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Manual Defibrillation:
Indications
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 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 indioventricular 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 12 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.
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 myocardial infarction.
Pulse Oximetry:
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.
Noninvasive Blood Pressure Monitoring:
Indications
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:
Indications
EtCO2 monitoring is indicated for detection of 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. It is intended for use on adult and pediatric patients.
Invasive Pressure Monitoring:
Indications
The LIFEPAK 12 invasive pressure monitor is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using and invasive catheter system with a compatible transducer. It may be used on the adult or pediatric patient.

The LIFEPAK 12 defibrillator/monitor was designed for use in a variety of hospital and pre-hospital settings including emergency departments, critical care areas, and air and ground ambulances. The LIFEPAK 12 defibrillator/monitor is powered by either a battery or AC power. LIFEPAK 12 defibrillator/monitor features include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-lead, 7-lead and interpretive 12-Lead), pulse oximetry, synchronized cardioversion. noninvasive blood pressure monitoring, end-tidal CO2 monitoring, and invasive pressure monitoring.
The LIFEPAK 12 defibrillator/monitor has been modified with new setup options in automated external defibrillation (AED) mode to give medical directors or physicians flexibility in establishing their AED protocols including consistency with the recently updated 2005 AHA Guidelines for CPR and ECC.

The provided text describes a 510(k) summary for the Medtronic LIFEPAK® 12 Defibrillator/Monitor, which was modified with new setup options in automated external defibrillation (AED) mode. However, the document does not contain any study data, acceptance criteria for performance, or details about how the device's performance was evaluated against specific metrics.

It primarily focuses on:

• Device Description and Intended Use: Explaining what the LIFEPAK 12 is, its features, and for what purposes it's used.
• Indications for Use and Contraindications: Detailing when each function (Manual Defibrillation, AED, Pacing, ECG, Oximetry, NBP, EtCO2, Invasive Pressure) should be applied and when it should not.
• Substantial Equivalence: Stating that the modified device is substantially equivalent to a previously cleared version, with the only change being new setup options for AED mode.
• Regulatory Information: Classification, contact person, and the FDA's clearance letter.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details because it is not present in the provided text. The document indicates a "Summary of Design Controls" and a "declaration of conformity to design controls," implying that internal testing and validation were performed to support substantial equivalence, but the specifics of these tests (e.g., performance metrics, sample sizes, ground truth establishment) are not included in this 510(k) summary.

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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 is a complete acute cardiac response system, which consists of a battery or auxiliary powered defibrillator (manual or automated), external pacemaker, ECG monitor (3-lead, 5-lead and interpretive 12-Lead), pulse oximeter, noninvasive blood pressure monitor, end-tidal CO2 monitor, and invasive pressure monitor. Patient data can be transmitted from the LIFEPAK 12 defibrillator to a fax machine, computer, or to a receiving station. This modification changes the pulse oximetry module and sensors used in the LIFEPAK 12 defibrillator/monitor from Nellcor to Masimo.

The provided text does not contain detailed information about specific acceptance criteria and a study that proves the device meets those criteria for the pulse oximetry feature. The document is a 510(k) premarket notification for a modification to the LIFEPAK 12 Defibrillator/Monitor, specifically changing the pulse oximetry module and sensors from Nellcor to Masimo.

The submission claims substantial equivalence to previously cleared devices and mentions design control activities, but it does not include granular data on the performance of the new Masimo pulse oximetry module against predefined acceptance criteria from a study.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an attempt to answer based only on the provided information, noting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the provided text.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified in the provided text.

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

• Not specified, as no study details (like ground truth establishment) are provided for the pulse oximetry performance.

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

• Not specified, as no study details are provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• A MRMC study is not mentioned. This device is a defibrillator/monitor with a pulse oximetry feature, not an AI diagnostic tool that human readers would use in conjunction with.

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

• A standalone performance study for the pulse oximetry accuracy is implied by the need for regulatory clearance for a new module, but the details (methodology, results, and whether it's "algorithm only") are not provided in this specific document. The document focuses on substantial equivalence via design control summaries and comparison to predicate devices, rather than a detailed performance study report.

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

• Not specified, as no study details for pulse oximetry accuracy are provided. For pulse oximetry, the typical ground truth would involve co-oximetry measurements from arterial blood gas analysis.

8. The sample size for the training set:

• Not applicable, as this is hardware/firmware modification of a medical device, not a machine learning algorithm that requires a "training set" in the conventional sense.

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

• Not applicable for the same reason as above.

Summary of what the document does provide regarding "proof":

The document primarily states that "This 510(k) includes a summary of design control activities and a declaration of conformity to design controls." and that "The information in this 510(k) notification demonstrates that the modified LIFEPAK 12 defibrillator/monitor is substantially equivalent to the predicate device."

The basis for the pulse oximetry change is that "The modified LIFEPAK 12 uses the same sensors and an updated version of the Masimo SET pulse oximetry module used in the currently marketed LIFEPAK 20 defibrillator/monitor." This implies that the performance of the new Masimo module is already established and cleared through the predicate LIFEPAK 20, and that the "proof" for the LIFEPAK 12 modification relies on this existing equivalence and design control adherence, rather than new, detailed performance study data presented within this 510(k) summary.

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