(379 days)
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.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.