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The Syntec Femoral Nail System is indicated for long bone fracture fixation which may include the following: Fractures, and tumor resections; Fractures proximal to a total knee arthroplasty; Supracondylar and ipsilateral fractures; Delayed union fractures; Open and closed femur shaft fractures; Combined inter and subrochanteric fractures; High subtrochanteric fractures; Pseudoarthrosis and correction osteotomy; Pathological fractures, impending pathologic and tumor resections; Pertrochanteric fractures; and Nonunions and malunions.

The Syntec Femoral Nail System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) nail with a 5° proximal bend allows the nail to be inserted through the tip of the greater trochanter for an easier surgical approach. These nails have a 135° recon screw angle for easier placement of two 6.3 mm Recon Screws into the femoral neck and ø5mm internal hex captured screws in various lengths for cross-screw fixation in both the proximal and distal portion of the nail. Also, an End Cap ø13 in 3, 5, 10, 15mm lengths is available for proximal closing of the nail. The Syntec Femoral Nail System (nail, screw and end cap) are provided Non-Sterile and single use only. Also, it is not for spinal use. Associated instrumentation such as aiming device for proximal and distal, insertion guide wire, drill accessories, system and removal instruments are available with the system.

This document describes the Syntec Femoral Nail System, an intramedullary fixation rod. The information provided outlines the system's design, intended use, and a comparison to predicate devices, but it contains limited details regarding specific acceptance criteria and study outcomes.

Here's an analysis of the provided text in relation to your request:

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

The document mentions that "The procedure of evaluating the device tests was according to the standard of ASTM-F1264-16." It also states, "According device test report of performance data demonstrate that the Syntec Femoral Nail is as safe and effective as K040462, K984543 and K161327."

However, the document does not provide a table of specific acceptance criteria (e.g., minimum bending strength, torsional stiffness, fatigue life) or the actual reported device performance values against those criteria. It only states that the testing was performed and demonstrated substantial equivalence to the predicate devices. To fulfill this request, concrete numerical values for both acceptance criteria and the device's performance would be needed.

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

The document states, "The testing was done to our Syntec Femoral Nail System device to demonstrate substantial equivalence."

The document does not specify the sample size used for the test set, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective study design). Given that the testing was "to our Syntec Femoral Nail System device," it's likely referring to a bench testing study on the device itself, rather than a clinical study with human patients.

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 to the type of study described. The document refers to "device tests" according to a standard like ASTM-F1264-16, which are typically mechanical or material property tests performed in a lab setting, not evaluations requiring expert interpretation of medical images or clinical outcomes.

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

This information is not applicable for the same reasons as point 3. Adjudication methods are relevant for studies involving human interpretation or clinical endpoint assessments, which are not detailed here.

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. The device described is an intramedullary fixation rod, a physical implant for fracture fixation. It is not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

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 a physical medical implant, not an algorithm or software.

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

For the "device tests" mentioned (which are presumed to be mechanical testing), the "ground truth" would be established by the specific test methods and measurement standards outlined in ASTM-F1264-16. For example, force exerted, displacement measured, or cycles to failure. These are objective, measurable physical properties, not ground truth established by expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This information is not applicable as the device is a physical product and does not involve machine learning or AI that would require a training set.

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

This information is not applicable for the same reasons as point 8.

In summary, the provided text describes the regulatory clearance of a physical medical device (Syntec Femoral Nail System) based on substantial equivalence and performance testing to an industry standard (ASTM-F1264-16). It lacks the detailed information typically found in documentation for AI/software medical devices regarding acceptance criteria, study design, expert involvement, and ground truth establishment. The context of your questions seems to overlap with requirements for AI/ML-based medical devices, which the Syntec Femoral Nail System is not.

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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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