickly away from the skin in the opposite direction of hair growth. The resulting area is left substantially cleared of hair, decreasing impedance and increasing electrode-to-skin contact.

The provided document describes the FDA 510(k) premarket notification for the "Rapid Hair Removal Pads" (RHRP) and its substantial equivalence determination to a predicate device. The document details performance testing conducted to support this claim, which includes Human Factors/Usability testing, Impedance testing, and Biocompatibility studies.

Here's an breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with numerical targets, but rather describes the successful outcomes of the tests. Based on the reported findings, we can infer the implicit acceptance criteria met by the device.

• RHRP labeling effectively directs users.
• Application and removal of RHRP can be completed within a reasonable timeframe (implied performance goal).
• No user confusion or error identified. | - Training of ALS personnel and RHRP labeling effectively directed users on proper application and removal.
• Proposed labeling changes will further enhance the user interface.
• Timed simulation: ALS personnel were able to properly place and remove RHRP in under 15 seconds.
• No user confusion or user error identified based on simulation and questionnaire responses. |
  | Impedance Testing | - RHRP application should substantially decrease impedance at electrode placement sites.
• This decrease in impedance should optimize electrode-to-skin contact and aid defibrillation therapy. | - The hair removal accomplished by the RHRP adhesive substantially decreases impedance, thereby optimizing the electrode pad-to-skin contact and aiding defibrillation therapy.
• Impedance readings were taken before and after RHRP application to demonstrate this effect. |
  | Biocompatibility | - No detectable interaction with human cells (cytotoxicity).
• Minimal or temporary skin irritation (human use testing).
• No chemical irritation of the skin.
• The adhesive materials coming into contact with the skin are non-toxic, do not contain color additives, and have no adverse environmental effects (based on manufacturer records). | - Cytotoxicity test results show no detectable interaction between RHRP and human cells, with a reactivity grade of "O".
• Human Use Testing showed only minor and temporary mechanical irritation of the skin.
• No chemical irritation of the skin was experienced after application and removal.
• Analysis of the RHRP adhesive material (based on manufacturer records) deemed them non-toxic, free of color additives, and with no adverse environmental effects. |

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

• Human Factors/Usability Testing:
  • Sample Size: 15 Advanced Life Safety (ALS) trained professionals.
  • Data Provenance: Prospective, conducted in a simulated emergency setting with live human subjects. The country of origin is not specified but is implied to be within the jurisdiction of the FDA submission (USA).
• Impedance Testing:
  • Sample Size: 26 total chest pulls (implying the RHRP was used 26 times, likely on different subjects or areas).
  • Data Provenance: Prospective, as impedance readings were taken before and after RHRP application. Country of origin not specified (implied USA).
• Biocompatibility Studies:
  • Cytotoxicity Test: Sample size not explicitly stated for the test itself, but performed on the device material.
  • Human Use Testing: Sample size not explicitly stated, but implies observation on human subjects.
  • Adhesive Material Analysis: Based on manufacturer records (no specific sample size for a test set provided here).
  • Data Provenance: Assumed prospective for cytotoxicity and human use testing, retrospective/document review for adhesive material analysis. Country of origin for tests not specified (implied USA).

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

• Human Factors/Usability Testing: The "ground truth" here is the ability of ALS personnel to correctly and efficiently use the device without confusion or error. This was established through observation and questionnaire responses from 15 ALS trained professionals. Their specific qualifications are stated as "Advanced Life Safety trained professionals (ALS personnel)".
• Impedance Testing: The "ground truth" is the change in impedance. This was measured objectively using a "CheckTrode Ohm meter" by presumably study personnel, not through expert consensus on images or outcomes.
• Biocompatibility Studies:
  • Cytotoxicity: Measured objectively in a lab setting by trained personnel following established protocols.
  • Human Use Testing: Based on observation of skin reactions, likely by trained medical observers.
  • Adhesive Material Analysis: Based on manufacturer records, implying expert analysis of material composition and safety data by the manufacturer's qualified personnel.

The document does not detail a process of using a specific number of "experts" to establish ground truth in the sense of image interpretation or medical diagnosis for these types of tests.

4. Adjudication Method for the Test Set

• Human Factors/Usability Testing: No explicit adjudication method (like 2+1 or 3+1) is mentioned. User performance was assessed through direct observation during a simulated environment and through post-testing questionnaire responses from the 15 ALS personnel. "No user confusion or user error was identified" suggests a consensus or clear determination from the observed data.
• Impedance Testing: No adjudication method. It relies on objective meter readings.
• Biocompatibility Studies: No adjudication method. Based on laboratory test results and observations.

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 MRMC comparative effectiveness study was done or reported. The device is a physical hair removal pad, not an AI or digital diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

• Not applicable. As the device is a physical hair removal pad, there is no "algorithm only" performance separate from its interaction with a human user applying it.

7. The Type of Ground Truth Used

• Human Factors/Usability Testing: Observational data (user performance, task completion time) and self-reported feedback (questionnaire responses) from trained professionals.
• Impedance Testing: Objective quantitative measurements (impedance readings in ohms) from a testing device (CheckTrode Ohm meter).
• Biocompatibility Studies: Laboratory assay results (cytotoxicity grade), clinical observation of skin reactions (human use testing), and material composition analysis (manufacturer records).

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product and does not involve AI/machine learning algorithms that require a "training set" in the context of data. The "training" mentioned in the Human Factors study refers to training the ALS personnel on how to use the device.

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

• Not applicable. (See point 8).

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Manual Defibrillation:
Indications: 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.
Contraindications: Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as idioventricular or ventricular escape rhythms, and in the treatment of asystole.

Automated External Defibrillation:
Indications: 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 8 years old.

Noninvasive Pacing:
Indications: Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.

12-lead Electrocardiography:
Indications: 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:
Indications: 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:
Indications: 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.

End-Tidal CO2 monitoring:
Indications: 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:
Indications: 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.

Temperature Monitoring:
Indications: Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature.

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 was designed for use in a variety of hospital and pre-hospital settings including emergency rooms, catheterization laboratories, electrophysiology laboratories, crash carts, operating rooms, and ground ambulances. Features of the LIFEPAK 15 monitor/defibrillator include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-lead. 7-lead and interpretive 12-Lead), pulse oximetry (SpO2, SpCO, and SpMet), synchronized cardioversion, noninvasive blood pressure monitoring, end-tidal CO2 monitoring, invasive pressure monitoring, and temperature monitoring. The LIFEPAK 15 monitor/defibrillator is powered by rechargeable lithium-ion batteries or from AC power sources via an AC power adapter or DC power sources via a DC power adapter. The primary difference between the proposed LIFEPAK 15 monitor/defibrillator and the previously cleared predicate device is a combination of software and hardware modifications completed to support component obsolescence. The proposed LIFEPAK 15 monitor/defibrillator includes the same monitoring features, defibrillation waveform, pacing waveform, and Shock Advisory System™ algorithm as the previously cleared predicate device. Additionally, there are no changes to the intended use or indications for use of the previously cleared predicate device.

The provided text is a 510(k) Premarket Notification for the Physio-Control LIFEPAK 15 monitor/defibrillator. The document focuses on demonstrating substantial equivalence to a previously cleared device, primarily due to software and hardware modifications for component obsolescence. It does not provide detailed acceptance criteria or a specific study demonstrating performance against such criteria for the entire device's functionalities in the context of an AI/algorithm-driven medical device submission.

However, based on the information provided regarding the "Shock Advisory System™ algorithm," we can infer the aspects that would typically involve performance criteria for an automated external defibrillator (AED) algorithm.

Here's an attempt to answer your questions based on the available information, noting that much of the specific detail for AI/algorithm performance is not present in this 510(k) submission, as it predates the widespread regulatory focus on standalone AI algorithm performance studies. The Shock Advisory System™ algorithm mentioned is likely a rule-based algorithm rather than a modern AI/ML algorithm.

1. A table of acceptance criteria and the reported device performance

The document states: "The proposed LIFEPAK 15 monitor/defibrillator includes the same monitoring features, defibrillation waveform, pacing waveform, and Shock Advisory System™ algorithm as the previously cleared predicate device."

This implies that the performance of the Shock Advisory System™ algorithm is assumed to be equivalent to the predicate device. For AED algorithms, typical acceptance criteria would involve sensitivity (true positive rate for shockable rhythms) and specificity (true negative rate for non-shockable rhythms). While specific numerical acceptance criteria are not presented in this document for the current submission, for similar AED algorithms, these often fall within ranges like:

Study Proving Acceptance Criteria:
The document states: "No human clinical studies were submitted as part of this 510(k) Premarket Notification." Instead, the submission relies on "Performance Testing" including:

• Design Requirements Testing
• Hardware Verification
• Software Performance
• Electrical Safety and Electromagnetic Compatibility
• Design Validation via Animal Studies and Simulated Use Testing

The core claim is substantial equivalence to previously cleared LIFEPAK 15 monitor/defibrillators (K082937, K103567). The performance of the Shock Advisory System™ algorithm is explicitly stated as unchanged from the predicate device. Therefore, the "study" proving acceptance criteria for the algorithm's performance would have been conducted for the predicate devices, and the current submission relies on that prior clearance and the assertion that the algorithm itself has not changed.

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

Not provided in this document. Information on test set size and data provenance for the Shock Advisory System™ algorithm would have been part of the original 510(k) submission for the predicate devices. This document explicitly states: "No human clinical studies were submitted as part of this 510(k) Premarket Notification."

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 provided in this document. This information would be specific to the ground truth establishment for the predicate device's algorithm validation.

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

Not provided in this document. This information would be specific to the ground truth establishment for the predicate device's algorithm validation.

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 MRMC study was done or reported in this 510(k) submission. The Shock Advisory System™ algorithm in an AED is typically a standalone algorithm designed to automatically detect shockable rhythms, rather than an AI-assisted interpretation tool for human readers in the context of MRMC studies. The device is intended for use by trained medical personnel, including those using the "Automated External Defibrillation" mode, which implies the algorithm is acting as a decision-maker (shock/no shock) rather than an assistant to a human interpreter in the sense of a diagnostic imaging AI.

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

Yes, for the Shock Advisory System™ algorithm, its function in AED mode is inherently standalone in its determination of whether a rhythm is shockable or not. The document states: "Automated External Defibrillation: 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." This "analysis" is performed by the algorithm. The performance of this standalone algorithm would have been assessed during the predicate device's clearance. This 510(k) asserts the algorithm is unchanged.

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

Not explicitly stated in this document. For AED algorithms, ground truth for rhythm classification (e.g., ventricular fibrillation, asystole, normal sinus rhythm) is typically established by:

• Expert Consensus on ECG Tracings: Review by cardiologists or emergency physicians.
• Simulated Rhythms: Using synthesized or recorded rhythm libraries with known classifications.
• Clinical Outcomes/Events: Correlation with actual patient response to therapy, though less direct for algorithm validation.

It's highly probable that expert consensus on ECG tracings was used for the predicate device.

8. The sample size for the training set

Not provided in this document. This information would be specific to the development and validation of the Shock Advisory System™ algorithm for the predicate devices. Modern AI/ML algorithms often have very large training sets; for the kind of algorithms in AEDs cleared in 2009/2011, training sets might have been smaller, focusing on diverse representations of specific arrhythmias.

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

Not provided in this document. Similar to question 7, ground truth for the training set (if applicable, as the algorithm might be rule-based rather than machine learning trained) would have been established by expert review of ECG tracings or use of labeled rhythm databases.

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Defibrillator Function: The E Series ALS products contain a DC defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation. The E Series ALS products must be prescribed for use by a physician or medical advisor of an emergency response team.

Intended Use — Manual Operation: Use of the E Series ALS products in the Manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions: Unconsciousness, Absence of breathing, and Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In Manual mode, the E Series ALS unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate.

Intended Use - CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.

Intended Use - Pacemaker: This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. Note: This device must not be connected to internal pacemaker electrodes. The purposes of pacing include: Resuscitation from standstill or bradvcardia of any etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia.

Pediatric Pacing: Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.

Monitor Intended-Use Multi-parameter Monitoring: This product may be used for monitoring various patient vital signs, including: electrocardiogram (ECG), Pulse Oximetry (SpO2), Carboxyhemoglobin (SpCO), Methemoglobin (SpMet), End Tidal CO2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP). ECG monitoring is performed by connecting the patient to the 3 or 5 lead patient cable, MFE Pads, or through the paddles. SpO2 monitoring is indicated for detecting arterial oxygen saturation of blood and pulse rate for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpCO monitoring is indicated for detecting carbon monoxide concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpMet monitoring is indicated for detecting oxidized hemoglobin concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO2) and respiration rate for adult, pediatric and neonatal patients. 12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction or other cardiac arrhythmias. NIBP monitoring is indicated for the measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.

The predicate ZOLL E Series External Defibrillator/Monitor reviewed and cleared by the FDA (K111594 and K092598) is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment. It combines the function of a manual defibrillator, noninvasive transcutaneous pacer. ECG monitor, pulse oximeter, end tidal CO2 monitor. 12-Lead EGG monitor, non-invasive blood pressure monitor and CPR performance monitor along with data printing and recording capabilities. Functions are offered as options, and functions can be configured during manufacturing to meet the needs of a particular application. Through a manufacturing configuration option that is already available in the device's software and currently offered for distribution (reviewed and cleared by FDA under K111594), the ECG rhythm analysis (advisory) option can be disabled during the manufacturing of the device. This creates a manual-only/ non-AED configuration of the device which is marketed as E Series ALS and intended to be used by ACLS qualified personnel. On the hardware side, the front panel that is offered with this configuration does not include the analyze button that is used to initiate ECG rhythm analysis.

This document is a 510(k) premarket notification for the "Zoll E Series ALS" device. The manufacturer is seeking clearance for a specific configuration of an existing device (Zoll E Series cleared under K111594 and K092598) as a standalone Class II device. The key aspect is that this new configuration, E Series ALS, disables the ECG rhythm analysis (advisory) option and removes the "analyze" button, making it a manual-only/non-AED configuration.

Based on the provided text, there are no specific acceptance criteria or a dedicated study described to demonstrate the device meets acceptance criteria as typically found for new device functionality or performance claims. The fundamental argument for clearance in this submission is that no new device functionality or performance is being introduced.

Here's an analysis based on the structure of your request:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: Not explicitly stated as new criteria. The device is leveraging the performance and safety established for its predicate device (Zoll E Series, K111594 and K092598). The central "acceptance" is that the removal of the AED/advisory functionality does not introduce new risks or modify existing performance.
   • Reported Device Performance: No new performance metrics are reported in this particular submission. The device's performance characteristics (defibrillation energy delivery, pacing, monitoring vital signs, CPR feedback) are presumed to be the same as the cleared predicate device.

2. Sample size used for the test set and the data provenance

   • No new test set was used for this submission. The submission explicitly states: "No new product or software requirements were introduced... and therefore, no additional design or software verification or validation testing was necessary." This implies reliance on the testing performed for the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   • Not applicable. No new test set requiring expert ground truth establishment for novel functionality was used in this submission.

4. Adjudication method for the test set

   • Not applicable. No new test set.

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

   • Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study was conducted or referenced in this document.

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

   • Not applicable. This device is a medical device with various monitoring and therapeutic functions, not an algorithm. The 510(k) submission itself is for a "standalone Class II clearance" in the regulatory sense, but not for a standalone algorithm performance study. In fact, the removal of an "algorithm-like" function (ECG rhythm analysis/advisory) is a key aspect of this submission.

7. The type of ground truth used

   • Not applicable for this submission. For the predicate device, the ground truth would have been established through a combination of engineering testing, clinical studies, and compliance with performance standards typical for defibrillators, pacemakers, and patient monitors.

8. The sample size for the training set

   • Not applicable. This submission does not involve a machine learning algorithm or a specific training set.

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

   • Not applicable.

Summary of the document's argument regarding acceptance criteria and testing:

The core of this 510(k) submission for the Zoll E Series ALS is that it is a configuration of an already cleared device (Zoll E Series, K111594). The key modification is the disabling of the ECG rhythm analysis (advisory) option and the removal of the "analyze" button, effectively creating a manual-only defibrillator for use by ACLS qualified personnel.

The manufacturer explicitly states:

• "No software modifications were needed to produce the E Series ALS..."
• "The capability to configure the device as E Series ALS during the manufacturing process by disabling the ECG rhythm analysis already existed in the predicate device cleared under K111594."
• "No new product or software requirements were introduced... and therefore, no additional design or software verification or validation testing was necessary."
• "Removal of the 'Analyze' button from the front panel... did not introduce any new risks, or raise any usability issues or concerns..."

Therefore, the "acceptance criteria" discussed in this document are implicitly the safety and effectiveness criteria established and met by the predicate device (K111594/K092598). The "study that proves the device meets the acceptance criteria" is essentially the original testing and clearance data for the predicate device, combined with the argument that removing a feature does not negatively impact the device's substantial equivalence or safety profile. The FDA's issuance of the clearance letter (Pages 0-1) indicates their agreement with this assessment for regulatory purposes.

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The FR3 is intended for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). The FR3 is used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms:

• · Unresponsiveness
• · Absence of normal breathing
  If in doubt, apply the pads.

The FR3 is intended for adults and children over 55 lbs (25 kg) or 8 years old. The FR3 is also intended for children under 55 lbs (25 kg) or 8 years old when used with the optional FR3 Infant/Child Key. If the Infant/Child Kev is not available, or you are uncertain of the child's age or weight, do not delay treatment. Apply the pads as illustrated for a child and use the defibrillator.

The FR3 is intended for use by responders who have been trained in its operation and qualified by training in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The FR3 can be configured under the guidance of a Medical Director to enable Advanced Use mode and alternative cardiopulmonary resuscitation (CPR) protocols, such as CPR while Armed, CPR First-User, and CPR First-Always.

WARNING: Performance of the SMART CPR AUTOI and AUTO2 settings for the CPR First feature has not been established in patients under 55 1b (25 kg) or 8 years old.

CPR Meter with Q-CPR:
The FR3 can be used with the optional CPR meter with Q-CPR® technology by Laerdal. The system is designed for application by a responder trained in its use. It serves as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old or 55 lb (25 kg). If the age or weight of the patient is in doubt, do not delay treatment. Perform CPR without using the CPR meter.

WARNING: The CPR meter is not intended for use on SCA victims under 8 years old or 55 lb (25 kg). If the Infant/Child Key is installed in the FR3, the CPR meter is disabled.

When attached to the bare chest of a suspected victim of SCA and connected to an FR3 used with compatible pads properly placed, the CPR meter provides real-time feedback on CPR in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, release, and rate of chest compressions. It also provides notification for lack of expected CPR activity and a stay-clear icon display during FR3 rhythm analysis and shock delivery. In addition, the FR3 alerts the responder when it detects hyperventilation (more than 12 ventilations per minute) of the patient during CPR.

3-Lead ECG Cable:
In addition, at the discretion of a responder trained in its use, the optional FR3 3-Lead ECG Cable can be connected to the FR3 ECG model to provide a non-diagnostic ECG display of the heart rhythm of a patient who is responsive and breathing normally but at risk of cardiac distress. The system is intended for use on a conscious or breathing patient, regardless of age, for attended patient monitoring. The responder can select display of lead vectors I. II. or III. While connected to the 3-Lead Cable, the defibrillator's shock capability is disabled, but the FR3 continues to evaluate the patient's ECG. In addition, the FR3 alerts the responder to check the patient if the ECG indicates that the heart rate is less than 30 BPM or if the heart rhythm may benefit from a defibrillation shock. If the patient's rhythm or status changes, the responder can attend to the patient, as appropriate.

FR3 Rechargeable Battery:
The FR3 rechargeable battery is intended for use by organizations, such as EMS or fire departments that use the FR3 frequently and want to decrease cost-per-use and reduce environmental waste. The rechargeable battery should only be used by organizations committed to providing the resources required to operate a battery maintenance program. Due to changes in the performance characteristics of rechargeable batteries over time, it is important for the battery maintenance program to monitor how many battery charge/discharge cycles the battery experiences, in order to determine when to retire it from service. The FR3 rechargeable battery is not recommended for infrequent-use environments such as office buildings, airlines, or public access defibrillation (PAD) programs. It should not be used as the spare or backup battery; instead, the standard primary battery should be used due to its long shelf-life.

These battery powered, automated external defibrillators are available in two models, one with ECG (model 861389) and the other in text only (model 861388). Both models include the Philips SMART biphasic, impedance-compensating exponential waveform and a multi-parameter Patient Analysis System (PAS) algorithm for determining if the rhythm is shockable. The models 861389 and 861388 deliver a nominal 150J to adults and a nominal 50J to infants and children when the optional infant/child key mode is used. As with previous generations of Philips AEDs, the models 861389 and 861388 have several methods of testing themselves and alerting the user if there is a problem. In addition to the periodic self-tests performed each time the device is turned on, both models perform power on self-tests, runtime selftests, and runtime operation checks. Using voice prompts, text prompts, graphics, audible tones, light emitting diodes (LEDs) and buttons, the responder is guided through the event.

The models 861388 and 861389 are compatible with several accessories. These items including the Smart Pads III, the Infant/Child Key, a non-rechargeable training battery, an optional Bluetooth transceiver module, an optional data card, an optional language card an optional rechargeable Clinical Use Battery, an optional 3-Lead ECG Cable, an optional CPR Meter with Q-CPR Technology, and various carry cases.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

The provided text (K130684) for the Philips HeartStart FR3 AED models 861388 and 861389 primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's enhanced features and accessories. Crucially, it does not contain a dedicated section outlining specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its core functionality (like the Patient Analysis System algorithm) or a study report explicitly detailing how these criteria were met.

Instead, the submission relies on the concept of substantial equivalence to previously cleared devices. This means that the core safety and performance characteristics are assumed to be similar to the predicates because the underlying technologies (waveform, Patient Analysis System algorithm, SMART CPR algorithm) are unchanged from a prior 510(k) clearance (K111693). New accessories and features are also claimed to be "within the predicate device functionality."

Therefore, much of the requested information regarding acceptance criteria and a specific study proving those criteria are met for the core AED functionality cannot be extracted directly from this document. The information it does provide largely pertains to the supplementary accessories and the general claim of equivalence.

Here's the breakdown of the information you requested, based only on the provided text. Where information is not present, it will be explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

As described above, this document does not explicitly state quantitative acceptance criteria or a specific performance study for the core defibrillation algorithm (Patient Analysis System) for K130684. It relies on the substantial equivalence to a prior 510(k) (K111693) where those criteria would have presumably been established and met.

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

The document does not specify a separate "test set" or its sample size for the core AED functionality in the context of K130684. It relies on the prior clearance (K111693) for validation of the core algorithm.

For the new accessories:

• CPR Meter with Q-CPR Technology: The claim is that performance is "similar" to predicate devices (Laerdal Medical CPRmeter K122050, Philips Compression Sensor with MRx K051134). No new specific test set or data provenance is detailed for K130684, implying it leverages the validation from those predicate devices.
• 3-Lead ECG Cable: No specific test set data is provided in this document. The functionality is described, but not a study proving its performance against acceptance criteria.

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

This information is not provided in the K130684 document. This would typically be part of the original validation study for the Patient Analysis System algorithm, which occurred during the clearance of the predicate device K111693.

4. Adjudication Method for the Test Set

This information is not provided in the K130684 document. This would typically be part of the original validation study for the Patient Analysis System algorithm, which occurred during the clearance of the predicate device K111693.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the K130684 document. Medical devices like AEDs typically perform analysis and advise actions (shock/no shock) autonomously, rather than assisting a human "reader" in interpreting data in the way an AI diagnostic tool might. The CPR meter provides real-time feedback to assist human responders, but an MRMC study demonstrating improvement with AI assistance is not described.

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

The primary functionality of the AED (the "Patient Analysis System algorithm for determining if the rhythm is shockable") is inherently a standalone algorithm-only function. The device makes the shock/no-shock decision based on its analysis. However, this specific 510(k) (K130684) does not detail a new standalone study for this algorithm; it relies on the fact that the algorithm is unchanged from previous clearances.

7. The Type of Ground Truth Used

This information is not provided in the K130684 document. For AEDs, ground truth for rhythm analysis (shockable vs. non-shockable) typically comes from expert electrophysiologist consensus interpretation of ECG tracings or, in some cases, clinical outcomes. This would have been established during the validation of the original Patient Analysis System algorithm in the predicate device.

8. The Sample Size for the Training Set

This information is not provided in the K130684 document. The document states the "Patient Analysis System algorithm... are also unchanged" from K111693, implying any training would have occurred for that prior submission.

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

This information is not provided in the K130684 document. As with the test set ground truth, this would have been established during the original algorithm development and validation for the predicate device K111693.

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The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are intended for use in the hospital, physician's office, and clinic setting by personnel who are authorized by a physician/medical director. Thev are intended for use on a "crash cart" as well as for portable emergency response throughout a hospital.

Indications for Use (for both the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors):

Manual Defibrillation
Indications: Defibrillation is a recognized means of terminating 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.
Contraindications: Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA) such as idioventricular escape rhythms, and in the treatment of asystole.

Automated External Defibrillation:
Indications: The 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 20 (and LIFEPAK 20e) defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.

Noninvasive Pacing
Indications: Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.

Pulse Oximetry
Indications: The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.

End-Tidal CO2 monitoring:
Indications: EtCO2 monitoring is used to detect 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.

The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors were designed especially for hospitals and clinics for use on "crash carts" as well as for portable emergency response throughout a hospital. Features of the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-wire or 5-wire), pulse oximetry, and synchronized cardioversion. The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are powered by AC power and a backup internal battery. The LIFEPAK 20 defibrillator/monitor utilizes a nickel-metal hydride internal battery while the LIFEPAK 20e defibrillator/monitor utilizes a lithium-ion internal battery. The LIFEPAK 20e defibrillator/monitor also has a battery status indicator on the device screen.

In addition to the features described above, the proposed LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors have a new CO2 monitoring feature, CPR metronome feature, wireless data transmission capability and a new optional accessory named the CodeManagement Module™.

This document describes the Physio-Control LIFEPAK® 20 defibrillator/monitor and LIFEPAK® 20e defibrillator/monitor. The notification focuses on a new CO2 monitoring feature and a CPR metronome feature added to these existing devices.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the new features in the proposed LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are similar to the CO2 monitoring and CPR metronome features in the predicate LIFEPAK 15 monitor/defibrillator.

The conclusion of testing states: "The information in this 510(k) notification demonstrates that the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are substantially equivalent to the predicate LIFEPAK 20 defibrillator/monitor, LIFEPAK 20e defibrillator/monitor and the LIFEPAK 15 monitor/defibrillator with respect to safety, effectiveness, and performance."

Since the primary claim for the new features is substantial equivalence to existing predicate devices, the "acceptance criteria" are implicitly met by demonstrating that the new features function comparably to the predicate device, the LIFEPAK 15 monitor/defibrillator. The provided text does not explicitly list quantitative acceptance criteria for the CO2 monitoring or CPR metronome features, nor does it provide a table of "reported device performance" in terms of specific metrics like accuracy, sensitivity, or specificity for these new features. Instead, it relies on the established performance of the predicate device.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document states "Performance testing of the proposed devices consisted of bench testing."
• Data Provenance: Not specified, but generally, bench testing would involve laboratory-generated or simulated data. It does not mention real patient data or country of origin.
• Retrospective/Prospective: Not applicable as no clinical studies were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No experts or ground truth establishment relevant to algorithm performance (like image interpretation) using a test set is described. The evaluation was bench testing based on substantial equivalence.

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

• Not applicable. No human adjudication for a test set is described.

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 or non-clinical (i.e. animal) studies were submitted as part of this 510(k) notification." This means no MRMC study was conducted.

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

• Yes, in a sense, as the performance testing described as "bench testing" would evaluate the device's CO2 monitoring and CPR metronome features independently, likely against known physiological parameters or simulated conditions. However, the exact methodology and metrics are not detailed beyond "bench testing."

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

• For "bench testing," the ground truth would typically be established by known, controlled inputs (e.g., a gas mixture with a specific CO2 concentration, or a mechanical device simulating CPR compressions at a known rate). The document does not specify the exact nature of the ground truth for the bench testing, but it would not be expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. The document describes a 510(k) submission for device modifications (CO2 monitoring and CPR metronome) based on substantial equivalence to a predicate device. It is not an AI/ML algorithm requiring a training set in the conventional sense. The features are presented as being "similar to" those in the predicate, implying established engineering principles and likely internally validated existing algorithms from the predicate device.

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

• Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. .

The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation.

The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25kg (55lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.

ECG Monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring

The LIFPAK 1000 defibrillator is a semi-automatic defibrillator with optional manual mode and ECG display. It is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. There are 3 modes of operation for the LIFEPAK 1000 defibrillator: AED mode (automated external defibrillation), manual mode (operator ECG interpretation, operator control of charge and shock functions), and ECG mode (ECG display allows for rhythm and heart rate monitoring). The currently marketed LIFEPAK 1000 defibrillator is powered by a non-rechargeable lithium-manganese battery.

The proposed LIFEPAK 1000 defibrillator has the same features and functions as the predicate LIFEPAK 1000 defibrillator with an additional battery option - a rechargeable lithium-ion battery.

The provided document is a 510(k) summary for the LIFEPAK 1000 defibrillator, seeking substantial equivalence to a previously cleared device. The key information is that the only change is the addition of a rechargeable lithium-ion battery option. The document explicitly states that the "defibrillation waveform, ECG analysis system, and monitoring and defibrillation features of the proposed LIFEPAK 1000 defibrillator are unchanged from the previously cleared LIFEPAK 1000 defibrillator."

This directly implies that no new clinical studies were conducted to prove device performance or meet acceptance criteria related to its core defibrillation or ECG analysis functions. The substantial equivalence is based on the fact that these critical functional components remain identical to the predicate device, and new testing was likely focused on the safety and performance of the new battery option (though specifics of this testing are not detailed in this summary).

Therefore, this document does not contain the information required to answer most of your questions about acceptance criteria and associated studies for the device's functional performance.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance:

• Cannot be provided. The document states that the defibrillation waveform and ECG analysis system are unchanged from the predicate device. It does not provide acceptance criteria or performance metrics for these functions for the current submission, nor does it refer to specific studies done for this submission.

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

• Cannot be provided. No clinical performance test set details are presented for the updated device in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Cannot be provided. No clinical performance test set details are presented.

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

• Cannot be provided. No clinical performance test set details are presented.

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:

• Cannot be provided. This device is an external defibrillator, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or relevant here.

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

• Cannot be provided. While defibrillators have algorithms for AED mode, no specifics of standalone algorithm performance studies are described in this summary for the updated device. The document emphasizes the unchanged nature of the ECG analysis system from the predicate.

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

• Cannot be provided. No specific studies requiring ground truth establishment are detailed for this submission.

8. The sample size for the training set:

• Cannot be provided. No training set for an algorithm is discussed in this submission.

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

• Cannot be provided. No training set is discussed.

Summary of available information:

• Device: LIFEPAK 1000 defibrillator
• Change: Addition of a rechargeable lithium-ion battery option.
• Justification: Substantial equivalence based on the core functional components (defibrillation waveform, ECG analysis system, monitoring and defibrillation features) being unchanged from the predicate device (K042404).
• Conclusion: The 510(k) notification argues that due to the only change being a battery option and the core functions remaining identical to a previously cleared device, the updated device is substantially equivalent to the predicate, implying that specific clinical performance studies for defibrillation efficacy or ECG analysis were not required for this particular submission.

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