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The AxSOS 3 Ankle Fusion System is indicated for arthrodesis of the includes tibio-talo-calcaneal, tibiotalar, and tibio-calcaneal arthrodesis, in possible conjunction with osteotomies of the distal tibia, talus, and calcaneus.

AxSOS 3 Ti is intended for long bone fracture fixation.
Indications include:

• · Diaphyseal, metaphyseal, 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.
Screws can also be used for arthrodesis.

AxSOS 3 AF (Ankle Fusion) is an internal fixation system composed of sterile and non-sterile plates, and associated instruments. These plates are available in a variety of anatomical orientations and made of titanium alloy, with Type II anodization, and used with compatible screws.

AxSOS 3 Ti 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. Implants of this system are available in titanium alloy, with Type II anodization.

I am sorry, but the provided text does not contain information about acceptance criteria or specific studies proving a device meets these criteria. The document is a 510(k) premarket notification for the AxSOS 3 AF System and AxSOS 3 Ti System, which details the device's indications for use, technological characteristics, and a summary of non-clinical performance data (mechanical testing and MR compatibility).

It explicitly states: "Clinical testing was not a requirement for this submission."

Therefore, I cannot extract the information required for your request, as clinical acceptance criteria, detailed performance results demonstrating meeting those criteria, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details are not present in this document.

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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 system (also referred to as "AxSOS 3 Ti Locking Plate System") is a system used for internal fixation applications. The system includes anatomically contoured monoaxial locking plates, screws, blind screws, and auxiliary components. The plates have been designed with holes that can accommodate either locking or non-locking screws, holes for suture and/or Kirschner wires (K-wires). The screws come in 3 types (locking, cortical, and cancellous) and are available in several different diameters and lengths. Implants can be delivered sterile or nonsterile. The various plates and screws are manufactured from titanium alloy (ASTM F-136).

This traditional 510(k) submission is intended to introduce an additional component into the AxSOS 3 Ti System. The Variable Angle Extension Arm connector is an assembly made from an anodized titanium frame (Ti-6Al-4V, ASTM F136) and Co-Cr inlay (ASTM F1537, CoCr28Mo6). These preassembled Variable Angle Extension Arms can be affixed to the previously cleared Distal Lateral Femur Plates, the 5.0 mm narrow waisted compression plates, or the 5.0 mm broad waisted compression plates. The Variable Angle Extension Arms are affixed to the plate using the 4.0 mm blind screw and use a 4.0 mm locking screw to secure it into the desired targeted location of the fragment. These Variable Angle Extension Arms are used for periprosthetic fractures.

The provided document is a 510(k) summary for the AxSOS 3 Ti device, a metallic bone fixation appliance. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical efficacy studies. Therefore, it does not contain the detailed information typically found in studies designed to prove a device meets specific acceptance criteria for performance in a clinical setting.

Based on the information provided, here's what can be inferred and what is not available:

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

This information is not explicitly provided in the document in the format of a table with specific acceptance criteria and reported device performance. The document states that "Bench testing was conducted comparing the cleared plates and screws with the Variable Angle Extension Arms against the predicate and reference devices." It also lists specific tests related to MR compatibility.

• Acceptance Criteria Mentioned (Implicit/General): The implicit acceptance criterion is "substantial equivalence" to the predicate device in terms of design, indications for use, technological characteristics, and performance characteristics.
• Reported Device Performance (Implicit/General): "Testing demonstrated that the subject device is substantially equivalent to the marketed predicate device."

For MR compatibility testing, the document lists the types of tests performed:

• Magnetically Induced Displacement Force per ASTM F2052
• Magnetically Induced Torque per ASTM F2213
• Heating by RF Fields per ASTM F2182
• Image Artifacts per ASTM F2119

However, the specific numerical results of these tests and the acceptance thresholds are not detailed in this summary.

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

• Sample Size: The document does not specify the sample size for the bench testing. It refers to "cleared plates and screws with the Variable Angle Extension Arms" implying a set of device components were tested, but no numbers are given.
• Data Provenance: The data provenance for the bench testing is not specified beyond it being "bench testing." It is not clinical data, so country of origin or retrospective/prospective nature is not applicable in the typical sense.

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)

This information is not applicable or provided. Since this is a 510(k) submission primarily relying on bench testing for substantial equivalence, clinical ground truth establishment by medical experts is not discussed.

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

This information is not applicable or provided. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts. Since this is bench testing, such a method would not be relevant.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
• Effect Size: Therefore, no effect size of human readers improving with or without AI assistance is provided or applicable. The device is a bone fixation appliance, not an AI-assisted diagnostic tool.

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

This information is not applicable. The AxSOS 3 Ti device is a physical medical implant, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is irrelevant.

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

The concept of "ground truth" as typically defined in clinical or AI studies (e.g., expert consensus, pathology) is not directly applicable to this 510(k) submission which focuses on the physical and mechanical properties of an implant. The "truth" in this context is established through engineering and materials standards (e.g., ASTM standards) and direct comparison to a predicate device's established performance through bench testing.

8. The sample size for the training set

This information is not applicable or provided. As this is a physical medical device and not an AI/ML algorithm, there is no "training set" in the computational sense.

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

This information is not applicable or provided for the same reason as point 8.

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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 system (also referred to as the AxSOS 3 Ti Locking Plate system) is a system used for internal fixation applications. The system includes anatomically contoured monoaxial locking plates, as well as screws and blind screws (limited to waisted compression plates) . The plates have been designed with holes that can accommodate either locking or non-locking screws, and also include holes for suture and Kirschner wires (K-wires). The screws come in 3 types (locking, cortical, and cancellous) and are available in several different diameters. All implantable components are available sterile and non-sterile and are manufactured from titanium alloy (Ti6Al4V-ELI) per ASTM F136.

The AxSOS 3 Ti 5.0mm Cable Plug is categorized as permanent, direct bone/tissue patient contacting implant with contact duration >30 days. It is manufactured from titanium alloy (ASTM F136, Ti6Al4V-ELI) and is Type II anodized. It is designed to be used in combination with the 5.0mm AxSOS 3 Ti system. It is an aid for internal fixation component used in conjunction with the AxSOS 3 Ti 5.0mm distal lateral femur, broad compression and narrow compression plates. The Cable Plug is threaded or clicked into a 5.0mm universal locking hole of the AxSOS 3 Ti plates and provides a positioning point for a cerclage cable.

The provided text is related to a 510(k) premarket notification for a medical device (AxSOS 3 Ti) and focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a study demonstrating the device meets specific acceptance criteria through AI/ML performance.

The document discusses:

• Device Name: AxSOS 3 Ti
• Regulation Number and Name: 21 CFR 888.3030 (Single/Multiple Component Metallic Bone Fixation Appliances And Accessories) and 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener).
• Regulatory Class: Class II
• Product Code: HRS, HWC
• Indications for Use: Long bone fracture fixation, including various types of fractures, non-unions, malunions, normal and osteopenic bone, osteotomies, and periprosthetic fractures. Also specific indications for Waisted Compression Plates in pediatric patients and for the scapula and pelvis.
• Predicate Devices: AxSOS 3 Ti (K153379 & K162439) and Dall-Miles Homogenous Vitallium Cable (K961283).
• Reference Devices: Fixos Screw System (K133451) and Asnis III Cannulated Screw System (K000080).
• Non-Clinical Testing: Performed to ASTM standards for pull-out, dynamic compression, and MR compatibility (magnetically induced displacement force, torque, heating, and image artifacts).
• Clinical Testing: Not required for this submission.

Therefore, we cannot answer your request based on the provided text because it does not contain information about:

• Acceptance criteria and reported device performance related to AI/ML. The device is a bone fixation system, not an AI/ML-driven diagnostic or therapeutic device.
• Sample size for a test set (in the context of AI/ML).
• Data provenance (country of origin, retrospective/prospective) for AI/ML data.
• Number of experts and their qualifications for establishing ground truth for AI/ML.
• Adjudication method for an AI/ML test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI/ML.
• Standalone (algorithm only) performance for AI/ML.
• Type of ground truth (expert consensus, pathology, outcomes data) for AI/ML.
• Sample size for the training set (for AI/ML).
• How ground truth for the training set was established (for AI/ML).

The document is a regulatory approval letter for a conventional medical device based on engineering and materials testing, not an AI/ML performance study.

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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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The AxSOS 3 Ti Locking Plate System 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

This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market additional plates within the AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System includes anatomically contoured monoaxial locking plates. The 5.0mm System consists of the Distal Lateral Femur Plates (K123964). The 4.0mm System comprises the Proximal Lateral Tibia Plate, Proximal Medial Tibia Plate, Distal Medial Tibia and Distal Anterolateral Tibia Plate (K123964 & K141121). This submission adds the Proximal Lateral Humerus Plate to the 4.0mm System of the AxSOS 3 Ti Locking Plate System. The system includes three (3) types of screws available in various diameter and thread length: locking, cortical, and cancellous (K 123964 & K133440). The plates have been designed with holes that can accommodate either a locking or non-locking screw at the peri-articular end and along the shaft of the plates also have an oblong hole located at the metaphyseal junction used to aid in positioning. The subject components will be available sterile and non-sterile.

The associated accessories include:

• Aiming Block, Proximal Lateral Humerus, Right ●
• . Aiming Block, Proximal Lateral Humerus, Left
• X-Ray Template, Proximal Lateral Humerus ●
• Tag for Proximal Humerus Plate Insert ●
• . Proximal Lateral Humerus Insert

The provided text is a 510(k) Pre-market Notification for the AxSOS 3 Ti Locking Plate System. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than describing a study that proves the device meets specific acceptance criteria based on clinical outcomes or AI performance.

Therefore, many of the requested elements are not applicable to the information contained in this FDA submission.

Here's an analysis based on the provided text:

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

The document does not specify quantitative acceptance criteria in terms of clinical performance or a direct comparison of the subject device's performance against such criteria. Instead, it demonstrates substantial equivalence to a predicate device through non-clinical testing.

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

• Test Set (for non-clinical testing): Not explicitly stated, but the testing would involve a sample of the manufactured plates and screws. The number is typically determined by the testing standard (e.g., ASTM F382-99 requirements).
• Data Provenance: The testing was non-clinical laboratory testing. The submission is from Stryker Trauma AG, Switzerland, but the testing itself would likely be conducted in a controlled lab environment, potentially by the manufacturer or a contracted lab. The document does not specify the country of origin of the raw test data. It is prospective testing designed to support regulatory submission.

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)

This is not applicable. This submission does not involve expert review or establishment of ground truth in the context of diagnostic performance (e.g., for an AI algorithm). The "ground truth" here is the established performance benchmarks of the predicate device and the requirements of recognized standards like ASTM F382-99 and ISO 10993.

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

Not applicable, as this is not a study involving human reader performance or diagnostic accuracy.

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 medical device for fracture fixation, not an Artificial Intelligence (AI) diagnostic or assistive tool.

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.)

The "ground truth" in this context refers to:

• Mechanical Performance: Established mechanical properties and fatigue limits as defined by the ASTM F382-99 standard and the performance characteristics of the legally marketed predicate device (Synthes (USA) LCP Proximal Humerus Plates, Long, K041860).
• Biocompatibility: Criteria outlined in FDA Blue Book Memorandum #G95-1 and the ISO 10993-1 standard.

8. The sample size for the training set

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

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

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

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The AxSOS 3 Ti Locking Plate System 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

This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market additional plates and screws within the AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System includes anatomically contoured monoaxial locking plates. The 5.0mm System consists of the Distal Lateral Femur Plate (K123964). The 4.0mm System comprises the Proximal Lateral Tibia Plate (K123964) as well as the subject devices being the Distal Anterolateral Tibia Plate, the Distal Medial Tibia Plate and the Proximal Medial Tibia Plate. The system includes four (4) types of screws available in various diameter and thread length: locking, cortical, cancellous (K123964 & K133440) as well as the subject periprosthetic screws. The plates have been designed with holes that can accommodate either a locking or non-locking screw both at the peri-articular end and along the shaft of the plates also have an oblong hole located at the metaphyseal junction used to aid in positioning. The subject components will be available sterile and non-sterile.

The provided text describes a medical device, the "AxSOS 3 Ti Locking Plate System," and its clearance process through a 510(k) submission to the FDA. This submission focuses on establishing substantial equivalence to previously marketed predicate devices rather than demonstrating novel performance against defined acceptance criteria through a clinical or standalone study.

Therefore, many of the requested categories regarding acceptance criteria, study details, and expert involvement are not applicable to the information provided.

Here's a breakdown of the relevant and non-applicable information based on the input:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. No test set of patient data (e.g., images for an AI device) was used. The "test set" in this context refers to the worst-case subject plates and screws used for non-clinical, mechanical testing. The provenance of these physical samples is not specified, but they would be manufactured by the sponsor (Stryker Trauma AG).

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

• Not Applicable. As no patient data test set was used, no experts were involved in establishing ground truth for such data. Mechanical testing relies on standardized test methods (ASTM) and engineering evaluations rather than expert consensus on medical conditions.

4. Adjudication method for the test set:

• Not Applicable. No patient data test set requiring adjudication 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 bone plate and screw system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and related metrics are irrelevant.

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

• Not Applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" was derived from established mechanical standards and specifications (ASTM F382-99 and ASTM F543-07) and comparison to the performance of predicate devices. There is no biological "ground truth" in the clinical sense for this type of submission.

8. The sample size for the training set:

• Not Applicable. No training set, in the context of machine learning or AI, was used for this type of medical device submission.

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

• Not Applicable. As no training set was used, no ground truth needed to be established for it.

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The AxSOS 3 Ti Locking Plate System Line Extension 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

This Special 510(k) submission is being supplied to the U.S. FDA to introduce additional screw types and drive features to the currently marketed AxSOS 3 Ti Locking Plate System (K123964). The additional screw types will include: 3.5mm and 4.5mm Cortex Shaft screws, 4mm and 6mm Cancellous partially and fully threaded screws. The subject device is an internal fixation device that consists of monoaxial locking plates and various types of screws to fit different types of fractures in the tibia and femur. The subject device consists of anatomically contoured Femur and Tibia plates and various types of screws which were previously cleared in K123964. All components are manufactured from Titanium alloy per ASTM F136. The Distal Lateral Femur plates are fixed to the femur using 5mm locking screws or non-locking screws with either or 4.5mm Cortex and 6mm cancellous non-locking screws. The Proximal Lateral Tibia plates are fixed to the tibia using 4mm locking screws with either or 3.5mm Cortex and 4mm cancellous non-locking screws.

The provided text describes a 510(k) summary for the AxSOS 3 Ti Locking Plate System Line Extension, a medical device for long bone fracture fixation. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, much of the requested information regarding acceptance criteria, specific device performance metrics, and study details (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) is not applicable or available in this type of regulatory submission.

The document states that a non-clinical test was performed, which involved a risk analysis according to ISO 14971. This analysis aimed to demonstrate that the new device components did not present a "new worst case" and that the same verification and validation methods applied to the predicate devices were used. It concluded that the subject components met performance requirements and were as safe and effective as the predicate devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable/Available. The submission describes a non-clinical risk analysis and verification/validation methods rather than a clinical test set with human subject data.

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

• Not applicable/Available. Ground truth as typically understood for clinical performance studies (e.g., diagnostic accuracy) is not established or discussed in this non-clinical submission.

4. Adjudication method for the test set:

• Not applicable/Available. No clinical test set requiring adjudication 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 submission is for a medical implant (bone fixation system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant.

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

• Not applicable. This device is a physical implant, not a standalone algorithm.

7. The type of ground truth used:

• Not applicable. The "ground truth" in this context is based on engineering performance requirements and safety analyses as compared to predicate devices, not clinical outcomes or expert consensus for diagnosis.

8. The sample size for the training set:

• Not applicable. There is no "training set" as understood in machine learning or clinical study design, given this is an implant device verification.

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

• Not applicable. See point 8.

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The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Indications include:

• Diapyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
• . Non-unions and malunions
• Normal and osteopenic bone .
• Osteotomies .

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System is an internal fixation device that consists of monoaxial plates and various types of screws to fit different types of fractures in the tibia and femur. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 95-415mm in length and the screws will range from 10-150mm in length.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   The provided text does not include information on specific sample sizes for the non-clinical tests. The tests were performed on "AxSOS 3 Ti Locking Plate System components" but the number of components tested for each criterion is not specified.

   The data provenance is from non-clinical laboratory testing conducted for the AxSOS 3 Ti Locking Plate System components. The location of the laboratory or the specific country of origin for the testing data is not explicitly stated, but the sponsor is Stryker Trauma AG, Switzerland. The study type is non-clinical (benchtop) testing, not related to patient data, so "retrospective or prospective" does not apply in the typical sense.

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

   This information is not applicable as the study involved non-clinical mechanical testing, not a clinical evaluation requiring expert interpretation of medical images or data. Ground truth was established through standardized engineering tests.

4. Adjudication method for the test set:

   This information is not applicable as the study involved non-clinical mechanical testing, not a clinical evaluation requiring human interpretation or adjudication.

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 MRMC comparative effectiveness study was done. This submission explicitly states, "Clinical testing was not required for this submission." The study focused solely on non-clinical mechanical performance.

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

   No standalone (algorithm only) performance study was done. This device is a physical bone fixation system and does not involve AI algorithms.

7. The type of ground truth used:

   The ground truth used was based on results from standardized biomechanical and mechanical tests. This includes measurements of static strength, dynamic fatigue, shear-off properties, insertion forces, and pull-out resistance, all compared against established performance benchmarks or predicate devices.

8. The sample size for the training set:

   This information is not applicable as this submission is for a physical medical device (bone plates and screws) and does not involve an AI algorithm with a training set.

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

   This information is not applicable as this submission is for a physical medical device and does not involve an AI algorithm with a training set or associated ground truth establishment.

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