Search Results

AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 12 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.

Manual Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.

Noninvasive Pacing is indicated for patients with symptomatic bradycardia or asystole.

12-Lead Electrocardiography is useful in the early detection and prompt treatment of patients with acute myocardial infarction.

Pulse Oximetry is used to check the saturation of oxygen in arterial blood. It is indicated for use in any patient who is at risk of developing hypoxemia.

Noninvasive Blood Pressure Monitoring is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post-defibrillation recovery analysis.

End-Tidal CO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.

Invasive Pressure Monitoring is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using an invasive catheter system with a compatible transducer.

The LIFEPAK® 12 defibrillator/Monitor/Pacemaker is a complete acute response system, which consists of a battery or auxiliary powered cardiac response system (manual and automated), pacemaker, ECG monitor (3-lead, 5-lead, 5-lead and interpretive 12-Lead), pulse oximeter, noninvasive blood pressure monitor, end-tidal CO2 monitor, and invasive pressure monitor.

The modified LIFEPAK® 12 defibrillator/monitor/pacemaker provides the user with a new method of transmitting data from the LIFEPAK 12 defibrillator; the user can transmit data using either a data transfer cable or wirelessly via Bluetooth® wireless technology.

This 510(k) submission (K040775) is for a modification to the Medtronic Physio-Control LIFEPAK® 12 Defibrillator/Monitor/Pacemaker. The modification involves a new method of transmitting data (data transfer cable or wirelessly via Bluetooth®).

The submission explicitly states that "The features and functions of the LIFEPAK® 12 The reatures and rest/pacemaker are the same as those of the currently marketed LIFEPAK®12 defibrillator/monitor/pacemaker." and "The information in this 510(k) notification demonstrates that the modified LIFEPAK I he mormation in uns 316(tr) neasis substantially equivalent to the predicate device."

This indicates that the device's core functionality (defibrillation, monitoring, pacing, etc.) has not changed, and therefore, no new acceptance criteria, standalone study, or MRMC comparative effectiveness study was required or performed for this specific 510(k) submission. The submission is based on demonstrating substantial equivalence to a previously cleared device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, and ground truth for the modified device is not available in this document as it pertains to the original device's clearance. The current submission focuses solely on the data transmission modification and its substantial equivalence to the predicate.

Ask a specific question about this device

The LIFEPAK 500, LIFEPAK CR Plus, and the LIFEPAK 12 and LIFEPAK 20 in automated external defibrillation mode are intended for use on patients in cardiac arrest.

LIFEPAK 12 and LIFEPAK 20 Defibrillator/Monitor/Pacemakers: The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm.

LIFEPAK 500 Automated External Defibrillator: The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no coughing, no movement) before the device is used to analyze the patient's ECG rhythm.

LIFEPAK CR Plus Automated External Defibrillator: The LIFEPAK CR Plus defibrillator is indicated for use on patients in cardiac arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement).

The LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators are small, portable, battery operated devices intended for treatment of cardiac arrest. Both devices use a patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present. The LIFEPAK 500 and the semi-automatic version of the LIFEPAK CR Plus will then inform the operator if it detects a shockable rhythm and the operator can then press the shock button to deliver energy. The energy is delivered via disposable defibrillation electrodes applied to the chest. The LIFEPAK CR Plus is also available in a fully automatic version which does not require operator interaction to charge and discharge.

The LIFEPAK 12 and LIFEPAK 20 devices use the same shock advising software algorithm as the devices described above. Features available in addition to automated external defibrillation include manual external defibrillation, noninvasive pacing, ECG monitoring, pulse oximetry, and synchronized cardioversion. The LIFEPAK 12 also offers noninvasive blood pressure monitor, invasive blood pressure monitor, and end-tidal CO2 monitor features.

The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria. It is a 510(k) summary for Medtronic Physio-Control defibrillators, focusing on substantial equivalence to previously cleared devices rather than a de novo study with explicit acceptance criteria.

However, based on the general nature of such devices, we can infer some aspects and highlight what information is missing.

Here's an attempt to answer the questions, categorizing what can be inferred and what is explicitly not available in the provided text:

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

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 for Test Set: Not specified.
• Data Provenance: Not specified. The document focuses on substantial equivalence based on prior clearances and the shared algorithm, not new clinical study data details.
• Retrospective or Prospective: Not specified.

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 specified. The document does not describe a study involving human experts establishing ground truth for evaluating the device's performance.

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

• Not specified. As no expert ground truth establishment for a test set is detailed, no adjudication method is mentioned.

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, an MRMC comparative effectiveness study is not mentioned. This document is for a 510(k) clearance based on substantial equivalence, not a new comparative effectiveness study with human readers and AI assistance. The devices include an "automated external defibrillator" (AED) mode, implying the algorithm is the primary decision-maker for shock advice, not an "AI assistance" for human readers in a diagnostic capacity.

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

• Yes, implicitly. The core of the AED functionality described relies on a "patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present." While some devices (LIFEPAK 500 and semi-automatic CR Plus) then require operator interaction to press a shock button, the analytical part of the decision-making is automated. The fully automatic CR Plus explicitly "does not require operator interaction to charge and discharge." The substantial equivalence argument rests on this existing, cleared algorithm's performance.

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

• The document does not explicitly state the type of ground truth used for the original validation of the "patented software algorithm." However, for AEDs, ground truth for shockable rhythms (Ventricular Fibrillation (VF) and rapid Ventricular Tachycardia (VT)) is typically established by:
  • Expert Consensus: Review of ECG waveforms by cardiologists or electrophysiologists.
  • Physiological Correlation: In some research contexts, correlation with actual cardiac activity or response to defibrillation.
  • Standardized Databases: Often, development and validation use large, annotated ECG databases derived from various clinical situations.

8. The sample size for the training set

• Not specified. The document describes existing algorithms and devices, not the details of their initial training data.

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

• Not specified. As with the test set ground truth, the document refers to a "patented software algorithm" and its performance in previously cleared devices, but does not detail the methodology for establishing ground truth during its original development and training.

Ask a specific question about this device

Use the Infant/Child defibrillation electrodes on an infant or child up to 8 years old or up to 25kg (55lbs). Do not delay therapy to determine child's exact age or weight.

These electrodes are to be used only with LIFEPAK CR PLUS defibrillators and biphasic LIFEPAK® 500 AEDs configured with a pink cable connector.

The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are indicated for use on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no coughing, no movement) before the device is used to analyze the patient's ECG rhythm.

The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.

The attenuating electrode is designed to allow minimally trained responders to safely and effectively defibrillate infants and children under 8 using the LIFEPAK® CR Plus or biphasic LIFEPAK 500 AEDs manufactured after a certain date. (Compatible biphasic LIFEPAK 500 AEDs can be identified by the pink connector on the AED.)

The Infant / Child Reduced Energy Electrode assembly consists of currently marketed Pediatric QUIK-COMBO electrode pads, wires, a connector, and an attenuator. The attenuator is comprised of multiple resistors and a surge protector mounted on a PCB and installed in a flat plastic case.

The attenuator reduces the standard "adult" AED energy at a ratio of about 4 to 1. When used with the Infant / Child Reduced Energy electrodes, an AED set to deliver 200J first shock, 300J second shock, and 360J third shock for adult patients, will instead deliver about 50, 75, and 86J.

Here's a breakdown of the acceptance criteria and study information for the Medtronic Physio-Control Infant/Child Reduced Energy Electrodes, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on substantial equivalence to predicate devices rather than explicit, quantitative acceptance criteria for all performance metrics. However, it does outline the energy reduction ratio, which is a key performance characteristic.

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

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms" and "Non-Clinical testing of energy dosing" but does not specify:

• The exact sample size used for the test set in either category.
• The country of origin of the data.
• Whether the data was retrospective or prospective.

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

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms" but does not specify:

• The number of experts used to establish ground truth.
• The qualifications of those experts.

4. Adjudication Method for the Test Set

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms" but does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

A MRMC comparative effectiveness study was NOT mentioned or described in the provided text. The submission focuses on the performance of the device itself and its substantial equivalence to predicate devices, rather than measuring the improvement of human readers with AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms," which suggests a standalone evaluation of the algorithm's performance in analyzing ECG rhythms. However, further details on how this was conducted (e.g., specific metrics, comparison to human interpretation) are not provided. The primary focus seems to be the algorithm's ability to accurately identify pediatric rhythms for the defribrillator.

7. Type of Ground Truth Used

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms." For ECG rhythm analysis, the ground truth is typically established by expert consensus of cardiologists or electrophysiologists on the rhythm strips. However, the document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set

The document does NOT provide any information regarding the sample size used for the training set for the algorithm.

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

The document does NOT provide any information on how the ground truth for the training set was established.

Ask a specific question about this device

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.

The biphasic waveform has only been clinically studied on adults; it has not been studied on pediatric patients.

The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm.

In AED mode, the LIFEPAK 20 defibrillator/monitor is not intended for use on pediatric patients less than eight years old.

Noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.

Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.

The LIFEPAK 20 device is a defibrillator/monitor primarily intended for the hospital and clinic setting. It is easy to use, portable, easy to maintain, and fits comfortably on a gurney during transport. It has a built in AC power supply and backup NiMH battery. It uses a biphasic waveform with an energy range from 2 - 360 Joules.

Features and options include: external noninvasive pacemaker; pulse oximeter; 3-, 6-, and 7-lead ECG; defibrillation paddles; ability to use all disposable electrodes or paddles currently used with the LIFEPAK 12 defibrillator/monitor/pacemaker; internal paddles capability; 50 mm printer; automated external defibrillator mode; built in AC power with NiMH battery backup; digital remote synchronization to bedside monitor; and an infrared and serial ports for data download.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Medtronic Physio-Control LIFEPAK 20 Defibrillator/Monitor:

Overall Assessment:

The provided document (510(k) Premarket Notification) for the LIFEPAK 20 primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (LIFEPAK 9P and LIFEPAK 12). This means that instead of conducting new, extensive clinical studies to prove effectiveness and safety from scratch, the manufacturer argues that the new device is as safe and effective as existing, legally marketed devices.

Therefore, the document does not describe specific acceptance criteria and detailed study results in the manner one might expect for a de novo device submission where new performance metrics are established and then proven through dedicated trials. Instead, it relies on compliance with recognized standards and the inherent equivalence to predicate devices that have already met regulatory requirements.

1. Table of Acceptance Criteria and Reported Device Performance:

Given the nature of this 510(k) submission, a direct table of "acceptance criteria" against "reported device performance" (in the sense of specific clinical endpoints with numerical targets) is not explicitly provided. The acceptance criteria are implicitly tied to:

• Compliance with recognized standards: AAMI, IEC, and ISO standards for defibrillators, monitors, and pulse oximeters.
• Substantial equivalence to the predicate devices in terms of safety, effectiveness, and performance.

The document states that these criteria are met, but does not provide specific performance data points in a table format.

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

The document does not describe a specific "test set" or a new clinical study with a defined sample size for the LIFEPAK 20 itself. Instead, it relies on the established performance of its predicate devices and compliance with international standards.

• Sample Size for Test Set: Not applicable or not specified for a new, dedicated study. The evidence is based on the general acceptance of the predicate devices and standard compliance.
• Data Provenance: Not applicable in the sense of a new clinical trial. The "data" stems from the validation/clearance of the predicate devices and the technical verification processes (likely in-house testing) to ensure compliance with standards.

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

This information is not provided. Since no new clinical "test set" (in the sense of patient data requiring expert ground truth) is described for the LIFEPAK 20's performance validation, there's no mention of experts or their qualifications for establishing ground truth for a novel dataset.

4. Adjudication Method for the Test Set:

Not applicable, as no new clinical "test set" requiring expert adjudication is described in this 510(k) summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study is not mentioned or described in the provided text.

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

The LIFEPAK 20 is a medical device that includes various functions (defibrillation, monitoring, pacing, oximetry). While it has an "automated external defibrillator mode," the document does not describe a separate "standalone algorithm" performance study in the context of AI or advanced diagnostic algorithms. Its "automated" function would have been validated as part of its overall design and compliance with AED standards.

7. The Type of Ground Truth Used:

For the LIFEPAK 20 itself, the "ground truth" for its performance is implicitly derived from:

• Compliance with established performance standards (AAMI, IEC, ISO): These standards define performance requirements that are met through engineering validation and testing.
• Performance of predicate devices: The predicate devices (LIFEPAK 9P, LIFEPAK 12) have already undergone their own regulatory clearance, which would have involved demonstrating effectiveness and safety, potentially using clinical data, expert consensus, or other forms of ground truth suitable for those devices at their time of submission.

There's no mention of pathology, explicit expert consensus on a novel dataset for the LIFEPAK 20, or outcomes data specific to the LIFEPAK 20's primary 510(k) submission.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its design and functionality are based on engineering principles and established medical science, not on a machine learning model trained on a dataset.

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

Not applicable, as there is no "training set" for this type of device.

Ask a specific question about this device

Ask a specific question about this device

The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The The In Life In First 500 rassious, not breathing normally and showing no signs of circulation (for example, no pulse, no coughing, no movement) before the device is used to analyze the patient's ECG rhythm. This device is not intended for use on children less than eight years of age, per AHA/ILCOR Guidelines.

The LIFEPAK 500 Automated External Defibrillator (AED) is a portable battery powered, low energy defibrillator that applies a pulse of electricity to the heart via disposable defibrillation electrodes on the chest. A patented software algorithm analyzes the patient's electrocardiogram (ECG) and informs the operator if it detects a shockable rhythm. The operator can then press the shock button to deliver energy.

This 510(k) summary (K012428) primarily concerns a change to the operating instructions and voice prompts of the LIFEPAK 500 Automated External Defibrillator (AED) to align with updated American Heart Association Guidelines 2000 for CPR and ECC.

Therefore, the submission does not contain information about a new performance study to establish acceptance criteria or device performance for a new algorithm or a new hardware feature. Instead, it relies on the predicate devices' prior clearances.

The device (LIFEPAK 500 AED) is already cleared, and this submission is a Special 510(k) for a modification to its user interface and instructions, not a fundamental change to its shock advisory algorithm or defibrillation waveforms. The document explicitly states: "The shock advisory algorithm, defibrillation waveforms, etc. are all the same."

Given this context, I will extract the information available and note where specific details regarding a new performance study are not applicable or not provided.

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is for a modification to operating instructions and voice prompts, rather than a new performance study for the core defibrillation algorithm, a table of new acceptance criteria and new reported device performance (e.g., sensitivity, specificity for rhythm analysis) is not provided in this document. The device relies on the existing performance data from its predicate devices (K983393 and K955854). The relevant "performance" being updated here is the user's interaction with the device based on new guidelines.

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

Not applicable for a new performance study related to algorithm accuracy, as the algorithm itself is unchanged.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable for a new performance study related to algorithm accuracy, as the algorithm itself is unchanged. The rationale for the instructional changes comes from the American Heart Association Guidelines 2000 for CPR and ECC, which would have been developed by medical experts.

4. Adjudication Method for the Test Set

Not applicable for a new performance study related to algorithm accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study would typically be conducted for imaging or diagnostic algorithms where human reader performance is a factor. This submission pertains to a defibrillator's operating instructions.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. The defibrillation algorithm's standalone performance, such as sensitivity and specificity for shockable rhythms, was established during the clearance of its predicate devices (K983393 and K955854), as the algorithm remains "the same."

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the original algorithm development and validation (of the predicate devices), the ground truth for cardiac rhythm analysis would typically be established by expert cardiologists reviewing ECG recordings. However, for this specific 510(k), the "ground truth" for the changes in operating instructions and prompts is based on clinical guidelines and recommendations from the American Heart Association Guidelines 2000 for CPR and ECC. These guidelines are developed through extensive review of medical evidence and expert consensus.

8. The Sample Size for the Training Set

Not applicable for this 510(k). The device's algorithm was developed and trained prior to this submission.

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

Not applicable for this 510(k). For the original algorithm, ground truth would have been established by expert cardiologists analyzing ECG data used for training.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device