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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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Manual Defibrillation:
Indications: Defibrillation is a recognized means of terminating certain 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.

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.

The LIFEPAK 20 defibrillator/monitor was created especially for hospitals and clinics for use on "crash carts" as well as for portable emergency response throughout a hospital. The LIFEPAK 20 defibrillator/monitor is equipped with AC power and a backup internal battery. Features of the LIFEPAK 20 defibrillator/monitor include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-wire or 5-wire), pulse oximetry, and synchronized cardioversion.

The LIFEPAK 20 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 document describes a 510(k) premarket notification for a modification to the Medtronic LIFEPAK® 20 Defibrillator/Monitor. While it outlines the device's features and intended use, it does not contain specific acceptance criteria or details of a study that proves the device meets those criteria for its modified features.

The modification described is related to "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 document states: "The new cprMAX setup options only affect operation in automated external defibrillation mode. Features of the modified LIFEPAK 20 defibrillator/monitor such as the ECG analysis system, defibrillation waveform, pacing, and pulse oximetry are the same as those of the predicate device. Defibrillation technology and functionality of the LIFEPAK 20 defibrillator/monitor has not changed from the previously cleared device."

This implies that for the new setup options, the company is asserting substantial equivalence based on consistency with guidelines rather than presenting a new study with acceptance criteria. For the core functionalities (ECG analysis, defibrillation waveform, pacing, pulse oximetry), they rely on the previous clearances (K033275, K012274) of the predicate device, as those features have not changed.

Therefore, I cannot extract the requested information (1-9) as it pertains to a new study proving performance against acceptance criteria for the modified device, because such information is not present in the provided text. The document focuses on regulatory compliance through substantial equivalence, not on new performance study data for the specific modification.

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The LIFEPAK 500 AED is intended for use on patients in cardiac arrest. It is intended for use in hospital and in out-of-hospital environments.

The LIFEPAK 500 AED is intended for use by personnel who are authorized by a medical director and have, at a minimum, the following skills and training:

• CPR training
• AED training equivalent to that recommended by the American Heart Association
• Training in the use of the LIFEPAK 500 AED

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. With Infant/Child Reduced Energy Defibrillation Electrodes, the specially configured biphasic LIFEPAK 500 AED may be used on children up to 8 years old or 25kg (55 lb).

The LIFEPAK 500 automated external defibrillator is a small, portable, battery operated device intended for treatment of cardiac arrest. The device uses a patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present. The LIFEPAK 500 AED will inform the operator if it detects a shockable rhythm and the operator can press the shock button to deliver energy. The energy is delivered via disposable defibrillation electrodes applied to the chest.

The provided 510(k) summary for the Medtronic biphasic LIFEPAK 500 Automated External Defibrillator (AED) focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed study proving the device meets specific acceptance criteria in the traditional sense of a performance study with numerical endpoints.

The submission states: "The features and functions of the modified biphasic LIFEPAK 500 AED are the readies and railer [likely a typo, suggesting 'the same as and similar'] to the previously cleared Medtronic LIFEPAK 500 AED, Substantially Squarants K955854 (11/4/96), K983393 (05/05/99), K012428 (09/28/01), 310(k) hambers 119690); and the Philips Medical Systems Heartstream Heartstart FR2+ AED, 510(k) number K013425 (01/14/2002)." It also mentions, "Defibrillation technology and functionality are unchanged from the previously Declorination technology and Imerely and 500 software has been modified to allow the medical director or physician greater control over CPR settings."

Therefore, the "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate devices, and the "study" is a demonstration of substantial equivalence through design control activities and comparison to those predicates. The document does not provide quantitative performance metrics, sample sizes for a test set, ground truth experts, or details of a standalone or MRMC study.

However, based on the information provided, we can infer some aspects and highlight 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. The submission relies on substantial equivalence to predicate devices, which would have undergone their own testing. There is no new, independent clinical or performance test set described for this modified device.
• Data Provenance: Not specified for new testing. The reference devices K955854, K983393, K012428, and K013425 would have generated their own clinical data.

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

• Not applicable as no independent test set or ground truth establishment process is described for this specific 510(k). The regulatory review of the predicate devices would have involved expert review.

4. Adjudication method for the test set

• Not applicable as no independent test set or adjudication process is described for this specific 510(k).

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 is mentioned. This device is an AED that uses an algorithm to determine shockable rhythms, not an AI-assisted diagnostic tool for human readers in the context of MRMC studies.

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

• The device inherently operates as a "standalone" algorithm in its primary function of ECG analysis. The human operator presses the shock button after the device informs them a shockable rhythm is detected. However, the document does not describe a formal "standalone performance study" with specific metrics (e.g., sensitivity, specificity for rhythm analysis) for this specific modified device. It relies on the performance of the predicate devices. The algorithm's performance for rhythm analysis would have been established for the original LIFEPAK 500.

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

• Not specified for this 510(k). For AEDs, ground truth for rhythm analysis typically involves expert review of ECGs, often verified against clinical outcomes where appropriate.

8. The sample size for the training set

• Not specified. The software algorithm is "patented" and "modified to allow the medical director or physician greater control over CPR settings," suggesting the core rhythm detection algorithm was developed and validated previously with an unspecified training set.

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

• Not specified. This would have been established during the development of the original LIFEPAK 500 algorithm. Typically, this involves a large dataset of ECGs with rhythm classifications established by expert cardiologists or electrophysiologists.

Summary of the "Study" provided in the 510(k):

The "study" for this 510(k) is a demonstration of substantial equivalence rather than a traditional performance study with new raw data. The core of the argument is that:

• The device's intended use and indications for use are the same as predicate devices.
• The fundamental defibrillation technology and functionality remain unchanged from previously cleared versions of the LIFEPAK 500.
• The software modification is related to CPR settings, not the core rhythm analysis or energy delivery, implying no impact on primary safety or effectiveness.
• The submission includes "a summary of design control activities and a declaration of conformity to design controls," which is the regulatory mechanism used to demonstrate that the modified device's changes do not introduce new safety or effectiveness concerns compared to the predicates.

Therefore, the acceptance criteria are met by virtue of the modified device being substantially equivalent to legally marketed predicate devices which have already met their respective acceptance criteria for safety and effectiveness.

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The LIFENET Exchange System is an optional data transmission system that provides the capability to transmit 12-Lead ECG reports and other physiological data to a receiving device at a remote location. Data is received from the field and can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.

The LIFENET® Exchange System is an optional data transmission system that provides the capability to transmit 12-Lead ECG reports and other physiological data to a receiving device at a remote location. Data is received from the field and can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.

The provided text describes a 510(k) premarket notification for the Medtronic LIFENET Exchange System. However, it does not contain specific acceptance criteria, performance metrics, or details about a study to prove the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices for its intended use as a data transmission system for 12-Lead ECGs and other physiological data.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the text:

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

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

• Not explicitly mentioned. The document focuses on demonstrating substantial equivalence through similar technological characteristics and performance claims, rather than detailing a specific clinical or technical test set with sample sizes.

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

• Not explicitly mentioned. The concept of "ground truth" for a specific test set is not detailed in this 510(k) summary, as the primary focus is on functional equivalence.

4. Adjudication method for the test set

• Not explicitly 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 study was not described. This device is a data transmission system, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable in the typical sense of an algorithm's diagnostic performance. The device's "performance" refers to its ability to reliably transmit data, which is a standalone function. The "study" mentioned refers to verification and validation (V&V) of its components and overall system.

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

• Not explicitly mentioned in the context of diagnostic "ground truth." For a data transmission system, the "truth" would likely be the accurate and timely transmission of the physiological data created by other medical devices (e.g., the LIFEPAK 12 ECG).

8. The sample size for the training set

• Not applicable/Not mentioned. This device is a data transmission system; it does not employ a "training set" in the context of machine learning algorithms.

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

• Not applicable/Not mentioned.

In summary: The provided 510(k) summary for the LIFENET Exchange System focuses on demonstrating substantial equivalence to existing predicate devices (LIFEPAK 12 data transmission and Phillips 12-Lead Transfer Station) by highlighting similar technological characteristics and functional performance in data transmission. It refers to general "verification and validation" activities but does not offer granular details about specific acceptance criteria, comprehensive studies with sample sizes, expert involvement, or ground truth methodologies that would typically be described for a diagnostic or algorithmic device.

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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 25 kg (55 lbs) 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 LIFEPAK 1000 defibrillator is a semi-automatic defibrillator with manual mode and ECG mode available as options. The manual mode allows a caregiver skilled in rhythm recognition to switch to manual mode and treat the patient without relying on the automated analysis feature and without connecting a separate defibrillator. Features and options of the LIFEPAK 1000 defibrillator include: ECG rhythm and heart rate monitoring using defibrillation electrodes or using an ECG cable with monitoring electrodes, data transmission via serial infrared link, power via non-rechargeable lithium manganese battery, and configurable voice prompts.

The provided text does not contain detailed acceptance criteria or a study that explicitly proves the device meets specific performance metrics. The submission focuses on substantial equivalence to previously cleared devices (Medtronic LIFEPAK 500 AED and Philips HeartStart FR2+ Defibrillator) and conformance to general electrical safety, electromagnetic compatibility, and defibrillator standards.

Therefore, many of the requested sections (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information) cannot be extracted from this document, as this type of information is typically found in detailed performance studies or clinical trials, which are not provided here.

However, based on the excerpt, here's what can be gathered:

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

The document does not specify quantitative acceptance criteria or a detailed performance table. It broadly states: "The information in this 510(k) demonstrates that the LIFEPAK 1000 defibrillator is substantially equivalent to legally marketed predicate devices with respect to safety, effectiveness, and performance." This implies that the performance is considered acceptable if it is comparable to the predicate devices.

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

This information is not provided in the document.

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

This information is not provided in the document. The device is a defibrillator, which uses automated analysis, and the document focuses on its standalone performance characteristics and equivalence, not a reader study.

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

The document states, "The manual mode allows a caregiver skilled in rhythm recognition to switch to manual mode and treat the patient without relying on the automated analysis feature and without connecting a separate defibrillator." This implies that the device has an "automated analysis feature" (algorithm only) that assists in defibrillation decisions. While specific standalone performance metrics are not listed, the reliance on an automated analysis feature suggests a standalone assessment would have been part of the underlying data submitted to the FDA, but it is not detailed in this summary.

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

Given that the device performs "automated analysis" for rhythm recognition in AED mode, the ground truth for such analysis would typically be established based on:

• Expert Consensus (ECG Interpretation): For rhythm recognition algorithms, the ground truth is typically derived from review of ECG waveforms by trained cardiologists or other experts.
• Clinical Outcomes (Defibrillation Effectiveness): For defibrillation itself, the ground truth relates to successful termination of arrhythmias, which would be observed clinically.

However, the specific type of ground truth used is not explicitly stated in this document.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of available information regarding performance:

The 510(k) submission for the Medtronic LIFEPAK 1000 Defibrillator primarily relies on the concept of substantial equivalence to previously cleared devices (Medtronic LIFEPAK 500 AED and Philips HeartStart FR2+ Defibrillator).

The document mentions that the submission included "documentation related to the conformance of the LIFEPAK 1000 defibrillator to electrical safety, electromagnetic compatibility, and defibrillator standards." While these are critical aspects of performance and safety, specific quantitative acceptance criteria or detailed study results for these conformance tests are not presented in this summary. The general statement is that the device demonstrates "safety, effectiveness, and performance" consistent with its predicate devices.

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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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