(30 days)
The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning of surgical instruments or spinal implants during general spine surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include: Posterior-approach spinal implant procedures, such as pedicle screw placement, with the lumbar region.
The subject devices, Image calibrator-21F and Image calibrator-31F are designed for use with Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513). The subject devices are modified from previously cleared devices to be compatible with the 21 cm/ 31 cm flat panel C-arm for CT image position and calibration.
The software upgrade is due to these newly added Image calibrators and one added function of auto-labeling for CT/C-arm image registration.
This 510(k) clearance letter and summary discuss the Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. However, the provided document does not contain the detailed acceptance criteria and the specific study data proving the device meets these criteria in the format requested.
The document states:
- "Verification and validation activities have been completed to provide sufficient assurance that the subject device meets the performance requirements under its indications for use conditions."
- "The test methods are the same as the previously cleared 510(k), K233513."
- "All the results are passed."
This indicates that performance testing was conducted and passed, but the specific metrics, criteria, and the results themselves are not enumerated in this public summary. This level of detail is typically found in the full 510(k) submission, which is not publicly released in its entirety.
Therefore, I cannot extract the information needed to fill out the requested table and answer the specific questions about the study design, sample sizes, expert qualifications, and ground truth establishment from the provided text.
Based on the provided text, here's what can be inferred or explicitly stated regarding performance testing, but not the detailed acceptance criteria or results:
- Type of device: Spine Surgery Navigation System. These systems are typically evaluated based on their accuracy in guiding surgical instruments or implants relative to anatomical structures.
- Performance Data Section: The document mentions "Verification and validation activities have been completed" for the subject device.
- Test Descriptions mentioned:
- Software: Verified and validated in accordance with FDA guidance for software in medical devices and IEC 62304.
- Risk Assessment: Effectiveness of risk control measures verified in accordance with ISO 14971.
- Design Verification: Design output fulfills design input requirements.
- Comparison to Predicate: "The intended use and fundamental technology of the subject device are identical to the predicate devices and could share the same testing methods as the predicate devices. All the results are passed." This implies that the performance was at least as good as the predicate device (K233513).
- Nature of changes: The current 510(k) is for a modification to the device, including compatibility with new Image Calibrators (21F and 31F for flat panel C-arm CT imaging) and an auto-labeling function for CT/C-arm image registration. Performance testing would have focused on verifying these changes do not adversely affect safety and effectiveness, and that the existing fundamental performance (e.g., accuracy of navigation) is maintained.
Conclusion: The provided text confirms that performance testing was conducted and passed, but does not provide the specific acceptance criteria or the reported performance data in a quantifiable manner. The document acts as a summary and approval letter, not a detailed study report.
§ 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).