(331 days)
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.
| Acceptance Criteria (Inferred from Equivalence Claim & Standards) | Reported Device Performance (Summary) |
|---|---|
| Patient Analysis System: Ensure proper pad/patient connection and accurate ECG rhythm analysis for shock determination. | "The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as the predicate device." |
| Defibrillation Therapy: Deliver appropriate impedance-compensated, biphasic truncated exponential shock (150 J adult, 50 J pediatric). | "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." |
| Hardware Verification: | Device meets functional and/or performance specifications. |
| Software Validation: | Device meets functional and/or performance specifications. |
| Design Validation: | Device meets functional and/or performance specifications. |
| Defibrillation Waveform Comparison: | Demonstrates equivalence to predicate device. |
| Safety Compliance (IEC 60601-2-4): Particular requirements for cardiac defibrillators. | Assures compliance with applicable industry safety standards. |
| EMC Compliance (IEC 60601-1-2): General requirements for safety - electromagnetic compatibility. | Assures compliance with applicable industry safety standards. |
| ECG analysis and shock advisory system performance per AHA recommendations: | Assures compliance with applicable industry safety standards ("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"). |
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.
§ 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.