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Synthes Large Fragment DCL is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation of non-unions or malunions.

The Large Fragment DCL system consists of limited-contact profile plates in broad and narrow sizes, which include combination dynamic compression/locking screw holes. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, and 5.0 mm locking screws. This device is manufactured in either stainless steel or titanium.

Synthes DCL System is a plate and screw system intended to treat fractures of various long bones. The primary feature of this system is limited-contact profile and the combination dynamic compression/locking screw holes. The standard screws facilitate reduction and create compression between the plate and bone, while the locking screws form a locked, fixed angle construct with the plate.

The DCL System includes both broad and narrow straight plates. The broad plates are 5.2 mm thick, 17.5 mm wide and are available in lengths ranging from 121 mm - 409 mm (6 - 22 screw holes). The narrow plates are 4.2 mm thick, 13.5 mm wide and are available in lengths ranging from 49 mm - 409 mm (2 - 22 screw holes). The screw holes are combined to allow placement of standard 4.5 mm cortex, 6.5 mm cancellous and 4.5 mm and 7.0 mm cannulated screws on one side of each hole, or 5.0 mm threaded conical, locking screws on the opposite side. The holes are uniformly spaced along the length of the plate. The holes are oriented so that the compression component of the holes is always directed towards the middle of the plate.

The DCL System utilizes a locking feature that screw to the plate, enabling unicortical or bicortical screw purchase. This feature consists of conical shaped, threaded locking screw holes in the plates that correspond with the conical- shaped, threaded head of the screw.

The 5.0 mm locking screws feature self-tapping tips, flat head profiles with rounded edges, and are available in lengths from 14mm to 90mm. The threads just below the head of each locking screw engages with the threaded side of the holes in the DCL plate. The engagement of these screws to the plate creates a locked, fixed angle construct.

The provided document is a 510(k) premarket notification for a medical device, the Synthes Large Fragment Dynamic Compression Locking (DCL) System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and detailed study results as one might find for novel devices or drugs.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is provided:

• Acceptance Criteria and Reported Performance: The document does not specify quantitative acceptance criteria or a study designed to measure the device's performance against such criteria (e.g., a specific threshold for bone healing rates, reduction in non-union incidence, or mechanical stability in a clinical setting). Instead, it focuses on demonstrating that the device is

  • Identical or similar in intended use: "fixation of various long bones..."
  • Identical or similar in technological characteristics: "limited-contact profile plates... combination dynamic compression/locking screw holes... manufactured in either stainless steel or titanium... utilizes a locking feature that screw to the plate..."
  • Raises no new questions of safety or effectiveness: This is implied by the comparison to predicate devices and adherence to material standards.

• Study That Proves the Device Meets Acceptance Criteria: There is no description of such a study. The 510(k) process relies heavily on:

  1. Comparison to Predicate Devices: The document explicitly lists "Synthes Broad and Narrow Dynamic Compression Plates" and "Synthes Anatomical Locking Plate System" as predicate devices (Page 0, Section Predicate Device). On Page 3, Section 12.0, it states: "A comparison of Synthes' DCL System to Synthes Broad and Narrow Dynamic Compression Plates and Synthes Anatomical Locking Plate System follows." This comparison is the primary "proof" of substantial equivalence.
  2. Material Standards: The device is manufactured from 316L stainless steel, commercially pure titanium, and Titanium - 6% Aluminum - 7% Niobium (Ti-6Al-7Nb), all of which adhere to specific American Society for Testing and Materials (ASTM) standards (F 139, F67, F 1295, respectively) (Page 1, Section 7.0). Adherence to these standards is intended to ensure biocompatibility and mechanical properties similar to already approved devices.
  3. Sterilization Validation: Moist heat sterilization parameters have been validated using AAMI guidelines to provide a sterility assurance level (SAL) of 10^-6 (Page 1, Section 8.0). This addresses a critical safety aspect.

In summary, the provided text describes a regulatory submission (510(k)) that does not include the detailed clinical study information you are asking for. It focuses on demonstrating substantial equivalence to existing devices rather than presenting novel performance data against pre-defined acceptance criteria.

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