(27 days)
The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compression locked.
The S2 Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
- . Open and closed tibial fractures
- . Pseudoarthrosis and correction osteotomy
- . Pathologic fractures, impending pathologic fractures, and tumor resections
- . Nonunion and malunion
The subject S2 Tibial Nail System, like the predicate T2™Tibial Nail System, is a fracture fixation device comprised of tibial nails and the related locking screws, compression screws and end caps. The S2 Tibial Locking Nail is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be static, dynamical and compression locked.
The provided text does not contain detailed acceptance criteria and supporting studies for device performance beyond a high-level statement. The document describes a Special 510(k) submission for a design modification of a tibial nail system, focusing on material and design changes and comparing it to a predicate device.
Specifically, the text states:
"FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject S2 Tibial Nail System to the predicate T2™ Tibial Nail System."
This statement indicates that finite element analysis (FEA) and mechanical testing were performed to show that the modified S2 Tibial Nail System has comparable mechanical properties to the predicate T2™ Tibial Nail System. However, it does not provide:
- Specific quantitative acceptance criteria (e.g., minimum bending strength, fatigue life).
- The actual results of the FEA or mechanical testing.
- Details about the study design, sample sizes, or ground truth establishment.
- Information related to expert involvement, adjudication, or comparative effectiveness with human readers.
Therefore, most of the requested information cannot be extracted from the provided text.
Based on the available information:
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A table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Not explicitly stated (implied to be comparable mechanical properties to predicate T2™ Tibial Nail System) FEA analysis and mechanical testing demonstrated comparable mechanical properties to the predicate T2™ Tibial Nail System. -
Sample size used for the test set and the data provenance: Not provided. The studies mentioned are FEA and mechanical testing, which typically involve simulations and physical tests, not patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of study (FEA/mechanical testing of an orthopedic implant) does not involve expert review or ground truth establishment in the way clinical diagnostic AI studies do.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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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 orthopedic implant, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The studies mentioned are FEA (an algorithmic simulation) and mechanical testing (a standalone physical test). The results "demonstrate comparable mechanical properties."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical expert review. For mechanical testing, the "ground truth" would be established by validated test methods (e.g., ISO or ASTM standards) for material properties and device performance.
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The sample size for the training set: Not applicable. FEA and mechanical testing do not typically involve 'training sets' in the machine learning sense. FEA models are built based on material properties and design specifications.
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How the ground truth for the training set was established: Not applicable. See point 8.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.