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The Periarticular Plates are intended for use in long bone fracture fixation.

The 3.5mm and 4.5mm Periarticular Plate components are intended for use in long bone fracture fixation.

The 3.5mm and 4.5mm proximal tibial Periarticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the tibia. The 4.5mm distal femur Periaticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the femur.

This Special 510(k) submission is intended to address a line extension to the predicate SPS Small Fragment Set and SPS Basic Fragment Set which are both part of the Stryker Plating System. Both the SPS Small Fragment Set and SPS Basic Fragment Set consist of plates and screws for the fixation of fractures of the cortical and metaphyseal areas of long bones as well as fractures of the pelvis. There is no change in intended use for the modified device when compared to the previously cleared devices. The line extension involves offering a new Periarticular Plate version for the fixation of fractures of the cortical and metaphyseal regions of long bones. Howmedica Osteonics intends to add the new components to the current product line, thereby offering additional design options for the surgeon. The Periarticular Plates will be available in stainless steel (316L).

The provided document describes a Special 510(k) Premarket Notification for a line extension to the Stryker Plating System, specifically involving 3.5mm and 4.5mm Periarticular Plates. This submission is for a medical device (bone plates) and not an AI/ML powered medical device. Therefore, many of the typical acceptance criteria and study components related to AI/ML performance (like sample sizes for test and training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable here.

However, I can extract information related to the device's functional equivalence based on the provided text.

Acceptance Criteria and Device Performance

Study Information (as applicable to a physical medical device submission)

1. Sample size used for the test set and the data provenance: Not applicable. This submission is for a physical device, and the "study" primarily consists of engineering analyses (FEA) and comparison to predicate devices, not data from a patient test set in the traditional sense.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical properties is typically established through engineering standards, material testing, and computational modeling, not by expert consensus on clinical data.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 not an AI/ML-powered device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML-powered device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical properties, the "ground truth" would be established by engineering principles, accepted material standards, and results from a validated Finite Element Analysis (FEA) model. The comparison is against the mechanical properties of a predicate device.
7. The sample size for the training set: Not applicable. This involves a physical device and engineering analysis, not a machine learning model.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study (Demonstration of Substantial Equivalence):

The "study" in this context is a demonstration of substantial equivalence to existing legally marketed predicate devices, as required for a 510(k) submission.

• Methodology: The submission relies on Finite Element Analysis (FEA) to compare the mechanical properties of the proposed Periarticular Plates with those of the predicate SPS Basic Fragment Set.
• Basis for Equivalence: Equivalency is based on similarities in:
  • Intended Use: "long bone fracture fixation" remains unchanged from the predicate devices.
  • Materials: Use of 316L stainless steel.
  • Design: Comparison to other currently marketed plating systems, specifically the predicate SPS Basic Fragment Set.
• Conclusion: The FEA analysis "demonstrates the comparable mechanical properties" of the new plates and the predicate, supporting the claim of substantial equivalence. This allows the new components to be added to the product line as a "line extension."

In essence, for this type of medical device submission, the "study" is an engineering validation and comparative analysis to a predicate device, rather than a clinical trial or performance study involving patient data or AI algorithms.

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