(106 days)
The Stryker SpineMap® 3D Navigation System, when used with a Stryker computer workstation, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.
The system is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a rigid anatomical structure can be identified.
The Stryker SpineMap® 3D Navigation System assists in precise positioning of instruments for procedures on the spine, including:
· Pedicle screw placement
The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker SpineMap® 3D Navigation System. It is placed onto the patient's skin dorsal to the spine.
- · In combination with intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery.
- · When used for patient tracking, the Stryker SpineMask™ Tracker supports minimally invasive procedures on the lumbar and thoracic spine.
The Stryker SpineMap® 3D Navigation System is an image guided surgery system to enable open or percutaneous computer-assisted spinal surgery.
The system uses wireless optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a CT image.
The system consists of a software application, smart instruments (e.g. patient/instrument trackers, pointers, navigated surgical instruments), and several accessories to enable the tracking of surgical instruments. The system also includes the SpineMask™ Tracker, a new patient tracking device.
The software application runs on a Stryker computer platform, consisting of a Stryker computer, a navigation camera and an IO-Tablet.
The provided document is a 510(k) summary for the Stryker SpineMap® 3D Navigation System and the Stryker SpineMask™ Tracker. It focuses on demonstrating substantial equivalence to predicate devices and outlines non-clinical testing. Crucially, the document explicitly states "No clinical testing has been conducted." Therefore, there is no study described that proves the device meets acceptance criteria through clinical performance.
However, the document details non-clinical acceptance criteria and the performance related to those:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Test | Acceptance Criteria (Description) | Reported Device Performance (Description from "Non-Clinical Testing" section) |
|---|---|---|
| SpineMask Tracker Patient Tracking | Equivalence of SpineMask Tracker and the Spine Clamp / Spine Tracker combination for minimally invasive procedures. | Validated the equivalence of SpineMask Tracker and the Spine Clamp / Spine Tracker combination for minimally invasive procedures. |
| User Needs | Validation of the product with users in cadaver labs or simulated use tests. Verified compatibility with conventional operative technique and other devices used in spinal surgery. | Validated the product with users in cadaver labs or simulated use tests. Verified compatibility with conventional operative technique and other devices used in spinal surgery. |
| Accuracy | Mean navigation accuracy of ± 2mm point displacement and ± 2° angular axis displacement according to ASTM F2554:2010 and in phantom tests. Equivalent system accuracy compared to predicate in cadaver tests. | Verified the mean navigation accuracy of ± 2mm point displacement and ± 2° angular axis displacement according to ASTM F2554:2010 and in phantom tests. Verified equivalent system accuracy compared to predicate in cadaver tests. |
| Safety | Effectiveness of all risk controls determined in the device risk analysis. | Verified the effectiveness of all risk controls determined in the device risk analysis. |
| General Requirements and Performance | All components against their design specifications. | Verified all components against their design specifications. |
| Software | Verification and validation according to IEC 62304:2006 and FDA guidance on general principles of software validation, June 9, 1997. | Verification and validation according to IEC 62304:2006 and FDA guidance on general principles of software validation, June 9, 1997. |
| Shelf Life Testing | Functionality of the single-use, sterile device and integrity of the packaging after aging. | Verified functionality of the single-use, sterile device and integrity of the packaging after aging. |
| Biocompatibility | Biocompatibility of all patient contact materials according to ISO 10993-1:2009 and FDA draft guidance on the use of ISO 10993-1, April 23, 2013. | Verified the biocompatibility of all patient contact materials according to ISO 10993-1:2009 and FDA draft guidance on the use of ISO 10993-1, April 23, 2013. |
| Electrical Safety | Conformance to ANSI/AAMI ES 60601-1:2006-02. | Verified conformance to ANSI/AAMI ES 60601-1:2006-02. |
| Electromagnetic Compatibility | Conformance to IEC 60601-1-2: 2007-03, CISPR 11 Group 1, Class B requirements as well as additional testing to verify compatibility with RFID devices operating in the 125 - 134 kHz frequency band. | Verified conformance to IEC 60601-1-2: 2007-03, CISPR 11 Group 1, Class B requirements as well as additional testing to verify compatibility with RFID devices operating in the 125 - 134 kHz frequency band. |
| Shipping | Functionality of the device after simulated shipping conditions. | Verified functionality of the device after simulated shipping conditions. |
| Sterilization | EO sterilization process for the single-use, sterile device according to ISO 11135-1:2007 to a sterility assurance level (SAL) of 10-6 and verified EO and ECH residuals are within the limits defined in ISO 10993-7:2008. | Validated the EO sterilization process for the single-use, sterile device according to ISO 11135-1:2007 to a sterility assurance level (SAL) of 10-6 and verified that the EO and ECH residuals are within the limits defined in ISO 10993-7:2008. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide specific sample sizes for the "test set" in the context of clinical data because no clinical testing was performed. For non-clinical testing:
- Accuracy: Tested in phantom tests and cadaver tests. No specific sample size (number of phantoms or cadavers) is mentioned.
- User Needs: Validated in cadaver labs or simulated use tests. No specific sample size is mentioned.
- Data provenance: Not specified for non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as no clinical testing was performed. For User Needs validation (cadaver labs/simulated use), it mentions "users," but does not specify their number or qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no clinical testing was performed.
5. 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 as no clinical testing was performed and the device is a navigation system, not an AI diagnostic/reader tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the navigation system components (software and hardware) independently, which is covered by the non-clinical tests for accuracy, software validation, electrical safety, etc. The "Accuracy" test specifically reports on the system's inherent navigation precision.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Accuracy: "Ground truth" would be established by precise measurement tools in phantom and cadaver settings, comparing the system's output to the known position/orientation.
- Other tests (Software, Electrical Safety, EMC, Sterilization, Biocompatibility): Ground truth is compliance with relevant industry standards (e.g., ISO, IEC, ASTM, ANSI/AAMI) and internal design specifications.
8. The sample size for the training set
Not applicable in the context of machine learning model training. The device is a navigation system, not an AI model that learns from training data in the traditional sense of AI diagnostics. Its software is validated against established specifications and standards.
9. How the ground truth for the training set was established
Not applicable as there is no "training set" for an AI model. "Ground truth" for system design and verification is based on engineering specifications and adherence to international standards.
§ 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).