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The Basic Fragment Set is intended for use in long bone fracture fixation.

Reconstruction plates, wide and narrow straight and waisted compression-plates are indicated for fixation of long bone fractures including but not limited to:

• Fractures of the femur .
• Fractures of the tibia .
• Fractures of the humerus .
• Fractures of the pelvis .

T-Plates, T-buttress Plates and L-buttress-Plates are indicated for fractures at the proximal or distal end of long bones including but not limited to:

• Fractures of the femoral condyles .
• Fractures of the tibial plateau .
• Fractures of the distal tibia .
• Fractures of the proximal-humerus ●

The Basic Fragment Set is part of the Stryker Plating System. The Basic Fragment Set is consists of plates and screws for the fixation of fractures of the cortical and metaphyseal area of long bones as well as fractures of the pelvis. The implant set is available either in stainless steel (316L) or titanium alloy (Ti6Al4V).

This document is a 510(k) summary for the Stryker Plating System Basic Fragment Set, submitted to the FDA in 2001. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided text.

Here is a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

   • Not Applicable. The document is a 510(k) summary demonstrating substantial equivalence, not a performance study with defined acceptance criteria and reported device performance metrics in the way these terms are typically used for diagnostic or AI devices. The substantial equivalence is based on similarities in intended use, materials, and design to other currently marketed plating systems.

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. No test set or data provenance is mentioned as this is not a clinical performance study. The substantial equivalence analysis does not involve a "test set" in this context.

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 establishment by experts is not relevant to this 510(k) submission, which focuses on substantial equivalence based on design and materials.

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

   • Not Applicable. No test set or adjudication method is described.

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 is a hardware device (bone plate system), not an AI or diagnostic device that would undergo an MRMC study.

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

   • Not Applicable. This is a hardware device, so a standalone algorithm performance study is not relevant.

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

   • Not Applicable. Ground truth, in the context of clinical studies for AI or diagnostic devices, is not a concept applied to this type of device submission.

8. The sample size for the training set

   • Not Applicable. There is no "training set" as this is not a device employing machine learning or AI.

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

   • Not Applicable. As no training set exists, ground truth establishment for it is not applicable.

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