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The E Series 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 products must be prescribed for use by a physician or medical advisor of an emergency response team. Do not use the unit's AED function on patients under 8 years of age.

Use of the E Series 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 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. The Advisory function should be used to confirm ventricular fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed).

The E Series AED unit is designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation.

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.

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 bradycardia of any etiology, As a standby when standstill or bradvcardia might be expected, Suppression of tachycardia.

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 ZOLL E Series® Defibrillator, reviewed and cleared by FDA under premarket notification K111594, is designed for all emergent care situations and provides multiparameter monitoring of patients in critical care and transport. The ZOLL E Series combines defibrillation, CPR feedback, ECG monitoring, noninvasive transcutaneous pacing, pulse oximetry (SpO2), end tidal CO2 (EtCO2), 12-Lead ECG monitoring, noninvasive blood pressure measurement and data printing and recording in a single instrument.

The previously cleared Shock Conversion Estimator (SCE), initially reviewed and cleared by the agency under K072923, utilizes Shock Predictive (SPI) as a parameter in the shock advisory algorithm. Shock Predictive Index number is also called "Amplitude Spectral Area (AmSA) value" of the ECG Waveform, developed by the Weil Institute of Critical Care Medicine. In the previously cleared version of the E-Series, when the E Series device is configured to enable the Shock Conversion Estimator (SCE) function, the software compares the calculated Shock Predictive Index (AmSA) against a userconfigurable threshold during shock advisory rhythm analysis. If the rhythm is shockable and the computed index is greater-than or equal-to the pre-configured threshold, the shock advisory algorithm will then issue a "Shock Advised" prompt to the user. If the Shock Predictive Index (AmSA) is less-than the threshold, the shock advisory algorithm will then issue a "Continue CPR" prompt to the user.

With the current application, we are proposing a software revision that will enable the E Series device to display the calculated Shock Predictive Index (AmSA) when used in manual mode with CPR defibrillation electrodes. After the trained rescuer has confirmed the ECG rhythm by manually analyzing the characteristics of the ECG waveform, the rescuer may utilize the displayed Shock Predictive Index (AmSA) value to perform the same function as the Rhythm Analysis Function Shock Conversion Estimator (SCE), reviewed and cleared by the agency under K072923.

This document describes a 510(k) premarket notification for a software revision to the ZOLL E Series Defibrillator, specifically enabling the display of the Shock Predictive Index (AmSA) in manual mode. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, many of the requested categories (like extensive clinical studies with specific sample sizes, ground truth adjudication, or MRMC studies) are explicitly stated as "Not Applicable" or implicitly not performed as the primary evidence relies on non-clinical software verification and validation, alongside literature support for the underlying AmSA concept.

1. Table of Acceptance Criteria and 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)

• Test Set Sample Size: Not explicitly mentioned for specific clinical data in this submission. The "test set" primarily refers to software verification and system-level validation, rather than a traditional patient-based clinical study.
• Data Provenance: Not applicable for a separate test set as the primary evidence relies on non-clinical software testing and validation. The literature cited for AmSA would have their own data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as the submission focuses on software verification and system-level validation for a software update, rather than a clinical study requiring expert-established ground truth on patient data for the new specific functionality (displaying AmSA). The underlying concept of AmSA and its use as a predictor of defibrillation success would have been established and validated in the scientific literature cited.

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

• Not applicable. The validation method for this software update is described as "software verification and system level validation," which typically involves engineering and quality assurance processes against predefined requirements, rather than clinical adjudication on patient cases.

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. Clinical evidence was explicitly stated as "N/A - Clinical evidence was not necessary to show substantial equivalence." The device provides information (AmSA) to the human operator, who then makes a decision; the study does not compare human performance with vs. without this specific display.

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

• The original Shock Conversion Estimator (SCE), cleared under K072923, was an "algorithm only" function that issued a "Shock Advised" or "Continue CPR" prompt. The current software revision allows the human operator to manually perform the function by interpreting the displayed AmSA value. Therefore, a standalone (algorithm only) performance study of this new manual interpretation functionality was not conducted, as the intent is human-in-the-loop.

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

• For the new functionality (displaying AmSA for manual interpretation), a clinical "ground truth" involving patient outcomes was not specifically established or documented in this submission. The ground truth for the concept of AmSA as a predictor of defibrillation success is derived from the scientific literature cited, which would have based findings on various methods including clinical outcomes. For the software itself, the "ground truth" during verification and validation would be adherence to software requirements and specifications.

8. The sample size for the training set

• Not applicable. This submission is for a software revision to display an already calculated parameter; it does not describe a new algorithm requiring a training set in the machine learning sense. The AmSA calculation itself was presumably developed and validated in prior efforts as referenced by existing predicate devices and literature.

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

• Not applicable, as there was no new training set for a new algorithm described in this submission.

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The X Series is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series. The X Series is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The X Series will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The X Series unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.

Manual Defibrillation: Use of the X Series in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, 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. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.

Semiautomatic Operation (AED): X Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the X Series in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse.

ECG Monitoring: The X Series is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.

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.

External Transcutaneous Pacing: This product can be used 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, Suppression of tachycardia, Pediatric pacing.

Non-Invasive Blood Pressure Monitoring: The X Series is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg.

Temperature Monitoring: The X Series is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user.

SpO2 Monitoring: The X Series pulse CO-oximeter, with Masimo Rainbow SET technology and the Rainbow series of sensors, is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation (SpMet).

Respiration Monitoring: The X Series is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator.

CO2 Monitoring: The X Series is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate.

Invasive Pressure Monitoring: The X Series is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring.

12-Lead Analysis: The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data.

The ZOLL X Series Defibrillator/Monitor cleared under 510k application K112432 is a light weight, portable device designed to be used by trained medical personnel who are familiar with vital signs monitoring and emergency cardiac care. As in its previously cleared configuration, the modified X Series combines the functions of a Semi-automatic (AED)/ manual defibrillator, external transcutaneous pacer and patient monitor (including ECG, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and impedance respiration monitoring). X Series software has been revised to support the OneStep Pediatric CPR Electrode. This electrode was previously cleared for use with the ZOLL R Series (K120907). As in the R Series, the electrode will enable the X Series device to provide CPR monitoring for Pediatric patients. The labeling of the X Series will be revised to remove the contraindication "The CPR monitoring function is not intended for use on patients under 8 years of age" from the Indications For Use for CPR Monitoring currently cleared for the X Series (K112432).

The ZOLL X Series Defibrillator/Monitor (K133269) received 510(k) clearance based on its substantial equivalence to predicate devices (ZOLL X Series K112432 and ZOLL R Series K120907). The modification primarily involved a software revision to support the OneStep Pediatric CPR Electrode for pediatric CPR monitoring. The submission did not include a traditional study with acceptance criteria and reported device performance metrics in the typical sense of a diagnostic or predictive AI algorithm.

Instead, the acceptance criteria are implicitly tied to demonstrating that the modified device performs as well as the predicate devices and meets its functional and performance specifications, especially concerning the new pediatric CPR monitoring feature.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) is for a modification to an existing device, the "acceptance criteria" are not presented as specific performance metrics and thresholds (e.g., sensitivity, specificity) but rather as compliance with existing safety and performance standards, and comparison to predicate devices. The document explicitly states: "Extensive performance testing in the software verification and system level validation ensures that the ZOLL X Series performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards."

Therefore, a table of specific quantitative acceptance criteria and reported device performance values cannot be constructed from the provided text in the way one would for a diagnostic AI. The acceptance criteria essentially were:

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

The document does not specify a "test set" in the context of clinical data for a direct performance evaluation of the modified pediatric CPR monitoring algorithm. Instead, the assessment relies on software verification and system-level validation. This implies engineering tests rather than a cohort of patient data.

• Sample Size for Test Set: Not applicable/not specified as clinical test data in the provided document.
• Data Provenance: Not applicable, as no clinical test data for the specific modification is detailed. The assessment was based on engineering and validation testing.

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

Not applicable. The submission is based on engineering verification, system-level validation, and comparison to predicate devices. There is no mention of a test set requiring expert-established ground truth in the context of diagnostic performance for the new feature or the overall device.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as above.

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 mentioned. The device provides CPR monitoring feedback; it is not described as an AI system assisting human readers in interpreting clinical data.

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

The device's CPR monitoring function provides automated feedback (rate and depth) but operates with a human rescuer in the loop. The document doesn't describe a "standalone algorithm" performance study in the absence of human interaction. The functions described are inherent to the device and its sensors, providing real-time data to the user.

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

For the pediatric CPR monitoring feature, the "ground truth" would implicitly be the physical measurements of chest compression rate and depth, compared against the AHA/ERC recommended targets (e.g., 100 compressions per minute, 1.5-2.0 inches depth). This "truth" is established by physical measurement standards rather than expert clinical consensus or pathology. The document, however, does not detail the specific methodology for verifying the accuracy of these measurements. It states that "performance testing" and "software verification and system level validation" were performed.

8. The Sample Size for the Training Set

Not applicable. The document describes a software revision for a medical device. There is no mention of a "training set" for a machine learning or AI algorithm in the context of this 510(k) submission.

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

Not applicable, as no training set for a machine learning or AI algorithm is mentioned.

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Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by:

• · Unconsciousness and
• · Absence of normal breathing and
• · Absence of a pulse or signs of circulation

When a victim is less than 8 years of age, or weighs less than 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

The device is a lightweight, portable, battery-powered semi-automatic external defibrillator that uses voice prompts and visual icons to guide a user through a cardiac arrest rescue. The device utilized the ZOLL Rectilinear Bi-Phasic defibrillation waveform. The device is designed to be used by trained responders for the treatment of cardiac arrest.

When connected with ZOLL AED Plus defibrillation electrodes to a patient, the predicate device will analyze the electrocardiographic (ECG) ihythm of the patient and detect whether the rhythm is shockable or non-shockable. If the device detects a nonshockable rhythm, the device will prompt the user to begin CPR. The electrodes used with the device incorporates an accelerometer that measures the depth of CPR compressions. This information is used by the device to provide feedback to the user and encourage the user to administer CPR in compliance with the 2010 American Heart Association (AHA) Guidelines. If the device detects a shockable rhythm, the semiautomatic configuration of the device charges the capacitor, enables the treatment button and prompt the user to deliver the defibrillation energy to the patient. The user would then press the treatment (shock) button to deliver the defibrillation shock to the patient. The new fully automatic configuration would deliver the shock to the patient without the need for the user (rescuer) to press the shock button.

The ZOLL Fully Automatic AED Plus is a semi-automatic external defibrillator that has been updated to deliver a shock automatically without the user pressing a button, following appropriate prompts and a warning tone.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or specific performance metrics for the new fully automatic feature of the ZOLL Fully Automatic AED Plus. Instead, it relies on a comparison to a predicate device.

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

The document does not provide specific sample sizes for any test sets related to the fully automatic feature. It broadly mentions "Extensive performance testing" and "Safety testing." There is no information on data provenance (e.g., country of origin of the data, retrospective or prospective).

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 document. The study described does not appear to involve human expert ground truth determination in the conventional sense for algorithmic performance, but rather focuses on functional and safety equivalency.

4. Adjudication Method for the Test Set

This information is not provided.

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

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is present. The focus is on the device's functional equivalence and safety, not on human reader improvement with or without AI assistance. The device is an automated external defibrillator, where the "AI" (algorithm) is designed to act on its own, not to assist human readers in interpreting information.

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

The study described primarily assesses the standalone performance of the algorithm in the context of its new fully automatic shock delivery. The product is an "Automatic External Defibrillator," implying standalone algorithmic function. The document states:

• "When a shockable rhythm has been detected defibrillation energy is delivered by the device without the need for the user (rescuer) to depress the treatment (shock) button following a sequence of appropriate prompts and a warning tone."
• "All other functions of the device and its Indications for Use have remained unchanged."

This indicates that the core rhythm analysis and shock advisory/delivery mechanism, which is the heart of the algorithm's standalone function, is the primary subject of evaluation for the change.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance testing. However, given it's an AED, the ground truth for rhythm analysis (shockable vs. non-shockable) would typically be established based on:

• Electrophysiological standards (e.g., specific ECG waveform characteristics recognized as ventricular fibrillation or ventricular tachycardia).
• Potentially, expert ECG review.

For the fully automatic shock delivery, the ground truth would be whether a shockable rhythm was correctly identified according to established criteria, and whether the device then proceeded to deliver the shock as designed.

8. Sample Size for the Training Set

This information is not provided. The document focuses on regulatory submission and substantial equivalence, not the details of algorithm development or training data.

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

This information is not provided.

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Use of the R Series products in the manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:

• · Unconsciousness.
• · Absence of breathing.
• · 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 unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.
  The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (listed above).
  R Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient.
  They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.
  Use of the R Series in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
• · Unconsciousness.
• · Absence of breathing.
• · Absence of pulse.
  The unit is intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology. In ECG monitoring mode, the unit is intended to be used by personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or advanced life support, or other physician-authorized emergency medical training.
  The Real CPR Help 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 compression depth in accordance with AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult patients.
  This product can be used 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.
  · Suppression of tachycardia.
  The R Series pulse oximeter, with the Masimo® SET® technology and the LNCS® series of oximeter sensors, is indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no motion and patient motion conditions for adult patients, and no motion conditions for pediatric and neonatal patients in a hospital or prehospital environment.
  The ZOLL R Series EtCO2 option with Respironics Novametrix technology is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, in-hospital transport, or anesthesia.
  The ZOLL R Series NIBP option is indicated for the non-invasive measurement of arterial blood pressure for resting patients in critical care and in-hospital transport.

The ZOLL R Series® External Defibrillator is intended for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including Franboataneous Pulse Oximetry, Non-Invasive Blood Pressure measurement, End Tidal CO2 Monitening, Fulls and data printing and recording for resting patients in critical care and transport. The ZOLL R Series 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. The design facilitates table top use while still providing a light weight and easy to carry device for transport.
The proposed enhancements to the ZOLL R Series are intended to provide personnel trained in its use with modified CPR feedback. The display of the Real CPR Help technology has been modified to provide rescuers with feedback data for chest compression depth, rate, and release. The proposed changes are also intended to support a modified pediatric electrode with a CPR feedback sensor.

The ZOLL R Series external defibrillator with modifications to its CPR feedback feature and the addition of a CPR feedback sensor to pediatric electrodes.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not explicitly state numerical acceptance criteria for the modified CPR feedback feature or the pediatric electrode with the CPR feedback sensor. Instead, it refers to:

• AHA/ERC recommended rate of 100 compressions per minute.
• AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult patients for compression depth.

The document states that the "Real CPR Help 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 compression depth in accordance with AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult patients." This implies that the device's performance aligns with these recommendations by providing appropriate feedback to guide users to meet them.

Without explicit numerical acceptance criteria, a table cannot be fully constructed. However, if we infer the acceptance criteria from the intended function, it would be:

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

The document states that "Extensive performance testing ensures that the proposed ZOLL R Series performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards."

No specific sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective) is provided for the CPR feedback modifications or the pediatric electrode. The testing seems to be internal performance and safety testing.

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

This information is not provided. The document refers to compliance with "recognized industry and safety standards" and the device's ability to drive users toward "AHA/ERC recommendations," but it does not detail a process for establishing ground truth via experts for the performance of the CPR feedback mechanism itself during testing.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned. The testing described is general performance and safety testing, not a clinical study requiring adjudication of expert consensus.

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

No MRMC comparative effectiveness study is mentioned. The document focuses on the device's functionality and its ability to guide users to follow established guidelines, not on a comparison of human reader performance with or without AI assistance. This device is not an AI-assisted diagnostic tool in the sense of image analysis.

6. Standalone (Algorithm Only) Performance Study:

The document implies a standalone performance for the CPR feedback algorithm in that it states the algorithm "provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate." This suggests the algorithm itself was tested to ensure its feedback mechanism is accurate and effective in guiding compressions to the specified rates and depths. However, no specific standalone study details (e.g., methodology, specific metrics, results in isolation from a human user) are provided.

7. Type of Ground Truth Used (for CPR feedback):

The implied ground truth for the CPR feedback mechanism is based on established medical guidelines and recommendations:

• AHA/ERC recommended chest compression rate (100 bpm).
• AHA/ERC recommended chest compression depth (≥ 2 inches / 5 cm for adults).

The device is designed to provide feedback to help rescuers achieve these established standards.

8. Sample Size for the Training Set:

This information is not applicable or provided. The CPR feedback feature appears to be based on an algorithm that monitors physical parameters (rate, depth, release) and provides feedback based on pre-defined thresholds derived from medical guidelines, rather than being trained on a large dataset like a machine learning model for diagnosis.

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

This information is not applicable or provided. As above, the device's functionality seems to stem from a rules-based system implementing established medical guidelines, not from a machine learning training process that requires a dedicated training set with established ground truth.

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The Propaq MD is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care and the use of the Propaq MD. The Propaq MD is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The Propaq MD will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The Propaq MD can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.

Manual Defibrillation: Use of the Propaq MD in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, 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. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.

Semiautomatic Operation (AED): The Propaq MD products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the Propaq MD in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse.

ECG Monitoring: The Propaq MD is intended for use to monitor and/or record 3, 5, 12-Lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.

External Transcutaneous Pacing: This product can be used 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, Suppression of tachycardia.

Non-Invasive Blood Pressure Monitoring: The Propaq MD is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user.

Temperature Monitoring: The Propaq MD is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user.

SpO2 Monitoring: The Propaq MD is intended for use to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user.

Respiration Monitoring: The Propaq MD is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. It is not intended to be used as an apnea monitor.

CO2 Monitoring: The Propaq MD is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate.

Invasive Pressure Monitoring: The Propaq MD is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring.

12-Lead Analysis: The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data.

The ZOLL Propaq MD device (reviewed and cleared by the agency under application K100654) is being revised with additional software features. The Propaq MD is a light weight, portable device designed to be used by trained medical personnel who are familiar with basic monitoring, vital sign assessment and emergency cardiac care. As in its previous configuration, the Propaq MD combines the functions of an ECG monitor, manual defibrillator, external transcutaneous pacer, pulse oximeter, non-invasive blood pressure monitor, invasive pressure monitor, respiration rate monitor and temperature monitor. Functions are offered as options and functions can be configured to meet the needs of a particular application. Additionally, the proposed configuration adds the following features: Semi-automatic external defibrillation function (AED) Mode, Inovise Audicor 12-Lead ECG Interpretive Algorithm, ECG Life Threatening Alarms, Expanded Data Logging capabilities.

Here's an analysis of the acceptance criteria and the study information for the ZOLL Propaq MD, based on the provided text:

Important Note: The provided 510(k) summary (K112761) from 2012 focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study results for the newly added features like the Inovise Audicor 12-Lead ECG Interpretive Algorithm. FDA 510(k) submissions for substantial equivalence often refer to the predicate device's performance for new features, or use a general statement about performance and safety testing. Therefore, the information directly addressing specific quantitative acceptance criteria and detailed study designs for the new features is limited in this document.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for substantial equivalence, specific quantitative acceptance criteria for the newly added features (e.g., specific sensitivity/specificity for the 12-Lead ECG Interpretation) are not explicitly stated in this document. Instead, the "acceptance criteria" are generally implied to be that the device performs as well as the predicate devices and meets its functional requirements and performance specifications.

The document claims:

• "Extensive performance testing ensures that the proposed ZOLL Propaq MD performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications."
• "Safety testing assures that the device complies with applicable sections of recognized industry and safety standards."

For the purpose of this analysis, I will infer the performance for the Inovise Audicor 12-Lead ECG Interpretive Algorithm feature by noting that the algorithm itself was a previously cleared device (K032145). In a typical 510(k) for an integrated component, the performance of the integrated component would usually be established in its own prior submission or validated against its established performance. The current K112761 document doesn't re-detail the specific performance of that algorithm in this submission.

Study Details for K112761:

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

   • The document does not specify a separate "test set" for the newly added features of the ZOLL Propaq MD (K112761). The focus is on demonstrating substantial equivalence to predicate devices (K100654, K072923, and K032145).
   • For the Inovise Audicor 12-Lead ECG Interpretive Algorithm, its original 510(k) (K032145) would detail the specific test set and provenance used to establish its performance. This information is not present in the K112761 summary.
   • The document implies that "extensive performance testing" was conducted on the integrated device, but no specifics about sample size or data provenance (e.g., country of origin, retrospective/prospective) are provided for this new submission.

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

   • Not specified within the K112761 document for the additional features. This information would typically be detailed in the original submission for the Inovise Audicor 12-Lead ECG Interpretive Algorithm (K032145) if expert review was part of its ground truth establishment.

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

   • Not specified within the K112761 document. Again, this would be part of the performance evaluation for the underlying Inovise Audicor 12-Lead ECG Interpretive Algorithm (K032145) at the time of its original clearance.

4. 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 is mentioned for the new features in this 510(k) summary (K112761). The submission is based on substantial equivalence, not a clinical effectiveness study of human-AI collaboration.

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

   • For the Inovise Audicor 12-Lead ECG Interpretive Algorithm, its performance was established as a standalone algorithm in its own original 510(k) (K032145). The current submission integrates this pre-cleared standalone algorithm. The K112761 document notes that the "interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data," indicating it's an assistive tool, not a diagnostic replacement.

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

   • Not specified within the K112761 document for the new features. For the Inovise Audicor 12-Lead ECG Interpretive Algorithm, the ground truth would have been established during its original clearance (K032145), likely using expert cardiologists' consensus readings of ECGs, potentially correlated with clinical outcomes or other diagnostic tests depending on the specific conditions the algorithm interprets.

7. The sample size for the training set:

   • Not specified within the K112761 document. The training set size for the Inovise Audicor 12-Lead ECG Interpretive Algorithm would be found in its original 510(k) submission (K032145).

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

   • Not specified within the K112761 document. This information would have been part of the original submission for the Inovise Audicor 12-Lead ECG Interpretive Algorithm (K032145), likely involving expert review and annotation of ECGs.

Summary of Approach for K112761:

This 510(k) submission (K112761) demonstrates substantial equivalence by stating that the expanded ZOLL Propaq MD (with new features) is comparable to:

• The previous version of the Propaq MD (K100654) for most functions.
• The ZOLL E Series (K072923) for AED functionality.
• The Inovise Audicor 12-lead Interpretive algorithm (K032145) for the 12-Lead ECG interpretation feature.

For device modifications or integration of pre-cleared components like this, the focus of the 510(k) is often on ensuring that the integration does not negatively impact the performance, safety, or effectiveness established by the predicate devices. Detailed performance studies for the integrated algorithm are typically covered in its original 510(k) submission (K032145 in this case), not re-detailed in subsequent integrations unless significant modifications to the algorithm or its intended use are made. The current document asserts that "Extensive performance testing ensures that the proposed ZOLL Propaq MD performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications," but does not provide details of these tests.

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The X Series is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series. The X Series is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The X Series will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The X Series unit can be used on pediatric patients, (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.

Manual Defibrillation: Use of the devicein the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, 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. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.

ECG Monitoring: The device is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.

External Transcutaneous Pacing: This product can be used 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, Suppression of tachycardia, Pediatric pacing.

Non-Invasive Blood Pressure Monitoring: The device is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user.

Temperature Monitoring: The device is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user.

Respiration Monitoring: The device is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor.

CO2 Monitoring: The device is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate.

Invasive Pressure Monitoring: The device is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply.

Semiautomatic Operation (AED): The device is designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse.

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.

SpO2 Monitoring: The X Series pulse CO-oximeter, with Masimo Rainbow SET technology and the Rainbow series of sensors, is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation (SpMet). The pulse CO-oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospital-type facilities, or in mobile environments.

12-Lead Analysis: The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data.

The ZOLL Propaq MD device is being revised with additional features and optional modules. This configuration of the device will be marketed as the ZOLL X Series. The X Series is a light weight, portable device designed to be used by trained medical personnel who are familiar with basic monitoring, vital sign assessment and emergency cardiac care. As in its previous configuration, the X Series combines the functions of an ECG monitor, manual defibrillator, external transcutaneous pacer, pulse oximeter, noninvasive blood pressure monitor, invasive pressure monitor, respiration rate monitor and temperature monitor. Functions are offered as options and functions can be configured to meet the needs of a particular application. Additionally, the proposed configuration (ZOLL X Series) adds the following features: Semi-automatic external defibrillation function (AED) Mode, CPR rate and depth monitoring, See-Thru CPR ECG filtering, Inovise Audicor 12-Lead ECG Interpretive Algorithm, ECG Life Threatening Alarms, Masimo Rainbow MX3 Option with SpO2, SpCO, and SpMet monitoring, Oridion microMediCO2 module replaces miniMediCO2 module, Expanded Data Logging capabilities, Wide-format printer option, Wireless Data Transfer.

This document describes a 510(k) premarket notification for the ZOLL X Series, a multi-functional medical device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific, new acceptance criteria for the ZOLL X Series or detailing performance against them. Most performance claims are implicit in the statement of substantial equivalence to previously cleared devices.

However, the document mentions specific functional aspects and their intended performance:

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

The 510(k) summary does not provide specific details on the sample size used for the test set or the data provenance for the features mentioned (CPR monitoring, AED rhythm analysis, 12-lead ECG interpretation).

The filing relies heavily on the "substantial equivalence" argument, meaning that the performance of the integrated components (like the Inovise Audicor 12-Lead ECG Interpretive Algorithm) has already been established and reviewed in their original 510(k) clearances (e.g., K032145 for Inovise Audicor). The current filing does not present new clinical study data for these components themselves.

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 510(k) summary. For components like the 12-lead ECG interpretive algorithm, such details would have been part of its original 510(k) submission (K032145 for Inovise Audicor).

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

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 MRMC comparative effectiveness study is not explicitly mentioned or detailed in this 510(k) summary. The document emphasizes the device's functionality and substantial equivalence. For the 12-lead ECG analysis, it states, "The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data." This implies a human-in-the-loop approach where the device provides information for the caregiver, but it does not quantify improvement with AI assistance.

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

For components like the AED's rhythm analysis function and the 12-lead ECG interpretive algorithm, standalone performance would have been evaluated as part of their original clearance processes. The current submission for the ZOLL X Series integrates these cleared algorithms. The 510(k) summary refers to "Specifications for the ECG rhythm analysis function are provided in the Operator's Manual section 'ECG Analysis Algorithm Accuracy' on page A-33," suggesting that standalone algorithm performance data exists but is not included in this summary.

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

This information is not explicitly stated in the 510(k) summary. For the 12-lead ECG interpretive algorithm, it is highly likely that expert consensus (e.g., multiple cardiologists' interpretations) would have been used as ground truth in its original validation studies. For AED algorithms, ground truth for rhythm detection typically comes from expert review of ECG waveforms.

8. The Sample Size for the Training Set

The 510(k) summary does not provide any information regarding the sample size for the training set for any of the algorithms or features. This information would typically be part of the original development and validation of the individual algorithms (e.g., Inovise Audicor).

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

This information is not provided in the 510(k) summary. Similar to the test set ground truth, the methodology for establishing ground truth for training data would have been detailed in the original submissions for the individual algorithms.

Summary of the Study Discussed in the Document:

The provided document is a 510(k) summary (K112432) for the ZOLL X Series. It is not a detailed clinical study report but rather a regulatory filing designed to demonstrate substantial equivalence to previously cleared predicate devices.

The "study" presented here is a collection of performance and safety testing aimed at showing that the newly configured ZOLL X Series, incorporating additional features and modules, functions as intended and is as safe and effective as its predicates.

According to the document:

• Type of Study: The document describes "Extensive performance testing" and "Safety testing" to ensure the device performs as well as predicate devices and meets its specifications. It is a design verification and validation effort rather than a comparative clinical effectiveness trial.
• Purpose: To demonstrate that the ZOLL X Series' new features (e.g., AED mode, CPR monitoring, See-Thru CPR, Inovise Audicor 12-Lead ECG Interpretive Algorithm, Masimo Rainbow MX3, Oridion microMediCO2) are substantially equivalent to previously cleared devices or modules.
• Key Finding: The conclusion states, "The information provided in this 510(k) demonstrates that the ZOLL X Series' features and functions are substantially equivalent to those of the indicated commercially distributed devices with regard to performance, safety and effectiveness."

In essence, this 510(k) summary indicates that the ZOLL X Series meets its acceptance criteria by demonstrating that its integrated components and overall system performance are equivalent to those of devices already cleared by the FDA, relying heavily on the pre-existing validation of those predicate devices and modules.

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RescueNet Link is intended for use in the collection and display of data that is entered by a user (caregiver), or captured from specified medical devices or from a vehicle navigation system. RescueNet Link is indicated for use by health care providers whenever there is a need for collection and display of patient, care reporting and transport data.

The proposed RescueNet Link is a software-only product. The ZOLL RescueNet Link system is an Emergency Medical Services (EMS) data system that electronically captures and displays patient monitoring, charting and ambulance location and navigation system data within the ambulance and communicates it for display to other locations throughout the pre-hospital and inhospital system of care. The system is comprised of two computer hardware/software based components, MobileLink and FieldLink. Both components use general purpose, commercially available computers, networking and communications hardware combined with software supplied by ZOLL. The MobileLink component resides within each EMS ambulance where it collects, integrates and displays patient monitoring, care reporting and ambulance location and navigation data on a large, easy to read touch screen display. Patient, care and transport data collected by MobileLink are transmitted to a central FieldLink server via cellular/internet connections. This server provides a distribution point from which internet accessible web pages displaying the information collected within each ambulance can be viewed. The FieldLink server also provides each receiving hospital with web pages showing information about the MobileLink-equipped ambulances currently on route to the medical facility and monitoring and charting information about the patients they are transporting. RescueNet Link is non-alarming software.

The provided text is a 510(k) summary for the ZOLL RescueNet Link device, which is a software-only product for collecting and displaying patient, care reporting, and transport data in emergency medical services (EMS) settings.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific, quantified performance results. Instead, it makes a general statement about performance testing:

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

The document does not specify the sample size used for performance testing (e.g., number of cases, records, or patients). It also does not explicitly state the country of origin of the data or whether the data was retrospective or prospective.

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

The document does not provide information about the number of experts used to establish ground truth or their qualifications. Given that this is a data collection and display system, and not an AI-driven diagnostic tool, the concept of "ground truth" derived from expert consensus may not directly apply in the same way. The performance testing likely focused on the accuracy and reliability of data capture, transmission, and display compared to expected system behavior.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none). This information is typically relevant for studies where subjective interpretation or complex diagnostic decisions are involved.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic AI tools where human reader performance is being evaluated with and without AI assistance. The ZOLL RescueNet Link is described as a data collection and display system, not a diagnostic AI.

6. Standalone (Algorithm Only) Performance Study

The document describes "Performance Testing" which indicates a standalone evaluation of the algorithm's functionality and specifications. However, it does not explicitly label it as a "standalone (i.e. algorithm only without human-in-the-loop performance) study." The device is a "software-only product" and the testing would assess its software features and functions.

7. Type of Ground Truth Used

The document implies that the ground truth for performance testing would be based on the expected functional requirements and performance specifications of the device, likely assessed against reference data or simulated scenarios to ensure accurate data collection, transmission, and display. It does not mention pathology, outcomes data, or expert consensus in the context of establishing ground truth for this device's performance.

8. Sample Size for the Training Set

As this device is a software system for data collection and display and not a machine learning or AI model in the sense of predictive analytics or image analysis, there is no mention of a "training set" in the document.

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

Since there is no mention of a training set, the method for establishing its ground truth is also not applicable or described.

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The ZOLL E Series® External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, end tidal CO2, 12-Lead ECG monitoring, non-invasive blood pressure measurement, CPR performance and data printing and recording for resting patients in critical care and transport. The device 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. The device is light weight and easy to carry for transport.

Use of the E Series products in the Manual mode for defibrillation is indicated on victims of cardiac arrest where 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 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.
  The Advisory function should be used to confirm ventricular fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed).

The E Series AED unit is designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient.
They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.
Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation.

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.

This product may be used 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
• Suppression of tachycardia

The ZOLL E Series® External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, end tidal CO2, 12-Lead ECG monitoring, non-invasive blood pressure measurement, CPR performance and data printing and recording for resting patients in critical care and transport. The device 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. The device is light weight and easy to carry for transport.
The proposed enhancements to the ZOLL E Series are intended to provide personnel trained in its use with improved CPR feedback. The design of the previously approved CPRReadyCharge (K091265) feature has been simplified. The display of the previously approved Real CPR Help (K062177) technology has been enhanced to provide rescuers with feedback data for chest compression depth, rate, and release.
The E Series 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.
Some E Series products may include an optional transcutaneous demand pacemaker consisting of a pulse generator and ECG sensing circuitry. Non-invasive Transcutaneous Pacing (NTP) is an established and proven technique. This therapy is easily and rapidly applied in both emergency and non-emergency situations when temporary cardiac stimulation is indicated.
The output current of the pacemaker is continuously variable from 0 to 140 mA. The rate is continuously variable from 30 to 180 pulses per minute (ppm).
The pacing output pulse is delivered to the heart by specially designed ZOLL MFE Pads placed on the back and the precordium.
The unique design of the E Series products allow clear viewing and interpretation of the electrocardiogram (ECG) on the display without offset or distortion during external pacing.
The E Series products will defibrillate, cardiovert and monitor ECG using either defibrillation paddles or ZOLL Multi-Function Electrode (MFE) Pads. The pacer version of the E Series paces using ZOLL MFE Pads.
ENERGY SELECT, CHARGE, and SHOCK controls are located on the paddles and front panel. When using MFE Pads, you must use the controls on the front panel of the unit. To switch from paddles to MFE Pads, remove the Multi-Function cable from the apex paddle and connect the MFE pads to the Multi-Function cable.
You cannot activate the Advisory function unless MFE Pads are attached to the Multi-Function Cable and used as the ECG monitoring lead.
Adult and pediatric MFE Pads, and ECG electrodes (not the ECG cable) are disposable, single use items.

The provided text is a 510(k) summary for the ZOLL E Series device, which details its intended use, classification, and how it demonstrates substantial equivalence to predicate devices. However, the document does not contain specific information about the acceptance criteria or a dedicated study proving the device meets those criteria, as typically found in clinical performance data sections.

The document mostly focuses on the substantial equivalence of the enhanced CPR feedback and simplified CPRReadyCharge features to previously cleared ZOLL E Series products (K091265, K062177, and K110168). It mentions "Extensive performance testing ensures that the device meets all of its functional requirements and performance specifications" and "Safety testing assures the device complies with applicable sections of recognized industry and safety standards," but it does not elaborate on the details of these tests, including specific acceptance criteria, study designs, sample sizes, or ground truth establishment.

Therefore, most of the requested information cannot be extracted directly from this document.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Performance and safety testing of the device demonstrates that its features, functions and incorporated ECG advisory processing algorithm are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness."

However, it does not provide a table of specific acceptance criteria (e.g., sensitivity, specificity for rhythm analysis, accuracy for CPR depth/rate) nor specific reported numerical performance values for these criteria for the device being submitted (K111594). It implicitly relies on the performance of the predicate devices.

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

This information is not provided in the document. The text mentions "Extensive performance testing" but does not specify sample sizes or data provenance (country of origin, retrospective/prospective nature).

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

This information is not provided in the document. The establishment of ground truth for any performance testing is not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The enhancements are primarily related to CPR feedback display and simplification of features, not to diagnostic interpretation by human readers.

6. Standalone Performance Study (Algorithm Only)

The document mentions "incorporated ECG advisory processing algorithm" but does not detail any standalone performance study specifically for this algorithm. Its performance is asserted to be "substantially equivalent" to predicate devices. For the CPR monitoring function, it describes the purpose of the feedback ("encourage rescuers to perform chest compressions") rather than providing a standalone accuracy study for depth or rate measurement.

7. Type of Ground Truth Used

This information is not provided in the document.

8. Sample Size for the Training Set

This information is not provided in the document. The document refers to enhancements to existing, FDA-cleared technology, implying incremental changes rather than a new algorithm requiring a large, explicitly defined training set for submission.

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

This information is not provided in the document.

In summary: The 510(k) summary for ZOLL E Series (K111594) primarily focuses on demonstrating substantial equivalence through technological characteristics and general statements about performance and safety testing. It lacks detailed information on specific acceptance criteria, quantitative performance metrics, study designs (sample sizes, expert involvement, ground truth, adjudication methods) for either testing sets or training sets, which would typically be found in direct performance studies.

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The ZOLL R Series® External Defibrillator is intended for the defibrillation. Noninyasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including ECG Monitoring, Pulse Oximetry, Non-Invasive Blood Pressure measurement, End Tidal CO2, CPR performance and data printing and recording for resting patients in critical care and transport. The ZOLL R Series 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.

The ZOLL R Series® External Defibrillator is intended for the defibrillation. Noninyasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including ECG Monitoring, Pulse Oximetry, Non-Invasive Blood Pressure measurement, End Tidal CO2, CPR performance and data printing and recording for resting patients in critical care and transport. The ZOLL R Series 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. The design facilitates table top use while still providing a light weight and easy to carry device for transport.

The ZOLL R Series software, which currently supports the 2005 American Heart Association's (AHA) Guidelines for CPR, has been revised to optionally support the new revised 2010 AHA's Guidelines for CPR. The specific changes include:

• Adding, in the form of a configuration option, a minimum CPR target compression depth . of at least 2.0 inches in addition to the 2005 AHA guidelines depth as described in Chapter 6 of the R Series ALS Operator's guide included in Attachment 11-1 and Chapter 7 of of the R Series Plus/ R Series BLS Operator's Guide included in Attachment 11-2. Both depth configurations are necessary since the training to and implementation of the new guidelines occur over a number of years.
• . Adding an optional configuration option to display an informational message to remind the users to release their hands from the chest between compressions in order to allow the chest to recoil. When the R Series is configured to display this new message, the message FULLY RELEASE will be displayed every 45 seconds, for 5 seconds, as long as CPR compressions are detected.

The provided text describes a 510(k) Summary for the ZOLL R Series® with a 2010 AHA Guidelines Software Update. This document details the device's intended use, technological characteristics, and a general statement about performance testing, but it does not contain specific acceptance criteria, detailed study designs, or reported performance metrics for the updated software features related to the 2010 AHA guidelines. The document primarily focuses on establishing substantial equivalence to previously cleared devices.

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. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Extensive performance testing ensures that the ZOLL R Series Defibrillator meets all of its functional requirements and performance specifications." And "Performance testing of the ZOLL R Series Defibrillator demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness."

However, no specific acceptance criteria (e.g., minimum accuracy percentages, sensitivity/specificity thresholds) or the results of this "extensive performance testing" are provided for the software update. The original device (without the 2010 AHA update) would have had such criteria, but they are not detailed for the changes introduced by this specific submission. The new software specifically changes the CPR compression depth prompt from 1.5"-2.0" to "at least 2.0"" and adds a "FULLY RELEASE" message. No performance metrics are given for these specific new features.

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

Not specified in the provided text for the software update.

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

Not specified in the provided text for the software update.

4. Adjudication Method for the Test Set:

Not specified in the provided text for the software update.

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

Not mentioned in the provided text. The submission is for a software update that primarily changes CPR feedback prompts, not for an AI-assisted diagnostic tool that would typically undergo MRMC studies.

6. Standalone (Algorithm Only) Performance Study:

Not directly addressed as a "standalone" study in the context of an AI algorithm. The software update is integrated into a medical device. The document implies that the device's overall performance was tested, but not specifically the algorithm driving the new CPR feedback in isolation with detailed metrics.

7. Type of Ground Truth Used:

Not specified for the software update. For the original "ECG Rhythm Analysis Algorithm Accuracy" mentioned on page A-29 (not included in the provided text but referenced), the ground truth for rhythm analysis would typically be expert cardiologist review, but this is not confirmed for the new software.

8. Sample Size for the Training Set:

Not applicable. The software update primarily adjusts existing CPR feedback logic based on updated AHA guidelines. There is no mention of a machine learning model being trained with data.

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

Not applicable. As above, there's no indication of a training set for a machine learning model. The basis for the software changes is the 2010 American Heart Association Guidelines for CPR.

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Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by: Unconsciousness and Absence of normal breathing and Absence of a pulse or signs of circulation. When a victim is less than 8 years of age, or weighs less thank 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

The device is a lightweight, portable, battery-powered semi-automatic external defibrillator that uses voice prompts and visual icons to guide a user through a cardiac arrest rescue. The device utilized the ZOLL Rectilinear Bi-Phasic defibrillation waveform. The device is designed to be used by trained responders for the treatment of cardiac arrest. When connected with ZOLL AED Plus defibrillation electrodes to a patient, the device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the rhythm is shockable or non-shockable. If the device detects a shockable rhythm, the device charges the capacitor, enables the treatment button and prompt the user to deliver the defibrillation energy to the patient. If the device detects a non-shockable rhythm, the device will prompt the user to begin CPR. The electrodes used with the device incorporates an accelerometer that mesures the depth of CPR compressions. This information is used by the device to provide feedback to the user and encourage the user to administer CPR in compliance with the American Heart Association (AHA) Guidelines. The device provides feedback in the form of a metronome (to encourage the proper CPR frequency of 100 compressions per minute) and a visual depth indicator on the display (to encourage the recommended compression depth).

Here's an analysis of the acceptance criteria and study information for the ZOLL AED Plus with the 2010 AHA Guidelines Software Update, based on the provided text.

Based on the provided text, the device in question is a software update for an existing Automatic External Defibrillator (AED), the ZOLL AED Plus. The update primarily changes the CPR compression depth feedback to align with the 2010 AHA Guidelines.

It is critical to understand that this submission is a 510(k) for a software update to an already cleared device, not a new device requiring extensive clinical trials for a de novo clearance. This means the performance testing primarily focuses on demonstrating that the updated software maintains the safety and effectiveness of the predicate device and meets the new CPR depth recommendations.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format that would typically be seen for a new device's diagnostic performance (e.g., sensitivity, specificity for a diagnostic algorithm). Instead, the "acceptance criteria" implicitly relate to adhering to the new AHA guidelines and demonstrating substantial equivalence to the predicate device.

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