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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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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 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.

The AxSOS 3 Ti Plating System consists of various monoaxial plates and screws made from Ti-6AI-4V (ASTM F-136 ELI). The system contains previously cleared distal lateral femur plates, proximal lateral tibial plates, distal anterolateral tibia plates, distal medial plates, proximal medial tibia plates and proximal humerus plates provided in various lengths (K123964, K133440, K141121, and K143138). This premarket notification introduces 4.0 mm waisted compression plates and 5.0 mm broad and narrow waisted compression plates in various lengths and number of holes. The system contains previously cleared screws with various lengths and diameters and provided in various configurations (fully or partially threaded) identified in previously cleared premarket notifications (K123964, K133440, K141121, and K143138). This premarket notification introduces blind screws used with the 4.0 mm and 5.0 mm waisted compression plates.

The provided text is a 510(k) summary for the AxSOS 3 Ti device, a bone fixation system. It details the device's indications for use, its description, and its substantial equivalence to predicate devices based on bench testing. However, it explicitly states that clinical testing, and therefore, any studies proving the device meets acceptance criteria, were not required or performed for this submission.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as no such study is described in this document. The submission relies on demonstrating substantial equivalence to previously cleared devices through bench testing and engineering analysis, rather than a clinical trial with specific performance metrics.

Here's a breakdown of why each specific point you requested cannot be fully addressed based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document does not define specific acceptance criteria for a clinical study or report device performance in that context. The "performance" mentioned refers to characteristics demonstrated during bench testing, not clinical outcomes.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No clinical test set was used. The submission relies on bench testing and engineering analysis.

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. No clinical test set with ground truth established by experts was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set was used.

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 device is a physical medical implant (bone fixation system), not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic imaging devices or AI algorithms.

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 consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth was established for the purpose of this submission. The "ground truth" for the substantial equivalence would implicitly be the established safety and effectiveness of the predicate devices.

8. The sample size for the training set: Not applicable. This is not an AI algorithm, so there is no training set in that context.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence for a physical medical device (bone fixation system), not on presenting clinical study data with specific performance metrics or AI algorithm validation.

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