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The intended uses of Lifetech Cardio Temporary Pacemaker are

1. to provide temporary single chamber synchronous or asynchronous anti-brady pacing therapy, and
2. to test electrical performance of an implanted lead system, including pacing threshold, sensing sensitivity and impedance.
   Lifetech Cardio Temporary Pacemaker is only intended to be operated
3. in a clinical setting, and
4. by trained professionals.
   Indications for anti-brady pacing therapy may be based on symptomatic bradycardia conditions that:
5. results from an acute and reversible cause and will likely not require permanent pacing, and
6. causes symptoms and/or severe hemodynamic impairment and when permanent cardiac pacing is not immediately indicated or available.
   Examples of specific indications for temporary pacing may include:
   a) Sick sinus syndrome
   b) Sinus bradycardia
   c) Atrial and/or ventricular arrhythmias
   d) Complete atrioventricular block
   e) Asystole
   f) Bradycardia accompanied by congestive heart failure
   g) Patient support, management and evaluation before the implantation of implantable pacemaker
   h) Support during the replacement of implantable pacemaker
   i) Cardiac complications occurring during intervention or surgery
   j) Support after the cardiac surgery
   k) Acute myocardial infarction complicated with cardiac conduction block
   l) High-rate burst pacing for the treatment of supraventricular tachyarrhythmias

The Lifetech Cardio Temporary Pacemaker (hereinafter called "TPM") is a handheld device powered by two common size AA 1.5V Alkaline (LR6) batteries, which is intended for temporary single chamber anti-brady pacing therapy and implanted system analysis. The TPM offers a complete set of pacing and sensing controls and supports either SSI (synchronous) or SOO (asynchronous) pacing modes. Its analysis features enable pacing threshold, sensing sensitivity and impedance measurement.

This document is a 510(k) Premarket Notification from the FDA, focusing on substantial equivalence for a medical device. It does not contain the kind of detailed information about acceptance criteria, study methodologies (like sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, or specific ground truths) that would be present in a clinical performance study report for an AI/ML-based device.

The document discusses a temporary pacemaker and its modifications, primarily focusing on manufacturing specifications, intended use, and comparison to a predicate device. The "Performance Tests" section lists high-level tests like "Analysis Cable test," "Pacing Percentage Statistics test," "Rapid Atrial Pacing function test," and "Software verification and validation." These are engineering/bench tests to verify hardware and software functionalities against design specifications, not clinical performance studies with patient data and ground truth as typically understood for an AI/ML diagnostic or prognostic device.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication, MRMC, standalone performance, ground truth types) because it is not present in the provided text. The document is about a hardware medical device (pacemaker), not an AI/ML algorithm.

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