Search Results

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.

Ask a specific question about this device

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

4. Adjudication method for the test set

   • Not applicable. No new test set.

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

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

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

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

7. The type of ground truth used

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

8. The sample size for the training set

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

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

   • Not applicable.

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

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

The manufacturer explicitly states:

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

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

Ask a specific question about this device

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.

Ask a specific question about this device

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.
  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, reviewed and cleared under 510(k) K042007 and K062177, is a portable device designed to be used by trained emergency care personnel in both the hospital and pre-hospital arenas. The ZOLL E Series is designed for all emergent care situations and provides multi-parameter monitoring of patients in critical care and transport. The E Series combines defibrillation, ECG monitoring, noninvasive transcutaneous pacing, pulse oximetry, end tital CO2 12-Lead ECG monitoring, noninvasive blood pressure measurement, data printing and recording and CPR feedback in a single instrument.
The ZOLL E Series software, which currently supports the American Heart Association's (AHA) Guidelines for CPR 2005, has been revised to optionally support the AHA's Guidelines for CPR 2010. The specific changes include:

• Adding support, in the form of a configuration option, for a minimum CPR target compression depth of at least 2.0 inches (AHA Guidelines for CPR 2005 specified a minimum compression depth of at least 1.5 inches.) as described in Section 7 of the Operator's Guide included in Attachment 11-1.
• Modifying the reference markers associated with the displayed CPR compression bargraph when the CPR target compression depth is configured for 2.0 inches.
• Adding an optional informational message to remind the user to release their hands from the chest between compressions in order to allow the chest to recoil. When the E 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 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 refer-ence. 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.

The provided document is a 510(k) summary for the ZOLL E Series with a 2010 AHA Guidelines Software Update. It describes the device, its intended use, and substantial equivalence to previously cleared devices. However, the document does not contain specific information about acceptance criteria, detailed study designs, sample sizes for test or training sets, expert qualifications for ground truth establishment, or adjudication methods for performance testing. It only broadly states that "Extensive performance testing ensures that the ZOLL E Series Defibrillator meets all of its functional requirements and performance specifications" and "Performance testing of the ZOLL E Series Defibrillator demonstrates that its features and functions are substantially equivalent".

Therefore, I cannot provide a detailed answer to your request based on the provided text. The document focuses on regulatory clearance based on substantial equivalence rather than presenting a performance study with detailed acceptance criteria and results.

Here's a summary of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated or organized into a table in the provided document. The document implies compliance with the 2010 AHA Guidelines for CPR regarding compression depth and full chest recoil.
• Reported Device Performance: The document only states that "Performance testing... 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." No specific metrics (e.g., accuracy, precision, sensitivity, specificity) for the CPR monitoring function or other features are provided. The key change is the software update to support a minimum CPR target compression depth of at least 2.0 inches, up from 1.5 inches.

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

• Sample Size: Not specified.
• Data Provenance: Not specified.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified.

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

• MRMC Study: No mention of an MRMC study. The document focuses on device performance and substantial equivalence, not comparative effectiveness with human readers.
• Effect Size of Human Readers with vs. without AI Assistance: Not applicable, as no MRMC study or AI assistance comparison is presented. The device provides feedback, but it's not described as an "AI assistance" in the context of improving human reader interpretation of data.

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

• The document implies standalone testing of the device's functions, as it refers to "performance testing" of the defibrillator's features and functions. However, detailed results of such standalone testing with specific metrics are not provided. The CPR monitoring function is an algorithm-driven feature that provides feedback, which is a form of standalone function before human-in-the-loop interaction.

7. The Type of Ground Truth Used:

• Not specified. Given the nature of the device (defibrillator with CPR feedback), ground truth for performance testing would likely involve simulated CPR scenarios with controlled compression depths and rates, or potentially data from actual CPR events where precise measurements of depth and rate are obtained through external sensors.

8. The Sample Size for the Training Set:

• Not applicable as the document describes a software update to an existing device, implying a rule-based or algorithm update rather than a machine learning model that requires a "training set" in the conventional sense. The "training" here refers to meeting the new AHA guidelines, likely through parameter adjustments in the existing software.

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

• Not applicable for the same reason as point 8, as it's not a machine learning model. The "ground truth" for the software update would be the 2010 AHA Guidelines recommending at least 2.0 inches compression depth and full chest recoil.

In summary, the provided text serves as a regulatory submission for a software update rather than a detailed scientific and performance study report. It confirms the device's substantial equivalence to existing cleared devices after the software modification, but lacks the specific details of performance testing requested.

Ask a specific question about this device

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 enhancement to the ZOLL E Series® CPRReadyCharge, is intended to provide personnel trained in its use, with reduced interruption to CPR during victim treatment. The ECG Rhythm Advisory Algorithm will perform ECG rhythm analysis during manual CPR chest compressions and detect shockable rhythms with high accuracy.

Use of the E Series units 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 fibrilation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heats. 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 Rwave 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).

Use of the E Series unit in CPRReadyCharge Mode is designed for use by qualified medical personnel who have been trained in ACLS (Advanced Cardiac Life Support). The purpose of the CPRReadyCharge algorithm is to anticipate the need to deliver a therapy shock. CPRReadyCharge Mode uses an advisory algorithm that is designed to perform in the presence of CPR artifact. However, the accuracy of the CPRReadyCharge algorithm in the presence of CPR artifact is lower than the accuracy observed in the Advisory or Semiautomatic (AED) algorithm used with artifact-free ECG. The advisory result should always be confirmed through visual inspection of the ECG rhythm by the operator before the delivery of anv therapy. See Table A-4 in Appendix A for a summary ofthe performance. E Series products with CPRReadyCharge Mode 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 E Series units in CPRReadyCharge Mode for defibrillation is indicated on victims of cardiac arrest where is apparent lack of circulation. E Series units in CPRReadyCharge Mode, when used in conjunction with CPR-D padz, prompt the emergency care personnel to perform CPR, and perform rhythm analysis during CPR compressions. If an underlying shockable rhythm is detected during CPR, the E Series unit in CPRReadyCharge Mode prepares the defibrillator to deliver a shock at the end of the CPR interval.

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 Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where is apparent lack of circulation. Specifications for the ECG rhythm analysis function are provided at the end of this section.

The CPR monitoring function provides visual and audio feedback designed to encourage resouers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) 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 ofany 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 light weight and easy to carry for transport.

The proposed enhancement to the ZOLL E Series® CPRReadyCharge, is intended to provide personnel trained in its use, with reduced interruption to CPR during victim treatment. The ECG Rhythm Advisory Algorithm will perform ECG rhythm analysis during manual CPR chest compressions and detect shockable rhythms with high accuracy.

The E Series products contain a DC defibrillator capableof 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-qelled, 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. 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 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.

Here's an analysis of the acceptance criteria and study information for the ZOLL E Series® with CPRReadyCharge, based on the provided text:

Important Note: The provided text is a 510(k) summary for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device and typically does not contain the detailed performance study reports, ground truth establishment methodologies, or expert qualifications that would be present in a comprehensive clinical study report. Therefore, much of the requested information (like sample sizes, expert qualifications, adjudication methods, and detailed ground truth establishment for the training set) is not explicitly stated in this 510(k) summary. I will highlight what is available and note what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a dedicated table. Instead, it states that the "ECG Rhythm Advisory Algorithm will perform ECG rhythm analysis during manual CPR chest compressions and detect shockable rhythms with high accuracy" and refers to "Table A-4 in Appendix A for a summary of the performance." However, "Table A-4 in Appendix A" is not included in the provided text.

Therefore, I cannot provide a table with specific acceptance criteria and reported device performance directly from the given document.

The summary does make the following general performance claims:

• CPRReadyCharge Mode: "detect shockable rhythms with high accuracy."
• CPRReadyCharge Mode vs. Advisory/AED: "the accuracy of the CPRReadyCharge algorithm in the presence of CPR artifact is lower than the accuracy observed in the Advisory or Semiautomatic (AED) algorithm used with artifact-free ECG." (This implies a comparison but doesn't give specific numbers.)

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

• Test Set Sample Size: Not explicitly stated in the provided text. The document refers to "Table A-4 in Appendix A for a summary of the performance," which would likely contain this information, but the appendix is missing.
• Data Provenance: Not explicitly stated (e.g., country of origin). The document does not specify whether the data was retrospective or prospective.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study measuring human readers' improvement with AI assistance is not mentioned. The document describes the "CPRReadyCharge Mode" as an advisory algorithm intended to "anticipate the need to deliver a therapy shock" and reduces "interruption to CPR." It also states, "The advisory result should always be confirmed through visual inspection of the ECG rhythm by the operator before the delivery of any therapy." This indicates a human-in-the-loop design where the AI provides an advisory function for a human operator, but a formal MRMC study comparing human performance with and without this specific AI assistance is not described in the provided text.
• Effect Size of Human Improvement: Not applicable, as an MRMC study is not described.

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

• Standalone Study: The document implies a standalone performance evaluation of the "ECG Rhythm Advisory Algorithm" within the CPRReadyCharge Mode. It states the algorithm "will perform ECG rhythm analysis during manual CPR chest compressions and detect shockable rhythms with high accuracy" and refers to "accuracy of the CPRReadyCharge algorithm" as being "lower than the accuracy observed in the Advisory or Semiautomatic (AED) algorithm used with artifact-free ECG." This suggests the algorithm's performance was evaluated independently to determine its accuracy in detecting shockable rhythms. However, detailed metrics (sensitivity, specificity, PPV, NPV) are not provided in the main text but are likely in the referenced "Table A-4."

7. The Type of Ground Truth Used for the Test Set

• Type of Ground Truth: The document implicitly refers to the ground truth as the "underlying shockable rhythm" detected during CPR compressions. This implies that the ground truth would be based on expertly determined ECG rhythm classifications. It does not mention pathology or outcomes data as the ground truth for the rhythm analysis itself, but for the broader indication of use in cardiac arrest, clinical outcomes are obviously the ultimate goal.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated in the provided text. 510(k) summaries often do not detail training data.

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

• Training Set Ground Truth Establishment: Not explicitly stated in the provided text. Given it's an ECG rhythm analysis algorithm, it's highly probable the ground truth for the training set would also be established by expert ECG interpretation.

Summary of Missing Information:

Many specific quantitative details regarding the device's performance study, especially concerning sample sizes, expert involvement, and detailed ground truth methodologies, are not present in this 510(k) summary. These details would typically be found in an attached appendix or a full study report, which is not provided. The summary focuses on demonstrating equivalence and making high-level performance claims.

Ask a specific question about this device

The ZOLL E Series® Defibrillator is designed for all emergent care situations and provides multi-parameter 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, non-invasive blood pressure measurement (NIBP), and data printing and recording in a single instrument.

The proposed enhancement, the ZOLL E Series® with SpCO/SpMet Option, is intended to provide personnel trained in its use with the ability to monitor carbon monoxide concentration in arterial blood and 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.

Defibrillator Function: 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.

Intended Use - Manual Operation: 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).

Intended Use - Semiautomatic Operation (AED): 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.

Intended Use - CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.

External Pacemaker (Pacer Version Only) Intended Use - Pacemaker: 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.

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

Monitor Intended-Use Multi-parameter Monitoring: This product may be used for monitoring various patient vital signs, including, electrocardiogram (ECG), Pulse Oximetry (SpO2), Carboxyhemoglobin (SpCO), Methemoglobin (SpMet), End Tidal CO2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP).

ECG monitoring is performed by connecting the patient to the unit via 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, which was originally reviewed and cleared by the FDA under premarket notification K042007, is designed for all emergent care situations and provides multi-parameter 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, non-invasive blood pressure measurement (NIBP), and data printing and recording in a single instrument. The proposed enhancement, the ZOLL E Series® with SpCO/SpMet Option, is intended to provide personnel trained in its use with the ability to monitor carbon monoxide concentration in arterial blood and 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.

This 510(k) summary (K092598) describes the ZOLL E Series® Defibrillator with an added SpCO/SpMet Option. The device is a multi-parameter monitor and defibrillator, and the new option allows for monitoring of carbon monoxide (SpCO) and oxidized hemoglobin (SpMet) in arterial blood.

The submission claims substantial equivalence to existing devices and technologies. A critical point is that the SpCO/SpMet option is achieved by integrating the "Masimo Rainbow™ SET® technology," which was previously reviewed and cleared by the FDA under 510(k) K061204. This implies that the performance testing for SpCO/SpMet was conducted as part of the Masimo Rainbow™ SET® technology's clearance, and the current submission leverages that prior clearance.

Therefore, for aspects related to SpCO and SpMet monitoring, the detailed study information regarding acceptance criteria, sample sizes, ground truth establishment, etc., would primarily be found in the K061204 submission for the Masimo Rainbow™ SET® Radical 7 Pulse CO-Oximeter, rather than in this K092598 summary.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Extensive performance testing ensures that the ZOLL E Series Defibrillator meets all of its functional requirements and performance specifications." However, it does not provide specific numerical acceptance criteria or performance metrics for the new SpCO/SpMet option within this summary. It relies on the prior clearance of the Masimo Rainbow™ SET® technology (K061204).

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

The provided document (K092598) does not specify the sample size for a test set for the SpCO/SpMet option, nor does it provide data provenance (country of origin, retrospective/prospective). This information would likely be detailed in the supporting documentation for K061204.

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

This information is not provided in K092598. This would have been established during the clearance of the Masimo Rainbow™ SET® technology (K061204).

4. Adjudication Method for the Test Set:

This information is not provided in K092598. This would have been established during the clearance of the Masimo Rainbow™ SET® technology (K061204).

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

No MRMC comparative effectiveness study is mentioned in this submission (K092598) regarding the SpCO/SpMet option. The focus is on integrating an already cleared technology.

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

The SpCO/SpMet option is a monitoring device intended to display values to a human user. While the underlying algorithm operates in a standalone manner to generate the SpCO and SpMet values, the device itself is not typically evaluated in the context of "algorithm only without human-in-the-loop performance" in the way an AI diagnostic tool might be. Its performance would be assessed against a gold standard in terms of accuracy of its readings, which implies a standalone performance of the technology. This would have been established during the clearance of the Masimo Rainbow™ SET® technology (K061204).

7. The Type of Ground Truth Used:

For pulse co-oximetry devices like those measuring SpCO and SpMet, the ground truth is typically established through measured arterial blood gas (ABG) values analyzed by a laboratory co-oximeter. This is generally considered the "gold standard" for blood gas analysis. This information would have been part of the K061204 submission.

8. The Sample Size for the Training Set:

The provided document (K092598) does not mention a training set or its sample size. The algorithm (Masimo Rainbow™ SET® technology) was already developed and cleared.

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

This information is not provided in K092598. The ground truth for the development of the Masimo Rainbow™ SET® technology (K061204) would have been established using clinically acquired arterial blood samples analyzed by a laboratory co-oximeter.

Ask a specific question about this device

The ZOLL E Series External Defibrillator is indicated for the defibrillation, noninvasive transcutaneous pacing, CPR monitoring, and multi-parameter monitoring of patient vital signs including: ECG monitoring, Pulse Oximetry (SpO2), End Tidal CO2, 12 lead ECG monitoring, and Non Invasive Blood Pressure for resting patients in critical care and transport conditions. It also supports data printing, data recording, and 12 lead data transmission via cellular fax modem, RS232, and Bluetooth.

The ZOLL E Series with Bluetooth Dial Up Networking 12 Lead Transmission provides a means of transmitting the 12 lead patient record wirelessly, via Bluetooth, directly to a cellular device. The cellular device then makes an internet connection to a transfer station which redirects the record to a recipient via email or fax.

Based on the provided text, the device is the ZOLL E Series® with Bluetooth Dial Up Networking 12 Lead Transmission, and the submission is a 510(k) for a modification to an existing device (K042007). This submission primarily focuses on establishing substantial equivalence for a change in how the 12-lead ECG data is transmitted wirelessly, rather than introducing a new medical function that requires extensive clinical studies with specific performance criteria.

Therefore, the typical structure for "acceptance criteria" and "device performance" in terms of clinical accuracy metrics (like sensitivity, specificity, or AUC) for a diagnostic AI device is not applicable here. Instead, the "acceptance criteria" would relate to the functional requirements of the new transmission method and its equivalence to the predicate device. The "study" described is verification and validation testing to ensure the modified product maintains its intended functions and does not degrade existing performance.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document refers to "extensive performance testing" and "functional testing" but does not quantify the number of devices tested, the number of transmission events, or any patient data records used for testing the transmission function.
• Data Provenance: Not specified. Given that this is largely functional and software testing for a connectivity feature, the "data" would likely be test data generated specifically for verifying the Bluetooth transmission, rather than de-identified clinical data with specific provenance.

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

• Not Applicable. This submission is not for a diagnostic device that requires expert consensus for ground truth on clinical data. The testing is for the functional performance of a data transmission feature.

4. Adjudication method for the test set

• Not Applicable. No ground truth adjudication is mentioned as this is a functional/connectivity modification, not a diagnostic accuracy study.

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 done. This device is not an AI-assisted diagnostic tool for human readers; it's a medical device with a modified data transmission feature.

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

• No. This refers to the performance of a connectivity feature of a medical device, not a standalone algorithm's diagnostic performance. The 12-lead ECG analysis function that generates the data is part of the E Series device itself, and its performance would have been established during the original 510(k) (K042007) or previous submissions. This K081081 is about the transmission of that data.

7. The type of ground truth used

• Not Applicable (or implicitly, system specifications/expected output): For functional testing of a transmission feature, the "ground truth" would be the successful and accurate transmission of the 12-lead ECG data, matching the source data at the destination, within specified timing and reliability parameters. This is verified against the device's design specifications. No clinical "ground truth" like pathology or expert consensus is relevant for this specific modification.

8. The sample size for the training set

• Not Applicable. This modification is for a software/connectivity feature, not a machine learning algorithm that requires a training set.

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

• Not Applicable. As there is no training set mentioned or implied, this question is not relevant.

Summary of the K081081 Submission Context:

This 510(k) is for a relatively minor modification to an already cleared medical device. The "device" being discussed in the context of this submission is specifically the mechanism of 12-lead ECG data transmission (from indirect through an intermediate device to direct via Bluetooth Dial Up Networking). The performance testing described is focused on ensuring that this change in transmission protocol works correctly and does not negatively impact the device's overall safety, effectiveness, or other existing functions as a defibrillator, pacer, and multi-parameter monitor. It is not an AI or diagnostic algorithm submission.

Ask a specific question about this device

The ZOLL E Series with Intubation Assist Option is intended to provide the user with a simple way of counting breaths as detected by a capnometer once the Endotracheal Tube (ET) has been placed and the rescuer is delivering the first initial ventilations. Ventilations can be counted based on EtCO2 and/or tranthoracic impedance.

The ZOLL E Series products (K042007) combine a defibrillator, ECG Monitor, Noninvasive Transcutaneous Pacing, Pulse Oximetry, End Tidal Carbon Dioxide (EtCO2), 12-Lead ECG Monitoring, Non-Invasive Blood Pressure measurement (2:002), 12-2002 Pressure and Temperature and data printing and recording in a single instrument. The EtCO2 feature in the E Series supports both mainstream and sidestream options and allows for capnographic display of the CO2 waveform as well as capnometric and respiration rate readings. The mainstream and sidestream options use the same connector on the E Series unit and may be used interchangeably. Both sensor types determine CO2 concentration in the breathing inses by measuring the amount of light absorbed by gases flowing through the airway or sampling cell.

The Intubation Assist Option for those units equipped with EtCO2 provides a simple means of counting breaths after the endotracheal (ET) tube has been placed and the means or ocanting the first initial ventilations to confirm tube placement. Counting breaths as detected by a capnometer is a standard initial step in determining tube placement. Both EtCO2 and transthoracic impedance are standard features in the currently cleared E Series.

The provided text does not contain detailed acceptance criteria or a study proving the device meets acceptance criteria for the "ZOLL E Series with Intubation Assist Option." The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with specific acceptance criteria.

The key information regarding performance is:

• Performance Testing: "Extensive performance testing ensures that the ZOLL E Series with Intubation Assist Option performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications. Safety testing assures the device complies with applicable sections of recognized industry and safety standards."
• Conclusion: "Performance and safety testing of the ZOLL E Series with Intubation Assist Option demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness."

This indicates that some performance testing was done, but the specific acceptance criteria, reported performance, and details of the study (sample size, experts, ground truth, etc.) are not included in this summary.

Therefore, I cannot populate the requested table or provide the detailed study information as it is not present in the provided text. The document confirms that the device was deemed substantially equivalent based on unspecified "extensive performance testing" and safety testing to industry standards.

Ask a specific question about this device

Defibrillator Function: 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. Intended Use - Manual Operation: 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). Intended Use — Semiautomatic Operation (AED): 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.

External Pacemaker (Pacer Version Only): Intended Use - Pacemaker: 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. Pediatric Pacing: Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL. pediatric MFE Pads.

Monitor: Intended Use - Multi-parameter Monitoring: This product may be used for monitoring various patient vital signs, including: electrocardiogram (ECG), Pulse Oximetry (SpO2), 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. 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.

Intended Use -- CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients.

The ZOLL E Series External Defibrillator is indicated for the defibrillation, Noninyasive 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 light weight and easy to carry for transport. The device is capable of providing Basic Life-Saving (BLS) personnel the option of analyzing a patient's ECG signal via the Advisory feature on the device. The Advisory Algorithm will determine if the acquired heart rhythm is shockable or non-shockable and will prompt the end-user to provide therapy in the event of a shock advised determination. The user will be prompted to perform Cardiopulmonary Resuscitation in the event that the Analyze feature determines that CPR compressions are more beneficial to the victim.

The provided document does not contain explicit acceptance criteria tables or detailed study results for the Advisory Algorithm within the ZOLL E Series Defibrillator. While it states that "Performance and safety testing of the ZOLL E Series Defibrillator demonstrates that its features, functions and incorporated interpretive algorithm are that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness," it relies on substantial equivalence to the Philips Medical Systems HeartStart FR2+ AED (K051632) rather than presenting a standalone study with specific metrics for the Advisory Algorithm's performance.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be directly extracted from the provided text.

However, based on the context of an Automated External Defibrillator (AED) and its advisory function, we can infer common performance metrics and the type of acceptance criteria that would typically be expected, even if not explicitly stated with numerical targets.

Inferred Acceptance Criteria and Reported Device Performance (Based on AED Standards and Substantial Equivalence):

Given that the device's Advisory Algorithm determines if a rhythm is shockable or non-shockable, the key performance metrics would revolve around its accuracy in this determination.

Detailed Study Information (Based on Available Text):

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified. Given the context of a 510(k) submission, it's likely that a dataset of previously recorded ECGs (retrospective) would have been used for algorithm testing, but this is not explicitly stated.

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

   • Not specified. For AED rhythm analysis, ground truth is typically established by expert cardiologists or emergency physicians, but details are not provided.

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

   • Not specified.

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:

   • Not specified. The document focuses on the AED's standalone advisory function, not an AI-assisted human reading scenario. The device prompts the end-user based on its analysis, but there's no mention of a study comparing human performance with and without this specific AI's assistance.

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

   • Yes, implicitly. The "Advisory Algorithm will determine if the acquired heart rhythm is shockable or non-shockable and will prompt the end-user." This describes the algorithm's standalone function (without immediate human intervention in the analysis process itself, though a human acts on the advice). The "Performance Testing" section states this testing was done.

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

   • Not explicitly stated. For AED rhythm analysis, the ground truth for ECG interpretation (e.g., whether a rhythm is Ventricular Fibrillation, asystole, etc.) is typically established by expert consensus of cardiologists/electrophysiologists analyzing the ECG waveforms.

7. The sample size for the training set:

   • Not specified. The document describes the "Advisory Algorithm" but does not detail its development or training process.

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

   • Not specified. Assuming a similar methodology to the test set, it would likely involve expert interpretation of ECGs, but this is not confirmed.

Ask a specific question about this device

The ZOLL E Series with 12SL™ is intended for the recording and automated analysis of 12-Lead ECG signals acquired from adult and pediatric patients in the supine, resting position.

The 12SL™ Analysis Option using the GE/Marquette 12SLTM Algorithm is useful in the diagnosis of patients with acute myocardial infarction (AMI) and is useful in the interpretation and documentation of other transient cardiac arrhythmias that may occur. The 12-Lead ECG Analysis is indicated for the recording and analysis of 12 Lead ECG signals acquired from adult and pediatric patients in the supine, resting position. The Acute Cardiac Ischemia-Time Insensitive Predictive Instrument (ACI-TIPI) and Thrombolytic Predictive Instrument (TPI) are decision aids for qualified clinicians who may currently wish to calculate ACI-TIPI and TPI in adult patients.

12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction.

The ZOLL E Series products (K042007) combine a defibrillator, ECG Monitor, Noninvasive Transcutaneous Pacing, Pulse Oximetry, End Tidal CO2 , 12-Lead ECG Monitoring, Non-Invasive Blood Pressure measurement Invasive Blood Pressure and Temperature and data printing and recording in a single instrument.

The ZOLL E Series 12SLTM Analysis Option utilizes the same interpretive features and functions to those of the currently marketed ZOLL E Series 12SL™ Analysis Option (K042007). The device acquires an ECG signal through a 10wire cable assembly and commonly used patient electrodes placed in a standard 12-Lead configuration. The device is also capable of storing that data to memory and/or transmitting that data via cellular telephone, RS232 port, or wirelessly using Bluetooth™ technology.

I am sorry, but the provided text does not contain information about the acceptance criteria or the study that proves the device meets the acceptance criteria. It primarily focuses on the device's description, intended use, substantial equivalence claim, and general performance and safety testing. There are no details on specific performance metrics, sample sizes for test or training sets, ground truth establishment, or any comparative effectiveness studies.

Ask a specific question about this device