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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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