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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 premarket notification are modifications to the SURESHOT™ Distal Targeting System V4.0- targeter which has been designed with a reduced size and weight compared to the previous design of the targeter (K092497). The SURESHOT Targeting system targeter is intended to be used the SURESHOT trauma interfaces (K170977, K100107) and software V4.0 (K170280).

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 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™ Distal Targeting System V4.0 targeter is intended to be used with existing Smith & Nephew software, trauma interface, instruments and implants, No new instruments or implants are being cleared via this premarket notification.

The provided text describes a 510(k) premarket notification for the Smith & Nephew SURESHOT Distal Targeting System V4.0. The submission focuses on modifications to an existing device (targeter) with reduced size and weight, and largely relies on the substantial equivalence to a predicate device (PiGalileo Screw Targeting System V1.1) and pre-clinical testing.

Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them:

Overall Conclusion from the Document:

The document states that "Clinical data was not needed to support the safety and effectiveness of the subject device." This is a crucial piece of information, as it indicates that the FDA's acceptance was primarily based on:

1. Substantial Equivalence: Demonstrating that the modified device is as safe and effective as a legally marketed predicate device with identical indications for use and equivalent technological principles, despite minor design changes (reduced size/weight).
2. Pre-clinical Testing (Verification and Validation): Ensuring the device's functionality, electrical safety, electromagnetic compatibility, and software performance meet specified standards.

Therefore, for the SURESHOT Distal Targeting System V4.0 targeter, the "acceptance criteria" are not framed as specific performance metrics derived from a human-in-the-loop or standalone AI study, but rather as successful demonstration of substantial equivalence and compliance with engineering/software V&V standards.

Detailed Breakdown for the SURESHOT Distal Targeting System V4.0:

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

Since no clinical study data with specific performance metrics (like accuracy, sensitivity, specificity, etc., which are common for AI/diagnostic devices) are provided, the "acceptance criteria" are derived from the substantial equivalence and pre-clinical testing mentioned.

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

• Test Set Sample Size: Not applicable in the context of clinical data for performance evaluation. The "test set" here refers to the units of the device and associated software/hardware components subjected to engineering and software verification/validation tests. The document doesn't specify the number of physical targeters or software instances used for these tests, but it indicates the tests were conducted successfully.
• Data Provenance: The data provenance is from internal Smith & Nephew pre-clinical testing, performed to demonstrate compliance with standards and equivalence. It is not patient or clinical data, thus "country of origin" and "retrospective/prospective" are not relevant in this context.

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

• Not applicable. As this approval is based on substantial equivalence and pre-clinical V&V, there was no "ground truth" derived from expert medical review of patient data. The "ground truth" for the engineering tests would be the established engineering specifications and regulatory standards. The experts involved would be engineers, quality assurance personnel, and regulatory affairs specialists within Smith & Nephew who designed, built, tested, and submitted the device. Their qualifications would align with these disciplines.

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

• Not applicable. No clinical test set requiring human adjudication of ground truth was conducted. The "adjudication" in this context would be the internal review and sign-off processes for engineering and software validation reports, ensuring tests met predefined acceptance criteria.

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. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject device." Therefore, no MRMC study, or any clinical comparative effectiveness study involving human readers/users, was performed or presented. This device is a surgical tool, not an AI diagnostic/interpretative device the FDA typically reviews with MRMC studies.

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

• Not directly applicable in the terms of standalone diagnostic AI performance. However, extensive standalone software validation (algorithm performance) was conducted through the listed "Software verification and validation testing," which included tests like "Targeting Calculations META," "Targeting Calculations TAN/FAN," "Drill Depth Measurement," and "Nail Rotation." These tests verify the accuracy and correctness of the algorithms within the software, independent of a human operator, by comparing computed results against expected outputs based on known inputs or simulations. This is a form of "standalone" evaluation of the software's functional correctness.

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

• For the software testing, the "ground truth" was deterministic: it was established through engineered specifications, mathematical models, and simulated inputs that define the expected correct output of the algorithms. For example, for "Targeting Calculations," the ground truth would be the precisely calculated correct target coordinates based on the software's intended geometric and kinematic models. For "Drill Depth Measurement," the ground truth would be the predefined correct depth for a given input. This is not medical expert consensus, pathology, or outcomes data.
• For the hardware (EMC, electrical safety), the ground truth was established international and national regulatory standards (e.g., IEC 60601 series).

8. The sample size for the training set:

• Not applicable. This device is a surgical targeting system, not an AI/machine learning model that requires a "training set" of data in the typical sense (e.g., for image classification or prediction). The software is deterministic and rule-based, performing calculations and tracking based on predefined engineering principles and algorithms, rather than learning from data.

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

• Not applicable, as no training set was used.

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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 premarket notification are modifications to the SURESHOT™ Distal Targeting System trauma interface which include reduced overall size and weight, addition of HDMI video output, removed VESA Mounting Post, improved screen resolution and reduced screen size compared to the previous design of the trauma interface (K100107). The second generation trauma interface uses the SURESHOT Targeting System V4.0 software (K170280).

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 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™ Distal Targeting System trauma interface is intended to be used with existing Smith & Nephew software, targeter, instruments and implants. No new instruments or implants are being cleared via this premarket notification.

The provided text describes a 510(k) premarket notification for the Smith & Nephew SURESHOT™ Distal Targeting System V4.0 Trauma Interface. This submission primarily focuses on modifications to the existing device (K100107) and its software (K170280), rather than presenting a new clinical study with specific acceptance criteria and performance metrics for a novel AI algorithm or diagnostic device.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods for a study proving the device meets acceptance criteria is not explicitly present in the provided document. The document states that "Clinical data was not needed to support the safety and effectiveness of the subject device."

However, I can extract information related to the device's technical validation and comparison to its predicate.

Here's a breakdown of the available information in relation to your request:

Acceptance Criteria and Reported Device Performance

Given that clinical data was not required for this 510(k) submission, there are no specific performance criteria (e.g., sensitivity, specificity, accuracy) related to a clinical study presented. Instead, the acceptance criteria are based on compliance with standards for electromagnetic compatibility, electrical safety, and software validation. The reported "performance" is compliance with these standards and equivalence to the predicate device.

• Similar intended use, design features, sterilization methods, operational principles, instrumentation, packaging, materials, system design, and tracking system (Aurora, Northern Digital Inc.).
• Software compatibility with SURESHOT Distal Targeting System V4.0 software (K170280). |
  | Physical/Hardware Modifications | Functionally equivalent to the predicate despite reduced overall size (31cm x 26cm x 13cm vs 40cm x 38cm x 20cm) and weight (3.5kg vs 9kg), improved screen resolution (1280x800 vs 1024x768), reduced screen size (10 inch vs 15 inch), and addition of HDMI output (N/A on predicate). The VESA Mounting Posts were removed. |

Study Details (Based on the provided document)

Since a clinical study was not required, the following points address what is mentioned concerning testing:

1. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is described. The validation involves engineering tests (EMC, electrical safety) and software verification/validation, not a clinical test set with patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established by experts for a test set in this submission.
3. Adjudication method for the test set: Not applicable. There was no clinical test set requiring adjudication.
4. 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 device is a computer-assisted orthopedic surgery tool, not a diagnostic AI that assists human readers in interpreting medical images. There is no mention of an MRMC study or AI-assisted human performance improvement.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The software validation falls under standalone performance in a technical sense, ensuring the software performs as intended. However, this is not a study assessing clinical performance in isolation from the human surgeon. The device is explicitly designed as an "intraoperative image guided localization system" and a "computer assisted orthopedic surgery tool" intended to "aid the surgeon."
6. The type of ground truth used:
   • For Electromagnetic Compatibility and Electrical Safety: Ground truth is defined by the technical specifications and requirements of the IEC 60601-1 and IEC 60601-1-2 standards.
   • For Software Verification & Validation: Ground truth is the functional requirements and specifications of the software, validated against documented expected behavior.
   • For Substantial Equivalence: Ground truth is the performance characteristics and indications for use of the predicate device (K100107 and K170280).
7. The sample size for the training set: Not applicable. The document does not describe the development of an AI algorithm based on a training set of data. The software mentioned (SURESHOT Targeting System V4.0 software K170280) is an electromagnetic tracking software, not a machine learning model requiring a patient data training set as typically understood in AI/ML medical devices.
8. How the ground truth for the training set was established: Not applicable, as no training set (for AI/ML) is mentioned or used in this context.

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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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