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Heartstream Electrode Adapter: For use with Automatic and Manual External Defibrillators and Heartstream Electrodes. For Defibrillation, Monitoring and Pacing.

Heartstream electrode adapters serve as an interface to allow Heartstream electrodes to be connected to various manual and automatic defibrillators for external cardiovascular pacing as well as monitoring and delivery of defibrillation shocks up to 360J.

Heartstream electrode adapters are made of rigid thermoplastic and conductive material (or equivalent), with varying configurations depending upon the defibrillator for which they are designed. The adapters will be provided as reusable stand-alone accessories to be used in conjunction with standard Heartstream electrodes.

The provided text describes the Heartstream Electrode Adapter and its submission for 510(k) clearance. However, it does not contain detailed acceptance criteria, specific study results, or the other requested information regarding device performance, sample sizes, ground truth establishment, or expert involvement in a manner that allows for a direct answer to your detailed questions.

The document primarily focuses on:

• Description of the device and its intended use: To allow Heartstream electrodes to connect to various manual and automatic defibrillators for external cardiovascular pacing, monitoring, and delivery of defibrillation shocks.
• Technological characteristics and compliance with standards: Mentioning IEC 601-1, IEC 601-2-4, IEC 601-2-25, and ANSI/AAMI DF39-1993.
• Summary of Substantial Equivalence: Comparing it to a predicate device, stating similar form, fit, function, technology, and compliance with standards.
• Conclusion: The new adapter does not raise new safety or effectiveness concerns.
• FDA Clearance Letter: Granting 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, or training set information because these details are not present in the provided text.

The only relevant information that can be extracted regarding "acceptance criteria" and "study" is:

• Acceptance Criteria (Implied): Compliance with the voluntary standards:

  • IEC 601-1, Medical electrical equipment, Part 1: General requirements for safety, 1993
  • IEC 601-2-4, Medical electrical equipment, Part 2: Particular Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator/Monitors, 1993
  • IEC 601-2-25, Medical electrical equipment, Part 2: Particular requirements for the safety of electrocardiographs
  • ANSI/AAMI DF39-1993, Automatic external defibrillators and remote-control defibrillators, September 16, 1993

• Study/Testing (Implied): "Testing per these standards demonstrated that the Heartstream electrodes effectively deliver defibrillation energy up to 360J, allow for external transcutaneous cardiac pacing, demonstrate mechanical and electrical compatibility with manual and automatic defibrillators, and minimize safety risks to the user and patient."

No specific quantitative acceptance criteria (e.g., specific thresholds for performance metrics) or detailed results from this testing are reported in the document. The focus is on demonstrating compliance with recognized standards and substantial equivalence to a predicate device, rather than detailed performance metrics of a novel algorithm or AI system.

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