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Permanent pacing lead, Model Physique™ is indicated for pacing and sensing of the ventricle and/or atrium of the heart. This lead is used in conjunction with a compatible implantable pulse generator (pacemaker).

Permanent Pacing Lead, Model Physique™

The provided text is a 510(k) clearance letter from the FDA for a medical device: a Permanent Pacing Lead, Model Physique™. This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The letter explicitly states that the device is approved based on its substantial equivalence to a legally marketed predicate device. This means that the FDA reviewed existing data and information for similar devices already on the market and determined that the new device is as safe and effective as those already approved.

Therefore, I cannot provide the requested information from this document. The document's purpose is to grant marketing clearance, not to detail the specific studies and acceptance criteria for product development and validation.

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