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The Asnis® III Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
The Asnis® PRO Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

The Asnis® III Cannulated Screw System, previously cleared in K000080, K024060, consists of self-tapping cannulated screws and the corresponding washers. All devices in the system are provided sterile and non-sterile. The thread diameters are 4.0, 5.0. 6.5, and 8.0 mm. They are either fully or partially threaded. All screws are self-drilling and self-tapping. There are corresponding washers to the 4.0 and 5.0 mm screws respectively and one washer fitting for both diameters, 6.5 and 8.0 mm. Screws and washers are made of stainless steel and titanium alloy.
The Asnis® PRO Cannulated Screw System consists of self-tapping cannulated screws. All devices in the system are provided sterile and non-sterile. The thread diameters are 6.5, and 8.0 mm. They are either fully or partially threaded. All screws are self-drilling and self-tapping. Screws are made of stainless steel and titanium alloy.
The subject of this bundled traditional submission is to introduce minor design specification changes; MRI Labeling, shelf-life update of existing package to 10 years, and re-branding Ø6.5/8.0 mm long screws (130-180 mm to Asnis® PRO Cannulated Screw System) to the Asnis® III Cannulated Screw System, cleared in K000080 and K024060 and to introduce a new system Asnis® PRO Cannulated Screw System.

The provided document is a 510(k) Summary for the Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System. It outlines the reasons for the submission and compares the new devices to predicates. However, it explicitly states there was no clinical data or clinical trials needed for this device submission. The changes made (minor design specification changes, MRI labeling, shelf-life update, and re-branding) did not create a new "worst case" scenario that would necessitate mechanical testing beyond what was already performed for the predicate device.

Therefore, the following information regarding acceptance criteria and studies to prove device performance cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: No new performance data is presented, as the document states "No mechanical testing was deemed necessary."
2. Sample size used for the test set and the data provenance: No new test set was used for mechanical performance, and no clinical data was collected.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no test set requiring expert ground truth.
4. Adjudication method for the test set: Not applicable.
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 (screws), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding performance:

• Performance Data (Nonclinical):
  • "No mechanical testing was deemed necessary as the design modifications and the new system introduction do not create a new worst case. All bench tests performed in accordance with ASTM F543 and previously presented in Asnis® III Cannulated Screw System (K024060), remain true and accurate."
  • Tests performed to establish compatibility with a magnetic resonance environment:
    • Magnetically Induced Displacement per ASTM F2052
    • Magnetically Induced Torque per ASTM F2213
    • RF Heating per ASTM F2182
    • Image Artifacts per ASTM F 2119
• Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

In summary, this 510(k) submission relies on the substantial equivalence to its predicate devices and the existing non-clinical performance data for those predicates (K000080, K024060, and K140891), along with new MRI compatibility testing for the modified/new devices. No new trials or studies to establish performance against acceptance criteria in a traditional sense (e.g., diagnostic accuracy, clinical outcomes) were conducted or deemed necessary for this submission.

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The Femoral Neck System (FNS) is indicated for femoral neck fractures, including basilar, transcervical, and subcapital fractures, in adults and adolescents (12-21) in which the growth plates have fused or will not be crossed.

The subject Femoral Neck System is comprised of implants designed to treat femoral neck fractures as well as system-specific insertion instruments. The Femoral Neck System is a modular system consisting of four connected implant components forming a fixed-angle gliding fixation device which allows for controlled collapse of the femoral neck. The implants are manufactured from Titanium Alloy and are provided in a range of dimensions. The same construct can be used for the left and right femur.

The provided document is a 510(k) summary for the DePuy Synthes Femoral Neck System, a medical device for femoral neck fractures. It does not contain information about a study with acceptance criteria for device performance in the context of an AI/algorithm-based medical device.

Instead, the document details the regulatory clearance process for a physical medical implant, the Femoral Neck System (FNS). The "performance data" mentioned refers to non-clinical evaluations of the implant's mechanical properties, not an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot extract the requested information as it is not present in the provided text. Specifically:

• No acceptance criteria for AI performance: The document focuses on proving substantial equivalence to existing predicate devices based on design, materials, and mechanical testing, not on meeting specific performance metrics for an AI algorithm.
• No reported device performance for AI: There is no AI component to this device.
• No sample size for test set or data provenance: These concepts are not applicable to the non-clinical testing described.
• No experts to establish ground truth or adjudication methods: Not applicable to the type of device and testing presented.
• No MRMC study: Not relevant for this physical implant.
• No standalone algorithm performance: The device is an implant, not an algorithm.
• No ground truth type: Not applicable.
• No training set size or ground truth establishment for training set: Not applicable as there is no AI component.

The "Non-clinical Performance Data" section states: "The evaluation of simulated device volumes in the femoral neck and head demonstrates that the subject device does not present a new worst case for use in femoral neck fracture fixation compared to the predicate and reference devices. Hence it supports the proposed expanded 'Indications for Use' for the subject device." This is a biomechanical assessment, not an AI performance study.

The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." This further confirms that the kind of performance study you are asking about, which typically involves clinical data and AI evaluation, was not performed or required for this submission.

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The Large Screws range is intended for the fixation of bone fractures, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.

The Large Screws range consists of screws designed for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults. The Large Screws range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136-12a and/or ISO 5832-3). Function: The implants of the Large Screws range are indicated for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.

The provided text describes a medical device (Large Screws range) and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for a study, nor does it present the results of a study designed to meet specific acceptance criteria.

The document is a 510(k) summary, which is a premarket notification to the FDA demonstrating that a device is substantially equivalent to a legally marketed predicate device. This process typically relies on demonstrating equivalence through comparison of technological characteristics, materials, and non-clinical testing, rather than a study against specific performance acceptance criteria as one might see for a novel AI/software medical device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document lists "Non-clinical Test Summary" items (Comparative torsional tests, Comparative pullout engineering analysis, Driving torque tests) but does not provide specific acceptance criteria or performance data for these tests. It also explicitly states "No clinical studies were performed."
2. Sample size used for the test set and the data provenance: Not applicable, as there's no clinical "test set" described. The non-clinical tests would have involved samples of the screws, but details on sample size, other than implied through "comparative", are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant here as no clinical studies were performed.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical bone fixation fastener, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is for a physical medical device (bone screws) and focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing predicate devices, not on a study with specific acceptance criteria as would be typical for an AI/software medical device.

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The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

The CrossRoads Screw System is comprised of bone screws having various features in a variety of diameters and lengths to accommodate differing patient anatomy.

This document describes the CrossRoads Screw System, a bone fixation fastener. The acceptance criteria and the study that proves the device meets those criteria are detailed below, 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

The provided text describes "theoretical analysis" and "predicted performance" rather than physical testing on a 'test set' in the traditional sense of a clinical or laboratory study with a distinct sample size. The analysis appears to be computational/theoretical in nature.

• Sample Size: Not explicitly stated as a numerical sample size for a "test set" of physical devices. The analysis was performed on "worst case CrossRoads screws." This implies a selection of device configurations that are considered most challenging from an engineering perspective, rather than a random sample.
• Data Provenance: The study is described as "theoretical analysis." This suggests the data is derived from engineering calculations and modeling, rather than empirical data from human subjects or physical tests on manufactured devices that would have a country of origin.

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

Not applicable. The "ground truth" for this type of engineering performance study (torsional and pullout strength) is based on established engineering principles, material properties (ASTM F136 titanium alloy and ASTM F138 stainless steel), and calculation methods. It does not involve expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The study relies on calculated engineering values.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the mechanical properties of a medical device (screws) through theoretical analysis, not on the interpretation of medical images or clinical effectiveness where human readers would be involved.

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

This question is typically relevant for AI/ML-based diagnostic devices. In the context of a mechanical device like a screw system, the "standalone" performance refers to its intrinsic mechanical properties as determined by the theoretical analysis. The study described is precisely a standalone performance assessment of the device's predicted mechanical characteristics (torsional and pullout strengths) without human intervention in the performance itself (though humans designed the device and conducted the analysis).

7. The Type of Ground Truth Used

The "ground truth" for this study is based on:

• Established engineering principles and material science.
• Calculated values derived from theoretical models for torsional and pullout strengths.
• Performance of legally marketed predicate devices (K143039 CrossRoads Screw System, K000080 and K024060 Stryker Asnis III Screw System), which serve as a benchmark for "substantial equivalence."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML study that uses a "training set." The study involves theoretical engineering analysis.

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

Not applicable, as there is no "training set" for this type of engineering performance study.

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