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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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