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The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.

The Smith & Nephew PERI-LOC Ankle Fusion Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The PERI-LOC Ankle Fusion Plating System is indicated for ankle arthrodesis and fractures, including the distal tibia, fibula and calcaneus.

VLP FOOT Plating System and PERI-LOC Ankle Fusion Plating System bone plates and bone screws are for single use only.

The subject devices are comprised of locking bone plates and locking and non-locking bone screws. All described implant components are manufactured from stainless steel material. The subject implant devices are available in the following size ranges:

Device specific instruments are also described in this premarket notification in select sections and exhibits.

This document is a 510(k) summary for medical devices, specifically bone plates and screws. It details the device description, intended use, and substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria, device performance metrics, or study results in the context of an AI/ML device.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, experts, adjudication, or MRMC/standalone studies as this information is not present in the provided text.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

• Similar Indications for Use: The VLP FOOT Plating System and PERI-LOC Ankle Fusion Plating System have similar indications for fracture fixation, reconstruction, arthrodesis, and ankle arthrodesis as the predicate devices.
• Similar Materials: All described implant components are manufactured from stainless steel, similar to predicate devices.
• Similar Technological Design Characteristics: The components are "very similar" to legally marketed predicate devices.
• Pre-clinical Testing: Engineering analysis, four-point bend fatigue testing of plates, and construct fatigue testing of plate/screw constructs were conducted to further support substantial equivalence.

In summary, this document is a regulatory submission for a traditional medical device (bone plates and screws), not an AI/ML powered device, and thus does not contain the information required to answer your questions regarding acceptance criteria and performance studies for an AI/ML device.

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The Smith & Nephew SURESHOT Targeting System is intended to be an intraoperative image guided localization system. It is a computer assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew SURESHOT Targeting System is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

Subject of this Special Premarket Notifications to existing SURESHOT® Targeting System software. The SURESHOT® Targeting System is a computer controlled electromagnetic tracking system. It assists the surgeon in locating and positioning screws in an intramedullary nail implant during orthopedic trauma surgery. The link between the sterile surgical area (patient) and the instrument system is provided through an electromagnetic tracking system. Electromagnetic spatial measurement systems determine the location of instruments that are embedded with sensor coils. When the sensor-embedded instrument is placed inside controlled, varying magnetic fields, voltages are induced in the sensor coils. These induced voltages are used by the measurement system to calculate a 3D virtual position of the instrument. Because the magnetic fields are of a low field strength and can safely pass through human tissue, location measurement of an object is possible without the line-of-sight constraints of an optical spatial measurement system that requires a camera.

The SURESHOT® Targeting System software is intended to be used with existing Smith & Nephew platform, instruments and implants. The software devices subject of this premarket notification are the following:

• SURESHOT® Distal Targeting System Software V2.0.2 .
• . Trauma Launcher V1.0.1

The provided document is a 510(k) premarket notification for the Smith & Nephew, Inc. SURESHOT® Distal Targeting System V2.0.2. This document primarily focuses on demonstrating substantial equivalence to predicate devices and describes the software verification and validation activities. It does not contain detailed acceptance criteria, specific device performance metrics, or a dedicated study section with the information requested in your prompt.

Specifically, the document states:
"Software verification and validation testing was completed in line with FDA's guidance document entitled, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," dated January 11, 2002. A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended. Clinical data was not needed to support the safety and effectiveness of the subject device."

This directly implies that a clinical study, with predefined acceptance criteria and performance metrics, was not conducted or considered necessary for this specific submission to demonstrate the device's safety and effectiveness. The submission relies on software validation and verification testing which is not detailed in this public summary.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text.

Here's a breakdown of why each point cannot be addressed from the given information:

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

• Cannot be provided. The document states that clinical data was not needed, and it does not present any specific acceptance criteria or performance metrics (e.g., accuracy, precision) from software validation/verification.

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

• Cannot be provided. No clinical test set is mentioned. The software validation/verification would have internal test cases, but details like sample size or data provenance are not in this summary.

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)

• Cannot be provided. No clinical test set or expert ground truth establishment is described.

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

• Cannot be provided. No clinical test set or adjudication method 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

• Cannot be provided. This device is a computer-assisted surgical tool, not an AI diagnostic system that provides assistance to "human readers" in the typical sense of interpreting images. No MRMC study is mentioned.

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

• Cannot be provided. The device is described as assisting the surgeon, indicating it is inherently "human-in-the-loop." No standalone performance details are provided.

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

• Cannot be provided. No clinical ground truth is discussed. For software validation, ground truth would relate to expected software outputs for given inputs, but these details are not provided.

8. The sample size for the training set

• Cannot be provided. There is no mention of a "training set" in the context of an AI/machine learning model. This document describes a traditional software system, not one developed via machine learning.

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

• Cannot be provided. As above, no training set is mentioned.

The document is a regulatory submission demonstrating substantial equivalence for a software update to an existing device, relying on software verification and validation, rather than new clinical studies.

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