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BIOTRONIK's endocardial leads are designed for use with implantable pulse generators that require pacing leads with a bipolar IS-1 connector configuration they may be used with single or dual chamber pacing systems. The leads are designed for use in patients for whom single or dual chamber pasing of pasing therapy is medically indicated. This indication for them single of the Class I definition of the ACC/AHANASPE This Indication This Indication inal recommended in Title Class I demind of the of Cardiac Pacemakers Reports, Aladoa Aloon More 2 2002 Ghuelle Opdate of Inplantabon CordialemyAmadon Mond Anad Anada Arabarhythmia Devices: A Report of the American Colleg CardiologyAmerican Heart Association Task Force on Practice Guidelines (ACCAHANASPE Committee on Pacemaker Implantation)" (Gregoratos et al. 2002).

The straight lead models are intended for placement in either the right atrium or right ventricle. The JBP lead models have a pre-formed distal end to facilitate lead placement in the ight atrial appendage.

BIOTRONIK proposes modifications to the packaging process and containers for bradycardia pacing leads, at BIOTRONIK's manufacturing and sterilization facility (BIOTRONIK GmbH & Co. KG) in Pertin, Germany and contract manufacturing facility (BIOTRONIK AG) in Bülach Switzerland.

The provided document is a 510(k) premarket notification for "Packaging Changes for Endocardial Pacing Leads." This submission is about modifications to the packaging process and containers for existing, previously approved bradycardia pacing leads, not the leads themselves or any associated AI/software-based device.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of device performance, as typically understood for AI/software devices (e.g., accuracy, sensitivity, specificity studies), is not applicable here.

This 510(k) is demonstrating substantial equivalence for a manufacturing/packaging change. The "proof" for this type of submission would typically involve:

• Engineering studies and validation reports showing that the new packaging maintains the safety, sterility, and functional integrity of the leads as established for the predicate devices. This would include tests like:
  • Sterilization validation (if the sterilization method or cycle is affected by packaging changes).
  • Packaging integrity tests (e.g., seal strength, burst testing, dye penetration).
  • Shelf-life studies to ensure sterility and material integrity are maintained over the claimed shelf-life.
  • Biocompatibility assessments (if new packaging materials are introduced that could interact with the device).
  • Transit testing to simulate shipping stresses.

Since the document provided is only the 510(k) summary and the FDA's clearance letter, it does not contain the detailed study reports or acceptance criteria for these packaging validation tests. The FDA's clearance indicates that they reviewed these underlying data and found them acceptable to demonstrate substantial equivalence.

Therefore, I cannot populate the requested table and sections regarding acceptance criteria and performance statistics because the nature of this 510(k) submission does not involve a "device performance study" in the context of typical AI/software or diagnostic devices.

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