(241 days)
The Stryker OrthoMap Express Knee system, which is comprised of the OrthoMap Express Knee 2.0 Software and a platform of the NAV31 platform family, is intended as a planning and intra-operative 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 Express 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 surqical 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 Express Knee 2.0 software is compatible with the NAV3i 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 (K141551)
- Stryker NAV3i Platform (K130874) ●
- Stryker NAVSuite3 Kit (K150301) ●
The platforms consist of the following components:
- Stryker computer
- Navigation camera ●
- IO-Tablet
- Monitor ●
- Mobile cart (if applicable) ●
The provided document is a 510(k) Premarket Notification for the Stryker OrthoMap Express Knee System, cleared by the FDA on July 7, 2016. This document details the device's intended use, comparison to predicate devices, and performance testing to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specification) | Reported Device Performance (Result) |
|---|---|
| System Accuracy (Translational): 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).