(88 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 to include software updates (V4.0) to include the ability to target for the TRIGEN META-TAN Nail (previously cleared in K092748), the ability for on screen rotation using the SURESHOT™ Targeter, additional languages of the graphical user interface (for international users), updates to the graphical user interface, and updates to the Launcher program
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 software is intended to be used with existing Smith & Nephew platform, 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. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a standalone study proving device performance against specific targets.
However, I can extract information related to software validation and verification testing, which serves as the basis for demonstrating the device works as intended.
Here's a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding device performance metrics (e.g., accuracy in mm, failure rate thresholds). Instead, it states that "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."
The acceptance criteria are implicitly met if the listed preclinical tests passed, demonstrating that the "software will perform as intended." The reported performance is that "there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended as compared to the predicate."
Implicit Acceptance Criteria (based on tests performed):
| Test Category | Implied Acceptance Criterion | Reported Performance |
|---|---|---|
| Software Validation & Verification | Software functions as designed, without introducing new safety or effectiveness issues. | All tests passed; no new safety/effectiveness issues. |
| Deployment Distal Targeting Software | Software deploys and functions correctly for distal targeting. | Performed as intended. |
| Workflow and System Settings | Workflow and system settings operate correctly. | Performed as intended. |
| Tool Connections | Tools connect reliably and are recognized by the system. | Performed as intended. |
| Sleeve Selection | Sleeve selection functions correctly. | Performed as intended. |
| Implant Selection | Implant selection functions correctly. | Performed as intended. |
| Drilling Screen | Drilling screen displays correct information and functionality. | Performed as intended. |
| Hardware Failure | System handles hardware failures gracefully or as designed. | Performed as intended. |
| Drill Depth Measurement | Drill depth measurement is accurate (though specific precision not stated). | Performed as intended. |
| Targeting Calculations (META, TAN/FAN, Humeral, META-TAN, Field Check) | Targeting calculations for various nail types are accurate and reliable. | Performed as intended. |
| Translations (Chinese, English, French, German, Italian, Japanese, Portuguese, Finnish, Spanish) | Graphical User Interface (GUI) is correctly translated and functional in specified languages. | Performed as intended. |
| Nail Rotation | Nail rotation functionality operates correctly. | Performed as intended. |
| View Selection | View selection functionality operates correctly. | Performed as intended. |
| Customer Validation | (Details not provided, but implies the software meets user needs/expectations). | Performed as intended. |
| Regression Test | (Details not provided, but implies new changes did not adversely affect existing functionality). | Performed as intended. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of subject or case count for the preclinical testing. The tests listed are functional and technical software validation tests, typically performed in a controlled environment. Clinical data was explicitly not used or needed to support the safety and effectiveness of the subject device for this 510(k) submission. Therefore, there's no data provenance in the context of clinical studies (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The preclinical software tests described do not involve human expert adjudication of medical images or diagnoses to establish a "ground truth." The ground truth for these tests would be the intended software behavior and calculation correctness as defined by engineering specifications.
4. Adjudication Method for the Test Set
Not applicable, as no expert adjudication for medical data is described. The "adjudication" for software testing would be the engineering team verifying that the test results match the expected outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject device." The submission relies on demonstrating substantial equivalence to a predicate device and software verification/validation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The listed preclinical tests are essentially standalone algorithm/software verification, focusing on the functionality and calculations of the device's software. The device itself (SURESHOT™ Distal Targeting System) is an "intraoperative image guided localization system" and a "computer assisted orthopedic surgery tool to aid the surgeon with drill positioning," implying a human-in-the-loop during actual clinical use. However, the testing described is of the underlying software's performance (e.g., targeting calculations, GUI functionality) in a controlled environment, which can be considered standalone verification of the software components.
7. The Type of Ground Truth Used
For the software validation and verification, the "ground truth" is likely defined by:
- Design specifications: The intended behavior, outputs, and calculations as per the software design documents.
- Known correct values: For calculations (e.g., "Targeting Calculations META"), the ground truth would be precise, pre-calculated results for a given input.
- Previous versions' behavior: For regression testing, the ground truth is the expected behavior of the existing features from prior, cleared versions.
8. The Sample Size for the Training Set
Not applicable. The text describes software updates to an existing system and verification/validation testing. This is not a machine learning model, so there is no training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a machine learning model 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).