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Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures.

In addition to the indications for interlocking intramedullary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (periprosthetic fractures).

Indications for the TRIGEN Hindfoot Fusion Nail (HFN) include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations of the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint.

The TRIGEN Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

The TRIGEN InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures.

Knee Fusion Nails are intended for intramedullary knee arthrodesis.

The purpose of this Traditional 510(k) is to add the MR safety information to the labeling and update the information within the package insert for the Smith & Nephew Intramedullary Nail Systems. The Smith & Nephew Intramedullary Nail Systems consist of the following previously cleared devices:

• Trigen Antegrade Tibial/Retrograde Femoral Nailing System (K981529 S.E. . 7/9/1998, K051557 S.E. 6/30/2005 and K061019 S.E. 6/6/2006)
• Trigen Tan/Fan Nailing System (K981529 S.E. 7/9/1998, , K040929 S.E. 5/25/2004, ● and K111025 S.E. 7/1/2011)
• Trigen Hindfoot Fusion Nail System (K043052 S.E. 11/24/2004) .
• . Trigen Humeral Nail System (K032722 S.E. 10/1/2003)
• Trigen Intertan Intertrochanteric Antegrade Nail System (K040212 S.E. 2/20/2004) ●
• . Trigen Knee Fusion Nail System (K050938 S.E. 5/4/2005)
  The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices as a part of this subject 510(k).

The provided text describes a 510(k) premarket notification for Smith & Nephew Intramedullary Nail Systems. The primary purpose of this submission is to add MR safety information to the labeling and update the information within the package insert for existing, previously cleared devices. This means the device itself has not changed in design, material, sterilization, or manufacturing processes. Therefore, the "study that proves the device meets the acceptance criteria" is focused on Magnetic Resonance Imaging (MRI) compatibility testing.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a tabular format with specific performance metrics for the device itself (e.g., fracture healing rates, strength). Instead, the acceptance criteria relate to MRI compatibility, which is assessed against established standards and guidance documents. The "reported device performance" in this context refers to the successful completion of these tests.

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not detail the specific sample size of devices tested for MRI compatibility. The testing information is generic, referring to "MRI compatibility testing was conducted." Given the nature of medical device MR safety testing, it typically involves a representative sample of device configurations (e.g., different sizes, materials, locking mechanisms) rather than a large "dataset" of patient data.

The data provenance is implied to be laboratory testing conducted according to the listed ASTM and IEC standards. There is no mention of patient data (retrospective or prospective) from any specific country of origin, as the submission is about changes to labeling based on technical testing, not clinical performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This question is not applicable to this submission. The "ground truth" for MRI compatibility testing is established by the scientific principles and methodologies outlined in the referenced international standards (ASTM, IEC, ISO/TS) and FDA guidance documents, not by expert consensus on clinical cases. Testing engineers and MR safety specialists would be involved in conducting and interpreting these tests, but they are not "experts establishing ground truth" in the way radiologists might for diagnostic imaging.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human reviewers assess the same case and discrepancies need to be resolved. This submission is about technical testing of device properties, not clinical assessment by human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC comparative effectiveness study involves human readers (e.g., radiologists) assessing cases, often with and without AI assistance, to measure the impact of AI on their performance. This submission does not involve an AI component or the assessment of human reader performance.

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

No. This submission is for physical intramedullary nail systems, not a software algorithm or AI device.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is derived from the established physical and electromagnetic principles and measurement standards for MRI compatibility. The tests measure physical parameters like temperature rise, displacement force, torque, and artifact generation under defined MR conditions, with the standards themselves defining acceptable limits and testing methodologies.

8. The Sample Size for the Training Set:

Not applicable. This submission does not involve a training set as it pertains to physical devices and their MRI compatibility testing, not machine learning algorithms.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set.

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