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The Shotel Ankle Arthrodesis Nail System is intended for the following:

• Charcot Foot
• Avascular necrosis of the talus
• Failed total ankle arthroplasty
• Trauma (malunited tibial pilon fracture)
• Severe deformity or instability as a result of talipes equinoivarus, cerebral vascular accident, paralysis or other neuromuscular disease
• Revision ankle arthrodesis
• Neuroarthropathy
• Rheumatoid arthritis
• Osteoarthritis
• Pseudoarthrosis
• Post-Traumatic arthrosis
• Previously infected arthrosis
• Severe end stage degenerative arthritis
• Severe defects after tumor resection
• Pantalar arthrodesis

The Shotel Ankle Arthrodesis Nail System is an implantable intramedullary system of fusion nails, bone screws, a nail cap and a set of instruments for primary ankle fusion. The curved fusion nail has 6 screw holes that can accommodate up to 6 bone screws and is available in seven (7) diameters in two configurations, left and right. The four (4) distal cross locking holes provide the surgeon with either a static or dynamic cross locking hole in alternative 90 degree orientation configurations. The 5mm fixation bone screws are offered in 27 lengths and the nail caps are available in two configurations; standard nail cap length and a plus 5 mm nail cap length affording the surgeon the ability to slightly adjust the final nail assembly length. All three implant components are manufactured from titanium Ti-6Al-4V and are single use only. Components are offered sterile and non-sterile.

This document is a 510(k) premarket notification for a medical device called the "Shotel Ankle Arthrodesis Nail System." It describes the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to legally marketed predicate devices.

Here's a breakdown of the requested information based on the provided text, with a strong caveat: This document is a regulatory submission for a medical implant (a nail system), not an AI/software as a medical device (SaMD) or diagnostic imaging device. Therefore, many of the requested elements (like acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or not provided in the context of this type of device.

The "performance data" referred to in this document relates to mechanical and material performance of the implant, not diagnostic accuracy or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This is not a study assessing a diagnostic or AI device with a test set of data. The "testing" refers to physical and mechanical evaluation of the implant itself, not evaluation on patient data.
• Data Provenance: Not applicable in the context of diagnostic/AI data. The materials and mechanical tests were performed on the device components.

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

• Not applicable. Ground truth as typically understood for diagnostic/AI studies (e.g., expert consensus on images, pathology results) is not relevant for this mechanical device submission.

4. Adjudication method for the test set

• Not applicable. There is no "test set" in the diagnostic/AI sense to adjudicate.

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 not a study involving human readers or AI assistance.

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 an algorithm.

7. The type of ground truth used

• Not applicable in the diagnostic/AI sense. The "ground truth" for this device's performance would be established through engineering standards (e.g., ASTM F1264) and measurements comparing the device's physical properties to those standards and predicate devices.

8. The sample size for the training set

• Not applicable. There is no training set as understood for AI/machine learning.

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

• Not applicable. There is no training set for this device.

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The Tornier ForeFoot STP Screw System is indicated for fixation of fractures, fusions, and osteotomies of bones of the hand and foot.

The submission is regarding the ForeFoot STP System. This system consists of screws of various diameters, lengths and thread configurations.

This document is a 510(k) premarket notification for the Tornier ForeFoot STP System, a medical device. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. Based on the provided text, a "study" in the context of device performance refers to mechanical testing rather than a clinical study or a study involving AI/software analysis of data.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table format for this 510(k) submission. However, it mentions the types of tests performed and the conclusion that the device is substantially equivalent based on these tests.

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

This document describes mechanical testing of a physical medical device (screws), not a study analyzing data (like images or patient records). Therefore, the concept of a "test set" in the context of data provenance (country of origin, retrospective/prospective) and sample size for data analysis does not directly apply.

• The "sample size" would refer to the number of physical screws tested in the mechanical evaluations. This information is not provided in the document.
• "Data provenance" is not applicable as this concerns mechanical properties of the device itself, not clinical or image data.

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

This is not applicable. The "ground truth" for mechanical testing of screws is defined by the physical properties of the materials and the engineering standards for such devices. It does not involve expert interpretation in the way clinical or imaging studies do.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical testing results are objective measurements based on engineering principles and test protocols, not subjective interpretations requiring 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

This is not applicable. This submission is for a physical medical device (fixation screws), not an AI or software-based medical device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the mechanical testing of the ForeFoot STP System would be based on engineering standards and established material properties for bone fixation devices. The performance is compared against the known performance of the predicate devices, which also comply with these engineering standards. The focus is on demonstrating equivalent mechanical strength and characteristics.

8. The Sample Size for the Training Set

This is not applicable. This refers to a physical medical device, not an AI or software-based system that uses a "training set."

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

This is not applicable. This refers to a physical medical device, not an AI or software-based system.

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