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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® Recon Nail System is a fracture fixation device comprised of Femoral Nails and the related accessories such as Washers, Locking Screws, Set Screws, End Caps, and Lag Screws. The subject and predicate devices are 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® Recon Nail indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

The T2® Recon Nail System is a family of IM Nails for various types of femoral fractures. This Special 510(k) submission is a line extension to the T2® Recon Nail System to add an alternate design of Set Screw to the system. There is no change in intended use for the subject device, which is provided below.

The provided text is a 510(k) summary for a medical device (T2® Recon Nail System Line Extension) and does not contain detailed information about acceptance criteria or a study that proves the device meets specific performance metrics in the way typically found for AI-driven or diagnostic devices.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. For medical implants like this, the "study" is primarily mechanical and functional testing, and "acceptance criteria" are based on meeting established standards or demonstrating equivalence to the predicate device's performance.

Here's an attempt to extract the information you requested, based on the provided text, and highlighting what is not available in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a device like an intramedullary nail, specific numerical acceptance criteria (e.g., fatigue strength, torsional stiffness, bending strength) would be defined in testing protocols but are not detailed in this 510(k) summary. The summary focuses on assuring the FDA that the new device performs "comparably" to the already-cleared predicate.

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

This information is not available in the provided 510(k) summary. For mechanical tests, the "sample size" would refer to the number of devices tested, not human subjects or data sets. The data provenance would be from internal lab testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable to this type of device submission. Ground truth, in the context of device performance, relates to mechanical and material properties, not expert-derived clinical outcomes or image interpretations.

4. Adjudication Method for the Test Set

This is not applicable to this type of device submission. Adjudication methods are typically used for clinical endpoints or image interpretation, not for mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable to this type of device. MRMC studies are used for diagnostic imaging devices to assess human reader performance with and without AI assistance. This device is a surgical implant.

6. Standalone (Algorithm Only) Performance Study

This is not applicable to this type of device. There is no algorithm for this implant.

7. Type of Ground Truth Used

For this device, the "ground truth" would be established through engineering standards, material specifications, and validated mechanical testing methods. The performance of the predicate device would also serve as a reference for comparison.

8. Sample Size for the Training Set

This is not applicable to this type of device. There is no "training set" in the context of mechanical device testing; this term applies to machine learning algorithms.

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

This is not applicable for the same reasons as above.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided text, the study that proves the device meets acceptance criteria is:

• Functional and mechanical testing: "Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject T2® Recon Nail System to the predicate device."

The core thrust of this 510(k) submission is to demonstrate substantial equivalence to an existing legally marketed predicate device (also the T2® Recon Nail System, but presumably an earlier version or one without the new set screw design). The "acceptance criteria" are thus implicitly met if the new design performs comparably to the predicate device in terms of materials, intended use, indications for use, and mechanical/functional properties. Specific test results and detailed criteria are usually found in the full 510(k) submission, not typically in the public summary.

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The T2® Recon Nail indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

The T2® Recon Nail System is a family of IM Nails for various types of femoral fractures. This Special 510(k) submission is a line extension to the T2® Recon Nail System to add an alternate material. The subject T2® Recon Nail System is a fracture fixation device comprised of Femoral Nails and associated instruments, Locking Screws, Set Screws, End Caps, and Lag Screws. The subject and predicate devices are intended to provide strong and stable internal fracture fixation while minimizing soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

The provided text describes a 510(k) submission for a line extension to the T2® Recon Nail System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for novel devices.

Therefore, many of the typical elements of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic or AI-based devices are not applicable to this submission. This is a claim of equivalent performance to an existing device, not a claim of specific performance metrics against a clinical standard.

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

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

• Acceptance Criteria: In a 510(k) for a line extension to an existing device, the "acceptance criteria" is typically demonstrating substantial equivalence to the predicate device. This means the new device performs at least as well as, and is as safe as, the predicate device. For mechanical devices like IM nails, this often involves showing comparable mechanical properties.
• Reported Device Performance: The submission states: "The subject device is made of titanium alloy and PEEK while the predicate device is made of titanium alloy. Mechanical testing demonstrates the comparable mechanical properties of the subject T2® Recon Nail System to the predicate device."

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

• Not Applicable (N/A): This is a 510(k) for a mechanical device (intramedullary nail system). It relies on mechanical testing rather than clinical or performance data from human "test sets" in the way an AI/diagnostic device would. The "sample size" would refer to the number of devices tested mechanically, which is not specified in this summary.
• Data Provenance: The text does not provide information on the country of origin of the mechanical testing data, nor whether it was retrospective or prospective, as these are not standard reporting requirements for this type of submission summary.

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)

• Not Applicable (N/A): This submission does not involve establishing ground truth by human experts in the context of clinical diagnostic accuracy. The assessment is based on engineering principles and mechanical testing of the device's physical properties.

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

• Not Applicable (N/A): No adjudication method is mentioned or relevant, as this is for mechanical device testing, not clinical "test sets" requiring expert review for ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable (N/A): This is a mechanical device, not an AI or diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

• Not Applicable (N/A): This is a mechanical device, not an algorithm.

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

• Mechanical Equivalence: For this type of submission, the "ground truth" is typically established by accepted engineering standards and physical measurements demonstrating the mechanical properties (e.g., strength, fatigue life) of the device are comparable to the predicate device. The text states "Mechanical testing demonstrates the comparable mechanical properties."

8. The sample size for the training set

• Not Applicable (N/A): This is a mechanical 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 (N/A): See point 8.

In summary:

The K051624 submission for the T2® Recon Nail System Line Extension is a 510(k) for a mechanical medical device. The primary "study" that proves it meets the "acceptance criteria" of substantial equivalence is mechanical testing. This testing would compare the physical and performance characteristics of the new device (made of titanium alloy and PEEK) against the predicate device (made of titanium alloy) to ensure they are comparable, especially concerning strength, durability, and biocompatibility (though biocompatibility isn't explicitly mentioned beyond material composition). The details of the specific mechanical tests (e.g., torsion, bending, fatigue) and the number of specimens tested are not included in this summary document.

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The T2 Recon Nail indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

The subject T2 Recon Nail System is a fracture fixation device comprised of femoral nails and the related accessories such as washers, locking screws, end caps, and lag screws. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation of the tibia and femur. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

This document describes a Special 510(k) submission for the T2 RECON Tibial Nail System, which is a medical device for fracture fixation. However, the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML powered device.

The document is a regulatory submission for a physical medical implant (a tibial nail system). The evaluation of such devices typically involves:

• Mechanical Testing: Assessing the strength, fatigue life, and other physical properties of the implant.
• Material Compatibility Testing: Ensuring the materials are biocompatible.
• Design Verification: Confirming the new design meets specifications.
• Comparison to Predicate Device: Demonstrating substantial equivalence to a legally marketed device, often through bench testing and sometimes animal or limited human studies (though not typically for a 510(k) unless specifically requested).

The text explicitly mentions: "FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject T2 Recon Nail System to the predicate devices." This is the core evidence presented for this type of device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them in the context of an AI/ML powered device, as the provided text is for a physical orthopedic implant.

If you are looking for information regarding an AI/ML powered medical device, please provide a different input document.

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