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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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