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The indications for use of this internal fixation device include:

• Open and closed tibial fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Fractures involving osteopenic and osteoporotic bone
• Nonunion and malunion
  The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The T2 Alpha Tibia Nailing System is a fracture fixation system and includes sterile implants (tibial nails in various diameters, compression screw tibia and end caps) as well as non-sterile instruments (targeting devices). The sterile implants are made of titanium alloy (Ti6A14V ELI) per ASTM F136. The adapters and nail holding screws are manufactured from stainless steel. The Targeting Arm Tibia and Adjusting Device Tibia are made of stainless steel. PEEK unreinforced as well as PEEK with 30% and 50% carbon fibers. The Distal Targeting Arm Tibia is made of PEEK with 30% and 50% carbon fibers.

The IMN Screws System includes bone screws (locking screws and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. All screws are made of titanium allov (Ti6Al4V ELI) per ASTM F136.

The provided FDA 510(k) summary (K193308) for the Stryker T2 Alpha Tibia Nailing System and IMN Screws System does not contain information related to software-based medical devices, AI/ML performance, or human-reader studies. Therefore, I cannot extract the acceptance criteria and study details as requested for such systems.

The document discusses implantable medical devices (intramedullary rods and bone screws) and focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and material compatibility analyses.

Here’s a breakdown of what is available in the document, which falls under traditional medical device clearance, not AI/software:

1. Table of Acceptance Criteria and Reported Device Performance

This table would typically be relevant for software performance metrics (e.g., sensitivity, specificity, AUC). For this device, the "acceptance criteria" are implied by the mechanical testing standards and successful demonstration of substantial equivalence.

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

This information is not applicable. The "test set" here refers to physical samples for mechanical and biological testing, not a dataset for an AI model.

• Sample Size: Not specified in terms of number of devices tested, but mechanical tests were performed.
• Data Provenance: Not applicable in the context of clinical data for AI. These are laboratory-based mechanical and material test results.

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

Not applicable. "Ground truth" in this context would be the physical properties confirmed by mechanical tests and material analyses, not human interpretation of medical images or data.

4. Adjudication Method

Not applicable. There is no adjudication process described for the mechanical test results.

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

No. The document explicitly states: "No clinical testing of the T2 Alpha Tibia Nailing System has been conducted." and "No clinical testing of the IMN Screws System has been conducted."

6. Standalone (Algorithm Only) Performance

Not applicable. This device is not an algorithm or software.

7. Type of Ground Truth Used

For mechanical testing, the "ground truth" is defined by the physical behaviors and material properties measured according to established ASTM standards (e.g., ASTM F1264 for intramedullary fixation rods, ASTM F543 for metallic bone fixation fasteners). For MR compatibility, it relates to the measured displacement, torque, heating, and artifact characteristics in an MR environment. For bacterial endotoxin, it refers to a specified endotoxin limit.

8. Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of AI/ML.

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

Not applicable.

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The indications for use of these internal fixation devices include:

• Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, 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
• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Ipsilateral femur fractures
• Fractures proximal to a total knee arthroplasty
• Nonunions and malunions
• Fractures involving osteopenic and osteoporotic bone

The indications for use of this internal fixation device include:

• Open and closed tibial fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Fractures involving osteopenic and osteoporotic bone
• Nonunion and malunion
  The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The IMN Instruments System is intended to enable the implantation of intramedullary nail and screw.

A Special 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to the existing T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System and IMN Instruments System previously cleared in K180436. Modifications include an increase of shelf-life from 5 years to 10 years for the sterile implants and a change of dimensional specifications for the Advanced Locking Screw, Targeting Arm Femur GT and Targeting Arm Femur PF.

The T2 Alpha Femur Antegrade GT/PF Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw femur, set screws and end caps) as well as non-sterile instruments (targeting devices).

The T2 Alpha Tibia Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (tibial nails in various diameter, compression screw tibia and end caps) as well as non-sterile instruments (targeting devices).

The IMN Screws System previously cleared in K180436 includes bone screws (locking screws and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct.

The IMN Instruments System includes the distal targeting device femur antegrade previously cleared in K180436. There are also associated surgical instruments (class I devices) that support the implantation and extraction of intramedullary nails and screws.

This document describes a Special 510(k) Premarket Notification for modifications to existing intramedullary nailing systems (T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, and IMN Instruments System). The submission's purpose is to demonstrate substantial equivalence to the previously cleared predicate device (K180436) for these modifications.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states: "No clinical testing of the T2 Alpha Femur Antegrade GT/PF Nailing System has been conducted." This indicates that there was no "test set" in the context of clinical performance evaluation. The data provenance supporting the modifications (shelf-life increase and dimensional changes) would be from in-house engineering and quality testing, likely conducted by Stryker Trauma GmbH in Schoenkirchen, Germany. These are likely retrospective data based on existing product infrastructure.

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

As no clinical testing was conducted and the performance data primarily relates to engineering and quality assessments for modifications, there is no mention of "experts" establishing ground truth in the context of a clinical test set. The validation would have been performed by qualified engineers and quality control personnel within Stryker Trauma GmbH.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication by experts was used for this Special 510(k) submission.

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

No MRMC comparative effectiveness study was mentioned or performed. The submission is for modifications to an existing device, and clinical efficacy was not under evaluation, nor was comparison with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable, as this device is a physical medical implant system, not a software algorithm or AI-powered device.

7. Type of Ground Truth Used:

The "ground truth" for this submission's modifications primarily relies on:

• Engineering specifications and data: For dimensional changes, ensuring the modified components still meet their intended design parameters.
• Packaging integrity and sterility data: For the shelf-life extension, ensuring the packaging maintains sterility and functionality over the new extended period.
• Risk analysis methodology: As per DIN EN ISO 14971, to confirm that the changes do not introduce new hazards or increase existing risks.

These are established through internal quality and engineering testing, not clinical outcomes, pathology, or expert consensus on patient data.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.

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

Not applicable, for the reasons stated above.

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The indications for use of this internal fixation device include:

• Open and closed tibial fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Fractures involving osteopenic and osteoporotic bone
• Nonunion and malunion
  The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.

The indications for use of these internal fixation devices include:

• Fixation of subtrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaff 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
• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Ipsilateral femur fractures
• Fractures proximal to a total knee arthroplasty
• Nonunions and malunions
• Fractures involving osteopenic and osteoporotic bone

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The IMN Instruments System is intended to enable the implantation of intramedullary nail and screw.

The T2 Alpha Tibia Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter, compression screw and end caps) as well as non-sterile instruments (targeting devices). The sterile implants are made of titanium alloy (Ti6A14V ELI) as per ASTM F136. The T2 Alpha Tibia Nailing System will be used with the locking screws cleared in K003018 (Titan Tibial Nail) and K172774 (IMN Screws System). Further, End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System can be used with T2 Alpha Femur Antegrade GT/PF Nailing System (K172774). The T2 Alpha Tibia Nailing System will be used with the existing instruments previously cleared in K131365 (T2 Tibial Nailing System) and 510(k) exempt devices. The T2 Alpha Tibia Nailing System is intended for use with IMN Screws System and IMN Instruments System.

The IMN Screws System includes bone screws (locking screws previously cleared in K172774 and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. The screws are made of titanium alloy (Ti6A14V ELI) as per ASTM F136. The IMN Screws System is intended for use with T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Instruments System.

The IMN Instruments System includes distal targeting device femur antegrade previously cleared in K172774 as well as surgical instruments that support the implantation and extraction of intramedullary nails and screws. The IMN Instruments System is intended for use with T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Screws System.

The T2 Alpha Femur Antegrade GT/PF Nailing System previously cleared in K172774 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw, set screws and end caps) as well as non-sterile instruments.

The T2 Alpha Femur Antegrade GT/PF Nailing System will be used with the locking screws originally cleared in K003018 (Titan Tibial Nail) that have subsequently also received clearance for use in locking femoral nailing systems (K010801, T2 Femoral Nail System) as well as locking screws previously cleared in K172774 (IMN Screws System) and the T2 Lag Screw Recon previously cleared in K032898 (T2 Recon Nail System). Further, it will be used with the existing instruments previously cleared in K172774 (IMN Instruments System) and 510(k) exempt devices. The T2 Alpha Femur Antegrade GT/PF Nailing System is intended for use with IMN Screws System and IMN Instruments System.

The provided document is a 510(k) Premarket Notification for a medical device, specifically orthopaedic implants and instruments (T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, and IMN Instruments System).

This document does not describe a study involving an AI or software-as-a-medical-device (SaMD) product that requires human-in-the-loop or standalone performance evaluation with clinical data and expert ground truth. Instead, it focuses on demonstrating substantial equivalence of traditional medical devices to previously cleared predicate devices through bench testing and biocompatibility assessments. Therefore, most of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment methods, MRMC studies, and effect sizes of AI assistance are not applicable to this type of submission.

The document describes non-clinical performance data primarily from bench testing to demonstrate the substantial equivalence of the new devices or line extensions to previously cleared devices.

Here's a breakdown of the applicable and non-applicable information based on the provided text:

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

The document does not provide a quantitative table of acceptance criteria and reported device performance in the format typically seen for AI/SaMD studies. Instead, it states that "Testing demonstrated that T2 Alpha Tibia Nailing System is equivalent in mechanical performance to the predicate devices (K003018, K082770, and K040762)." Similar statements are made for the other systems.

The types of tests performed indicate the implicit acceptance criteria:

• T2 Alpha Tibia Nailing System:
  • Testing of mechanical properties per ASTM F1264
  • Fatigue strength testing (proximal and distal)
  • Cut-out testing
  • Targeting accuracy testing
  • Biocompatibility testing (ISO 10993-1, -5, -18)
  • Bacterial Endotoxin Testing
• IMN Screws System (advanced locking screws):
  • Testing of mechanical properties as per ASTM F543
  • Biocompatibility assessment (ISO 10993-1)
  • Bacterial Endotoxin Testing
• IMN Instruments System:
  • Performance testing in cadaver lab
  • Compatibility evaluation
  • Biocompatibility testing (ISO 10993-1, -5, -18)
• T2 Alpha Femur Antegrade GT/PF Nailing System:
  • Compatibility assessment

The reported "performance" is primarily a statement of equivalence or suitability to the predicate devices based on these tests. No specific numerical thresholds or results are presented.

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

This information is not provided in typical AI/SaMD study terms. The "test set" here refers to samples of the physical medical devices used in bench testing. The document does not specify the number of physical samples tested for each mechanical or biocompatibility test. Data provenance in terms of 'country of origin of data' or 'retrospective/prospective' is not relevant as it's not a clinical study on human subjects with data collection over time.

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. Ground truth in the context of this submission refers to the established mechanical properties, biocompatibility standards, and functional performance of the devices as measured by standardized tests. It does not involve expert readers reviewing clinical cases.

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

Not applicable. There is no adjudication method described as it is not a clinical study requiring consensus among multiple readers.

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. This submission is for traditional medical devices (implants and instruments), not an AI/SaMD product. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This document describes physical medical devices, not an algorithm.

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

The "ground truth" for this submission is established through objective, standardized bench testing for mechanical properties, biocompatibility standards (e.g., ISO standards), and functional performance (e.g., targeting accuracy, cadaver lab performance). It is not derived from expert consensus on medical images, pathology, or clinical outcomes data.

8. The sample size for the training set

Not applicable. This is not an AI/ML product that requires a training set.

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

Not applicable. This is not an AI/ML product that requires a training set.

In summary, this 510(k) submission for conventional orthopaedic devices focuses on demonstrating substantial equivalence through non-clinical bench testing and adherence to recognized standards, rather than clinical studies or evaluations of AI performance. Therefore, most of the detailed questions about acceptance criteria, sample sizes, expert involvement, and ground truth establishment methods as typically understood for AI/SaMD products are not relevant to this document.

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The Hoffmann LRF (Limb Reconstruction Frame) System is intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.

The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:

• Open and Closed Fractures .
• Post-traumatic joint contracture which has resulted in loss of range of motion .
• . Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis or non-union of long bones .
• Limb lengthening by epiphyseal or metaphyseal distraction .
• Correction of bony or soft tissue deformity .
• Correction of segmental bony or soft tissue defects .
• Joint arthrodesis .
• Management of comminuted intra-articular fractures of the distal radius

The Stryker Hoffmann LRF System is indicated in adults for:

• Osteotomy .
• . Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures .
• Fusions and replantations of the foot t
• Charcot foot reconstruction ●
• Lisfranc dislocations

The Hoffmann LRF System is an external fixation device that consists of Carbon and Aluminum Full/Open rings and ring segments, Aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolts, wire bolt offset adapters, pin bolts and pin adapters. This external fixation system may also be used with the components in other Howmedica Osteonics external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II MRI External Fixation System, and the Stryker Trauma Pelvic Set and in conjunction with commercially available Apex Pins, Hoffmann II External Fixation 90° Post, Carbon Connecting Rod and Miami Post.

The provided text pertains to a 510(k) premarket notification for the Hoffmann LRF (Limb Reconstruction Frame) System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical performance studies with specific statistical acceptance criteria.

Therefore, the information requested for acceptance criteria, device performance, sample sizes used for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable (N/A) in this context, as a clinical performance study with such metrics was explicitly not required for this 510(k) submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not Applicable (N/A) - No clinical test set was used.
• Data Provenance: Not Applicable (N/A) - No clinical data was used for a test set.

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

• Number of Experts: Not Applicable (N/A) - No clinical test set requiring expert ground truth was performed.
• Qualifications of Experts: Not Applicable (N/A)

4. Adjudication Method for the Test Set

• Adjudication Method: Not Applicable (N/A) - No clinical test set requiring adjudication was performed.

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

• MRMC Study Done: No.
• Effect Size: Not Applicable (N/A) - This device is an external fixation system, not an AI-assisted diagnostic tool.

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

• Standalone Study Done: No. This device is an external fixation system, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not Applicable (N/A) - No clinical ground truth was established for performance evaluation against a specific diagnostic or prognostic outcome. The "ground truth" in this context refers to the material and mechanical properties of the device meeting established engineering standards and being comparable to predicate devices.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not Applicable (N/A) - No training set was used as this is not an AI/machine learning device.

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

• Ground Truth Establishment for Training Set: Not Applicable (N/A) - No training set was used.

Summary of the Study that Proves the Device Meets the Acceptance Criteria (Substantial Equivalence):

The Hoffmann LRF (Limb Reconstruction Frame) System demonstrated substantial equivalence by means of non-clinical laboratory testing.

• Study Design/Methodology: Non-clinical testing was performed in compliance with ASTM F1541-02 - "Standard Specification and Test Methods for External Skeletal Fixation Device."
• Tests Conducted: The testing included:
  • Static and dynamic frame testing.
  • Wire Strength testing.
  • Compression testing.
  • Bending testing.
  • Slipping testing.
  • Splitting testing on frame components.
• Conclusion of Testing: The testing "demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System is substantially equivalent to devices currently cleared for marketing."
• Predicate Devices: The device was compared to the following predicate devices to establish substantial equivalence in intended use, materials, and performance characteristics:
  • K031181 External Fixation Systems (Smith & Nephew)
  • K041706 Hoffman II Foot Ring
  • K003018 Titan Tibial Nail (T2 Nail)
• Clinical Testing: The submission explicitly states: "Clinical testing was not required for this submission." This reinforces that the evaluation was based on non-clinical, mechanical, and material comparisons to existing devices.

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