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• Defibrillation
• ECG Monitoring
• Cardioversion ●
• CPR Feedback ●

The CPR Dura-padz Reusable Defibrillation Electrode is used in conjunction with Dura-padz Gel, and for use with the following ZOLL Biphasic-only defibrillators with max. energy setting of 200 Joules:

• AED Pro
• M Series ●
• E Series ●
• R Series ●

The device will be used in pre-hospital, alternate care and hospital settings by trained personnel only, including:

• . Physicians
• Nurses
• Paramedics
• Emergency Medical Technicians ●
• Cardiovascular Laboratory Technicians
• First Responders

The CPR Dura-padz Reusable Defibrillation Electrodes are not for use with ZOLL AED Plus and/or any Public Access Defibrillators.

The CPR Dura-padz Reusable Defibrillation Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

As with the cleared predicate device (K100565), the CPR Dura-padz Reusable Defibrillation Electrode is intended for use with the following ZOLL biphasic-only defibrillators: AED Pro, E Series, R Series and M Series for ECG monitoring, defibrillation and cardioversion. The addition of a CPR sensor (cleared per K110742) to the subject device will enable CPR feedback. As with the currently marketed predicate device (K100565), the CPR Dura-padz electrode is intended for use in conjunction with Dura-padz Gel on adult patients, and the electrode is reusable up to 100 patient uses.

The provided text does not contain specific acceptance criteria for a device, nor does it describe a study detailing the device's performance against such criteria. The document is a 510(k) premarket notification for the "CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel," which is an FDA submission for substantial equivalence to legally marketed predicate devices.

Instead of acceptance criteria and device performance, the document states:

• "Substantial Equivalence - Non-Clinical Evidence:" "Safety, efficacy and substantial equivalence was shown through verification and validation testing." And earlier: "The existing features and functions (defibrillation, cardioversion and ECG monitoring) of the CPR Dura-padz Reusable Defibrillation Electrode have been cleared per K100565. ... The CPR Feedback monitoring function is the same technology used in the predicate device cleared per K110742."
• "Substantial Equivalence - Clinical Evidence: N/A - Clinical evidence was not necessary to show substantial equivalence."
• "Performance Testing:" "The CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel has been subjected to extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards. Performance testing is provided in Section 18 of this submission."

Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text. The document refers to "Section 18 of this submission" for performance testing details, which is not included here. The core of this FDA submission is to demonstrate equivalence to existing devices (K100565 and K110742) rather than presenting a novel study against specific, new acceptance criteria.

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• Defibrillation
• Cardioversion
• Noninvasive Pacing
• ECG Monitoring
• CPR Feedback
  For use with ZOLL® Defibrillators, such as:
• R Series
• X Series
  Trained Personnel only, Including:
• Physicians
• Nurses
• Paramedics
• Emergency Medical Technicians
• Cardiovascular Laboratory Technicians
  The OneStep Pediatric CPR electrodes are indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

As with the currently marketed OneStep Pediatric CPR Multi-Function Electrode (reviewed and cleared with K120907), the modified OneStep Pediatric CPR Multi-Function Electrode (MFE) is intended for use with ZOLL R Series and ZOLL X Series defibrillators for ECG Monitoring, Defibrillation, External Noninvasive Pacing, Cardioversion and CPR Feedback for use on patient less than 8 years of age or weighing less than 55lbs (25kg) in either the hospital environment. The currently marketed OneStep Pediatric CPR MFE provides users with accurate depth compression feedback when CPR is performed on a firm surface – a known recommended practice. A recent publication by the AHA acknowledges that "accelerometers are insensitive to mattress compression" and stresses the need for "continued development of optimal and widely available CPR monitoring." So. with the current submission. we are proposing to modify the OneStep Pediatric CPR MFE to incorporate a second motion sensor on the posterior electrode thereby allowing rescuers to obtain accurate depth compression feedback when CPR is performed on soft/ compressible surfaces. Dual sensor technology, utilized in the proposed OneStep Pediatric CPR MFE. has been reviewed and cleared by the agency with OneStep CPR II MFE (K133441).
As with the predicate device, the proposed electrode and wire harness with a ZOLL proprietary connector will have a pre-connect feature that enhances the user's ability to deliver immediate therapy. And like the predicate device, the OneStep Pediatric CPR electrode is also designed to support the defibrillator's self test and expiration date identification. Each electrode pad is structurally comprised of a solid hydrogel with a pure tin electrical conductive element having a polyethylene terephtalate (PET) backing with an adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment.

The provided text is a 510(k) summary for the ZOLL OneStep Pediatric CPR Multi-Function Electrode (MFE). It describes a modified device that incorporates a second motion sensor for improved CPR depth feedback on soft surfaces. However, it does not explicitly provide a table of acceptance criteria or detailed results of a study proving the device meets specific performance metrics in the way that would typically be presented for image-based diagnostic or AI-driven medical devices.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical evidence and performance testing against recognized standards. There is no mention of a study involving human readers or AI in the context of diagnostic accuracy.

Therefore, many of the requested elements cannot be extracted directly from this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy) for a diagnostic outcome, nor does it present device performance in that manner. Instead, it states that the device was subjected to "extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards."

The performance testing listed consists of categories rather than specific metrics:

• EMC Testing in accordance with IEC 60601-1-2.
• Electrical, mechanical, bio-compatibility and simulated use testing per the applicable requirement of international recognized standards IEC 60601-1, IEC 60601-2-4, ISO 10993-1, ISO 10993-5 and ISO 10993-10.
• Testing to qualify the use of the electrode with R Series and X Series devices.
• Usability testing.

The "reported device performance" is essentially that these tests were conducted and the device met its functional requirements and specifications, allowing it to be deemed substantially equivalent.

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

The document does not refer to a "test set" in the context of diagnostic performance data (e.g., medical images or patient records). The "testing" mentioned refers to engineering and safety performance tests of the device itself (electrical, mechanical, usability). Therefore, sample sizes for such a test set and data provenance (country, retrospective/prospective) are not applicable or provided in this context.

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

This information is not applicable. The device is a multi-function electrode for CPR and defibrillation, not an interpretative diagnostic tool. Ground truth in the sense of expert consensus on diagnostic findings is not relevant to the described testing.

4. Adjudication Method:

Not applicable, as there's no diagnostic ground truth being established.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is compared with and without AI assistance. This document describes a physical medical device (electrodes) and its substantial equivalence based on engineering and safety performance, not a diagnostic algorithm.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone algorithm performance study was not done. The device in question is a hardware component with a function to provide feedback (CPR depth), not an independent algorithm for diagnostic interpretation.

7. Type of Ground Truth Used:

The "ground truth" for the performance testing described would be the verifiable measurements and standards for electrical safety, biocompatibility, mechanical integrity, and functional performance (e.g., accurate depth compression feedback as measured by a calibrated system). It is not expert consensus, pathology, or outcomes data in the diagnostic sense.

8. Sample Size for the Training Set:

Not applicable. The device is not an AI/ML algorithm that requires a training set of data.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary regarding acceptance criteria and study in the context of the provided document:

The provided document describes the ZOLL OneStep Pediatric CPR Multi-Function Electrode and seeks 510(k) clearance by demonstrating substantial equivalence to existing predicate devices.

Instead of providing a typical "acceptance criteria" table with specific performance metrics for a diagnostic claim, the document indicates that acceptance was based on the device meeting functional requirements and performance specifications as defined by applicable National/International recognized standards.

The study (or rather, "performance testing") used to demonstrate this involved:

• EMC Testing: In accordance with IEC 60601-1-2.
• Electrical, Mechanical, Biocompatibility, and Simulated Use Testing: Per IEC 60601-1, IEC 60601-2-4, ISO 10993-1, ISO 10993-5, and ISO 10993-10.
• Device Qualification Testing: To ensure compatibility with ZOLL R Series and X Series defibrillators.
• Usability Testing.

The primary change being approved is the addition of a second motion sensor to improve CPR depth feedback on soft surfaces, a technology already cleared in a similar predicate device (OneStep CPR II MFE, K133441). Clinical evidence was explicitly stated as "N/A - Clinical evidence was not necessary to show substantial equivalence." This indicates that the regulatory decision was based on engineering and performance testing against established standards for physical devices, rather than a clinical trial or diagnostic performance study.

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• Defibrillation ●
• Cardioversion ●
• Noninvasive Pacing o
• ECG Monitoring ●
• CPR Sensor .

For use on adult patients with ZOLL® R Series® defibrillator by trained personnel only, including:

• Physicians
• Nurses
• Paramedics ●
• Emergency Medical Technicians ●
• Cardiovascular Laboratory Technicians ●

The OneStep CPR II Adult Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

As with the cleared predicate device (K110742), the OneStep CPR II MFE is intended for use with ZOLL R Series defibrillators for ECG Monitoring, Defibrillation, External Noninvasive Pacing, Cardioversion and CPR Feedback for adult patients in either the hospital or pre-hospital environment. The currently marketed OneStep CPR MFE provides users with accurate depth compression feedback when CPR is performed on a firm surface - a known recommended practice. A recent publication by the AHA acknowledges that "accelerometers are insensitive to mattress compression" and stresses the need for "continued development of optimal and widely available CPR monitoring".

The proposed device incorporates a second motion sensor on the posterior electrode which will allow rescuers to obtain accurate depth compression feedback when CPR is performed on soft/ compressible surfaces. The dual sensor technology works by detecting motion in the posterior sensor and communicating it to the anterior sensor to allow for compensation for a compressible surface underneath the patient. The accelerometers in each CPR sensor work in series to provide a signal to the defibrillator which interprets that signal to determine actual chest compression depth when compressions are performed on a compressible surface. The dual sensor technology can also be used on a solid surface as the design of the posterior sensor is not influenced by lack of movement.

As with the predicate device, the proposed electrode and wire harness with a ZOLL proprietary connector will have a pre-connect feature that enhances the user's ability to deliver immediate therapy. And like the predicate device. the OneStep CPR II electrode will also have the ability to perform a defibrillation self test and expiration date identification with the ZOLL R Series Defibrillator. Each electrode pad is structurally comprised of a solid hydrogel with a pure tin electrical conductive element having a polyethylene terephtalate (PET) backing with an adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment.

I am sorry, but the provided text does not contain the requested information about acceptance criteria and a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter and summary for a medical device (OneStep CPR II Adult Multi-Function Electrode).

It describes the device, its intended use, and states that it has been subjected to "extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards." However, it does not provide the specific acceptance criteria, the results of the performance testing, the study design, sample sizes, ground truth establishment, or any details about multi-reader multi-case studies or standalone algorithm performance.

To answer your request, I would need a different document, likely a detailed study report or validation protocol (e.g., from Section 18 mentioned in the text).

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To assist users in the performance of effective CPR on a victim 8 years or older.

PocketCPR™ is a device that uses voice prompts and visual indicators to assist rescuers in the performance of cardiopulmonary resuscitation (CPR). PocketCPR is designed to be used by a rescuer to perform CPR. PocketCPR provides rescuers with real-time feedback during the administration of CPR.

PocketCPR has two operating modes: Normal and Silent Operating Mode which allows the rescuer to perform CPR in any type of environmental condition. In Normal Operating Mode, PocketCPR operates with all sounds, including voice prompts and metronome beeping. In Silent Operating Mode, PocketCPR operates with visual flashing metronome and chest compression lights "only".

The PocketCPR directly measures acceleration through the use of an integrated accelerometer and The Fookers' It allocaly model is not compressing the chest at least 1.5 inches Instantal. Books are will instruct them to increase compression depth. The rate of compression is (comm), the Fooketer ( will morable non signal, encouraging the rescuer to keep pace with the prompled by the ace of a fiten 30 compressions or about 18 seconds of chest compressions, PocketCPR will instruct the rescuer to give breaths.

The provided text describes the 510(k) summary for the PocketCPR™ device, but it lacks the detailed information required to fully answer the request regarding acceptance criteria and a specific study proving those criteria are met. The document states that "Extensive performance testing ensures that the PocketCPR meets all of its functional requirements and performance specifications" but does not elaborate on what these specifications are, the methodologies used, or the results of such testing.

Here's an attempt to answer based on the available information, with significant gaps noted:

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria in a quantitative manner, nor does it provide a table of reported device performance against such criteria. It implicitly suggests that the device performs as intended in terms of providing feedback for CPR compression depth and rate.

Implicit Performance Claims from the text:

• Compression Depth: "The PocketCPR will instruct them to increase compression depth" if not compressing at least 1.5 inches. This implies it accurately measures and provides feedback for depths below 1.5 inches.
• Compression Rate: The device "will monitor and signal, encouraging the rescuer to keep pace with the prompt led by the pace" (intended to be about 100 compressions per minute). This implies it accurately measures and provides feedback for compression rate.
• Breaths Prompts: "After 30 compressions or about 18 seconds of chest compressions, PocketCPR will instruct the rescuer to give breaths." This implies accurate counting of compressions or timing.

No explicit acceptance criteria or reported performance data are provided to populate the table.

Detailed breakdown of information requested that is NOT AVAILABLE in the provided text:

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

   • Not Available. The document does not provide a table with specific acceptance criteria (e.g., "Compression depth accuracy: +/- X mm") nor does it report the device's measured performance against any such criteria. It only makes general statements about "functional requirements and performance specifications."

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

   • Not Available. The document mentions "Extensive performance testing" but provides no details on sample sizes, study design (retrospective/prospective), or 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 Available. No information is provided regarding how "ground truth" (if applicable in this context, e.g., for accurate CPR performance) was established for any testing.

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

   • Not Available. No information on adjudication methods for a test set is provided.

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/Not Available. The PocketCPR is a device providing real-time feedback for CPR, not an AI or imaging diagnostic tool that would typically involve human "readers" or an MRMC study in the traditional sense. While the device assists human rescuers, the text does not describe any study comparing human performance with and without the device, nor does it quantify an "effect size" of improvement.

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

   • Not Available. The device's primary function is to provide real-time feedback to a human rescuer, implying a human-in-the-loop context. No information is given about a standalone algorithm performance test.

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

   • Not Available. The document does not specify the type of ground truth used for any performance testing. For a CPR feedback device, ground truth might involve objective measurements of compression depth/rate on a manikin, or expert observation of CPR technique.

8. The sample size for the training set:

   • Not Applicable/Not Available. The PocketCPR is described as using an "integrated accelerometer" and having "two operating modes." It is presented more as a real-time sensor-based feedback system rather than a machine learning/AI model that would typically require a "training set" in the conventional sense. If internal calibration or development involved data, it is not mentioned.

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

   • Not Applicable/Not Available. (See point 8).

Conclusion based on Provided Text:

The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices (CPR EZY, ZOLL AEDPLUS®, ZOLL AEDPRO®) rather than detailing specific performance studies with quantitative acceptance criteria and results. It makes general claims about "extensive performance testing" ensuring the device meets "functional requirements and performance specifications" but does not provide the specifics of these tests, the criteria themselves, or the outcomes required to answer your questions comprehensively.

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The pedirpadz™ Radiolucent MFE's are intended to be used on pediatric patients, 0-8 years of age at

The pediepadz™ Radiolucent Pediatric Multi-Function Electrodes consist of a pair of liquid gel electrodes with permanently attached lead wires that join together at a proprietary ZOLL connector. The connector interfaces with ZOLL the Pacemaker/Defibrillator multifunction cable.

The provided document is a 510(k) Premarket Notification for the pedi•padz™ Radiolucent Pediatric Multi-Function Electrode. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific, novel acceptance criteria through a clinical study. Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of an algorithm or AI.

The document discusses the technological characteristics of the device and its compliance with standards, which are a type of acceptance criteria for medical devices (e.g., IEC 60601-2-4 Medical Electrical Equipment, ANSI/AAMI DF-2: 1996, Cardiac Defibrillator Devices). However, these are general engineering and safety standards, not performance metrics based on data analysis from a study as would be relevant for an AI/algorithm.

Here's why the requested information cannot be extracted from this document:

• Device Type: The pedi•padz™ is a physical medical electrode, not a digital algorithm, AI, or software-as-a-medical-device (SaMD).
• Regulatory Pathway: A 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical performance studies for efficacy or diagnostic accuracy.
• Focus of the Document: The document focuses on the device's description, intended use, and compliance with existing electrical and safety standards, and its equivalence to predicate physical electrodes. There is no mention of an "algorithm" or "AI."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/algorithm, because this information is not present in the provided text.

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The BIO-DETEK Electrode Adapter is indicated for use with ZOLL CPR-D, stat-padz™ and statepadz II™ Electrodes for connection with Medtronic Physio-Control Defibrillator and data: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cable.

The BIO-DETEK Electrode Adaptor is made of rigid thermoplastic and conductive material. The adaptor will be provided as a reusable stand-alone accessory to be used in conjunction with ZOLL CPR-D, Statpadz, and Statpadz II Electrodes.

The provided text describes the BIO-DETEK Electrode Adaptor and its 510(k) premarket notification. However, it does not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on:

• Device description and intended use.
• Technological characteristics and compliance with standards.
• The FDA's decision regarding substantial equivalence to a predicate device.
• Indications for Use.

Therefore, I cannot provide the requested information from the given text.

To answer your request, a study report or clinical data section would be needed, which is not present in this 510(k) summary and FDA letter.

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The BIO-DETEK Modified Adult Multi-Function Electrode with Connector is indicated for use with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 500, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cables, for defibrillation, cardioversion, non-invasive pacing, and electrocardingraph monitoring.

The BIO-DETEK Modified Adult Multi-Function Electrodes with Connector is indicated for use with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cable, for defibrillation, cardioversion, non-invasive pacing, and electrocardiograph monitoring.

The provided document does not contain information about specific acceptance criteria, device performance, a study conducted to demonstrate the device meets acceptance criteria, sample sizes, ground truth establishment, or human expert involvement.

Instead, this document is a 510(k) Premarket Notification Submission for the BIO-DETEK Modified Adult Multi-Function Electrodes with Connector. It focuses on demonstrating substantial equivalence to a previously marketed predicate device (BIO-DETEK Adult Multi-Function Electrodes, K931801).

The core of this submission is to show that the new device has "operation and technological characteristics" that are sufficiently similar to the predicate device, not necessarily to present a study proving the new device meets specific, quantifiable performance acceptance criteria.

The information provided includes:

• Device Name: BIO-DETEK Modified Adult Multi-Function Electrodes with Connector
• Intended Use: For use with specific Medtronic Physio-Control Defibrillator Models (LIFEPAK 9, 10C, 11, 12, 20) with QUIK-COMBO Therapy Cables for defibrillation, cardioversion, non-invasive pacing, and electrocardiograph monitoring.
• Predicate Device: BIO-DETEK Adult Multi-Function Electrodes (K931801)
• Compliance with Standards: The device is designed to comply with applicable portions of IEC 60601-2-4, ANSI/AAMI/ISO DF39-1993, ANSI/AAMI EC53:1995, and 21 CFR Part 898. These standards would contain performance requirements that the device should meet, but the document does not explicitly state the acceptance criteria derived from these standards or present test results against them.
• FDA Decision: The FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

Therefore, based on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and performance study details. The document is a regulatory submission for substantial equivalence, not a detailed technical report of a performance study.

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ZOLL Superpadz Adult Multi-Function Electrodes will be used for the following clinical applications:

• Defibrillation .
• Cardioversion .
• Noninvasive Pacing .
• Electrocardiograph Monitoring .
  In conjunction with these devices:
• ZOLL PD™ 1200 Pacemaker/Defibrillator .
• ZOLL PD™ 1400 Pacemaker/Defibrillator .
• ZOLL PD™ 2000 Pacemaker/Defibrillator .
• ZOLL D 900 Defibrillator .
• ZOLL D 1400 Defibrillator .
• ZOLL D 2000 Defibrillator .
• ZOLL 1600 Pacemaker/Defibrillator .
• ZOLL 1700 Pacemaker/Defibrillator .
• ZOLL NTP 1000 Noninvasive Temporary Pacemaker .
• ZOLL M Series .

Superpadz Adult Multi-Function Electrodes

The provided text is a letter from the FDA regarding a 510(k) premarket notification for the "ZOLL Superpadz Adult Multi-Function Electrode." It's a regulatory document confirming substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market their product.

The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. It is a regulatory approval letter, not a scientific study report.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information is simply not present in this document.

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ZOLL First Responder Padz Adult Defibrillation Electrodes will be used for the following clinical applications:

• Defibrillation
• Electrocardiograph Monitoring
  In conjuction with these devices:
• ZOLL PD™ 1200 Pacemaker/Defibrillator
• ZOLL PD™ 1400 Pacemaker/Defibrillator
• ZOLL PD™ 2000 Pacemaker/Defibrillator
• ZOLL D 900 Defibrillator
• ZOLL D 1400 Defibrillator
• ZOLL D 2000 Defibrillator
• ZOLL 1600 Pacemaker/Defibrillator
• ZOLL 1700 Pacemaker/Defibrillator
• ZOLL 1700 Facemanen sive Temporary Pacemaker
• ZOLL M Series

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Bio-Detek Incorporated for their ZOLL First Responder Padz Adult Defibrillation Electrodes. This document primarily focuses on the regulatory approval process and the determination of substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information such as:

• Table of acceptance criteria and reported device performance
• Sample size and data provenance for a test set
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth used
• Sample size for training set
• Method for establishing ground truth for training set

This document is a regulatory approval letter, not a technical report or study summary.

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