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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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