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Code Writer is intended for the collection, storage and display of patient data that is entered by a user (ACLS caregiver) or uploaded from a ZOLL R Series defibrillator/ monitor. Code Writer is intended for use by qualified ACLS caregivers responding to cardiac arrest events in a hospital environment to document the care provided. Code Writer is indicated for use by health care providers whenever there is a need for generation of a record of patient data for cardiac arrest events in a hospital environment. Code Writer should only be used by those whose responsibilities do not include direct delivery of therapy or diagnostic decision making.

The proposed ZQLL Code Writer is a software-only product. The primary goal of Code Writer is to provide a reliable and consistent method for Advanced Cardiac Life Support (ACLS) caregivers to electronically record observations and care interventions during cardiac resuscitation events and allow users to view, edit and integrate that data into their medical record systems. The Code Writer system is comprised of two components, Code Writer and Code Writer Service software. Code Writer is a software application that runs on a Microsoft Windows Smart Phone. Code Writer allows users to log code events in real time; code records can be saved to the mobile device for later viewing and modification. The code record can be transferred to a server computer using the wireless communication capabilities of the mobile device to communicate with the Code Writer Service software which is installed on the server computer. Code Writer Service software enables the uploading of defibrillator data to the code record that is stored in Code Writer.

The provided document is a 510(k) summary for the ZOLL Code Writer, a software-only product intended for the collection, storage, and display of patient data during cardiac resuscitation events. It states that extensive performance testing was conducted to ensure the device performs as well as the predicate device and meets its functional requirements and performance specifications. However, the document does not provide specific details regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.

Therefore, based on the provided text, the device meets the general requirement of performance testing to ensure functional and performance specifications are met, but specific details are not available.

Information not available in the document:

• A table of acceptance criteria and the reported device performance: The document states that "Extensive performance testing ensures that ZOLL Code Writer performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications." However, it does not provide any specific quantitative or qualitative acceptance criteria, nor does it report the device's performance against such criteria.
• Sample size used for the test set and the data provenance: No information is given regarding the sample size used for testing, nor where the data originated (e.g., country of origin, retrospective or prospective).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
• Adjudication method for the test set: Not specified.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not conducted or mentioned, as this is a data collection and display tool, not an AI diagnostic device.
• If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: The device is a "software-only product" for data collection and display, implying its performance is standalone in its intended function. However, no specific metrics for this standalone performance (e.g., data accuracy checks, latency, reliability) are provided.
• The type of ground truth used: Not specified, as no specific performance metrics are provided.
• The sample size for the training set: Not applicable, as this is a data collection and display software, not an AI model that requires a "training set" in the conventional machine learning sense for diagnostic or predictive tasks.
• How the ground truth for the training set was established: Not applicable for the reasons stated above.

General statements regarding performance testing:

• Performance Testing: "Extensive performance testing ensures that ZOLL Code Writer performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications."
• Conclusion: "The information provided in this 510(k) submission demonstrates that the features and functions of the proposed ZOLL Code Writer software product are substantially equivalent to the corresponding features and functions of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness."

Summary of available information regarding the device:

• Device Name: ZOLL Code Writer
• Intended Use: Collection, storage, and display of patient data entered by a user (ACLS caregiver) or uploaded from a ZOLL R Series defibrillator/monitor during cardiac arrest events in a hospital environment. It is not intended for direct delivery of therapy or diagnostic decision-making.
• Description: Software-only product running on a Microsoft Windows Smart Phone, allowing users to log code events in real time. Code records can be transferred wirelessly to a server computer via Code Writer Service software, which also enables uploading defibrillator data.
• Predicate Device: ZOLL RescueNet ePCR (K103473).
• Comparison: Both are software applications on Microsoft Windows mobile devices, intended for collection and storage of user-entered patient data, and can upload data wirelessly from ZOLL defibrillators to a server for review.
• Differences from predicate: The Code Writer is for ACLS caregivers in a hospital environment for cardiac arrest events, while the predicate is for EMS personnel in pre-hospital care.
• New Issues of Safety/Effectiveness: "No new issues of safety or effectiveness are raised by this premarket notification."

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