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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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The intended use of the I.T.S. IM Nail Systems is to stablilize and fix long bone fractures to facilitate healing in an adult patient and is composed of the following categories:

The I.T.S. CFN - Cannulated Femur Nail System is indicated for use in long bone femur fracture fixation which include:

Open and closed femur shaft fractures; Intertrochanteric, supracondylar and ipsilateral fractures; High subtrochanteric fractures; Combined inter and subrochanteric fractures; Pertrochanteric fractures; Pseudoarthrosis and correction osteotomy; Non-union, malunion and delayed union fractures; Pathological fractures, impending pathologic fractures, and tumor resections and; Fractures proximal to a total knee arthroplasty; The system is not for spinal use.

The I.T.S. CTN - Cannulated Tibia Nail System is indicated for use in long bone tibia fracture fixation which include:

Proximal, metaphyseal, epiphyseal and distal shaft fractures; Segmental, simple, compound and comminuted fractures; Transverse, oblique and spiral fractures; Surgically created defects using osteotomies,such as for leg length discrepencies or deformity; Pathologic fractures; Pseudoarthrosis, non-union, mal-union and delayed union of the tibia; Fractures involving osteopenic and osteoporotic bone; Open fractures of the tibia and; Reconstruction of the tibia after tumor resection and/or bone loss.

The system is not for spinal use.

The I.T.S. CHN - Cannulated Humeral Nail System is indicated for use in long bone humerus fracture fixation which include:

Dislocated, unstable 2, 3 and 4 part fractures of the proximal humerus; Valgusimpacted 4 part fractures of the proximal humerus; Proximal humeral fractures with diaphyseal extension into the shaft; Pseudoarthrosis, non-unions, mal-unions and malalignments of the proximal humerus and; Pathological and impending pathological fractures.

The system is not for spinal use.

The I.T.S. IM Nail Systems CFN-CTN-CHN consists of Predicate type intramedullary nail trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'Intramedullary (IM) Nail trauma implant devices' consist of the following categories:

1. CFN - Cannulated Femur Nail System
2. CTN - Cannulated Tibia Nail System
3. CHN - Cannulated Humeral Nail System

A brief and concise description of each system is enclosed as follows:

1. CFN - Cannulated Femur Nail System: The I.T.S. CFN -Cannulated Femur Nail System is a curved/bowed Intramedullary(IM) Nail in a right and left configuration to fit the natural bow of the femur and is inserted proximally/antegrade over 3.5/3.0mm calibrated guide wires. The CFN - IM Nail is composed of various nail diameters in sizes of 9.0, 10.0, 11.0, 12.0 and 13.0mm and various lengths from 240mm to 480mm in 20mm increments. The CFN - IM Nail accepts a 6.5mm Cortical Screw in various lengths for cross-screw fixation in the larger diameter proximal region of the nail and a 4.7mm Triple-lead Cortical Screw in various lengths for crossscrew fixation in the distal portion of the nail. A dynamization slot is located in the distal portion of the nail and an End Cap (in +0, +5, +10, +15, +20, +25 & +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole/slot location.

All CFN - JM Nail, End Cap and Screw components are manufactured from Alloyed 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

Associated instrumentation such as Insertion Guide accessories, guide pins, drill sleeves, drill guides, drills, screwdriver, depth gauge with removal instruments are available with the system. All CFN - IM Nails, End Caps and Screws are provided Non-Sterile.

2. CTN - Cannulated Tibia Nail System: The I.T.S. CTN -Cannulated Tibia Nail System is a universal straight Intramedullary(IM) Naïl with a 50 proximal and distal bend configuration to fit the anatomy of the tibia and is inserted proximally/antegrade over 3.5/3.0mm calibrated guide wires. The CTN - IM Nail is composed of various nail diameters in sizes of 9.0, 10.0. 11.0. and 12.0mm and various lengths from 240mm to 420mm in 1 5mm increments. The CTN - IM Nail accepts only the 4.7mm Triple-lead Cortical Screw in various lengths for cross-screw fixation in both the proximal/distal portion of the nail. A dynamization slot is located in the proximal portion of the nail and an End Cap (in +0, +5, +10, +15, +20, +25, +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole/slot and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole location.

All CTN - IM Nail, End Cap and Screw components are manufactured from Alloved 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

Associated instrumentation such as Insertion Guide accessories, guide pins, drill sleeves, drill guides, drills, screwdriver, depth gauge and removal instruments are available with the system. All CTN - IM Nails, End Caps and Screws are provided Non-Sterile.

3. CHN - Cannulated Humeral Nail System: The I.T.S. CHN -Cannulated Humeral Nail System is a right and left Intramedullary (IM) straight Nail with a 4 proximal bend configuration to fit the anatomy of the humerus and is inserted proximally over 2.0/2.5mm calibrated guide wires. The CHN - IM Nail is composed of various nail diameters in sizes of 7.0. 8.0. and 9.0mm and various lengths from 140mm to 320mm in 10 and 20mm increments. The CHN - IM Nail accepts only a 3.5mm Double-lead Cortical Screw in various lengths for cross-screw fixation in both the proximal/distal portion of the nail. An End Cap (in +0, +5, +10, +15, +20, +25 & +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole location.

All CHN - IM Nail, End Cap and Screw components are manufactured from Alloyed 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

Associated instrumentation such as Insertion Guide accessories, guide pin, drill sleeves, drill guides, drills, screwdriver, depth gauge and removal instruments are available with the system. All CHN -IM Nails, End Caps and Screws are provided Non-Sterile.

The provided text is a 510(k) summary for the I.T.S. IM Nail Systems CFN-CTN-CHN, which describes various intramedullary nails for stabilizing and fixing long bone fractures. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study to prove acceptance criteria based on device performance metrics like sensitivity, specificity, or accuracy.

Therefore, the following information cannot be fully extracted as it is not contained within the provided 510(k) summary:

• A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria or report a study comparing the device's performance against such criteria.
• Sample size used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described for a test set.
• Adjudication method for the test set: No adjudication method is described.
• 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 study is mentioned, nor is AI involved in this device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This pertains to algorithm performance and is not relevant to a physical medical device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth is established for a performance study.
• The sample size for the training set: Not applicable as this is not an AI/algorithm-based device and does not involve training sets.
• How the ground truth for the training set was established: Not applicable.

The 510(k) summary explicitly states the method used for demonstrating the device meets acceptance criteria:

Equivalence and Study that Proves the Device Meets Acceptance Criteria:

The acceptance criterion for this device is "Substantial Equivalence" to legally marketed predicate devices. The study that proves the device meets this acceptance criterion is a comparison of technological characteristics to predicate devices.

The document states:

• "The I.T.S. IM Nail Systems CFN-CTN-CHN are Substantially Equivalent(SE) to the various predicate IM Nail, End Cap and Screw Systems as listed." (Page 3)
• "No nonclinical testing was used in the determination of substantial equivalence." (Page 3)
• "The I.T.S. IM Nail Systems CEN-CTN-CHN are Similar in Material, Geometry Design/Markings, and Indications to predicate system(s) currently sold in the U.S. market." (Page 3)

This means the "study" for this 510(k) submission was a documentary comparison, not a clinical trial or performance study typical for AI/software devices. The device meets "acceptance criteria" by demonstrating that its materials, design, and intended uses are sufficiently similar to devices already approved by the FDA, thereby inferring the same safety and effectiveness.

Key information explicitly found in the document related to acceptance criteria and the "study":

1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable. No test set was used for a performance study. The evaluation was based on a comparison of device specifications and indications for use against predicate devices.

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

• Not applicable. No ground truth was established by experts for a test set. The review was primarily regulatory, comparing the new device's characteristics to existing predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No test set requiring adjudication was used.

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:

• No MRMC study was done. This device is a physical intramedullary nail system and does not involve AI or human readers for diagnostic interpretation.

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

• Not applicable. This device is a physical intramedullary nail system and does not involve algorithms.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not applicable. For a substantial equivalence claim for a physical device like an intramedullary nail, the "ground truth" implicitly refers to the established safety and effectiveness of the predicate devices based on their prior approval and post-market experience.

8. The sample size for the training set:

• Not applicable. This is not an AI/algorithm-based device.

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

• Not applicable. This is not an AI/algorithm-based device.

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Smith & Nephew IM Nail Systems Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew IM Nail Systems and their cleared Indications for Use.

Trigen Adolescent TAN Nail System and Trigen 130° TAN Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew Trigen Adolescent TAN Nail System and the Smith & Nephew Trigen 130° TAN Nail System and their cleared indications for use. Indications for interlocking intramedullary nails include: Simple long bone fractures, Severely comminuted, spiral, large oblique and segmental fractures, Nonunions and malunions, Poly trauma and multiple fractures, Prophylactic nailing of impending pathologic fractures, Reconstruction following tumor resection and grafting, Supracondylar fractures, Bone lengthening and shortening, 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 are indicated for the following: Subtrochanteric fractures with lesser trochanteric involvement, Ipsilateral femoral shaft/neck fractures, Intertrochanteric fractures.

Trigen Humeral Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Trigen System and its cleared indications for use. TRIGEN Humeral Nail System is indicated for: Proximal and/or diaphyseal fractures of the humerus, Nonunions, Malalignments, Pathological humeral fractures, Impending pathological fractures.

Trigen InterTAN Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Trigen InterTAN Nail System and its cleared indications for use. TRIGEN InterTAN Nails are indicated for: Simple long bone fractures, Severely comminuted spiral, long oblique, and segmental shaft, Nonunions and malunions, Poly trauma and multiple fractures, Prophylactic nailing of impending pathologic fractures, Reconstruction, following tumor resection and grafting, Bone lengthening and shortening, Subtrochanteric fractures, Ipsilateral femoral shaft/neck fractures, Intertrochanteric fractures, Intracapsular fractures.

Intramedullary Nail Systems Instruments are accessory devices and are intended to be used to assist in the implantation.of Smith & Nephew Intramedullary Nail Systems and their cleared indications for use. The Short Knee Nail, REVISION Nail and Hindfoot Fusion Nail (HFN) are indicated for: 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, Severe pilon fractures with trauma to the subtalar joint.

SURESHOT TAN Nail Systems Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew SURESHOT TAN Nail Systems and their cleared indications for use. SURESHOT TAN Nails are indicated for: Fractures of the femur including: simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures, Non unions and malunions, Poly trauma and multiple fractures, Prophylactic nailing of impending pathologic fractures, Reconstruction, following tumor resection and grafting, Supracondylar fractures, Bone lengthening and shortening, Fixation of fractures that occur in and between the proximal third and distal fourth of the femur. In addition, SURESHOT TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: Subtrochanteric fractures;, Intertrochanteric fractures;, Ipsilateral femoral shaft/neck fractures;, Intracapsular fractures.

Intramedullary Hip Screw System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Intramedullary Hip Screw Systems and their cleared indications for use. Intramedullary Hip Screws are indicated for: Intracapsular fractures of the femoral neck;, Trochanteric or subtrochanteric fractures;, Osteotomies for patients with diseases or deformities of the hip;, Hip arthrodesis;, Supracondylar fractures and distal femoral fractures using a supracondylar plate;, Ipsilateral femoral shaft/neck fractures;, Intertrochanteric fractures;, Femoral neck fractures;, Subcapital fractures;, Comminuted neck and shaft fractures;, Femur reconstruction following tumor resection;, Leg length discrepancies secondary to femoral inequality;, Prophylactic nailing of impending pathologic fractures.

Ender Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Ender Nail Systems and their cleared indications for use. ENDER Nails are indicated for: Fracture of the neck, trochanteric, and subtrochanteric region of the femur;, Distal femoral fractures with a distal fragment 10cm or longer, Tibial shaft fractures, Proximal humeral fractures.

TriMax Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew TriMax Nail Systems and their cleared indications for use. Femoral/Recon antegrade nails and retrograde nails are indicated for: Shaft fractures including severely comminuted, spiral, large oblique and segmental fractures, Non-unions and malunions, Bone lengthening/shortening, Severely comminuted shaft fractures, Pathologic fractures, pseudoarthrosis, failed osteosynthesis, Closed supracondylar fractures, Prophylactic nailing of impeding pathologic fractures. Additonal indications for the femoral/recon antegrade include: Subtrochanteric fractures with lesser trochanteric involvement, Ipsilateral femoral shaft/neck fractures. Additonal indications for retrograde nails include: Severly comminuted supracondylar fractures with or without difficult intra-articular extension, Fractures that require opening the knee joint to stabilize the femoral condylar segmarnt, Fractures above total knee implants. The TriMax Nail System is intended to be removed upon fracture healing.

Indications for interlocking intramedullary nails include: Simple long bone fractures, Severely comminuted, spiral, large oblique and segmental fractures, Nonunions and malunions, Poly trauma and multiple fractures, Prophylactic nailing of impending pathologic fractures, Reconstruction following tumor resection and grafting, Supracondylar fractures, Bone lengthening and shortening, 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, 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: 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 (peri-prosthetic fractures).

Knee Fusion Nail Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Knee Fusion Nails and their cleared indications for use. Knee Fusion Nails are indicated for: Intramedullary Knee Arthrodesis.

IP-XS Compression Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew IP-XS Compression Nail System and its cleared indications for use. The IP-XS Compression Nail System is inserted into the medullary canal of long bones for the : Alignment, stabilization, and fixation of fractures caused by disease or trauma, The fixation of long bones that have been surgically prepared {osteotomy) for correction of deformity, Arthrodesis.

SLIM (Friedl) Gliding Nail Systems Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew SLIM (Fried), Gliding Nails and their cleared indications for use. The SLIM (Friedl) Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in: Petrochanteric femoral fractures, Subtrochanteric femoral fractures, Lateral femoral neck fractures. Internal fixation with the SLIM (Friedl) Gliding Nail System is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the SLM (Friedl) Gliding Nail System is also suitable for medical femoral neck fractures with retention of the head and simple femoral shaft factures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.

TriGen Low Profile Bone Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew TriGen Low Profile Bone Screws and their cleared indications for use. The TRIGEN Low Profile Bone Screw can be used with several types of nails in Smith & Nephew's (TRIGEN) Titanium Nail System. The TRIGEN Low Profile Bone Screw therefore has the following indications: 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 and shortening. 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 (peri-prosthetic fractures). The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; intracapsular fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening. SURESHOT TAN Nails are indicated for fractures of the femur including 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 and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur. In addition, SURESHOT TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. intramedullary (IM) Nail Systems Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew IM Nails and their cleared Indications for Use. Smith & Nephew IM Nail Systems Instruments can be organized into instrument families which are categorized as follows: Torque/Tightening, trials, drills, extractors, impactors, replacements, alignment, other guides and gauges, and bone preparation.

The provided document is a 510(k) Premarket Notification for Intramedullary Nail Systems Instruments, which are accessory devices used to assist in the implantation of various Smith & Nephew IM Nails. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study with specific acceptance criteria and performance metrics for a novel device. Therefore, much of the requested information regarding acceptance criteria, performance, and detailed study methodologies for an AI/CADe device cannot be extracted directly.

This document describes the equivalence of the instruments used for implantation of nails, not the nails themselves or a diagnostic AI/CADe system.

However, I can extract the information that is present and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document as it is a 510(k) for accessory instruments, relying on substantial equivalence to predicate devices rather than demonstrating performance against specific clinical acceptance criteria. The "performance" described is the instruments' ability to assist in the implantation of already cleared nails, which is assessed through comparisons of materials, manufacturing, sterilization, and body contact.

• Share the same raw materials as predicate instruments.
• Be manufactured through the same processes as predicate instruments.
• Utilize the same sterilization procedures as predicate instruments.
• Have a similar nature of body contact as predicate instruments.
• Be similar in design and function to competing IM nail instrumentation on the market. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as there is no test set or clinical study conducted in the context of a new diagnostic algorithm or device requiring such data. The premarket notification relies on substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as there is no test set or ground truth to establish for this type of device (surgical instruments).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is 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

This information is not applicable as no MRMC study, or any study involving human readers and AI assistance, was conducted or described. The device consists of surgical instruments, not an AI/CADe system.

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

This information is not applicable as the device is surgical instrumentation, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable as no ground truth is required for demonstrating substantial equivalence of surgical instruments. The equivalence is based on physical characteristics and intended use.

8. The sample size for the training set

This information is not applicable as there is no training set mentioned or relevant for this type of device.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set or ground truth mentioned or relevant for this type of device.

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Indications for the Piccolo Composite Humeral Nail and Proximal Humerus Nail include simple humeral fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Humeral and Proximal Humerus Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.

The Piccolo Composite Nailing System includes humeral and proximal humerus nails. interlocking screws and a set of instruments.

The Piccolo Composite Nail is a cylindrical solid rod, made of carbon fiber reinforced polymer. The humeral nail diameter ranges from 7 mm to 8.5 mm, with lengths in the range of 180 mm to 280 mm. The dimensions of the proximal humerus nail are 8 mm diameter (11 mm at proximal end), and length of 150 mm. The nails provide for holes at proximal and distal sections, designed for the insertion of self-tapping, titanium-allovmade, interlocking screws. The nails have a closed, pointed distal end, and their proximal end incorporates a thread enabling connection of insertion/extraction instrumentation.

The provided text is a 510(k) summary for the Piccolo Composite Nailing System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical properties and intended use, rather than a clinical study evaluating diagnostic performance, as might be done for AI/ML-driven devices. Therefore, much of the requested information regarding acceptance criteria, study design for diagnostic performance, ground truth establishment, and expert involvement is not present in this document.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The term "acceptance criteria" in this context refers to the criteria for demonstrating substantial equivalence based on mechanical testing and intended use. The document states: "Biomechanical evaluation demonstrates comparable mechanical properties to the predicate device."

2. Sample size used for the test set and the data provenance

Not applicable. This is a mechanical device, and the "test set" would refer to the samples used in biomechanical testing. The document states "Biomechanical evaluation demonstrates comparable mechanical properties," but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable. "Ground truth" in this context would typically refer to clinical outcomes or definitive diagnoses for performance studies of AI/ML devices. For a mechanical device, the "ground truth" for biomechanical evaluation would be the physical properties and performance measured against engineering standards or predicate devices. No external experts for "ground truth" establishment are mentioned.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication method is described. The evaluation is based on biomechanical testing.

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 is a medical device, not an AI/ML diagnostic software. No MRMC study was performed or needed.

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

Not applicable. This is a mechanical medical device, not an algorithm.

7. The type of ground truth used

For the biomechanical evaluation, the "ground truth" would be established by standardized mechanical testing protocols and comparison against the known mechanical properties of the predicate devices. The specific type of ground truth (e.g., specific load-bearing capacity, fatigue strength) is not detailed, but it falls under "biomechanical properties."

8. The sample size for the training set

Not applicable. This is a physical device, and the concept of a "training set" is not relevant in the context of this 510(k) submission.

9. How the ground truth for the training set was established

Not applicable. As above, a "training set" and its "ground truth" are not relevant to this device's evaluation as described.

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