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The T2 Tibial Nailing System is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted or closed technique and can be statically, dynamically and compressed locked. The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: Open and closed tibial fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Nonunion and malunion.

The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation which may include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures, including those with intra-articular extension, Ipsilateral femur fractures, Fractures proximal to a total knee arthroplasty, Fractures distal to hip joint, Nonunions and malunions.

The T2 Supracondylar Nail System is indicated for: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures including those with intra-articular extension, Fractures distal to total hip prosthesis, Nonunions and malunions.

The T2 Recon Nail is indicated for: Subtrochanteric fractures, Intertrochanteric fractures, Ipsilateral neck/shaft fractures, Comminuted proximal femoral shaft fractures, Femoral fixation required as a result of pathological disease, Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

The T2 Greater Trochanter Nail is indicated for long bone fracture fixation, which may include the following: Open and closed femoral fractures, Pseudarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Ipsilateral femur fractures, Fractures proximal to a total knee arthroplasty, Nonunions and malunions.

The T2 Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: Post-traumatic or primary Arthrosis, Previously infected arthrosis (second degree), Revision of Failed Ankle Arthrodesis, Failed Total Ankle Replacement, Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis), Neuroarthropathy or Neuromuscular Deformity or other neuromuscular disease with severe deformity or instability of the ankle, Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot, Osteoarthritis, Nonunions or Pseudarthrosis of hindfoot and distal tibia, Malunited tibial pilon fracture, Charcot foot, Severe endstage degenerative arthritis, Severe defects after tumor resection, Pantalar arthrodesis.

The T2 Arthrodesis Nail is intended for long bone internal fixation, which may include the following: Aseptic failed total knee arthroplasty, Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathological fractures, impending pathological fractures, and tumor resections, Ipsilateral femur fractures, Failed external fixation, nonunions and malunions, Periarticular fractures where repair is not possible, Knee arthrodesis.

The T2 Tibial Nailing System is a cylindrical tube manufactured from titanium alloy and slightly bowed to accommodate the shape of the tibia. Locking screws, compression screws and an end cap are manufactured from titanium alloy and are used with the nails. The T2 Tibial Nailing System is available in three versions, each differing from the other only in diameter, length and number and orientation of screw holes.

The T2 Femoral Nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.

The T2 Supracondylar Nails are retrograde nails with a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with proximal rounded end. The T2 Supracondylar Nail is available in two versions: Short and Long. The T2 Supracondylar nails are available in lengths from 170 mm to 440 mm and in diameters from 9 mm to 14 mm. The T2 Supracondylar Nail System offers nails in varying lengths, a combination of locking screws, condyle screws, nuts and end caps.

The T2 Recon Nail System is a family of nails for various types of femoral fractures. The system includes Recon Nails in various lengths and diameters (both left and right versions), Lag Screws, Locking Screws, end caps, an Antegrade Set Screw and other accessories for use with the nails.

The T2 Greater Trochanter Nail (GTN) is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 GTN may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.

The T2 Ankle Arthrodesis Nail is a fluted, cannulated, titanium alloy nail and has a compression screw to provide internal compression of the upper ankle joint. The nail is inserted using an open or closed technique and can be locked in static, dynamic or compression mode. The T2 Ankle Arthrodesis Nail and accessories are intended for single use only. The T2 Ankle Arthrodesis Nail is available in left and right version in diameters 10 mm to 13 mm with the length ranging from 150 mm to 480 mm in increments of either 20mm or 50 mm. It has a 5 "lateral bend.

The T2 Arthrodesis Nails have a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with distal rounded end. The T2 Arthrodesis Nail is available in lengths from 540 mm to 780 mm in 40 mm increments, and in diameters from 10 mm to 15 mm.

This document describes the Stryker GmbH T2 Nail Systems, which are intramedullary fixation rods. The submission is a Traditional 510(k) Premarket Notification (K200880).

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria described for this device are not explicitly enumerated in a numerical or pass/fail table format within the provided excerpt. Instead, the "acceptance criteria" are implied by the nature of a 510(k) submission, which aims to demonstrate substantial equivalence to existing legally marketed predicate devices.

The reported device performance is demonstrated by showing that the newer components (IMN Locking Screws) perform equal to or higher than the previously cleared components (T2 Locking Screw) in various test disciplines.

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

• Test Set Sample Size: The document does not specify a numerical sample size for the "computational assessment" or "various test disciplines." It mentions "constructs of T2 nails and IMN Locking Screws" were compared to "constructs of T2 nails used with T2 Locking Screw." For the T2 Femoral Nail System, "new Student t-tests were performed with the corrected data input" and "the 09mm Synthes Solid Femoral Nail (K923580), which was tested in the same manner and statistically compared to the T2 Femoral Nails." These phrases imply testing was conducted on an unspecified number of physical or computational models.
• Data Provenance: The data appears to be from retrospective testing and analysis, as it refers to comparisons with "previously cleared" components and "reevaluation of the dynamic fatigue strength testing." There is no mention of country of origin for the data; typically, such non-clinical testing would be conducted in the manufacturer's R&D facilities or contracted labs, likely within the regions where the manufacturing or development is centered (e.g., Switzerland, as per the Sponsor's address, and/or the US).

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

This submission relies on non-clinical (benchtop) testing and computational assessment, not clinical data or expert visual assessment of medical images for ground truth. Therefore, the concept of "experts" establishing ground truth for a test set in the way it would apply to AI/imaging devices is not directly applicable here. The "ground truth" is defined by the objective, measurable mechanical properties and performance characteristics established through engineering principles and testing standards. Regulatory bodies (like the FDA) evaluate this data.

4. Adjudication Method for the Test Set

Not applicable, as this is non-clinical testing. Adjudication methods like "2+1" or "3+1" are typically used for clinical study data where multiple human readers are involved in assessing outcomes or classifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. The submission explicitly states: "Clinical testing was not required for this submission." MRMC studies are typically performed for diagnostic or AI devices where human reader performance is a key variable. This device is a mechanical implant.

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

This question is not applicable. The device is a mechanical implant (intramedullary fixation rod), not an algorithm or AI. The performance demonstrated is intrinsic to the device's physical and mechanical properties.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established by objective, measurable mechanical properties and performance characteristics derived from:

• Computational assessments (e.g., "IMN Screws DOF 25-039 Functional Interface Analysis-Locking Screws").
• Mechanical testing (e.g., "dynamic fatigue strength testing").
• Statistical comparisons against predicate devices ("Student t-tests").

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The data presented is from verification and validation testing of a mechanical device.

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

Not applicable, as there is no training set for this device.

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The T2 Femoral Nail System is a fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps. The T2 Femoral Nail System is intended to provide strong and stable fixation with minimal soft tissue irritation. This device is intended to provide fixation not as a substitute for normal intact bone and tissue.

The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may include the following:

• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Supracondylar fractures, including those with intra-articular extension
• Ipsilateral femur fractures
• Fractures proximal to a total knee arthroplasty
• Fractures distal to hip joint
• Nonunions and malunions

The T2 Femoral nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 Femoral Nail is inserted into the femoral canal using either a retrograde or antegrade surgical approach. The T2 Femoral Nail is currently available in diameters ranging from 8 to 15 mm and lengths ranging from 140 to 480 mm. Additional sizes will offer 16 and 17 mm diameters.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the T2 Femoral Nail, formatted as requested.

Introduction:

The provided document describes a 510(k) submission for modifications to the T2 Femoral Nail system, specifically the introduction of larger diameters (16 and 17 mm). The submission asserts that these modifications do not alter the intended use, material, or operational principles of the previously cleared predicate devices.

Acceptance Criteria and Device Performance:

The document implicitly defines the acceptance criteria as demonstrating that the modified device (T2 Femoral Nail with 16 and 17 mm diameters) maintains at least equivalent safety and effectiveness to its predicate devices.

Study Details:

The provided text describes a study that was performed to demonstrate the substantial equivalence of the modified T2 Femoral Nail.

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

   • Sample Size: Not explicitly stated as a numerical count of individual devices. It refers to "worst case predicate T2 Femoral Naily equivalent subject devices" and "the new 16 and 17mm diameter sizes." This implies a limited number of samples representing these specific configurations were tested.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The testing would have been conducted by Howmedica Osteonics Corp. or a contracted lab. It is inherently retrospective in the sense that it evaluates the modified device against pre-existing predicate devices.

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

   • Not applicable/Not mentioned. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical trials) where expert consensus is needed to define a "ground truth" for diagnostic accuracy. For a mechanical device, performance is typically measured against engineering specifications and industry standards, not expert-established "ground truth." The "ground truth" here is the expected mechanical performance and safety profile, established through engineering principles.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts. For mechanical testing, results are objective measurements and do not require expert adjudication in this manner.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI systems on human performance, often in diagnostic or imaging contexts. The T2 Femoral Nail is a mechanical implant, and the study described focuses on its physical properties and safety, not on human interpretation or AI assistance.

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

   • Yes, essentially a "standalone" performance evaluation was done for the device itself. The study focused purely on the mechanical properties and engineering analysis of the T2 Femoral Nail with the new diameters. There is no algorithm or human-in-the-loop component in this context. The device's performance was evaluated based on its inherent physical characteristics.

6. The type of ground truth used:

   • Engineering Principles, Mechanical Performance Standards, and Predicate Device Performance Data: The "ground truth" for this study is effectively the established safety and effectiveness profile of the predicate devices and general mechanical engineering principles applied to medical implants. The new devices must meet or exceed these established benchmarks.

7. The sample size for the training set:

   • Not applicable/Not mentioned. In the context described, there is no "training set" in the machine learning sense. The device's design is based on established engineering principles and prior device iterations, not on training data for an algorithm.

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

   • Not applicable. There is no training set mentioned or implied in the context of this mechanical device submission.

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The T2™ Femoral Nail System is a fracture fixations device comprised of femoral nails and the related locking screws, compression screws, and end caps. The T2™ Femoral Nail System is intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

The T2™ Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may include the following:

• Open and closed femoral fractures .
• Pseudoarthrosis and correction osteotomy .
• Pathologic fractures, impending pathologic fractures, and tumor resections ●
• Supracondylar fractures, including those with intra-articular extension .
• Ipsilateral femur fractures .
• Fractures proximal to a total knee arthroplasty .
• Fractures distal to hip joint ●
• Nonunions and malunions .

The T2™ Femoral Nail is a line extension to the T2™ Femoral Nail System. The T2TM Femoral Nail, in combination with the accessories from the predicate T2™ Femoral Nail Systems, is designed to treat various types of fractures of the femur.

This document describes a 510(k) premarket notification for a line extension to the T2™ Femoral Nail system. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing a study demonstrating performance against specific acceptance criteria. This type of submission relies on engineering analysis and comparison to existing devices. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable to this document.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific numeric or qualitative acceptance criteria are provided in the document, nor is there a study detailing the device's performance against such criteria. The document states that "An engineering analysis demonstrated comparable strengths to the predicate components and is substantially equivalent to these devices." This implies that the 'acceptance criteria' are met by demonstrating equivalence to the predicate device's established performance characteristics, which are not detailed here.

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

Not applicable. This submission relies on an engineering analysis and comparison to a predicate device, not clinical or performance testing with a 'test set' of subjects/data in the way described for AI/diagnostic devices.

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

Not applicable. See point 2.

4. Adjudication Method for the Test Set:

Not applicable. See point 2.

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

No. This is a medical device (intramedullary nail) submission, not an AI or diagnostic device that would typically involve an MRMC study.

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

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

7. The Type of Ground Truth Used:

Not applicable in the context of clinical "ground truth" as typically used for AI/diagnostic devices. The "ground truth" in this context is the established performance and safety profile of the predicate T2™ Femoral Nail system, which the new device aims to be substantially equivalent to, as supported by an engineering analysis.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI/machine learning model that requires a "training set."

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

Not applicable. See point 8.

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The T2" Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may include the following:

• Open and closed femoral fractures .
• . Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections .
• Supracondylar fractures, including those with intra-articular extension .
• Ipsilateral femur fractures .
• . Fractures proximal to a total knee arthroplasty
• Fractures distal to a hip joint .
• Nonunions and malunions .

The T2 Femoral nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach. The T2 Femoral Nail is available in diameters ranging from 9 to 15 mm and lengths ranging from 180 to 480 mm.

The provided document is a 510(k) summary for a medical device (T2 Femoral Nail System) and does not contain information about a study that assesses the device's performance against pre-defined acceptance criteria.

This submission is a "line extension" for an existing device, adding new shorter nail lengths. The core of the submission relies on demonstrating "substantial equivalence" to a predicate device, meaning the new versions are considered to have the same intended use, technological characteristics, and safety/effectiveness as the previously cleared device.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth details, MRMC study, or standalone algorithm performance) from the provided text. The document focuses on regulatory compliance based on equivalence rather than a new performance study for the device itself.

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The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may include the following:

• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Supracondylar fractures, including those with intra-articular extension
• Ipsilateral femur fractures
• Fractures proximal to a total knee arthroplasty
• Fractures distal to a hip joint
• Nonunions and malunions

The subject T2 Femoral Nail System is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, condyle screws/nuts and end caps.

The provided text is a U.S. FDA 510(k) summary for a medical device modification, specifically for the T2 Femoral Nail System. It describes the device, its intended use, and its substantial equivalence to a predicate device.

After reviewing the document, it's clear that it does not contain any information about acceptance criteria, study performance data, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance. The document is a regulatory submission for a device modification and asserts "comparable properties of the subject to the predicate device" but does not provide any detailed study or test results that would be necessary to answer the questions posed.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The necessary information for almost all parts of your request (1 through 9) is absent from this regulatory document.

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Ask a specific question about this device