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The T2 Alpha Humerus Nailing System is indicated for the treatment of humerus fractures. Fractures can include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures.

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

The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions, and non-unions of the humerus. The nails are inserted using an open or closed technique and can be static, dynamic, or compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but are not limited to, fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

The T2 Alpha Humerus Nailing System is an intramedullary humerus fracture nailing system consisting of sterile implants (Nails, End Caps, Compression Screw, and Washer) and non-sterile indication-specific instrumentation. The Nails, End Caps, Compression Screw, and Washer are made of titanium alloy as per ASTM F136. The T2 Alpha Humerus Nailing System will be used with the existing Locking Screws and Advanced Locking Screws of the IMN Screws System.

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 sterile and made of titanium alloy (Ti6Al4V ELI) per ASTM F136.

The T2 Humeral Nail System is an intramedullary nailing system that allows antegrade and retrograde humeral nailing. The nails, end caps, compression screw, and washer are provided sterile and made of titanium alloy as per ASTM F136.

The provided FDA 510(k) clearance letter (K251400) does not concern an AI/software device. Instead, it pertains to a physical medical device: the Stryker T2 Alpha Humerus Nailing System, IMN Screws System, and T2 Nailing System, which are intramedullary fixation rods and bone screws used for treating humerus fractures.

Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/software performance metrics (e.g., accuracy, sensitivity, specificity, F1-score, expert consensus, MRMC studies) are not applicable to this submission.

The document discusses non-clinical performance testing for the physical device, focusing on mechanical properties, sterilization, packaging, and biocompatibility, to demonstrate substantial equivalence to previously cleared predicate devices.

Key points from the document regarding "performance":

• Non-Clinical Performance: This section details various engineering and material tests performed on the physical implants, such as dynamic and static bending, torsional stiffness, targeting accuracy, insertion torque, pull-out force, MRI assessment (magnetically induced displacement/torque, RF-induced heating, image artifacts), packaging tests, and biocompatibility evaluation. All these tests are standard for orthopedic implants.
• Clinical Performance: The document explicitly states: "Clinical data were not needed for the subject devices to demonstrate substantial equivalence to the predicate devices." This is a common situation for 510(k) submissions of physical devices where substantial equivalence can be demonstrated through non-clinical testing and comparison to predicates.

Since the request asks for information relevant to AI/software device performance, and this document is for a physical orthopedic device, I cannot extract the requested information (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) because it is not present and not relevant to this specific biological device 510(k) submission.

In summary, there is no AI/software component in this device clearance that would require the types of performance statistics and study methodologies described in the prompt.

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The A.L.P.S Proximal Humerus Plating System is indicated for fixation of fractures and fracture dislocations, fusions, osteotomies and non-unions of the humerus, particularly in osteopenic bone.

The A.L.P.S. Proximal Humeral Plating System is made from a titanium alloy and is available in configurations for both the left and right sides, as well as in various lengths. This system includes both locking and non-locking screws/pegs, along with multidirectional screws crafted from titanium alloy and cobalt chromium. It comes complete with general orthopedic instrumentation and system-specific instruments designed for use during implant installation.

Implants are available in both gamma-sterilized and non-sterile options. The disposable instruments are provided only in a sterile condition, while the reusable instruments are offered non-sterile, allowing users to perform steam sterilization before use.

This FDA 510(k) clearance letter is for a medical device called the "A.L.P.S. Proximal Humerus Plating System," which is a metallic bone fixation appliance. As such, it is not an AI/ML (Artificial Intelligence/Machine Learning) device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI device is not applicable to this submission.

The FDA clearance for this device is based on comparing its technological characteristics and intended use to a legally marketed predicate device (K143697 - Biomet Proximal Humerus Plating System) and demonstrating substantial equivalence through non-clinical mechanical testing, rather than an AI performance study.

Summary of available information relevant to device performance and clearance (not AI-related):

• Acceptance Criteria & Reported Performance: The document states that the subject device's performance was evaluated through non-clinical testing. These tests include:

  • Implant Construct Axial Load Static Testing (for plates)
  • Implant Construct Axial Load Fatigue Testing (for plates)
  • Screw and Peg Performance Testing
  • The conclusion is that "any differences do not raise any different questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate devices." Specific numerical acceptance criteria and reported performance values from these mechanical tests are not provided in this clearance letter.

• Study Type: Non-clinical (mechanical) testing, not a clinical or AI performance study.

• Sample Size (Test Set): Not applicable in the context of an AI device's test set. For mechanical testing, the number of implants/constructs tested would be used, but this is not specified.

• Data Provenance (Test Set): Not applicable for an AI device. The "data" here refers to the results from mechanical testing of the device components.

• Number of Experts & Qualifications (Ground Truth for Test Set): Not applicable, as no expert-derived ground truth for an AI model's output is relevant here.

• Adjudication Method (Test Set): Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not conducted, as this is not an AI-assisted device.

• Standalone Performance (Algorithm Only): Not applicable, as there is no algorithm.

• Type of Ground Truth Used: Not applicable in the AI sense. The "ground truth" for this device would be established engineering standards and physical measurements from the mechanical tests.

• Sample Size for Training Set: Not applicable, as there is no AI model.

• How Ground Truth for Training Set was Established: Not applicable.

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The LORRAINE 2.5/3.5mm Distal Humerus System is indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. The subject LORRAINE 2.5/3.5mm Distal Humerus System is a variant of the Bonebridge Osteosynthesis Plating System.

The plates are primarily manufactured from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139) and include Titanium Inlay Clips (TICs) made from pure titanium (ASTM F67 or ISO 5832-2). The screws are manufactured entirely from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139).

All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the implants are MR Conditional.

The provided document is a 510(k) summary for the LORRAINE 2.5/3.5mm Distal Humerus System. It describes the administrative information, device classification, predicate devices, indications for use, device description, and a summary of non-clinical tests.

However, this document does NOT contain information about any study involving Artificial Intelligence (AI) or machine learning, human readers, or image-based diagnostics. The device described is a metallic bone fixation appliance, specifically plates and screws, used for orthopedic applications (fractures, osteotomies, non-unions of the distal humerus).

Therefore, I cannot extract the information required by your prompt, such as:

• Acceptance criteria and reported device performance related to AI/ML.
• Sample sizes for test or training sets, data provenance, expert ground truth establishment, or adjudication methods, as these relate to studies involving AI/ML performance.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth (expert consensus, pathology, outcomes data) in the context of AI/ML.

The "studies" described in the document are non-clinical tests related to the physical device itself:

• Sterilization validation: Ensuring the device can be properly sterilized.
• Packaging validation: Ensuring the sterile packaging integrity.
• Biocompatibility: Assessing the safety of the materials in a biological environment.
• Mechanical testing: Evaluating the strength and stiffness of the plates and screws, comparing them to predicate devices. This involves mechanical stresses, not data analysis or human-in-the-loop performance.
• MRI safety: Determining if the device is safe for patients undergoing MRI scans.

All these tests are standard for orthopedic implants and are designed to demonstrate the physical and material properties and safety of the device, not an AI or data-driven component.

Therefore, it is impossible to answer your request based on the provided text, as the text describes a physical medical device (orthopedic implant) and not an AI/ML powered device.

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The Proximal Humerus Fixtion System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The Skeletal Dynamics Proximal Humerus Fixation System is a set of medical-grade Titanium Alloy (Ti-6Al-4V ELI) bone plates and Titanium and Cobalt Chrome (CoCr) screws and pegs designed for the stabilization and repair of fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus in conjunction with general and specialized instrumentation. The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.

This document is a 510(k) K242436 FDA clearance letter for the Skeletal Dynamics Proximal Humerus Fixation System. It primarily focuses on demonstrating substantial equivalence to existing devices through performance testing, rather than reporting on a study with acceptance criteria and device performance as typically seen for AI/ML-based devices. Therefore, a direct response to some of the requested categories (like number of experts, adjudication method, MRMC study, training set details) will not be available in this document.

Here's the information extracted from the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This device is a mechanical fixation system, not a software or AI/ML device that uses a "test set" of data in the common sense. The "testing" refers to mechanical performance testing of the hardware components.

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

Not applicable. Ground truth, in the context of expert consensus, is not relevant for the mechanical testing of this hardware device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used for evaluating human or AI interpretations of medical images or data, not for the mechanical testing of orthopedic implants.

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

No. This document does not mention any MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a medical device (orthopedic implant), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance of this mechanical device is based on established engineering standards and measurements as defined by ASTM F382-17 for plates and ASTM F543-23 for screws. The comparison is made against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (orthopedic implant), not an AI/ML algorithm that requires a training set.

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

Not applicable. This is a medical device (orthopedic implant), not an AI/ML algorithm that requires a training set.

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Pangea Platform:
The Pangea Platform is indicated for the internal fixation and stabilization of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including:

• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• Non-unions, malunions, and deformities
• Periprosthetic fractures
  The Pangea Platform is also indicated for children (2-12 years) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.

Pangea Femur Plating System:
The Pangea Femur Plating System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including:

• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• Non-unions, malunions, and deformities
• Periprosthetic fractures

Pangea Tibia Plating System:
The Pangea Tibia Plating System is indicated for the internal fixation and stabilization of tibia bone fractures and osteotomies in normal and osteopenic bone, including:

• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• Non-unions, malunions, and deformities
• Periprosthetic fractures

Pangea Humerus Plating System:
The Pangea Humerus Plating System is indicated for the internal fixation and stabilization of humerus bone fractures and osteotomies in normal and osteopenic bone, including:

• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• Non-unions, malunions, and deformities
• Periprosthetic fractures

This traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the Pangea Platform, Pangea Femur Plating System, Pangea Humerus Plating System, and Pangea Tibia Plating System. This line extension consists of Class II instruments intended to assist in targeting.

The provided text describes a 510(k) premarket notification for the Stryker Pangea Platform and related plating systems. This document outlines the regulatory review and clearance of a medical device based on substantial equivalence to a predicate device, rather than a study demonstrating the device meets acceptance criteria through its own performance evaluation.

Specifically, the text states for "Performance Data":

• Non-Clinical Performance: "The new subject devices... are reusable and provided non-sterile. Comparative assessment to the predicate and reference systems demonstrated substantial equivalence. Testing was performed on the subject devices to verify that the T20 and T15 targeting construct can withstand typical physical loads during its use using functional aging. A biocompatibility safety evaluation was performed per ISO 10993-1 to support the verification of biological safety."
• Clinical Performance: "Clinical data was not needed for the subject devices to demonstrate substantial equivalence to the predicate devices."

The conclusion is that "The subject devices have identical intended use and indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design and labeling and are manufactured and sterilized using same materials and processes as the predicate devices. The performance analyses demonstrate that: Any differences do not raise new questions of safety and effectiveness; and The subject devices are at least as safe and effective as the legally marketed predicate devices."

Therefore, the document does not present a study with acceptance criteria and reported device performance in the way typically expected for a new AI/software device or a device requiring new clinical efficacy data. Instead, it relies on the concept of "substantial equivalence" to a predicate device.

Given this, I cannot extract most of the requested information, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets, as this type of information is not present in the provided 510(k) summary for this particular device submission.

I will, however, attempt to fill in what information can be inferred or directly stated from the text in relation to the non-clinical performance and the basis for clearance.

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

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

• Test Set Sample Size: Not specified in the provided text. The non-clinical testing mentioned "functional aging" but did not specify the number of units or cycles.
• Data Provenance: Not specified. The testing was non-clinical.

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 as no clinical or human-expert-based ground truth was established for this submission. The evaluation was primarily based on engineering and biocompatibility testing, and comparison to predicate devices.

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

• Not applicable for this type of submission.

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

• No. The device described is a metallic bone fixation appliance and accessories, not an AI or imaging diagnostic device that would typically undergo an MRMC study.

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

• Not applicable. This is not an AI algorithm.

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

• The "ground truth" for this 510(k) clearance is primarily based on compliance with established engineering standards (e.g., for mechanical load and biocompatibility) and the demonstrated "substantial equivalence" to legally marketed predicate devices, which are assumed to be safe and effective.

8. The sample size for the training set

• Not applicable, as this is not an AI/machine learning device.

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

• Not applicable, as this is not an AI/machine learning device.

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(1) Femur Reconstruction Interlocking Nail System
The Femur Reconstruction Interlocking Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.

(2) Femur Retrograde Interlocking Nail System
The Femur Retrograde Interlocking Nail System is indicated for simple long bone fractures: severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grating; 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 long bones being treated.

(3) Humerus Interlocking Nail System
The Humerus Interlocking Nail System indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures with diaphyseal extension, diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.

(4) Tibia Interlocking Nail System
The Tibia Interlocking Nail System is intended to stabilize fractures of the proximal and distal thatt; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions.

(5) Compression Hip Nail System
The Compression Hip Nail System is intended to treat stable proximal femoral fracture including Pertrochanteric fractures, Intertrochanteric fractures and High sub trochanteric fractures and combination of these fractures.

This intramedullary fixation rod is used for stabilization of shaft fracture in humeral bone, femoral bone and tibial bone. It is implanted into medullary cavity inside of the long bone (humeral bone, femoral bone and tibial bone) with a fracture and the fractured long bone (humeral bone, femoral bone and tibial bone) is fixed to the nail by using the locking screw at the upper and lower parts of the fractured part.
The nailing system consists of the Femur Reconstruction Interlock Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, and Compression Hip Nailing System.

The provided document is a 510(k) premarket notification FDA clearance letter for an intramedullary fixation rod system. It does not contain any information about acceptance criteria, device performance, study design, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is concerned with demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical characteristics, rather than reporting on a clinical or performance study with defined acceptance criteria.

The relevant sections explicitly state:

• "Clinical Test Conclusion: Clinical testing was not required for this submission."
• "Non-clinical Test Conclusion: The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices." (lists biological and mechanical standards).

To answer your questions, I would need a different document, such as a summary of safety and effectiveness data or a clinical study report.

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The XLO Brand of Locking Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

The system is indicated for use in adult patients only. All implants are for single use only.

The XLO Brand of Locking Distal Humerus Plating System consists of various shape and sizes of plates featuring compression and locking or non-locking holes, full threaded-cortical, locking or non-locking & self-tapping screws. The XLO Brand of Locking Distal Humerus Plating System consists of the following implants:

• Distal Humerus Locking Plate 2.7/3.5, Dorsolateral, Left & Right
• Distal Humerus Locking Plate 2.7/3.5, Dorsolateral, With Lateral Support Left & Right
• 3.5mm cortical screw
• 2.7mm locking screw
• 3.5mm locking screw

The aforementioned plates are used with cortical screws & locking Screws.

These bone plates are generally designed on the basis of the bone contour and anatomy.

The plates and screws are fabricated from titanium-alloy (Ti-6Al-4V).

These implants are sold non-sterile, the products have to be sterilized prior to use.

The provided text is a 510(k) summary for the XLO Brand of Locking Distal Humerus Plating System. This document focuses on demonstrating substantial equivalence to predicate devices for a physical medical implant (bone plates and screws), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories about AI performance studies, such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, and MRMC studies, are not applicable to this submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to performance criteria outlined in FDA guidance documents for orthopedic fracture fixation plates and metallic bone screws. The specific numerical acceptance criteria are not explicitly stated in the provided text, but the reported performance is that the device "conform[s] to the performance criteria outlined in [FDA guidance documents]."

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

This information is not explicitly provided. For mechanical testing of physical orthopedic implants, sample sizes are typically determined by specific ASTM standards (e.g., ASTM F382, ASTM F543) and validation protocols, rather than "test sets" in the AI/SaMD sense. The data provenance would be from laboratory mechanical testing.

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

Not applicable. This is a physical device, and its "performance" is evaluated through mechanical engineering tests against established standards, not through clinical interpretation or expert ground truth.

4. Adjudication method for the test set:

Not applicable. Mechanical tests have objective pass/fail criteria based on measured physical properties.

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 is not an AI/SaMD device.

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

Not applicable. This is not an AI/SaMD device.

7. The type of ground truth used:

The "ground truth" for this device's performance is objective mechanical engineering data compared against established industry standards (ASTM F382, ASTM F543) and FDA guidance documents.

8. The sample size for the training set:

Not applicable. This is not an AI/SaMD device and does not involve a training set.

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

Not applicable. This is not an AI/SaMD device and does not involve a training set or its associated ground truth establishment.

Summary of Applicable Information from the Document:

• Device Type: Physical Metallic Bone Fixation Appliances and Accessories (Bone Plates and Screws).
• Study Type: Non-clinical (benchtop) mechanical testing and material standards compliance.
• Standards Used:
  • Material: ASTM F136 (Wrought Titanium-6Aluminium-4Vanadium ELI Alloy for surgical implant applications).
  • Performance: ASTM F382 (Static Four Point Bend Test for plates), ASTM F543 (Torsional Strength, Driving Torque, Removal Torque, Axial Pull-out Strength for screws).
• Performance Comparison: Test results were compared to performance criteria outlined in FDA guidance documents: "Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway" and "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway."
• Conclusion: The device's test results conform to the specified performance criteria, and the material complies with the relevant standard, justifying its safety and effectiveness.
• Clinical Data: "Clinical data and conclusions were not needed for these devices to demonstrate substantial equivalence to the predicate devices."

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Pangea Femur Plating System:
The Pangea Femur Plating System is indicated for the internal fixation of femur bone fractures and osteotomies in normal and osteopenic bone, including:

• · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• · Non-unions, malunions and deformities
• · Periprosthetic fractures

Pangea Fibula Plating System:
The Pangea Fibula Plating System is indicated for the internal fixation of fibula bone fractures and osteotomies in normal and osteopenic bone, including:

• · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• · Non-unions, malunions, and deformities
• · Periprosthetic fractures

Pangea Tibia Plating System:
The Pangea Tibia Plating System is indicated for the internal fixation of tibia bone fractures and osteotomies in normal and osteopenic bone, including:

• · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• · Non-unions, malunions, and deformities
• · Periprosthetic fractures

Pangea Humerus Plating System:
The Pangea Humerus Plating System is indicated for the internal fixation of humerus bone fractures and osteotomies in normal and osteopenic bone, including:

• · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
  · Non-unions, malunions, and deformities
• · Periprosthetic fractures

This traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, and Pangea Humerus Plating System. This submission encompasses multiple systems that have similar intended use. All plates are manufactured from Ti6Al4V ELI (ASTM F136), are anatomically pre-contoured. and are available in different sizes and left/right versions. The plates are provided sterile or non-sterile and range in length from 68 mm to 441 mm. The plates allow for the use of locking and non-locking screws and are used with cable plugs and washers.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. Instead, it is an FDA 510(k) clearance letter for the Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, and Pangea Humerus Plating System.

The letter indicates that clinical testing was not required for this submission, and therefore, there are no details regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The document discusses non-clinical testing performed to support substantial equivalence, including:

• Dynamic construct testing
• Magnetic Resonance (MR) compatibility assessments:
  • Magnetically Induced Displacement per ASTM F2052
  • Magnetically Induced Torque per ASTM F2213
  • Image Artifacts per ASTM F2119
  • RF Heating per ASTM F2182

These tests are typically performed to ensure the physical and mechanical properties of the device and its compatibility with imaging environments, rather than evaluating performance for diagnostic or clinical decision-making.

Therefore, I cannot populate the requested table and information based on the provided text.

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