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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.

SPS Small Fragment Set The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis 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.

SPS Basic Fragment Set The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction 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-plates, Tbuttress 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.

The AxSOS 3 Ti system includes anatomically contoured monoaxial locking plates, as well as screws and blind screws. The plates have been designed with holes that can accommodate either locking or non-locking screws, and also include holes for suture and Kirshner wires (K-wires). The screws come in 3 types (locking, cortical, and cancellous) and are available in several different diameters. All implantable components come sterile and non-sterile.

The Basic Fragment Set is part of the Stryker Plating System. The Basic Fragment Set consists of plates and screws for fixation of fractures of the cortical and metaphyseal area of the long bone as well as fracture of the pelvis. The implant set is available in either in stainless steel (316 L) or titanium alloy (Ti6Al4V).

This submission is not intended to introduce any new implants into the system, but rather to demonstrate compatibility between the AxSOS 3 Ti system (K153379) and several of the titanium screw/plate components found in the Stryker Plating System (SPS) most recently cleared in K060798. The AxSOS 3 Ti plates and screws are manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and available sterile and non-sterile.

This document is a 510(k) premarket notification for a medical device called the "AxSOS 3 Ti; Stryker Plating System." As such, the purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria or conduct clinical trials in the way a PMA (Premarket Approval) submission would.

Therefore, the provided document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Instead, the document focuses on:

• Indications for Use: Detailing what the device is intended for (e.g., long bone fracture fixation, specific types of fractures, different anatomical locations).
• Device Description: Explaining the components (plates, screws), materials (titanium alloy), and forms (sterile/non-sterile).
• Predicate Devices: Identifying previously cleared devices to which the current device is compared for substantial equivalence.
• Non-Clinical Testing: Mentioning "Bench testing and an engineering analysis" to demonstrate compatibility between components, and bacterial endotoxin testing for pyrogenicity.
• Absence of Clinical Testing: Explicitly stating that "Clinical testing was not required for this submission."

The "Conclusion" section reinforces that the submission is about demonstrating cross-compatibility between two existing systems (AxSOS 3 Ti and Stryker Plating System) based on bench testing and engineering analysis, rather than proving performance against specific acceptance criteria through extensive studies as typically understood in the context of AI/software device evaluation.

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SPS Small Fragment Set: The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis 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.

SPS Basic Fragment Set: The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction 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-plates, 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 Special 510(k) submission is a line extension to address modifications to the Stryker® Plating System (SPS), which includes the SPS Small Fragment Set, the SPS Basic Fragment Set, the SPS Pelvic Set and the Stryker Locked Plating Set. This line extension is to add additional styles of plates based on the plates in the SPS Small Fragment Set and the SPS Basic Fragment Set.

The provided document is a 510(k) summary for the Stryker® Plating System. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving device performance against specific acceptance criteria through a clinical study in the way an AI/ML device submission would.

Therefore, many of the requested points related to acceptance criteria, specific studies, sample sizes, and ground truth establishment (which are common for AI/ML device evaluations) are not applicable or explicitly stated in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For a 510(k) submission, the "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This means the new device is as safe and effective as the predicate. The "reported device performance" is essentially the claim that the new device meets the equivalence standard in areas like design, intended use, performance, and operational principle. Specific quantitative performance metrics are usually not required for this type of submission unless a significant change that impacts safety or effectiveness is introduced, necessitating new testing.

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

• Not applicable/Not provided. This document does not describe a clinical study with a "test set" in the context of analytical or clinical performance evaluations for an AI/ML device. The submission is for a physical medical device (bone plates and screws). The "sample size" here refers to the number of new plate styles being added to an existing system.

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

• Not applicable/Not provided. This is not relevant for a 510(k) for a bone plating system. Ground truth establishment with experts is a concept often applied to AI/ML clinical evaluations, not for demonstrating substantial equivalence of orthopedic implants.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. This concept is not applicable to this type of device 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

• Not applicable/Not provided. This is irrelevant as the device is a physical bone plating system, not an AI/ML diagnostic or assistive tool.

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

• Not applicable/Not provided. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable/Not provided. The concept of "ground truth" as typically discussed in AI/ML device evaluations (e.g., pathology, outcomes data, expert consensus) does not apply directly here. For a bone plating system, the "truth" is established through design specifications, material properties, biocompatibility, and mechanical testing (though the details of such testing are not in this summary). Substantial equivalence is the primary "truth" being established in this document.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This device is not an AI/ML system that requires a "training set."

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

• Not applicable/Not provided. This device is not an AI/ML system that requires a "training set" or corresponding ground truth.

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SPS Small Fragment Set The Stryker Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following: One third tubular plate: fibula, metatarsals, metacarpals 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. SPS Basic Fragment Set The Basic Fragment Set is intended for use in long bone fracture fixation, Reconstruction 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-plates, 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 Special 510(k) submission is a line extension to address modifications to the Stryker® Plating System (SPS), which includes the SPS Small Fragment Set, the SPS Basic Fragment Set, the SPS Pelvic Set and the Stryker Locked Plating Set. This line extension is to add additional styles of monoaxial plates based on the SPS Small Fragment Set and the SPS Basic Fragment Set.

This document describes a Special 510(k) submission for a line extension to the Stryker® Plating System. It focuses on the substantial equivalence of the new components to existing predicate devices, rather than a study proving device performance against acceptance criteria in the traditional sense of a clinical or analytical performance study for a novel device.

Therefore, many of the requested elements for a performance study (like sample size, ground truth, expert adjudication, MRMC studies, standalone performance, and training set information) are not applicable in this context. The acceptance criteria here are about demonstrating that the modified device maintains the same safety and effectiveness as its already-cleared predicates.

Here's a breakdown based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is not a study with a test set of data in the traditional sense of evaluating an algorithm's performance on a dataset. The "test" here refers to the comparisons made to predicate devices for substantial equivalence. The data provenance would be the design and manufacturing specifications of the new components compared against those of the predicate devices.

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

Not applicable. Ground truth, in the context of device performance, usually refers to a definitive diagnosis or reference standard. Here, the "ground truth" for substantial equivalence is the FDA's regulatory framework and the established safety and effectiveness profiles of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There's no specific adjudication method described for a "test set" as this is a regulatory submission demonstrating substantial equivalence, not a performance trial. The FDA's review process itself serves as the "adjudication" for the substantial equivalence claim.

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

No. An MRMC study is performed to evaluate the diagnostic accuracy of a medical imaging device with and without AI assistance across multiple readers and cases. This document is for a bone plating system, not an imaging device, and its purpose is to demonstrate substantial equivalence, not comparative effectiveness of human readers.

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

Not applicable. This is a physical medical device (bone plating system), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" implicitly used for this submission is the established regulatory compliance and performance of the predicate devices. The new components are asserted to be equivalent to these cleared devices, meaning they meet the same safety and effectiveness standards already accepted by the FDA for the predicates.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm that requires a training set.

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

Not applicable.

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The Periarticular Plates are intended for use in long bone fracture fixation.

The 3.5mm and 4.5mm Periarticular Plate components are intended for use in long bone fracture fixation.

The 3.5mm and 4.5mm proximal tibial Periarticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the tibia. The 4.5mm distal femur Periaticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the femur.

This Special 510(k) submission is intended to address a line extension to the predicate SPS Small Fragment Set and SPS Basic Fragment Set which are both part of the Stryker Plating System. Both the SPS Small Fragment Set and SPS Basic Fragment Set consist of plates and screws for the fixation of fractures of the cortical and metaphyseal areas of long bones as well as fractures of the pelvis. There is no change in intended use for the modified device when compared to the previously cleared devices. The line extension involves offering a new Periarticular Plate version for the fixation of fractures of the cortical and metaphyseal regions of long bones. Howmedica Osteonics intends to add the new components to the current product line, thereby offering additional design options for the surgeon. The Periarticular Plates will be available in stainless steel (316L).

The provided document describes a Special 510(k) Premarket Notification for a line extension to the Stryker Plating System, specifically involving 3.5mm and 4.5mm Periarticular Plates. This submission is for a medical device (bone plates) and not an AI/ML powered medical device. Therefore, many of the typical acceptance criteria and study components related to AI/ML performance (like sample sizes for test and training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable here.

However, I can extract information related to the device's functional equivalence based on the provided text.

Acceptance Criteria and Device Performance

Study Information (as applicable to a physical medical device submission)

1. Sample size used for the test set and the data provenance: Not applicable. This submission is for a physical device, and the "study" primarily consists of engineering analyses (FEA) and comparison to predicate devices, not data from a patient test set in the traditional sense.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical properties is typically established through engineering standards, material testing, and computational modeling, not by expert consensus on clinical data.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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/ML-powered device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML-powered device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical properties, the "ground truth" would be established by engineering principles, accepted material standards, and results from a validated Finite Element Analysis (FEA) model. The comparison is against the mechanical properties of a predicate device.
7. The sample size for the training set: Not applicable. This involves a physical device and engineering analysis, not a machine learning model.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study (Demonstration of Substantial Equivalence):

The "study" in this context is a demonstration of substantial equivalence to existing legally marketed predicate devices, as required for a 510(k) submission.

• Methodology: The submission relies on Finite Element Analysis (FEA) to compare the mechanical properties of the proposed Periarticular Plates with those of the predicate SPS Basic Fragment Set.
• Basis for Equivalence: Equivalency is based on similarities in:
  • Intended Use: "long bone fracture fixation" remains unchanged from the predicate devices.
  • Materials: Use of 316L stainless steel.
  • Design: Comparison to other currently marketed plating systems, specifically the predicate SPS Basic Fragment Set.
• Conclusion: The FEA analysis "demonstrates the comparable mechanical properties" of the new plates and the predicate, supporting the claim of substantial equivalence. This allows the new components to be added to the product line as a "line extension."

In essence, for this type of medical device submission, the "study" is an engineering validation and comparative analysis to a predicate device, rather than a clinical trial or performance study involving patient data or AI algorithms.

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The Basic Fragment Set is intended for use in long bone fracture fixation.

Reconstruction 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 .
• Fractures of the tibia .
• Fractures of the humerus .
• Fractures of the pelvis .

T-Plates, 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 .
• Fractures of the tibial plateau .
• Fractures of the distal tibia .
• Fractures of the proximal-humerus ●

The Basic Fragment Set is part of the Stryker Plating System. The Basic Fragment Set is consists of plates and screws for the fixation of fractures of the cortical and metaphyseal area of long bones as well as fractures of the pelvis. The implant set is available either in stainless steel (316L) or titanium alloy (Ti6Al4V).

This document is a 510(k) summary for the Stryker Plating System Basic Fragment Set, submitted to the FDA in 2001. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided text.

Here is a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

   • Not Applicable. The document is a 510(k) summary demonstrating substantial equivalence, not a performance study with defined acceptance criteria and reported device performance metrics in the way these terms are typically used for diagnostic or AI devices. The substantial equivalence is based on similarities in intended use, materials, and design to other currently marketed plating systems.

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 test set or data provenance is mentioned as this is not a clinical performance study. The substantial equivalence analysis does not involve a "test set" in this context.

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 establishment by experts is not relevant to this 510(k) submission, which focuses on substantial equivalence based on design and materials.

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

   • Not Applicable. No test set or adjudication method is described.

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 a hardware device (bone plate system), not an AI or diagnostic device that would undergo an MRMC study.

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

   • Not Applicable. This is a hardware device, so a standalone algorithm performance study is not relevant.

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

   • Not Applicable. Ground truth, in the context of clinical studies for AI or diagnostic devices, is not a concept applied to this type of device submission.

8. The sample size for the training set

   • Not Applicable. There is no "training set" as this is not a device employing machine learning or AI.

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

   • Not Applicable. As no training set exists, ground truth establishment for it is not applicable.

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