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The RMU-2000 Automated Chest Compression System (ACC) is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

The RMU-2000 must only be used in cases where chest compressions are likely to help the patient.

The RMU-2000 ACC is intended for use as an adjunct to manual cardiopulmonary resuscitation (CPR) on adult patients when effective manual CPR is not possible (e.g., during patient transport, or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient personnel are available to provide effective CPR).

The RMU-2000 Automated Chest Compression (ACC) System is an automated, portable, battery-powered device that provides chest compressions on adult patients who have cardiac arrest.

The RMU-2000 ACC, when applied to a patient who is unconscious and not breathing, is designed to:

· Provide consistent depth and rate chest compressions.

• Allow for automated chest compressions in both the in-hospital and out of hospital settings, including during patient transport.

• Be applied to the patient with minimal interruption of CPR.
  The major components of the RMU-2000 ACC are the Backboard, the Frame and the Compression Module. The Backboard is placed under the patient to provide a base for the ACC system. After a single-use Suction Cup is pre-installed onto the Frame, the Compression Module is then mounted into the Frame, causing the Suction Cup to attach to the Compression Module's piston drive. The Compression Module and Frame assembly is then placed over the patient and snaps into the Backboard with self-locking latches. The Compression Module contains the user interface, a replaceable Battery Pack, and the piston drive and is used to generate the chest compressions.

The RMU-2000 ACC can be operated using a replaceable, rechargeable Battery Pack or with an external power adapter used in conjunction with the battery. A fully-charged, new Battery Pack can provide continuous operation for at least an hour and can be recharged in the Compression Module.

Once the RMU-2000 ACC has been powered on and applied to the patient, compressions are initiated by adjusting the piston to the patient's chest and pressing either of the Run Compressions buttons. Additional user interface features include a pause function, a warning indicator to notify the operator for possible misuse or malfunction, and a Battery Pack capacity gauge.

A Bluetooth® technology ON/OFF button on the user control panel allows the Compression Module to be wirelessly connected to a personal computer and for ACC data retrieval and event reporting when used in conjunction with utility software available at www.defibtech.com. A USB port on the underside of the Compression Module also allows connection to a personal computer when a wired connection is preferred or when a Bluetooth® connectivity is not possible or desired.

The provided text describes a 510(k) premarket notification for the Defibtech RMU-2000 Automated Chest Compression System, asserting its substantial equivalence to the predicate device, the LUCAS Chest Compression System. This document focuses on demonstrating that the RMU-2000 functions safely and effectively, similar to an already cleared device. As such, it does not contain details about a study evaluating AI performance, specifically the acceptance criteria or device performance in the context of AI. The device described is a mechanical system, not an AI or software algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets these criteria because the document does not pertain to an AI device.

However, I can extract the information related to the performance testing and safety/effectiveness claims made for this non-AI mechanical device:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, specific numerical acceptance criteria and a direct comparison table for the RMU-2000 against pre-defined performance thresholds (as would be typical for an AI study) are not detailed. Instead, the submission relies on demonstrating substantial equivalence to a predicate device. The performance claims are primarily comparative:

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The RMU-1000 ACC is intended for use as an adjunct to manual cardiopulmonary resuscitation (CPR) when effective manual CPR is not possible (e.g., during patient transport, or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient personnel are available to provide effective CPR).

The RMU-1000 Automated Chest Compression (ACC) System is an automated, portable, battery-powered device that provides chest compressions on adult patients who have cardiac arrest. The RMU-1000 ACC, when applied to a patient who is unconscious and not breathing, is designed to:

• Provide consistent depth and rate chest compressions.
• Allow for automated chest compressions in both the in-hospital and out of hospital settings, including during patient transport.
• Be applied to the patient with minimal interruption of CPR.

The major elements of the RMU-1000 ACC are the Backboard, Frame and Compression Module. The Backboard is placed under the patient to provide a base for the RMU-1000 ACC system. The Frame is placed over the patient and snaps into the Backboard with two self-locking latches, one on each side of the Frame. The Compression Module mounts into the Frame and contains the user interface, the replaceable lithium ion battery and the piston drive (and motor) used to generate the chest compressions. A replaceable, single-use Patient Interface Pad at the distal end of the Piston contacts the patient's chest and serves to soften the edges of the Piston during compressions.

Compression rate and depth, performed according to current American Heart Association (AHA) and other internationally-recognized resuscitation guidelines, are initiated using a simple three-step operational sequence once the RMU-1000 ACC has been applied to a patient:

• the Compression Module is turned on by pressing the power button;
• the Piston height adjusted for the patient's chest size by pressing the appropriate height adjust button; and
• the appropriate compressions button pushed (either continuous compressions or an automatic pause for breaths).

Additional user interface features include a compression pause function button, service warning indicator, warning mute button, and battery capacity gauge.

The RMU-1000 ACC can be operated using a replaceable, rechargeable lithium-ion battery pack or with an external power supply. A fully-charged, new battery can provide continuous operation for over an hour and can be recharged while in the Compression Module.

A USB port on the Compression Module allows maintenance functions to be performed (outside of emergency use) through a connection to a personal computer.

The RMU-1000 ACC fits in a carry case that holds all the various System elements and accessories, spares (optional) and labeling.

The provided document is a 510(k) Summary for the Defibtech RMU-1000 Automated Chest Compressor (ACC) System. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study to prove device performance in a clinical sense. Therefore, many of the requested items cannot be definitively answered from this document.

Here's an attempt to extract what is available and note what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets. Instead, it broadly states that the device "meets functional and/or performance specifications" and "demonstrates functionally equivalent performance characteristics as the predicate device."

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

This information is not provided in the document. The document refers to "testing" and "performance evaluations" but does not specify the type of test set (e.g., patient data, simulated data), its size, or its provenance.

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

This information is not applicable and not provided. The documentation describes a medical device for automated chest compressions, not an AI or diagnostic device that requires expert-established ground truth from a test set like medical images. The "ground truth" for the performance of this device would be its ability to physically deliver compressions according to established standards.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As noted above, this is not an AI/diagnostic device where adjudication of expert opinions on a test set would be relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement

This is not applicable as the device is an Automated Chest Compressor, not an AI-assisted diagnostic tool that would involve human readers interpreting medical cases. No MRMC study was performed or mentioned.

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

This concept is somewhat applicable but presented differently for an automated mechanical device. The document explicitly states the device is "an automated, portable, battery-powered device that provides chest compressions on adult patients who have cardiac arrest." Its performance is evaluated inherently as a standalone system (when in operation) in terms of its ability to deliver consistent compressions. The performance testing mentioned ("hardware verification, software validation, design validation, and compression waveform comparison") would assess its standalone capabilities.

7. The Type of Ground Truth Used

For a mechanical device like an automated chest compressor, the "ground truth" is typically defined by established resuscitative guidelines (e.g., American Heart Association guidelines for compression depth and rate). The device's performance is measured against these objective, quantifiable standards, not against expert consensus, pathology, or outcomes data in the way a diagnostic tool would be. The document notes that "Compression rate and depth, performed according to current American Heart Association (AHA) and other internationally-recognized resuscitation guidelines, are initiated."

8. The Sample Size for the Training Set

This information is not applicable and not provided. As a mechanical device, there isn't a "training set" in the machine learning sense. The device's design and operation are based on engineering principles and medical guidelines, not data-driven machine learning models.

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

This information is not applicable. As explained above, there is no "training set" for this type of device.

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The DDU-1000 Semiautomatic External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are:

• · Unconscious and unresponsive
• · Not breathing

For patients under 8 years old, or less than 55 pounds (25kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.

The DDU-1000 AED must be used by or on the order of a physician.

The DDU-1000 is a portable, Semiautomatic External Defibrillator (AED) intended for use on victims of sudden cardiac arrest (SCA). It is powered by a user-replaceable nonrechargeable battery pack and supports both adult and pediatric user-replaceable singleuse defibrillation/monitoring pads.

The DDU-1000 employs a Patient Analysis System that ensures proper pad/patient connection and analyzes the patient's ECG rhythm to determine whether a shock is required. If needed, the DDU-1000 provides a 150 J (50J pediatric) impedance compensated, biphasic truncated exponential defibrillation shock to the patient without user intervention. The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as the predicate device.

Voice prompts provide simple instructions for the operator. The DDU-1000 AED is capable of recording event information including electrocardiogram (ECG), audio data and SHOCK/NO SHOCK recommendations.

The provided document, a 510(k) summary for the DDU-1000 Semiautomatic External Defibrillator and Accessories (K131525), focuses on demonstrating substantial equivalence to a predicate device (DDU-2300, K081259) rather than presenting a standalone study with explicit acceptance criteria and detailed performance metrics of the DDU-1000 against those criteria.

The core argument is that the DDU-1000 uses the "same underlying technologies to provide functionally equivalent performance characteristics as the predicate device." Therefore, the "acceptance criteria" for the DDU-1000 implicitly align with meeting the established safety and performance of the predicate device, as confirmed through various tests.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance numbers for the DDU-1000 in a standalone context. Instead, it asserts functional equivalence to a predicate device (DDU-2300, cleared under K081259).

The performance testing listed focuses on demonstrating this equivalence and compliance with general safety and performance standards.

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

The document mentions "Performance testing, including hardware verification, software validation, design validation and defibrillation waveform comparison," but does not specify the sample size for any test set.

Data Provenance: Not explicitly stated, but the focus on equivalence to a previously cleared device (predicate) suggests that the underlying algorithm and waveform performance data would likely originate from the studies supporting the predicate device (K081259). If new data was generated for the DDU-1000, its provenance is not detailed here.

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

This information is not provided in the document. Given the nature of the device (AED) and the assertion that the "cardiac rhythm analysis algorithm... are the same as the predicate device," it's highly probable that ground truth establishment for the algorithm's performance would have been done for the predicate device. However, details are absent for the DDU-1000 submission itself.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The submission focuses on device equivalence and compliance with standards, not on the comparative effectiveness of human readers with or without AI assistance for this specific device. AEDs are designed for automated analysis and shock delivery, reducing the human interpretation component compared to diagnostic imaging AI.

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

The document states, "The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as the predicate device." It also mentions compliance with "the American Heart Association's Automatic External Defibrillators for Public Access Defibrillation: Recommendation for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms and Enhancing Safety."

This strongly implies that standalone algorithm performance testing (likely without human-in-the-loop) was performed to ensure the rhythm analysis algorithm meets established standards. However, specific details of this testing (e.g., dataset size, metrics) are not presented in this 510(k) summary for the DDU-1000, relying instead on its identity with the predicate's algorithm.

7. The Type of Ground Truth Used

Based on the nature of a cardiac rhythm analysis algorithm, the ground truth would typically be established by expert consensus of cardiologists or electrophysiologists reviewing ECG recordings, potentially alongside clinical outcomes if such data was integrated. However, the document does not explicitly state the type of ground truth used for this specific submission, only that the algorithm is the same as the predicate.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size for any training set. As the algorithm is stated to be the same as the predicate, any training would have occurred during the development of the predicate device (DDU-2300, K081259).

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

The document does not provide information on how the ground truth for the training set (if any, related to the original algorithm development) was established for this submission. This would likely have been detailed in the predicate device's submission.

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The DDU-120 AED is indicated for use on victims of sudden cardiac arrest ("SCA") when the patient is:

• Unconscious and unresponsive.
• Not breathing.
  For patients under 8 years old, use child/infant electrode pads. Do not delay therapy to determine exact age.
  The DDU-120 AED must be used by or on the order of a physician.

The DDU-120 is a portable, Automated External Defibrillator (AED) intended for use on victims of sudden cardiac arrest (SCA). It is powered by a user-replaceable nonrechargeable battery and supports both adult and pediatric user-replaceable single-use defibrillation/monitoring pads.
The DDU-120 employs a Patient Analysis System that ensures proper pad/patient connection and analyzes the patient's ECG rhythm to determine whether a shock is required. If needed, the DDU-120 delivers a 150 J (50J pediatric) impedance compensated, biphasic truncated exponential defibrillation shock to the patient without user intervention. The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as previous Defibtech AEDs.
Voice prompts provide simple instructions for the operator. The DDU-120 AED is capable of recording event information including ECG, audio data and SHOCK NO SHOCK recommendations.

Here's a breakdown of the acceptance criteria and study information for the DDU-120 Fully-Automatic External Defibrillator, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria or detailed reported device performance values for the DDU-120. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria (Implied):

• Functional Equivalence: The DDU-120 must provide functionally equivalent performance characteristics to the predicate device (DDU-100).
• Safety Standards: The DDU-120 must comply with applicable industry safety standards.
• No New Issues: The DDU-120 must not present new issues of safety or effectiveness compared to the predicate.
• Patient Analysis System: The Patient Analysis System must properly ensure pad/patient connection and accurately analyze the patient's ECG rhythm to determine if a shock is required.
• Defibrillation Delivery: If needed, the device must deliver a 150 J (adult) / 50 J (pediatric) impedance-compensated, biphasic truncated exponential defibrillation shock.
• Algorithm and Waveform: The cardiac rhythm analysis algorithm and defibrillation energy/waveform must be the same as previous Defibtech AEDs.

Reported Device Performance:
The document states:

• "Testing demonstrates that the DDU-120 meets functional and performance specifications."
• "Safety testing assures compliance with applicable industry safety standards."
• "The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as previous Defibtech AEDs."
• "The DDU-120 AED design characteristics are the same as those of the predicate device. Both devices employ the same underlying scientific technology for patient analysis and defibrillation therapy."

Since no specific quantitative performance metrics are provided (e.g., sensitivity, specificity, shock success rates), a table with numerical values cannot be created from this text. The core of the acceptance is based on demonstrating equivalence, not on hitting specific new, quantified performance targets.

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

The document does not specify a sample size for a "test set" in the context of algorithm performance or clinical trials. The performance testing mentioned is general and appears to be bench/functional testing rather than a separate clinical validation dataset for the algorithm. The data provenance is also not mentioned.

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

This information is not provided in the document. The submission focuses on substantial equivalence based on technical aspects and safety standards, rather than a de novo clinical ground truth establishment study.

4. Adjudication Method for the Test Set

Since no specific test set or expert ground truth establishment is described, the adjudication method is not applicable/not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is not mentioned in the document. The device is an Automated External Defibrillator (AED), which automates the analysis and shock delivery, rather than acting as an AI assistant for human readers/operators in a diagnostic context.

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

The device is a standalone device in the context of its primary function: it employs a "Patient Analysis System" that "analyzes the patient's ECG rhythm to determine whether a shock is required" and "delivers a 150 J (50J pediatric) impedance compensated, biphasic truncated exponential defibrillation shock to the patient without user intervention."

The document states, "The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as previous Defibtech AEDs." This implies the algorithm's standalone performance was established previously or is considered equivalent to existing cleared algorithms. No new standalone study specific to the DDU-120's algorithm performance is detailed here beyond its functional equivalence to the predicate.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used for validating the cardiac rhythm analysis algorithm. It only mentions that the algorithm is the "same as previous Defibtech AEDs," suggesting that its validation was performed for prior submissions. For AED algorithms, ground truth typically involves expert-labeled ECG rhythms (e.g., shockable vs. non-shockable), sometimes correlated with patient outcomes in clinical studies, but this specific information is absent from this submission.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. Given that the algorithm is stated to be the "same as previous Defibtech AEDs," any training would have occurred during the development of those previous devices.

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

This information is not provided in the document. As with the training set size, this would relate to the development of the existing algorithm from previous devices.

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The DDU-2400/2450 Semiautomatic External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are:

• . Unconscious and unresponsive
• . Not breathing
  For patients under 8 years old, or less than 55 (25kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.
  The DDU-2400/2450 AED must be used by or on the order of a physician.

The DDU-2400/2450 is a portable, Automated External Defibrillator (AED) intended for use on victims of sudden cardiac arrest (SCA). It is powered by a user-replaceable nonrechargeable battery and supports both adult and pediatric user-replaceable single-use defibrillation/monitoring pads.
The default mode of operation for the DDU-2400/2450 AED is Semiautomatic External Defibrillator (AED mode). In AED mode, after applying the defibrillation pads to the patient's chest, the AED automatically analyzes the patient's electrocardiogram (ECG) and, if needed, advises the operator to push the button and deliver a shock. The AED guides the operator through the rescue protocol using a combination of voice and text prompts, audible alerts, and visible indicators. The LCD display shows instructional videos and text prompts.
The DDU-2400/2450 provides some optional features for the advanced user. When used in AED mode, the user can set the LCD display to show the patient's ECG trace. These models also provide a non-diagnostic ECG monitoring mode to allow for rhythm and heart rate monitoring using an optional 3-wire monitoring pads adaptor with standard ECG electrodes.
The DDU-2400 (only) supports a Manual override mode. Manual mode permits the user to override the AED features of the defibrillator. Manual mode is intended for use by personnel trained in ECG recognition who want to use the defibrillator to deliver a shock independent of AED mode. Manual mode provides a display of the patient's ECG trace. operator-selected energy level along with charge, shock, and disarm functions.
The DDU-2400/2450 has a compact design and offers an easy-to-understand user interface with an LCD display. Voice prompts and a graphical user interface provide simple instructions for the operator. The DDU-2400/2450 AED is capable of recording event information including ECG, audio data and SHOCK/NO SHOCK recommendations.

The provided text describes a 510(k) summary for a Semiautomatic External Defibrillator (AED) and focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving performance against those criteria in the way a de novo or PMA submission might.

Therefore, many of the requested categories for acceptance criteria and study details cannot be fully populated from this document. The submission relies on the concept of "substantial equivalence" to cleared devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not explicitly provided in the document. The submission states that "Testing demonstrates that the DDU-2400/2450 meets functional and performance specifications, and safety testing assures compliance with applicable industry safety standards." However, it does not detail the nature of this testing (e.g., specific clinical studies, bench testing, etc.), sample sizes used for performance validation, or data provenance.

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

This information is not explicitly provided. Given that the submission relies on substantial equivalence and does not detail a new clinical efficacy study with a ground truth established by experts, this is expected.

4. Adjudication Method for the Test Set

This information is not explicitly 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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not done or described in this document. This device is an Automated External Defibrillator (AED), which functions largely autonomously in its primary AED mode, advising the operator on shock delivery. While it has an optional ECG display for advanced users and a manual override, the core of the submission for substantial equivalence is not based on a human-AI interaction study of this nature.

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

Yes, implicitly. The cardiac rhythm analysis algorithm is a standalone component of the AED. The document states that the DDU-2400/2450 uses "the same cardiac rhythm analysis algorithm" as the predicate device (DDU-2300 AED, K081259). This implies that the standalone performance of this algorithm, assessed during the clearance of the predicate device, is considered sufficient for this submission. However, specific details of those standalone performance tests (e.g., sensitivity, specificity for shockable rhythms, dataset used) are not provided in this current document.

7. The Type of Ground Truth Used

The type of ground truth used for the original cardiac rhythm analysis algorithm (from the predicate DDU-2300) would typically involve expert-annotated ECG recordings, which is a form of expert consensus and/or reference standard based on clinical outcomes for shockable vs. non-shockable rhythms. This document does not provide details specific to the DDU-2400/2450 validation, but rather leverages the ground truth established for the predicate device's algorithm.

8. The Sample Size for the Training Set

This information is not provided. This document relies on the prior clearance of the algorithm within the predicate device.

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

This information is not provided. This document relies on the prior clearance of the algorithm within the predicate device.

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The DDU-2300 Semiautomatic External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are:

• · Unconscious and unresponsive
• · Not breathing

For patients under 8 years old, or less than 55 pounds (25 kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.

The DDU-2300 AED must be used by or on the order of a physician.

The DDU-2300 is a portable, Automated External Defibrillator (AED) intended for use on victims of sudden cardiac arrest (SCA). It is powered by a user-replaceable nonrechargeable battery and supports both adult and pediatric user-replaceable single-use defibrillation/monitoring pads.

The DDU-2300 employs a Patient Analysis System that ensures proper pad/patient connection and analyzes the patient's ECG rhythm to determine whether a shock is required. If needed the DDU-2300 provides a 150 J (50J pediatric) impedance compensated, biphasic truncated exponential defibrillation shock to the patient. The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as previous Defibtech AEDs.

The DDU-2300 has a compact design and offers an improved user interface with an LCD display. Voice prompts and a graphical user interface provide simple instructions for the operator. The DDU-2300 AED is capable of recording event information including ECG, audio data and SHOCK/NO SHOCK recommendations.

The provided text describes a 510(k) summary for the Defibtech DDU-2300 Semiautomatic External Defibrillator (AED). However, it does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and the study that proves the device meets them.

The document states that "Testing demonstrates that the DDU-2300 meets functional and performance specifications" and refers to "Safety testing assur[ing] compliance with applicable industry safety standards" and "performance evaluations demonstrate that the Defibtech DDU-2300 AED is substantially equivalent to the predicate device." However, it does not provide specific acceptance criteria values, reported performance metrics, or details about the studies conducted (sample size, data provenance, ground truth, experts, adjudication, or standalone performance).

The primary focus of this 510(k) summary is to demonstrate substantial equivalence to a predicate device based on similar technology and intended use, rather than presenting a detailed performance study with specific acceptance criteria.

Therefore, for most of your requested points, the answer is "Information not provided in the document."

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the 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)

• Sample Size for Test Set: Information not provided.
• Data Provenance: Information not provided.

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)

• Information not provided. The document does not describe the specific ground truth establishment process or the involvement of experts for any test sets.

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

• Information not 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

• Information not provided. The document highlights the automated nature of the device's analysis system (Patient Analysis System that ensures proper pad/patient connection and analyzes the patient's ECG rhythm to determine whether a shock is required) but does not mention any MRMC studies involving human readers or AI assistance.

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

• The device is an "Automated External Defibrillator (AED)" and employs a "Patient Analysis System" and "cardiac rhythm analysis algorithm." While the document states that the "cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as previous Defibtech AEDs" and that the DDU-2300 "replaces the LED/text display with an LCD display," it does not provide details or results of a standalone performance study. It only asserts that the DDU-2300 "uses similar technologies to provide functionally equivalent performance characteristics as the predicate device" and "Testing demonstrates that the DDU-2300 meets functional and performance specifications."

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

• Information not provided.

8. The sample size for the training set

• Information not provided.

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

• Information not provided.

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The Attenuated Defibrillation/Monitoring Pads are to be used with Defibtech Series AEDs on victims of sudden cardiac arrest ("SCA") when the patient is:

• Unconscious and unresponsive
• Not breathing
• Less than eight years old
  Defibtech Attenuated Defibrillation/Monitoring Pads must be used by or on the order of a physician.
  Do not delay therapy to determine exact age or weight.

Defibtech Attenuated Defibrillation/Monitoring Pads are intended for use only with Defibtech DDU-100 Series AEDs or compatible Defibtech AEDs, on patients who are less than eight years of age.
Attenuated Defibrillation/Monitoring Pads are indicated for use on victims of sudden cardiac arrest (SCA) when the patient is:

• Unconscious and unresponsive -
• ・ Not breathing
• -Less than eight years old
  A pulse check is not required based on the recommendations of the American Heart Association Guidelines 2000 for CPR and ECC.
  Attenuated Defibrillation/Monitoring Pads consist of two self-adhesive defibrillation/ monitoring pads used to monitor ECG signals and, if necessary, to deliver defibrillation energy to the patient. Attenuated Defibrillation/Monitoring Pads incorporate an energy attenuator, which cuts the nominal defibrillation energy of a Defibtech Series AED (150 Joules) to 50 Joules. They are provided as a packaged, single-use disposable assembly.
  The impedance between the two pads is monitored to ensure proper pad-to-patient contact. Visual and audio prompts inform the operator of possible problems with patient contact. Voice prompts and visual indicators communicate the status of the AED and of the patient to the operator.
  Defibrillation energy is delivered as a biphasic truncated exponential waveform. The device delivers 150 Joules into a 50-ohm load. The pads incorporate an attenuator that decreases the energy delivered to the patient to 50 Joules. Delivered energy does not change significantly with patient impedance, although the duration of the generated waveform will vary. The Defibtech Series AED is designed to deliver up to 50J of defibrillation energy through a pediatric patient impedance range of 25 - 175 ohms.

This appears to be a 510(k) summary for the Defibtech AED with Attenuated Defibrillation/Monitoring Pads (Model DDU-100 with DDP-200P), intended for pediatric use.

Based on the provided text, there is no detailed study described that establishes specific acceptance criteria and then proves the device meets those criteria with statistical data. Instead, the document makes a general statement about safety and effectiveness.

Here's a breakdown of the requested information based on the provided text, with notes on what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document focuses on demonstrating substantial equivalence to a predicate device (Heartstream Attenuated Defibrillation Pads, K003819) rather than presenting a standalone clinical study with predefined acceptance criteria and performance outcomes. The "Conclusion Summary of Safety and Effectiveness" explicitly states this.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The document does not describe a clinical test set or its origin. It refers to "testing and performance evaluations," which could mean bench testing, animal studies, or internal verification, but no details are given.

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

• Not applicable as no clinical study with ground truth establishment is described.

4. Adjudication Method

• Not applicable as no clinical study requiring adjudication is described.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the provided text.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study is not described. The device is a physical medical device (defibrillator pads) that works in conjunction with an AED. Performance evaluations mentioned are likely related to its physical and electrical characteristics.

7. Type of Ground Truth Used

• Not applicable as no clinical study with ground truth is described. The assessment is based on "substantial equivalence" to a predicate device, implying that the predicate's established safety and effectiveness serve as a benchmark.

8. Sample Size for the Training Set

• Not applicable as no machine learning algorithm development (which would involve a training set) is described.

9. How Ground Truth for the Training Set was Established

• Not applicable as no training set or machine learning algorithm is described.

Summary of the Document's Approach:

The provided 510(k) summary primarily asserts substantial equivalence to a legally marketed predicate device (Heartstream Attenuated Defibrillation Pads, K003819). It states that "Testing and performance evaluations demonstrate that the safety and effectiveness" are equivalent. This type of submission often relies on a combination of:

• Bench testing: To confirm electrical characteristics, energy attenuation, impedance ranges, etc.
• Design specifications: Highlighting how the device's design meets the intended function (e.g., delivering 50J into a specific impedance range).
• Comparison to predicate device's established performance: Assuming the predicate device is safe and effective, the new device needs to demonstrate it functions similarly for the same indications.

It does not present a detailed clinical trial with specific acceptance criteria, statistical performance metrics, or a described ground truth methodology.

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FOR USE WITH DEFIBTECH ELECTRODES FOR AUTOMATIC AND MANUAL EXTERNAL DEFIBRILLATORS FOR MONITORING, PACING AND DEFIBRILLATION UP TO 360 JOULES.

The Defibtech Electrode Adapter provides an interface between Defibtech electrodes and various automatic and manual external defibrillators. Each adapter is reusable and is either a stand-alone accessory or can be preattached to a Defibtech electrode package.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with performance metrics in the format requested. The document is a 510(k) summary for the Defibtech Electrode Adapter, focusing on establishing substantial equivalence to a predicate device.

However, based on the limited information available, I can extract and infer the following:

Device: Defibtech Electrode Adapter (Model DAC-300 Series)

Intended Use: For use with Defibtech electrodes to monitor, pace, and defibrillate (up to 360 Joules) with automatic and manual defibrillators.

Overall Conclusion: "Testing and performance evaluations demonstrate that the safety and effectiveness of the Defibtech Electrode Adapter is substantially equivalent to the predicate devices." This implies that the device met the implicit acceptance criteria based on its equivalence to the predicate device.

Here's an attempt to structure the answer based on the provided text, with significant limitations due to the lack of explicit details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds). The primary "acceptance criterion" described is substantial equivalence to the predicate device. The performance is reported implicitly as meeting this equivalence.

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

The document does not provide details on the sample size used for any specific test set, nor does it mention data provenance (e.g., country of origin, retrospective/prospective). The statement refers generally to "testing and performance evaluations," suggesting various tests were conducted, but specifics are absent.

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

The document does not mention the use of experts or how ground truth was established for any test set. This type of information is typically associated with clinical studies involving human interpretation or pathology, which are not described here.

4. Adjudication method for the test set

No information is provided regarding adjudication methods.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging AI algorithms, and the Defibtech Electrode Adapter is a hardware accessory, not an AI diagnostic tool. Therefore, human reader improvement with/without AI assistance is not applicable in this context.

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

This question is not directly applicable. The device is an "Electrode Adapter," an interface between electrodes and defibrillators. It is not an algorithm that performs standalone analysis or diagnosis. The "performance evaluations" would likely focus on electrical parameters, safety, durability, and functionality when connected to other devices, rather than algorithmic performance in a diagnostic sense.

7. The type of ground truth used

The concept of "ground truth" (expert consensus, pathology, outcomes data) is not explicitly discussed in the context of specific performance measurements for the electrode adapter. Given the device's function, ground truth would likely relate to objective measurements of electrical conductivity, energy delivery accuracy, signal integrity for monitoring, and safety standards compliance.

8. The sample size for the training set

The document does not mention a "training set." This term is typically used in the context of machine learning or AI algorithm development. The Defibtech Electrode Adapter is a hardware accessory, not an AI system that requires a training set.

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

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

Summary of Limitations:

The provided document (a 510(k) summary) is primarily focused on demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not include detailed technical performance study reports with explicit acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies that would be typical for a comprehensive description of algorithmic or diagnostic device performance. The "performance evaluations" are broadly stated as demonstrating safety and effectiveness equivalent to the predicate.

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The Sentry AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is:

• Unconscious and unresponsive .
• Not breathing ●
• At least eight vears old .
  The Sentry AED must be used by or on the order of a physician.

The DDP-100 defibrillation pads are used in conjunction with the Defibtech Sentry semiautomatic external defibrillator and act as a conductive interface between the Sentry and the patient's skin. The disposable electrodes are non-sterile and for single patient use only. The pads are intended for external defibrillation and ECG monitoring in combination with a Defibtech defibrillator.

The Sentry is a semiautomatic external defibrillator (AED) designed to be portable and battery powered. It has only two user controls: the ON/OFF and SHOCK buttons. Voice prompts and visual indicators provide a simple interface for the operator. The Sentry AED is capable of recording event information including ECG, audio data (optional) and SHOCK/NO SHOCK recommendations.

When connected to a patient who is unconscious and not breathing the Sentry AED performs the following tasks:

• . Prompts the operator to take necessary actions to enable analysis
• Automatically analyzes the patient's ECG ●
• Determines whether a shockable rhythm is present ●
• Charges the defibrillation capacitor if the rhythm is shockable .
• . Arms the SHOCK button and prompts the operator to press the SHOCK button when the device is ready and a shock is recommended
• Delivers a shock if the user presses the SHOCK button and the device has . determined that a shock is required

The Sentry AED will NOT shock a patient automatically; it will only advise the operator. The SHOCK button is only enabled when a shockable rhythm is detected and the device is charged and ready to shock. Charging occurs automatically when the device detects a shockable rhythm. The operator must press the SHOCK button to initiate deffbrillation.

The Sentry AED uses two non-sterile self-adhesive defibrillation/monitoring pads to monitor ECG signals and, if necessary, to deliver defibrillation energy to the patient. These pads (also known as electrodes) are provided as a single patient use, packaged, disposable assembly.

The Sentry AED determines proper pad-to-patient contact by monitoring the impedance between the two pads. Visual and audio prompts inform the operator of possible problems with patient contact. Voice prompts and visual indicators communicate the status of the AED and of the patient to the operator. The Sentry AED has two pushbutton controls and several LED indicators.

Defibrillation energy is delivered as a biphasic truncated exponential waveform. The device delivers 150 Joules into a 50-ohm load. Energy delivered does not change significantly with patient impedance. although the duration of the generated waveform will vary. The Defibtech AED is designed to deliver up to 150J of defibrillation energy through a patient impedance range of 25 - 150 ohms.

Defibrillation and AED operating power is supplied by a replaceable (non-rechargeable) Lithium/Manganese Dioxide Battery Pack. Battery Packs are available in several configurations that are optimized for use in specific applications. Each Pack is marked with an expiration date.

The Sentry AED records event documentation internally and optionally, on Defibtech Data Cards (DDC). The optional DDC enables the AED to record event documentation. and audio, if enabled. Audio recording is available only for units with Defibtech Data Cards installed. Event documentation stored internally can be downloaded onto a DDC for review.

The provided text describes a 510(k) summary for the Defibtech Sentry Semiautomatic External Defibrillator (AED) and its associated defibrillation pads. It details the device description, intended use, and a conclusion summary of safety and effectiveness, including references to performance testing.

However, the provided document does not contain the specific acceptance criteria, reported device performance in a tabular format, or detailed information about a study proving the device meets acceptance criteria. It states that "Performance testing was performed in accordance with established industry standards (ANSI/AAMI DF39 -Automatic external defibrillators and remote-control defibrifikators: 1993) and recommendations (American Heart Association - Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms and Enhancing Safety: October 1996)."

Therefore, I cannot provide the requested information with the level of detail specified in your prompt from the provided text.

Here's what I can extract or infer based on the provided text, while also explicitly stating what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing. The document explicitly refers to established industry standards and recommendations (ANSI/AAMI DF39 and AHA recommendations for arrhythmia analysis algorithm performance) for performance testing. However, it does not detail the specific acceptance criteria derived from these standards or the quantitative reported performance of the Defibtech Sentry against these criteria in a table.

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

Missing. The document states "Performance testing was performed," but does not provide any details regarding the sample size of the test set, the type of data used (e.g., retrospective ECG databases, prospective patient data), or the country of origin of the data.

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

Missing. The document mentions "arrhythmia analysis algorithm performance" but does not describe how the ground truth for evaluating this algorithm was established – specifically, it doesn't mention the number or qualifications of experts involved in creating a reference standard for the test set.

4. Adjudication Method for the Test Set:

Missing. No information is provided regarding the adjudication method used to establish the ground truth for the test set (e.g., 2+1, 3+1 consensus, or other methods).

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

Missing. The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The Sentry AED is a device that advises the operator to shock, but does not provide assistance in interpreting ECGs for human readers in a way that would suggest an MRMC study.

6. Standalone (Algorithm Only) Performance:

Yes, implicitly. The document states, "Automatically analyzes the patient's ECG" and "Determines whether a shockable rhythm is present." This describes the core function of the algorithm operating in a standalone capacity (i.e., without human intervention in the analysis itself, only in the shock delivery). While specific performance metrics (e.g., sensitivity, specificity for shockable rhythms) are not reported, the statement that performance testing was done according to AHA recommendations for "Arrhythmia Analysis Algorithm Performance" strongly implies that the standalone performance of the algorithm was evaluated.

7. Type of Ground Truth Used:

Implicitly expert consensus or a gold standard derived from expert interpretation. Given the reference to "Arrhythmia Analysis Algorithm Performance" and the nature of AEDs, the ground truth for the algorithm's performance would typically involve a set of ECGs where the presence or absence of a shockable rhythm has been definitively classified by a panel of cardiologists or other experts, or by established criteria. However, the document does not explicitly state how the ground truth was established.

8. Sample Size for the Training Set:

Missing. The document does not provide any information about the training set used for the Sentry AED's algorithm, including its sample size.

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

Missing. Similar to the test set, the document does not describe how the ground truth for any potential training set was established.

Summary of what can be gleaned and what is missing:

The 510(k) summary focuses on the design and function of the AED, its intended use, and its substantial equivalence to predicate devices based on compliance with general industry standards. It lacks the detailed study methodology and explicit performance data that would be required to answer your questions thoroughly. The FDA letter confirms the device's substantial equivalence but does not elaborate on the specific performance study results.

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