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The S2 Tibial Nail System is a fracture fixation device comprised of tibial nails and the related locking screws, compression screws, end caps, condyle screws and a condyle screw nut. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

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 is a fracture fixation device comprised of tibial nails and the related locking screws, compression screws, end caps, condyle screws and a condyle screw nut. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

This Special 510(k) submission is intended to address a line extension to the predicate S2 Tibial Nail System. The line extension involves offering larger diameters of the nail. In addition. Condyle Screws, a Condyle Nut and an additional End Cap will be added to the system. Howmedica Osteonics intends to add the new components to the current product line, thereby offering additional design options for the surgeon. There is no change in intended use for the modified device when compared to the previously cleared device.

The provided text describes a Special 510(k) submission for a line extension to the S2 Tibial Nail System. This document is for a medical device (intramedullary nail) and its purpose is to extend the product line by offering larger diameters and adding new components.

Crucially, the document does not contain details about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the specific information requested in your prompt regarding artificial intelligence (AI) device evaluation.

The text focuses on:

• Submission Information: Sponsor, contact, date, device identification (proprietary name, common name, classification).
• Device Description: The line extension involves larger diameters and additional components (Condyle Screws, Condyle Nut, End Cap).
• Intended Use: Fracture fixation device for tibial nails and related components, providing strong and stable internal fracture fixation.
• Technological Comparison: Stating that the material is identical to the predicate and that FEA analysis and mechanical testing demonstrate comparable mechanical properties. This is the closest the document comes to mentioning any form of "study" or "performance."
• FDA Communication: A letter from the FDA confirming substantial equivalence to a predicate device.
• Indications For Use: Specific types of tibial fractures and conditions for which the device is indicated.

Since the document is about a mechanical orthopedic implant and not an AI-powered device, it does not include the type of information you've asked for within the context of AI device evaluation (e.g., test set, ground truth, MRMC study, standalone performance).

Therefore, I cannot extract the requested information (points 1-9) from the provided text.

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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 orthopedic implant, not an AI diagnostic tool.

6. 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."

7. 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.

8. 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.

9. How the ground truth for the training set was established: Not applicable. See point 8.

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