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These devices are fracture fixation devices comprised of femoral and tibial nails and the related accessories such as locking screws, compression screws, end caps, condyle screws, and a condyle screw nut. The S2 tibial nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The S2 femoral nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the femur.

S2 Tibial Nail: The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunions 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.

S2 Femoral Nail: The S2 Femoral Nail is indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures and tumor resections, Supracondylar fractures, including those with intra-articular extension, Ipsilateral femur fractures, Fractures proximal to a total knee arthroplasty, Fractures distal to a hip joint, Nonunions and malunions.

This Traditional 510(k) submission is being supplied to the US FDA to include targeter devices as accessories to the S2 Nail System that was cleared under K032579.

Here's a breakdown of the acceptance criteria and study information for the S2 Nail System, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Test set: Not explicitly stated as a numerical sample size. The text mentions a "human cadaveric lab." For the bench testing, no sample size is provided.
   • Data provenance: Not specified beyond "human cadaveric lab." No country of origin is mentioned, and the nature of the cadaveric lab (retrospective or prospective) isn't detailed.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of experts: Not explicitly stated. The testing was conducted in a "human cadaveric lab," which implies involvement of individuals with surgical or anatomical expertise, but their exact number and qualifications are not provided.
   • Qualifications of experts: Not explicitly stated.

3. Adjudication method for the test set:

   • Not applicable as the testing described is primarily observational (cadaveric lab, bench testing) rather than involving subjective interpretation requiring adjudication.

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:

   • No MRMC comparative effectiveness study was done. This device is a medical implant, not an AI diagnostic tool, so such a study would not be relevant.

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

   • No standalone algorithm-only performance study was done. This device is a physical implant, not a software algorithm.

6. The type of ground truth used:

   • For the cadaveric lab, the "ground truth" was the successful, complication-free implantation of the device as assessed by the operators.
   • For the mechanical tests, the "ground truth" was adherence to engineering performance standards demonstrating that modifications did not worsen performance.

7. The sample size for the training set:

   • Not applicable. This submission is for a physical medical device (intramedullary nail system), not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable. No training set for an AI algorithm was used.

Summary of the Study:

The provided document describes non-clinical testing performed for the S2 Nail System to support its substantial equivalence to predicate devices. This testing did not involve clinical trials or studies related to AI or diagnostic performance. Instead, it focused on:

• Cadaveric Study: Implantation of the S2 nails (with targeters) into human cadavers to ensure the devices could be used as intended without complications. This served as a practical demonstration of functionality.
• Mechanical/Bench Testing: Evaluation of modifications made to the existing nail adapter to ensure these changes did not negatively impact the product's performance or introduce new risks.

The conclusion drawn from these tests was that the S2 Nail System, including the new targeter devices, is substantially equivalent to the predicate devices and performs as intended. Clinical testing was explicitly stated as "not required for this submission."

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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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