(51 days)
The Stryker OrthoMap Precision Knee system, which is comprised of the OrthoMap Precision Knee 5.0 Software and a platform of the NAV3i platform family, is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery.
The system can be used for intraoperative guidance where a rigid anatomical structure can be identified. The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.
The Stryker OrthoMap Precision Knee system is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided knee surgery. The system uses wireless optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model of the patient's leg (femur and tibia). The computed model is based on an intra-operative anatomy survey of the leg. The system consists of a Stryker surgical software application (software), which runs on a platform, consisting of a Stryker computer, a navigation camera, an IO-Tablet and a monitor. The Stryker surgical software application interfaces with smart instruments (e.g. patient trackers, instrument trackers or pointers) and several accessories enabling the tracking of surgical instruments.
The Stryker OrthoMap Precision Knee 5.0 software is compatible with the NAV31 Platform Family. The NAV3i platform family is a family of platforms that, when used with a surgical software application, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The NAV3i platform family consists of the following three platforms that have been previously cleared independently or with other Stryker surgical software applications:
- Stryker NAV3 Platform
- Stryker NAV3i Platform ●
- Stryker NAVSuite3 Kit
The platforms consist of the following components:
- Stryker computer
- Navigation camera ●
- IO-Tablet ●
- Monitor
- Mobile cart (if applicable) ●
This document is a 510(k) summary for the Stryker OrthoMap Precision Knee system. It does not describe a study that validates AI performance, but rather outlines the performance criteria and testing for a computer-assisted surgical guidance system. Therefore, some of the requested information regarding AI-specific studies (e.g., MRMC studies, training set details) will not be available.
Here's an analysis of the provided text for the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Specification) | Reported Device Performance |
|---|---|
| Electrical Safety | Device conforms to ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) (FDA Rec# 19-4). |
| Electromagnetic Compatibility (EMC) | Device conforms to IEC 60601-1-2:2007: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (FDA Rec#19-1). |
| Software Verification and Validation | Conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered a "MAJOR" level of concern. |
| Accuracy of Localization and Tracking Technology | Verified using ASTM Standard F2554-10. (Specific performance result not explicitly stated here, but implied as meeting the general system accuracy below). |
| System Accuracy (Translational Error) | Mean translational error of |
§ 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).