Search Results

TRIGEN MAX Tibial Nail System:

The TRIGEN MAX Tibial Nail is indicated for stable and unstable fractures that occur in and between the proximal and distal third of the tibia, including the shaft.

INTERTAN MAX Hip Fracture Nail System:

The INTERTAN MAX Nails are indicated for fractures of the femur including:

· Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, and segmental shaft fracture; subtrochanteric fractures; intertrochanteric fractures;

ipsilateral femoral shaft/neck fractures; and intracapsular fractures

• · Polytrauma and multiple fractures
• · Prophylactic nailing of impending pathologic fractures
• · Reconstruction following tumor resection and grafting.

The Smith & Nephew TRIGEN MAX Tibial Nail and INTERTAN MAX Hip Fracture Nail systems consist of implant intramedullary nails, screws, nail caps, buttress plate, washers and their corresponding US Class II instrumentation. The TRIGEN MAX Tibial Nail system is designed to address fractures of the tibia and the INTERTAN MAX Hip Fracture Nail system is designed to address fractures of the proximal femur.

The provided text is an FDA 510(k) clearance letter and associated summary for the TRIGEN MAX Tibial Nail System and INTERTAN MAX Hip Fracture Nail System. This document does not describe a study involving an AI/software device that requires specific acceptance criteria for performance metrics like sensitivity, specificity, or AUC.

Instead, this clearance is for mechanical bone fixation appliances and accessories, which are physical medical devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical (benchtop) performance evaluations and biocompatibility testing to demonstrate substantial equivalence to predicate devices, not AI algorithm performance.

Therefore, I cannot provide a response with the requested information template (table of acceptance criteria with reported device performance, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set sample size, and ground truth establishment for training set) because those metrics and study types are relevant for AI/software medical devices, which this submission is not for.

The document explicitly states: "No clinical tests were performed to support safety and efficacy of the subject devices. The performance bench evaluations and tests were used as a basis for the determination of substantial equivalence. The results of each evaluation or test show that when compared to the predicate devices have demonstrated substantially equivalent performance."

The types of "acceptance criteria" for these devices are related to mechanical properties and material compatibility, derived from standards like ASTM and ISO. These are not presented in a quantitative performance table like for an AI device.

To summarize, based on the provided document:

• This submission is for physical metallic bone fixation appliances, not an AI/software device.
• Therefore, the requested information template for AI device performance and validation studies is not applicable.
• The "studies" performed were non-clinical benchtop tests (e.g., Finite Element Analysis, Insertion/Removal Torque, Fatigue Testing, Biocompatibility).
• The "acceptance criteria" are implied by meeting the requirements of the referenced ASTM and ISO standards for substantial equivalence to predicate devices.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Knee Fusion Nails are intended for intramedullary knee arthrodesis.

The Knee Fusion Nail is inserted in the medullary canal of long bones for knee arthrodesis. The Knee Fusion Nail features holes/slots on both ends of the nail for optional locking screws. The nails and screws are made of Stainless Steel. The screws were previously cleared in 510(k) K983942.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Knee Fusion Nail, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The review states "an analysis of bending strength and flexural rigidity based on the cross-sectional geometry of the nail's shaft region and the material strength properties using hand calculations." This implies a theoretical analysis based on design specifications and material properties rather than a test performed on a sample set of physical devices. Therefore, a traditional "sample size" for a test set and associated data provenance (country of origin, retrospective/prospective) are not applicable to this type of analysis.

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

• Number of Experts: Not applicable. The "ground truth" was established through engineering calculations and material property comparisons.
• Qualifications of Experts: Not applicable. The analysis was based on engineering principles and material science, not expert consensus on observations.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring expert adjudication.

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 done. The submission describes a device (Knee Fusion Nail) which is a physical implant, not a diagnostic or assistive technology that would be used by human readers for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. The "device" in question is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation was established using engineering principles, material strength properties, and design specifications (cross-sectional geometry of the nail's shaft region). The performance of the subject device was then compared against these established properties for predicate devices.

8. The Sample Size for the Training Set

Not applicable. The submission describes a physical medical device, not a machine learning model, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. There was no training set.

Ask a specific question about this device

Knee Fusion Nails are for intramedullary knee arthrodesis.

A Knee Fusion Nail is inserted into the medullary canal of long bones for knee arthrodesis. The design of the Knee Fusion Nail is based on Smith & Nephew's (formally Richards Medical) experience with intramedullary nail systems, which dates back to the 1950's. The Knee Fusion Nail includes intramedullary interlocking nails with corresponding screws. The Knee Fusion Nail and corresponding screws are made of Ti-6Al-4V titanium alloy with holes/slots for optional locking screws on both ends of the nail. Locking screws are available for optional and distal locking. Screws are available in 5.0mm, and 6.4mm diameters with varying lengths. The screws were previously cleared in 510(k) K981529. The device is intended for single use.

The provided document is a 510(k) summary for a medical device called "Knee Fusion Nail". It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain information regarding acceptance criteria for performance, clinical study data involving a test set, expert adjudication, or AI/human reader studies.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to existing devices, not on detailed performance metrics from a dedicated clinical study with specific acceptance criteria.

Ask a specific question about this device

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; and prophylactic nailing of impending pathologic fractures. Smith & Nephew, Inc. Intramedullary Hip Screws are for single use only.

Intramedullary Hip Screw

The provided text does not describe a study to prove acceptance criteria for a device using an AI algorithm.

Instead, it is a 510(k) premarket notification summary for a medical device called an "Intramedullary Hip Screw" manufactured by Smith & Nephew, Inc. This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of design features, indications for use, and material composition.

Therefore, I cannot populate the requested table and answer the study-related questions (2-9) because the information is not present in the provided text.

Here's a breakdown of what the document does provide:

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

The document states:

• Acceptance Criteria (Implied): Mechanical test data showed the device is "capable of withstanding expected in vivo loading without failure."
• Reported Device Performance: "A review of the mechanical test data indicated that the Intramedullary Hip Screw is equivalent to predicate devices currently used clinically and is capable of withstanding expected in vivo loading without failure."

Missing Information (as per your request, because it's an AI-related prompt and this document is not AI-related):

2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs. without AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device

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 are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. The Smith & Nephew, Inc. Trochanteric Antegrade Nail is for single use only.

Not Found

The provided text describes a 510(k) premarket notification for the "TriGen Trochanteric Antegrade Nail." This document focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria in a clinical study for a
new device.

Here's an analysis based on your requirements and the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not applicable. The document describes a 510(k) submission based on mechanical testing and substantial equivalence to predicate devices, not a clinical study with a "test set" of patients.
• Data Provenance: Not applicable. The data primarily comes from mechanical test data and comparisons to existing predicate devices. No patient-specific data is mentioned, thus no country of origin or retrospective/prospective nature is indicated.

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

• Number of Experts: Not applicable. As there was no clinical test set for this 510(k) submission, no ground truth was established by experts in this context. The "ground truth" for the submission is the regulatory determination of substantial equivalence based on engineering and design comparisons.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No clinical test set or human interpretation was involved in the data presented in this summary.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this summary. This is a premarket notification for a medical device (intramedullary nail), which typically relies on mechanical testing and substantial equivalence to existing devices rather than reader studies.
• Effect Size of AI Improvement: Not applicable, as no AI component or reader study was performed.

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

• Standalone Study: No, a standalone algorithm performance study was not done. The device is a physical implant (intramedullary nail), not an algorithm or software.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The "ground truth" in this context is the mechanical equivalence to established devices, as determined by engineering tests, and the regulatory determination of substantial equivalence by the FDA based on design, materials, and intended use as compared to predicate devices. It is not pathology, outcomes data, or expert consensus from a clinical trial.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable. There is no mention of a training set as this is not a machine learning or AI-based device.

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

• Ground Truth Establishment: Not applicable. No training set was used.

Ask a specific question about this device

aap Biorigid Nail Femur (BNF) is intended to use in fractures of the femoral bone.

The indications are:
Types of Fractures: Simple closed fractures, Comminuted fractures, Open fractures of first, second or third degree, Crush fractures
Antegrade Indications: Femur shaft fractures, Distal femur shaft fractures, Pathological fractures, e.g. tumor osteolysis, Periprosthetic femur fracture in the middle to third part with knee replacement in situ
Retrograde Indications: Supracondylary fractures, Simultaneous nailing of femur and tibia, Distal femur fracture with osteosynthesis or hip prosthesis in situ, Periprosthetic femur fracture at knee arthroplasty
Borderline Indications: Percondylar femur fracture, Pseudarthrosis (only reamed method), Osteoporosis

Intramedullary rods are used for the stabilisation of fractures or correction of deformity of ong bones with or without interlocking screws. The connection between the nail and the interlocking screw is realised with central holes or grooves. Reamed and unreamed intramedullary nailing and for the femoral bone the antegrade and retrograde entrance are standard methods today.

agp Bioriqid Nail Femur (BNF) is the consistent development of the Biorigid Nail Tibia for the femoral bone. The BNF is a full material nail. The interlocking of the nail happens with solid Ø 5.3 mm screws through central holes and grooves.

The central holes on the nail protect against rotational forces. The grooves are designed for interlocking possibility over the whole length of the nail and a defined reduction of the rigidity because of the full material nail.

The BNF permits the execution of different implantation techniques and interlocking with only one nail. Therefore it meets the different injury manners and necessity for individual solutions.

aap Biorigid Nail Femur (BNF) incorporates

• Nail in different diameters .
• Interlocking screws in different lenghts ●
• Interlocking nut ●
• Protection cap in different lengths ●
• CondyLock ●
• Accessories, like targeting devices etc. ●

This 510(k) summary does not contain information about specific acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided document. The document primarily establishes the device's intended use, materials, and comparison to existing devices.

Here's a breakdown of why the information is missing:

• Acceptance Criteria & Device Performance: The document does not define specific performance metrics (e.g., strength, durability, biocompatibility targets) or report test results against such criteria. The "Performance Standards" section refers generally to cGMP's, ASTM requirements, and harmonized standards like ISO 9001 / EN 46001, but these are quality management and material specification standards, not specific device performance acceptance criteria.
• Study Details: Since there's no mention of specific performance testing, there's no information on:
  • Sample sizes for test sets
  • Data provenance
  • Number or qualifications of experts
  • Adjudication methods
  • MRMC comparative effectiveness studies
  • Standalone performance studies
  • Type of ground truth used
  • Training set sample size or ground truth establishment

This document is a regulatory submission for a Class II medical device (intramedullary fixation rod) seeking 510(k) clearance by demonstrating substantial equivalence. For such devices, rigorous clinical trials or extensive performance studies with explicit acceptance criteria are often not required if substantial equivalence to a legally marketed predicate device can be shown. The FDA's letter explicitly states that the device is "substantially equivalent... to legally marketed predicate devices."

What the document does provide in lieu of a performance study:

• Predicate Devices: A list of several similar intramedullary nails from other manufacturers that serve as the basis for demonstrating substantial equivalence (e.g., Howmedica Osteonics Corp. T2 Femoral Nail System, Synthes Ti Distal Femoral Nail).
• Comparison of Technological Characteristics: It states that the aap Biorigid Nail Femur (BNF) is "substantially equivalent to the predicate devices with respect to physical/technical and material characteristics." This implies that the device is expected to perform similarly to those already on the market without needing to re-prove fundamental performance through new studies.
• Material Composition: Specifies the use of Titanium Alloy (Ti 6Al 4V E.L.I. = ASTM F136), a well-established and approved material for such implants.
• Intended Use: Clearly outlines the types of fractures and anatomical locations for which the device is indicated, which aligns with the predicate devices.

Ask a specific question about this device

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 (i.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.

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

The Titanium Nail System is intended to be removed upon fracture healing.

The Titanium Nail System includes femoral and tibial nails and screws. All components are manufactured from titanium alloy.

This document describes the Titanium Nail System, a device for fixing long bone fractures. However, it does not contain information about acceptance criteria or a study proving device performance using the requested metrics.

Instead, the document details a 510(k) premarket notification to the FDA, asserting that the Titanium Nail System is substantially equivalent to existing, legally marketed devices. The FDA's letter (K981529) confirms this substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a performance study, as this information is not present in the provided text.

The "study" cited for the device's safety and effectiveness is its "long history of use" of the predicate devices it is compared to, rather than a specific performance study of the Titanium Nail System itself.

Here's what can be inferred from the provided text regarding the closest equivalent to "acceptance criteria" and how "performance" is "proven":

1. Acceptance Criteria and Reported Device Performance

• TriMax Antegrade and Retrograde Nails (Smith & Nephew Orthopaedics)
• Kuntscher Nail (Smith & Nephew Orthopaedics)
• Aim Antegrade Femoral, Retrograde Femoral and Tibial Nails (Ace)
• Unreamed Femoral (URFN) and Tibial Nails (Synthes)
• Retrograde Femoral Nail (Biomet)
• Ace ART Femoral Nail (DePuy Ace) |
  | Criterion: Indications for Use Alignment with Predicate Devices | Performance: The Titanium Nail System's indications for use (fractures of long bones, specific femoral fractures, etc.) are consistent with those of the predicate devices. |
  | Criterion: Material Composition (Titanium Alloy) | Performance: All components are manufactured from titanium alloy, consistent with materials used in similar predicate devices. |
  | Criterion: Design Similarity to Predicate Devices | Performance: "All of the devices listed above are similar in design to the Titanium Nail System." |

2. Sample Size for the Test Set and Data Provenance:
* N/A. No performance study with a test set is described. The "proof" is based on the long history of use of predicate devices, not a test set for the Titanium Nail System itself.

3. Number of Experts and Qualifications for Ground Truth:
* N/A. No experts were used to establish ground truth for a performance test set, as no such test set or study is detailed. The "ground truth" for substantial equivalence is based on regulatory assessment by the FDA, considering existing market data for predicate devices.

4. Adjudication Method:
* N/A. No adjudication method is described as there is no performance study where ground truth was independently established and adjudicated.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
* No. No MRMC study was performed or described. This document is focused on regulatory clearance based on substantial equivalence, not comparative effectiveness.

6. Standalone Performance Study:
* No. No standalone performance study (i.e., algorithm only without human-in-the-loop performance) was performed or described. The device is a surgical implant, not an AI algorithm.

7. Type of Ground Truth:
* The "ground truth" for the device's safety and effectiveness is fundamentally based on the "long history of use" and established clinical outcomes of the predicate devices (other intramedullary nail systems). This is a form of historical outcomes data relating to the class of devices.

8. Sample Size for the Training Set:
* N/A. This device is a physical implant, not an AI/ML model that requires a training set in the typical sense.

9. How the Ground Truth for the Training Set was Established:
* N/A. Not applicable for a physical medical device.

Ask a specific question about this device