(138 days)
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™ Targeting System. The modifications to the SURESHOT™ Targeting System V3.0 include the implementation of the drill depth measurement function, the ability to target for 8.5mm Japanese nails, an updated graphical user interface, updates to the Launcher program, and the addition of new drill sleeves.
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 sensorembedded 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™ Distal Targeting System software is intended to be used with existing Smith & Nephew platform, instruments and implants. New instrumentation has been developed for the drill depth measurement application aspect of the software. The devices subject of this premarket notification include:
- SURESHOT™ Distal Targeting System Software V3.0 .
- SURESHOT™ Trauma Launcher Software V1.1.1 .
- SURESHOT™ Drill Depth Inner Drill Sleeves .
- SURESHOTTM Drill Depth Outer Screw Sleeve .
No new implants are being cleared via this premarket notification.
This document describes a Special 510(k) Premarket Notification for modifications to the SURESHOT™ Distal Targeting System V3.0. The notification focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a standalone study with acceptance criteria and a detailed validation report.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the modified device (SURESHOT™ Distal Targeting System V3.0). Instead, it relies on demonstrating that the software modifications perform "as intended" and do not introduce new safety or effectiveness issues, aligning with the performance of its predicate devices.
The "Technological Characteristics" section 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."
This implies that the acceptance criteria were met through standard software validation processes, which typically involve demonstrating that the software functions according to its specifications and user requirements. However, the exact performance metrics or thresholds are not detailed in this submission. The "reported device performance" is essentially that the device performs equivalently to the predicate devices without introducing new risks.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a clinical or performance study of the modified device. The submission explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject device."
The software validation and verification would have involved various testing scenarios, but these are generally considered engineering tests rather than clinical studies using patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
As no clinical test set is described, there's no mention of experts establishing ground truth for such a set. Software validation typically involves testing by engineers and possibly clinical subject matter experts (e.g., surgeons in a simulated environment) to verify functionality, but this is not equivalent to establishing ground truth for a diagnostic or predictive AI model.
4. Adjudication Method for the Test Set:
Not applicable, as no external test set requiring expert adjudication for ground truth establishment is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted. The document states that "Clinical data was not needed to support the safety and effectiveness of the subject device." The focus was on demonstrating substantial equivalence through software validation and comparison to predicate devices, not on quantifying the improvement of human readers with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
While software verification and validation would involve evaluating the algorithm's performance in a standalone manner (e.g., in a test environment), the document does not present this as a formal "standalone performance study" with specific metrics. The device is a "computer assisted orthopedic surgery tool to aid the surgeon," inherently designed for human-in-the-loop use. The "standalone" evaluation would be part of the general software V&V, ensuring the system calculates and assists correctly.
7. The Type of Ground Truth Used:
For the software validation, the "ground truth" would be the expected output and behavior of the software based on its design specifications and user requirements. This is established through engineering design, mathematical models, and simulated scenarios, not typically through clinical labels like pathology or outcomes data in this context. The accuracy of the electromagnetic tracking system itself would have been validated in previous submissions or as part of the overall system's design, likely against known physical measurements.
8. The Sample Size for the Training Set:
The document does not describe an AI/machine learning training set. This device is a "computer assisted surgery system" that uses electromagnetic tracking, not a system that relies on machine learning or AI models trained on large datasets. Therefore, there is no "training set" in the context of typical AI device submissions.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no AI/machine learning training set is described.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).