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The AxSOS Locked Plating System in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The AxSOS Locked Plating System is 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 Device Description. This Special 510(k) backing Insert is being modified as part of a line extension of the AxSOS® Locked Plating System. The AxSOS® Locked Plating System contains 4mm Locking Inserts to which changes are being made to improve manufacturability. The locking inserts are made from stainless steel per ASTM F138 and ASTM F139. The AxSOS® Locked Plating 4.0mm Locking Inserts have similar or identical and material properties to the predicate 4.0mm Locking Inserts determined substantially equivalent via 510(k) K050512.

This document describes a Special 510(k) submission for a line extension of 4mm locking inserts for the AxSOS® Locked Plating System. This type of submission is for modifications to a legally marketed device that do not alter its intended use or fundamental scientific technology. Therefore, the "study" conducted is primarily non-clinical mechanical testing to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test. The text mentions "non-clinical laboratory testing was performed," implying a sufficient number of samples were tested to generate reliable data for each mechanical test.
• Data Provenance: Not explicitly stated, but assumed to be laboratory-generated per standard non-clinical testing protocols for medical devices. There is no indication of country of origin for the data, but the manufacturer is based in New Jersey, USA. The testing is retrospective in the sense that it's performed on manufactured devices to compare them to an existing predicate.

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

• Not Applicable. This is a non-clinical, mechanical testing study for substantial equivalence, not a clinical study involving human patient data and expert interpretation. The "ground truth" is defined by established engineering and material science standards and the performance of the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical mechanical testing, there is no need for an adjudication method in the context of expert consensus or dispute resolution. Test results are objective measurements against defined performance requirements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC study was not done. The submission explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This is a purely non-clinical submission.

6. If a Standalone (i.e. 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. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on established engineering performance requirements and material standards (e.g., ASTM F138 and ASTM F139 for stainless steel), and the demonstrated performance of the legally marketed predicate device (K050512). The goal is to show the modified device performs "as safe and effective as their predicates."

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. It is a physical product undergoing mechanical validation.

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

• Not Applicable. As there is no training set, this question is not relevant.

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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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The VariAx™ Elbow System is intended for fracture fixation of long bones. Indications include:

• Distal Humerus
• Proximal Ulna

This submission is a line extension to the Stryker® Plating System. The components of the VariAx™ Elbow System are intended to add different types of plates and screws to the Stryker® Plating System portfolio.

The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) summary for the VariAxTM Elbow System, focusing on its substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and its substantial equivalence to other Stryker plating systems.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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