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Synthes External Fixation Devices are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.

LARGE/HYBRID: Provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures, Poyltrauma/multiple orthopedic trauma, Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures, Arthrodeses and osteotomies with soft tissue problems; failures of total joints, Neutralization of fractures stabilized with limited internal fixation, Non-unions/septics non-unions, Intra-operative reductions/stabilization tool to assist with indirect reduction, Unilateral rectilinear bone segment transport or leg lengthening, Hybrid components are designed for fixation of complex proximal and distal tibia fractures, particularly those involving the joint, when soft tissue injuries preclude open reduction and internal fixation, or the fracture pattern does not allow placement of Schanz screws for construction of a standard external fixation frame.

MEDIUM: Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.

SMALL: Stabilizes and provides treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle. Specifically, the components can be used for: Preliminary fixation before ORIF, Unstable fractures of the distal radius (both intra- and extra-articular), Open and/or comminuted bilateral fractures, Fractures in combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement, Fracture dislocations, Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations), Pediatric open fractures with bone loss and osteotomies.

MINI: Stabilizes and provides treatment for fractures of the hand and foot. Specifically, the components can be used for: Comminuted fractures of phalanges and metacarpals, Displaced intra-articular fractures, Segmental bone loss, Open fractures that do not allow stable internal fixation, Fractures with associated complex soft tissue injuries, Tumor resections.

Synthes Reprocessed External Fixation Devices consist of various clamps, rods, tubes, bars and rings that are used to construct an external fixation frame. These devices are for single use only, and have been returned to Synthes for reprocessing.

This document, a 510(k) summary for Synthes Reprocessed External Fixation Devices, focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not contain information about acceptance criteria or specific studies evaluating device performance against such criteria in the manner requested.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance evaluation, which is not presented here for this type of device.

Here's what can be gathered:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of quantitative clinical performance. The report states "Mechanical testing demonstrates that Synthes Reprocessed External Fixation Devices were shown to be equivalent to the predicate device." This implies the acceptance criterion was likely mechanical equivalence to a predicate device.
• Reported Device Performance: The document states that the reprocessed devices were "shown to be equivalent" to the predicate device based on mechanical testing. No specific performance metrics (e.g., strength, durability thresholds) or numerical results of this mechanical testing are provided in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. The document refers to "mechanical testing" rather than clinical or performance data from human subjects. The sample size for mechanical tests is not specified, nor is the provenance of the data in terms of country or retrospective/prospective nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth for mechanical testing would involve engineering specifications or physical measurements, not expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This is for expert review, not mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is an external fixation device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For "mechanical testing," the ground truth would likely be defined by established engineering standards, material properties, and performance specifications for external fixation devices, as well as the mechanical properties of the predicate device.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this is not an AI/machine learning study.

9. How the ground truth for the training set was established

• Not applicable. There is no mention of a "training set."

In summary, this document is a 510(k) premarket notification for a reprocessed medical device, focusing on mechanical equivalence to a predicate device. It does not provide the type of detailed clinical study information requested, as such studies were likely not performed or required for this type of submission.

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