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The MPC Model 7000 External Temporary Pacemaker System is indicated for temporary (1-10 days typical) ventricular cardiac pacing in a controlled clinical environment.

The MPC Model 7000 External Temporary Pacemaker System is a battery powered, single chamber external pacemaker. It consists of two major components: the MPC Model 3000 Programmer and the MPC Model 1000 Pulse Generator. The System also includes an MPC Model 5003 Patient Arm/Leg Strap used to secure the Pulse Generator to either the patient's arm or leg. An MPC Model 5002 Programmer Holder to store the Programmer on a wall is also available.

The MPC Model 3000 Programmer transmits the pulse programming data selected by the physician for patient therapy to the MPC Model 1000 Pulse Generator by infrared telemetry.

The MPC Model 1000 Pulse Generator and the MPC Model 3000 Programmer are re-usable. The MPC Model 1000 Pulse Generator and the MPC Model 3000 Programmer are designed so that they may be disinfected between patient use. The MPC Model 5003 Patient Arm/Leg Strap is disposable and labeled for single-use only.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": [
      "No new issues of safety when compared to the predicate device (Pace EV 4542 External Pacemaker)",
      "Operate safely and to specification in an environment with potential electromagnetic challenges",
      "Pass radiated emissions test",
      "Pass Drop Test",
      "Pass Ship Test",
      "Software validated and tested",
      "Cleaning and disinfection validated for MPC Model 1000 Pulse Generator and MPC Model 3000 Programmer",
      "MPC Model 5003 Patient Arm/Leg Strap determined to be biocompatible and non-cytotoxic"
    ],
    "Reported Device Performance": [
      "Tests show that differences due to the ergonomic design features do not introduce different safety issues. Extensive qualification and validation conducted. MPC 7000 significantly enhances patient safety considerations.",
      "Extensive Electromagnetic Compatibility (EMC), Electromagnetic Interference (EMI), and Safety testing was conducted. The MPC Model 7000 External Temporary Pacemaker passed these EMC/EMI/Safety and Defibrillation Tests.",
      "The MPC Model 7000 External Temporary Pacemaker System was tested for radiated emissions and passed this test.",
      "The MPC Model 7000 External Temporary Pacemaker System was Drop Tested and passed this test.",
      "The MPC Model 7000 External Temporary Pacemaker System was Ship Tested and passed this test.",
      "The MPC Model 7000 External Temporary Pacemaker System's software has been validated and tested.",
      "Cleaning and disinfection described in the Instructions for Use have been validated for the MPC Model 1000 Pulse Generator and MPC Model 3000 Programmer.",
      "The MPC Model 5003 Patient Arm/Leg Strap has been tested and determined to be biocompatible and non-cytotoxic."
    ]
  },
  "2. Sample sized used for the test set and the data provenance": "Not specified in the provided text. The testing appears to be primarily laboratory-based and engineering validation, not clinical trials with human subjects for the 'test set' in the traditional sense of a diagnostic device. The 'test set' here refers to the device and its components undergoing various engineering validations.",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts": "Not applicable. The study involves engineering and safety testing against established standards and predicate device performance, not expert-derived ground truth for diagnostic accuracy.",
  "4. Adjudication method for the test set": "Not applicable, as the evaluation is based on engineering and safety test results rather than expert adjudication of clinical outcomes or interpretations.",
  "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": "Not applicable. This device is an external temporary pacemaker, not an AI-assisted diagnostic tool. No human reader studies with or without AI assistance are mentioned.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This is a medical device (pacemaker), not an algorithm or AI system for standalone performance evaluation.",
  "7. The type of ground truth used": "Engineering specifications, safety standards, and performance characteristics of the predicate device (Pace Medical, Inc. Model EV 4542 External Pulse Generator). For biocompatibility, standard biological testing methods were used.",
  "8. The sample size for the training set": "Not applicable. This device is an external temporary pacemaker, not an AI system that requires a 'training set'. The 'extensive qualification and validation' likely refers to engineering testing of multiple device units, but this is not a 'training set' in the AI sense.",
  "9. How the ground truth for the training set was established": "Not applicable, as there is no 'training set' for this medical device."
}

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