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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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The AxSOSTM Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.

This Special 510(k) submission is a line extension to address modifications made to the AxSOSTM Locking Plate System which was cleared in K061012. This line extension is to add humeral long plates to the existing size range of the AxSOSTM Locking Plate System. These monoaxial long plates will be known as AxSOSTM Proximal Lateral Humerus TS (Threaded Shaft) Long Plates and will be available in 6 length sizes in left and right configurations.

The provided text describes a 510(k) submission for a medical device, the "AxSOS™ Locking Plate System," specifically focusing on a line extension called "AxSOS™ Proximal Lateral Humerus TS Long Plates." This document primarily addresses the substantial equivalence of the new device to a predicate device based on its design, materials, and intended use, supported by non-clinical mechanical testing.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative sense as might be found in a clinical trial or performance study. Instead, it focuses on demonstrating substantial equivalence to a predicate device through engineering design and mechanical testing. The performance is assessed against the predicate device, not against specific numerical clinical outcomes.

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

The document describes non-clinical testing (static strength and fatigue strength testing) of the device. It does not mention a "test set" in the context of patient data or clinical samples. Therefore, there is no information about the sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). The testing would have involved physical samples of the plates.

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 document describes non-clinical mechanical testing, not a clinical study involving experts establishing ground truth for patient outcomes.

4. Adjudication method for the test set

This information is not applicable as the document describes non-clinical mechanical testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this document pertains to a medical device's mechanical properties and equivalence, not an AI-assisted diagnostic tool or an evaluation of human reader performance.

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

This information is not applicable as the document describes a bone plate system, not an algorithm or software device.

7. The type of ground truth used

The "ground truth" in this context is the mechanical performance (static and fatigue strength) of the predicate device, which the subject device aims to be equivalent to. The performance parameters were established through engineering mechanical testing methods.

8. The sample size for the training set

This information is not applicable as the document describes non-clinical mechanical testing of a bone plate, not a machine learning model requiring a training set.

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

This information is not applicable as there is no training set mentioned. The ground truth for comparison was the established mechanical performance of the predicate device, determined through standard engineering test methods.

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The SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.

This Special 510(k) submission is intended to address modifications to the predicate Stryker Locking Inserts. The AxSOS® Locking Insert is being modified as part of a line extension of the AxSOS® Locked Plating System. The AxSOS® Locked Plating System contains 3mm Locking Inserts to which changes are being made.

The provided text describes a Special 510(k) submission for a line extension of 3mm locking inserts for the AxSOS® Locked Plating System. This type of submission is for modifications to a legally marketed device that do not alter the intended use or fundamental scientific technology. Therefore, the "study" conducted is a demonstration of comparable mechanical and functional properties to predicate devices, rather than a clinical study involving human subjects or AI performance.

Here's an analysis based on the provided text, addressing your points:

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

The document does not explicitly state quantitative "acceptance criteria" for the modified device in terms of specific performance thresholds (e.g., minimum tensile strength, fatigue life). Instead, the performance is evaluated in comparison to predicate devices. The implicit acceptance criterion is that the modified device demonstrates comparable mechanical and functional properties to the predicate devices.

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

The document does not specify the sample size used for the mechanical and functional testing. It also does not provide details on data provenance (e.g., country of origin) or whether it was retrospective or prospective, as it pertains to engineering bench testing rather than clinical study data.

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 question is not applicable to this type of submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic devices, particularly those involving image analysis or clinical assessments. This submission is for a medical implant (bone plates and screws), and the evaluation is based on engineering principles and mechanical testing, not expert interpretation of clinical data.

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

This question is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, typically in clinical ground truth establishment. For mechanical testing, the results are typically quantitative and objective, and do not involve human adjudication in the same way.

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 such study was done. MRMC studies are used to evaluate diagnostic systems, especially those assisted by AI, by comparing the performance of multiple human readers on multiple cases. This submission is for a mechanical medical device, not an AI-powered diagnostic tool.

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

No standalone algorithm performance study was done for the same reasons as above. This is not an AI/algorithm-based device.

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

As discussed, "ground truth" in the clinical sense is not directly applicable. The "ground truth" for the assessment of this device is based on established engineering standards and direct physical measurements from mechanical and functional testing. The comparable performance to predicate devices serves as the benchmark.

8. The sample size for the training set

This question is not applicable. Training sets are used for machine learning models (AI). This device is a mechanical implant and does not involve any AI components or machine learning.

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

This question is not applicable, as there is no training set for an AI model.

In summary:

This 510(k) submission is for a modification to a mechanical implant. The "study" involved mechanical and functional bench testing to demonstrate the modified device's performance is comparable to its predicate devices. Details regarding specific test parameters, sample sizes for testing, or objective acceptance criteria are not provided in this summary, but the overarching conclusion is that comparable performance was demonstrated. The concepts of expert ground truth, adjudication, MRMC studies, or AI algorithm performance are not relevant to this type of device and submission.

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