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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-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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