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The TRIGENTM Low Profile Bone Screw can be used with several types of nails in Smith & Nephew's (TRIGENTM) 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; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. 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 intramedulary 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; intertrochanteric fractures; ipsilateral 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.

META-TANTM Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; nonunions; 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, META-TAN™ 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; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.

The TRIGENTM Low Profile Bone Screw is intended for single use only.

The subject of this Special 510(k) Premarket Notification is the 5.0mm TRIGEN™ Low Profile Bone Screws. Specifically, subject devices are modified with a change in the tip. All described implant devices are manufactured from implant grade titanium alloy material (Ti-Al-4V) and designed for single use. The subject devices are provided in a sterile packaged option and will be sterilized via Gamma irradiation.

The subject devices are designed to be used with TRIGEN™ Titanium intramedullary nail systems.

This document describes a Special 510(k) Premarket Notification for the Smith & Nephew TRIGEN™ Low Profile Bone Screws, which involves a modification to the screw tip.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set (for Insertion Torque Evaluation Testing): The document does not explicitly state the sample size used for the insertion torque evaluation testing. It refers to "testing evaluated the performance of the subject device compared to the original design," but the number of devices tested is not provided.
• Data Provenance: The study appears to be a prospective in-house engineering study conducted by Smith & Nephew, Inc. No country of origin is explicitly mentioned for the data, but given Smith & Nephew's location (Memphis, Tennessee) and the FDA submission, it can be inferred that the testing was conducted under appropriate U.S. regulatory and quality standards.

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

• This information is not applicable to this type of submission. The studies described are primarily engineering/performance evaluations, not clinical studies requiring expert ground truth for interpretation (e.g., image analysis by radiologists). The "ground truth" for insertion torque is direct measurement, and for endotoxin testing, it's compliance with established quantitative limits.

4. Adjudication Method for the Test Set:

• This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies involving human readers/interpreters where there might be disagreement in interpretations. For mechanical testing and sterility assessments, the results are typically quantitative and objective measurements against predefined criteria.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device submission. This type of study is relevant for diagnostic devices where human readers interpret medical images. The TRIGEN™ Low Profile Bone Screw is an orthopedic implant for fixation of fractures.

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

• This concept is not applicable here as this is a physical medical device (bone screw), not an AI algorithm or software device. Performance is evaluated through mechanical testing and biological safety assessments.

7. The Type of Ground Truth Used:

• For Insertion Torque Evaluation Testing: The "ground truth" is the direct measurement of insertion torque of the device itself and its comparison to the direct measurement of the predicate device.
• For Bacterial Endotoxin Testing: The "ground truth" is established by quantitative limits specified in recognized international standards (e.g., ANSI/AAMI ST72) and FDA guidance documents.

8. The Sample Size for the Training Set:

• This information is not applicable. This submission is for a physical medical device and its performance evaluation, not an AI/machine learning model that requires a training set.

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

• This information is not applicable as there is no training set for a physical medical device.

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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 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.

The TRIGEN® Low Profile Bone Screw is intended for single use only.

Subject of this Traditional 510(k) Premarket Notification is the TRIGEN® Low Profile Bone Screw. The subject device is a modification of the bone screws included in the (TRIGEN) Titanium Intramedullary (IM) Nail System cleared by premarket notification K981529. The TRIGEN® Low Profile Bone Screw is manufactured from titanium alloy (Ti-6Al-4V), contains an internal hex drive feature in the screw head, and is available in the sizes included in Table 1 below.

Table 1: TRIGEN® Low Profile Screw Sizes

The subject device is designed to be used with the SURESHOT® TAN Nails cleared under K092748 as well as TRIGEN® titanium intramedullary nail systems designed to use 4.5 mm or 5.0 mm diameter screws.

This document describes the TRIGEN® Low Profile Bone Screw and focuses on its substantial equivalence to previously cleared devices rather than providing acceptance criteria and performance data from a study measuring specific metrics against those criteria.

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

1. Table of acceptance criteria and reported device performance:

The document does not explicitly state quantitative acceptance criteria (e.g., "torsional strength must be X Nm") or report specific numerical performance outcomes against such criteria for the TRIGEN® Low Profile Bone Screw.

Instead, it states that "Performance testing has been conducted to ensure the safety and effectiveness of the subject device. Static Torsional Strength, Bending Fatigue, and Axial Pullout Strength of the subject device have been evaluated. A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject device." This statement implies that the device met some internal or predicate-based performance benchmarks, but the benchmarks themselves and the specific test results are not provided.

The primary "performance" mentioned is in the context of substantial equivalence to predicate devices. The comparison in Table 2 focuses on design features (material, diameter, length, head drive, thread form, cutting tip geometry) rather than quantitative performance metrics.

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

• Sample Size: Not specified. The document only mentions "Performance testing has been conducted" without detailing the number of units tested.
• Data Provenance: The testing appears to be internal "Performance testing" conducted by Smith & Nephew, Inc. It is not indicated whether this was retrospective or prospective, or the country of origin.

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

This information is not provided and is not relevant to this type of 510(k) submission, which relies on engineering performance testing and substantial equivalence, not clinical study data with expert ground truth.

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

This information is not provided and is not relevant for the type of engineering performance testing described.

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 comparative effectiveness study was done. This document describes a medical device, a bone screw, not an AI or imaging diagnostic device. Therefore, AI assistance and human reader improvement are not applicable.

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

No standalone performance study for an algorithm was done. This is a physical medical device, not a software algorithm.

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

For the engineering performance testing (Static Torsional Strength, Bending Fatigue, Axial Pullout Strength), the "ground truth" would be the measured physical properties and mechanical behavior of the device compared against established engineering standards or the performance of predicate devices. There is no expert consensus, pathology, or outcomes data used for this type of "ground truth."

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI that would require a "training set."

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

Not applicable. No training set was used.

In summary of what the document does provide regarding performance and equivalence:

• Performance Testing Conducted: Static Torsional Strength, Bending Fatigue, and Axial Pullout Strength.
• Conclusion of Performance Testing: "demonstrated that there are no new issues related to the safety or effectiveness of the subject device." This implies the device met the necessary performance criteria, likely by showing equivalence to predicate devices or meeting recognized standards.
• Clinical Data: "Clinical data was not needed to support the safety and effectiveness of the subject device." This reinforces that the submission relies on engineering testing and substantial equivalence.
• Substantial Equivalence: The primary focus is on demonstrating substantial equivalence to predicate devices (K981529 and K983942) based on design, indications for use, intended use, materials, and sterilization. Table 2 details the comparison of design features between the subject device and the predicate devices.

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