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The BIOTRONIK Stylets are used in conjunction with the implantable systems (leads and pacemakers or ICD). Therefore, the same indications that apply for the designated active implant and leads, also apply for stylets.

BIOTRONIK stylets are intended for use with long-term implantable BIOTRONIK leads and are used during the implantation procedure of these leads. Stylets predominantly serve to stiffen the flexible lead during implantation in order to facilitate its positioning.

BIOTRONIK stylets consist of metal wires of different stiffness, lengths and shapes that are attached to a small plastic handle on their proximal end to simplify the manipulation of the stylet during lead implantation. The plastic handle carries a color-code that indicates the stylet length and the stiffness. In addition, the wire diameter and the length of the stylet are printed on the handle.

While the supplied text is a 510(k) premarket notification for Biotronik Stylets, it does not contain any information regarding acceptance criteria or a study proving that a device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Abbott stylets) based on:

• Indications for Use: The Biotronik stylets are used in conjunction with implantable systems (leads and pacemakers or ICDs), and therefore, the same indications and contraindications apply.
• Technological Characteristics: A comparison table highlights similarities and differences in stiffness, diameter, and length, concluding that these differences are non-relevant to equivalence.
• Performance Data: It merely states, "Performance was evaluated in the design validation" without providing any specific data, acceptance criteria, or study details.
• Verification and Validation Testing: It mentions that the stylets underwent and passed "validation and verification testing to ensure functionality," but again, no specific details, criteria, or results are provided. It also notes that particulate matter testing was not conducted due to the device not having body or blood contact.

Therefore, for your request, I must report that the provided input does not offer the necessary information to describe acceptance criteria or a study that proves the device meets those criteria. The document is a regulatory filing focused on substantial equivalence rather than a detailed performance study report.

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