(130 days)
The Stryker Navigation System is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure such as the skull, or vertebra, can be identified relative to medical images.
The Stryker Navigation System- Spine & Fluoroscopy Module supports, but is not limited to the following surgical procedures:
- Pedicle Screw Placement
- Navigation
- Precisely positioning instruments such as internal and external fixation devices during orthopedic surgery, to include operations performed with spinal structure, hip and bones in the upper and lower extremities and long bones.
- This submission is not intended for total joint replacement procedures.
Not Found
This FDA 510(k) clearance letter (K012380) for the Stryker Navigation System - Spine & Fluoroscopy Module is a clearance of substantial equivalence, not a detailed study report. Therefore, it does not contain the specific information requested about acceptance criteria, detailed study design, or performance metrics typically found in a clinical study report.
The letter states that the device is substantially equivalent to a legally marketed predicate device, implying that its safety and effectiveness have been deemed comparable based on the provided information, which often includes performance data in the submission. However, these specific details are not present in the provided document.
To answer your questions accurately, I would need access to the full 510(k) submission (K012380) including the sections detailing performance data and clinical studies, which is not provided here.
Based only on the provided document, I can infer the following about what is missing:
- 1. A table of acceptance criteria and the reported device performance: Not present in the provided document. The 510(k) letter states substantial equivalence, but not the specific performance data against acceptance criteria.
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present in the provided document.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not present in the provided document.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present in the provided document.
- 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 present in the provided document. The device is a "Navigation System," implying it's a guidance tool, not an AI interpretation tool for readers. An MRMC study is therefore unlikely to be directly applicable in the terms you describe.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present in the provided document. The device is described as "planning and intraoperative guidance system," inherently implying human-in-the-loop operation.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present in the provided document.
- 8. The sample size for the training set: Not present in the provided document.
- 9. How the ground truth for the training set was established: Not present in the provided document.
In summary, the provided FDA clearance letter indicates the device's intended use and regulatory classification but does not contain the detailed study information required to answer your specific questions about acceptance criteria, study design, and performance metrics.
§ 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).