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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 indications for use of these internal fixation devices include:

• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Supracondylar fractures, including those with intraarticular extension
• Fractures involving osteopenic and osteoporotic bone
• Fractures distal to a total hip prosthesis
• Periprosthetic fractures
• Nonunions and malunions

The struts of the T2 Alpha Femur Retrograde Nailing System are intended to be used only with the nails of this system; they are not to be used as stand-alone devices.

T2 Alpha Femur Retrograde Nailing System, previously cleared in K203819, consists of sterile implants (intramedullary nails in various diameter and sizes, compression screw and end caps), as well as nonsterile instruments (targeting devices).

The subject of this 510(k) submission is to introduce new devices of the T2 Alpha Femur Retrograde Nailing System. This line extension consists of anatomically pre-contoured struts and interlinking dowels designed to be used in combination with the existing nails of the T2 Alpha Femur Retrograde System for the treatment of complex fractures of the distal femur.

All struts are manufactured from Ti6Al4V ELI (Type II anodization) and are available in different sizes and left/right versions; these will be provided both non-sterile and sterile packaged. Interlinking dowels to the femoral nail are manufactured from CoCr and will be provided sterile packaged.

This appears to be a 510(k) clearance letter for an orthopedic implant, not an AI/Software as a Medical Device (SaMD). The document describes the "T2 Alpha Femur Retrograde Nailing System," which is a physical device used for internal fixation of femoral fractures.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert ground truth, MRMC studies, standalone performance, and training/test set provenance does not apply to this clearance document. These criteria are typically evaluated for AI/SaMD products, where algorithmic performance and human-AI interaction are critical.

The provided document details:

• Device Type: Intramedullary fixation rod (physical implant).
• Performance Data: Non-clinical bench testing (fatigue strength, cut-out performance, stiffness, shear-off, pull-out, insertion, static bending, fretting corrosion, targeting accuracy, MR assessment, packaging) and references to clinical evidence from peer-reviewed scientific literature.
• Comparison to Predicate Devices: Focuses on material, manufacturing, intended use, and mechanical performance equivalence.

No mention of AI, algorithms, or software performance evaluation is present.

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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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The VariAx 2 Distal Radius System is indicated for the fixation of fractures, osteotomies, nonunions and malunions of the bones of the hand and wrist, including osteopenic bone.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the VariAx 2 Distal Radius System. This line extension consists of anatomically pre-contoured plates for the treatment of simple and complex fractures of the distal radius, together with specialized instrumentation. All new plates are manufactured from CP Ti Grade 2 (Type II anodization) and are available in different sizes and left/right versions. The plates will be provided both non-sterile and sterile-packaged. They will use the well-established SmartLock technology to allow variable angle screw locking. The plates can be used with non-locking and locking VariAx 2 T8 screws. The VariAx 2 T8 screws have been previously cleared under K191412.

The provided text is an FDA 510(k) clearance letter for the Stryker VariAx 2 Distal Radius System. This document does not contain information about software performance, AI algorithms, or any type of study that would involve acceptance criteria for an AI/software device.

The document discusses a physical medical device (bone fixation plates and screws) and primarily relies on non-clinical performance data comparing the new device to previously cleared predicate devices. The performance data listed (engineering assessment, biomechanical tests, MR safety assessment, packaging tests, biocompatibility) are all related to the physical properties and safety of the implantable hardware, not software or AI performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets them, as the provided input does not describe such a study or device.

To fulfill your request, you would need to provide a document related to the clearance of a software as a medical device (SaMD) or a device that incorporates an AI/ML component.

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

The Stryker Hoffmann LRF 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, diaphyseal, 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
• . Bone transport

The 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
• Charcot foot reconstruction
• . Lisfranc dislocations

The Hoffmann LRF System is a modular, ring-based, external fixation system designed to address certain orthopedic conditions of the limbs. Through a series of pins and wires, the bone is connected to this system with the rings statically placed, or gradually manipulated, depending on the type of correction needed. The modular design allows the system to be customized according to the needs of the patient. The system components are manufactured from stainless steel, aluminum, PEEK, and carbon fiber.

Components of the following systems may be used with this system: Monticelli-Spinelli External Fixation System, Apex Pins, Trauma Pelvic Set, Hoffmann II External Fixation System, Hoffmann 3 External Fixation System, Hoffmann II External Fixation System 90° Post, Hoffmann II Miami Post, Hoffmann II Carbon Connecting Rods, Hoffmann II MRI External Fixation System, and Hoffmann II Compact MRI External Fixation System. Use of these components does not confer MRI compatibility to the Hoffmann LRF System.

This document is a 510(k) Premarket Notification from the FDA regarding the Hoffmann LRF System. It states that the device is substantially equivalent to a previously marketed predicate device (K203568).

The crucial information for addressing your request, particularly regarding acceptance criteria and performance studies, is explicitly absent.

Here's why and what can be inferred:

• No Acceptance Criteria or Performance Data Presented: The document states under "Performance Data":
  • "Non-Clinical Testing: No performance testing is necessary to support the claim of substantial equivalence."
  • "Clinical Testing: No clinical testing is necessary to support the claim of substantial equivalence."

This means that for this specific 510(k) submission (K233741), the FDA's clearance was based on the device's substantial equivalence to a predicate device (K203568), rather than requiring new, specific performance study data or predefined acceptance criteria to be met for this submission. The change from the predicate device is noted as a "dimensional change to the struts."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement because this information is not provided in the supplied text. The FDA's decision was based on a comparison to an already cleared device, implying that the performance and safety characteristics were considered to be sufficiently similar, and no new studies were deemed necessary for this particular submission.

In summary, based only on the provided text, the answer to all your specific questions regarding acceptance criteria and study details is that this information is not available within this 510(k) submission document.

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

• · Diaphyseal, metaphyseal, extra- and intra-articular fractures
• · Non-unions, malunions, and deformities
• · Periprosthetic fractures
  The Pangea Utility Plating System 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.

The Pangea Platform is indicated for the internal fixation 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 and metaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the Pangea Utility Plating System and the Pangea Platform. This submission encompasses multiple systems (Pangea Utility Plating System and Pangea Platform) that have similar intended use and/or will be used together during the surgical procedure. The Pangea Utility Plating System consists of mini-, small-, and large-fragment plates manufactured from Ti6Al4V-ELI per ASTM F136. The plates range in length from 26 mm to 486 mm. The Pangea Platform consists of screws and cable plugs. The screws are offered as locking or non-locking variants. The locking screws are manufactured from CoCr and are available as Ø2.7 mm (L8 mm – 80 mm), Ø3.5 mm (L10 mm – 120mm), Ø4.0 mm (L14 mm – 95 mm), Ø5.0 mm (flat tip) (L10 mm – 20 mm), and Ø5.0 mm (L14 mm – 120 mm). The non-locking screw is manufactured from Titanium alloy (Ti6Al4V-ELI per ASTM F136) and is available in Ø2.7 mm (L6 mm – 80 mm). The cable plugs are made of Titanium alloy (Ti6Al4V-ELI per ASTM F136), and the T15 and T20 cable plugs are available for the 3.5mm locking mechanism. The Cancellous screws are available as Ø4.0 mm fully and partially threaded (L10-100 mm) and Ø6 mm 16mm thread (L30 -150 mm), Ø6 mm 32mm thread (L45 -150 mm) and fully threaded (L20-150 mm).

The provided document is a 510(k) summary for the Stryker GmbH Pangea Utility Plating System and Pangea Platform. It is a regulatory submission for medical devices (bone fixation systems) and does not contain information about an AI/ML-based device or a study involving human readers and AI assistance.

Therefore, I cannot extract the information required to describe the acceptance criteria and the study proving an AI/ML device meets them, as the document pertains to physical orthopedic implants, not software or AI.

The bulleted list in your request (acceptance criteria, sample size, expert ground truth, adjudication, MRMC study, standalone performance, ground truth type, training set size, training ground truth establishment) is highly relevant for evaluating AI/ML medical devices, but this document does not contain such details. It focuses on the mechanical and material equivalence of the Pangea systems to previously cleared 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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The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone). The RC Lag Screw is also indicated for rotationally unstable fractures.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market new devices into the Gamma4 System, add new indications for use for the RC Lag Screws and update the current surgical technique to include an optional section to use bone void fillers.

The Gamma4 System was previously cleared in K222309, is a hip fracture nailing system and includes sterile implants (Trochanteric and Long Nails in various diameters and sizes, Lag Screws, and End Caps) as well as non-sterile instruments (targeting devices). The subject devices (Intermediate Nails and RC Lag Screw) are also sterile implants in various diameters and sizes as well as a non-sterile Intermediate Targeting Sleeve. All nails and screws are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136 and the targeting device is manufactured from stainless steel per AISI 431, carbon fiber reinforced PEEK and PEEK unreinforced.

The provided document, K230512, is a 510(k) premarket notification for the Stryker Gamma4 System. This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than proving the device meets specific performance criteria through clinical studies involving human patients or complex AI algorithm evaluations.

Therefore, the details requested about acceptance criteria and a study proving a device meets these criteria, especially concerning human-in-the-loop performance, AI algorithm training, and expert adjudication, are not present in this document.

The document explicitly states on page 6: "CLINICAL TESTING: Clinical testing was not required for this submission."

The non-clinical testing mentioned is primarily focused on mechanical performance and equivalence to predicate devices, such as:

• Targeting accuracy testing
• Bending Fatigue Strength per ASTM F1264
• Construct Fatigue Strength Testing
• Cut-out testing
• Torsional Stiffness per ASTM F1264
• MR evaluation

These tests are designed to show that the new Gamma4 System performs mechanically similarly to its predecessors, not to assess human or AI performance in a clinical setting.

Consequently, I cannot provide the requested information from the given document, as it does not contain details about a study designed to prove the device meets acceptance criteria related to a human-in-the-loop system, AI performance metrics, or complex clinical outcome data.

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The PeriPRO™ Femur Plating System is indicated for internal fixation of femur fractures and osteotomies in normal and osteopenic bone. This includes:
· Non-unions, malunions and deformities
· Fracture in the presence of intramedullary implants, including periprosthetic fractures

The Variable Angle Fixation System is indicated for the internal fixation of fractures and osteotomies of the femur in normal and osteopenic bone, including:

• · Non-unions, malunions and deformities
• · Periprosthetic fractures

AxSOS 3 Ti is intended for long bone fracture fixation. Indications include:
· Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures

• Non-unions and malunions
• · Normal and osteopenic bone
• · Osteotomies
• · Periprosthetic fractures of the femur and proximal tibia.
• The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:
• · Periprosthetic fractures
• · Diaphyseal and metaphyseal areas of long bones in pediatric patients.
  The 4 mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis. Screws can also be used for arthrodesis.

The Stryker Plating System, Small Frag Set is indicated for fractures of the metaphysis of the following:

• · One third tubular plate: fibula, metatarsals, metacarpals
• Fibular plate: fibula
• · Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle
• · Oblique T-plate: distal radius
• · T-plate: distal radius, calcaneus, lateral clavicle
• Cloverleaf plate: proximal humerus, distal tibia
• · Calcaneal plate: calcaneus
  · Reconstructive plate: humerus, pelvis Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone.
  The Basic Fragment Set is intended for use in long bone fracture fixation plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the PeriPRO Femur and Variable Angle Fixation System and align labeling across the AxSOS 3 Ti and SPS System. This submission encompasses multiple systems (PeriPRO Femur, Variable Angle Fixation, AxSOS 3Ti and SPS Systems) that have similar intended use and/or will be used together during the surgical procedure. The PeriPRO™ Femur System consists of proximal, interprosthetic and distal femur plates. All devices in the system are provided sterile and non-sterile. The proximal femur plates range from 257 up to 371 mm in length. The interprosthetic femur plate ranges from 320 up to 420 mm in length. The distal femur plates range from 173 up to 396 mm in length. All plates are made of titanium alloy (Ti6AL4VELI) according to ASTM 136. The Variable Angle Fixation System consists of screws and cable plugs. All devices in the system are provided sterile and non-sterile. Screws are offered as non-locking or locking variants. The locking screws are available as Ø4 (L22-95 mm), Ø5 mm (L22-120 mm) and Ø5 mm flat tip (L10-20 mm) are made of CoCr alloy. The Cable plugs are available in a 5 mm and are made of titanium alloy. The PeriPRO™ Femur System and Variable Angle Fixation contains Class II instruments as targeters, frame fixators, handles, Those devices are part of the targeting system and as such class II instruments. They are manufactured of either PEI/Carbon or stainless steel. AxSOS 3 Ti System is an internal fixation system composed of sterile and non-sterile plates, screws, and complementary implantable devices, along with associated instruments. The plates are available in a variety of anatomical orientations and lengths, the screws in a variety of diameters and lengths. Implants of this system are available in titanium alloy, with Type II anodization. The Stryker Plating System (SPS System) contains the Basic Fragment Set and the Small Fragment Set. Both sets contain plates, screws, and washers available in titanium alloy (Ti-6A14V) per ASTM F136 as well as stainless steel (316L) in sterile and non-sterile forms. SPS plates come with holes that can accommodate non-locking screws and include holes for suture or Kwires. The screws are provided in 2 types (cortical and cancellous) and are available in several different lengths and diameters.

The provided document is a 510(k) premarket notification for bone fixation systems (PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System).

Based on the provided text, there is NO information regarding acceptance criteria or a study proving device performance in the context of an AI/algorithm-driven device that would typically have such criteria.

The document solely addresses the substantial equivalence of these bone fixation systems to previously cleared predicate devices based on non-clinical performance data (mechanical testing and MRI compatibility).

Therefore, I cannot provide the requested information. The document focuses on the mechanical and material properties of the bone plates and screws.

Specifically, the document states under "Clinical Performance and Conclusions:" that "Clinical data and conclusions were not needed for this device." This further confirms that no clinical studies related to human reader performance, AI assistance, or standalone algorithm performance were conducted or reported for this submission.

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The PRO Plating System is indicated for:
· Fractures, non-unions, deformities and malunions of the pelvic ring and acetabulum
• Sacroiliac joint dislocations
The Stryker Trauma Pelvic Set (Matta) is indicated for:
• Fractures of the acetabulum, sacrum, illium, and entire pelvic ring;
• Revision surgery of pseudarthrosis, non-unions and mal-unions;
• Osteonomies;
• Arthrodeses;
• Sacroilic joint dislocations;
• Symphysis pubis disruptions

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the PRO Plating System, to align indication of the existing PRO Pelvis System and the new devices and add MRI labeling to the existing PRO Pelvis System and the Trauma Pelvic Set System (Matta). This submission encompasses multiple systems (PRO Pelvis System and Trauma Pelvic Set System (Matta)) that have similar intended use and/or will be used together during the surgical procedure.

The PRO Plating System (Pelvis II Implant System) is an internal fixation device that consists of different types of plates used with compatible screws to fit different types of fractures in the pelvis. All devices in the system are provided sterile and non-sterile.

The Stryker Trauma Pelvic Set System (Matta) consists of plate, screw, and washer components of various sizes. All are manufactured from stainless steel (ASTM F-138/139). All devices in the system are provided sterile and non-sterile.

This document describes a 510(k) premarket notification for the Stryker PRO Plating System and Stryker Trauma Pelvic Set (Matta). This submission is for a medical device (bone fixation appliances and accessories), not for an AI/ML powered device. As such, the sections regarding AI/ML performance criteria, ground truth, expert adjudication, and comparative effectiveness studies are not applicable.

Here's a summary of the non-clinical performance data provided, as relevant to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not specify the exact sample sizes used for each non-clinical test. For mechanical and MRI compatibility testing of medical devices, samples are typically chosen to represent the range of device types, sizes, and materials. The data provenance is implied to be from internal laboratory testing conducted by Stryker or a qualified testing facility, relevant to the manufacturing location (Selzach, Switzerland) and for the US market. The data is non-clinical/pre-clinical.

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

Not applicable. This device is not an AI/ML device that requires expert-established ground truth for its performance assessment. The "ground truth" for this type of device is established through engineering and material science principles, and adherence to recognized standards like ASTM.

4. Adjudication Method for the Test Set

Not applicable. This device is not an AI/ML device requiring human adjudication of its output.

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

No, an MRMC comparative effectiveness study was not done as this is not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a physical medical implant, not an algorithm, so standalone performance in the context of AI/ML is irrelevant.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on established engineering principles, material science, and conformance to recognized consensus standards (e.g., ASTM F382, F2052, F2213, F2182, F2119). These standards define the methodologies and acceptable performance metrics for the tested properties.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."

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

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

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