(22 days)
The Acumen ™ Surgical Navigation System is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
The Acumen ™ Surgical Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as-
- Spinal surgical procedures involving spinal stabilization, neural . decompression, or resection of spinal neoplasms.
- Orthopedic surgical procedures .
The Acumen ™ Surgical Navigation System described in this notification consists of the same following components as the previously cleared Z Box System by Z Kat :
- High Resolution color liquid crystal display (LCD) touch screen .
- Uninterruptible Power Supply (UPS) .
- Central Processing Unit (CPU) ●
- Isolation Transformer .
- Keyboard and Mouse .
- Optical Detector (on wheeled-base pedestal) .
- Operating Room Cart .
- Tool and accessories surgical tools and accessories . instrumented with LED or reflective markers
- dMIS kit- surgical instrument lit containing IGS tools and . accessories and dMIS key
- dMIS key- electronic storage media containing disposable . software application
This 510(k) submission (K051724) for the Acumen™ Surgical Navigation System is a "duplicate 510(k)" due to a transfer of ownership of the technology from Z-Kat, Inc. to EBI, L.P. The submission explicitly states that the Acumen™ system is identical to the previously FDA-cleared Z-Box system (K030764) in terms of intended use, indications for use (with minor exclusions), technological characteristics, and principles of operation/software applications.
Therefore, the "study that proves the device meets the acceptance criteria" refers to the performance data and acceptance criteria established and met for the original Z-Box system (K030764), as no new performance studies are presented in K051724. Without access to the original K030764 submission, a detailed table and comprehensive answers to all questions directly from K051724 are not possible. However, based on the information provided in K051724, we can infer the following:
1. A table of acceptance criteria and the reported device performance
Since this is a duplicate 510(k) for a transfer of ownership, new acceptance criteria and performance data are not typically presented or required. The acceptance criteria and reported device performance would have been established and reviewed during the clearance of the predicate device, Z-Box (K030764).
Based on the nature of a surgical navigation system, typical acceptance criteria would likely relate to accuracy, precision, and usability. Without the K030764 document, specific numerical values cannot be provided.
| Acceptance Criteria (Inferred from general surgical navigation system requirements) | Reported Device Performance (From K030764, not explicitly stated in K051724) |
|---|---|
| Accuracy of navigation (e.g., target registration error, fiducial registration error) | Presumed to meet established accuracy thresholds for surgical navigation, as cleared under K030764. |
| Precision/Repeatability of tracking | Presumed to demonstrate consistent and repeatable tracking, as cleared under K030764. |
| Usability/Workflow efficiency | Presumed to have demonstrated acceptable usability for its intended surgical procedures, as cleared under K030764. |
| Safety (e.g., electrical safety, electromagnetic compatibility, software validation) | Presumed to meet all applicable safety standards, as cleared under K030764. |
2. Sample size used for the test set and the data provenance
No new test set data is mentioned for K051724. The sample size and data provenance for the test set would have been part of the K030764 submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable to K051724, as no new ground truth establishment is described. This information would have been part of the K030764 submission.
4. Adjudication method for the test set
Not applicable to K051724, as no new test set adjudication is described. This information would have been part of the K030764 submission.
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. Surgical navigation systems are generally not assessed through MRMC comparative effectiveness studies involving "human readers" in the same way imaging AI is. Their effectiveness is typically evaluated through accuracy and precision metrics in simulated or cadaveric trials, and then confirmed through clinical use. No such study is mentioned in K051724.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept doesn't directly apply to a surgical navigation system in the same way it does to an AI diagnostic algorithm. A surgical navigation system "assists the physician" and provides "orientation and reference information during intra-operative procedures." Its performance is inherently tied to being used by a human surgeon. The "standalone" performance for such a device would relate to its technical specifications like tracking accuracy and precision, which would have been evaluated during the clearance of the predicate device (K030764).
7. The type of ground truth used
For a surgical navigation system, ground truth would typically involve:
- Physical measurements/phantom models: Highly precise measurements of actual positions and orientations using metrology equipment.
- Cadaveric studies: Comparison of navigated tool positions against anatomical landmarks identified by physical dissection or high-resolution imaging.
- Clinical outcomes (less commonly the primary ground truth for initial clearance): While clinical outcomes are important for overall effectiveness, the technical ground truth for navigation accuracy usually precedes widespread clinical use for initial clearance.
This information would have been detailed in the K030764 submission.
8. The sample size for the training set
Surgical navigation systems, especially of this era (2005), often rely on well-established geometric principles, image processing, and tracking algorithms rather than deep learning models that require large training sets of labeled data. Therefore, the concept of a "training set" in the context of machine learning's supervised learning might not be directly applicable or extensive in the same way it is for modern AI diagnostic tools. If any training was involved (e.g., for certain image registration algorithms), the sample size would have been detailed in K030764.
9. How the ground truth for the training set was established
As with point 8, the relevance of a "training set" in the modern AI sense is likely limited. If components of the system involved optimization or parameter tuning, the "ground truth" for these processes would have been established through methods relevant to the specific algorithms, such as:
- Simulated data: Known transformations or image distortions.
- Expert-defined parameters: Calibration using known physical objects.
This information would have been part of the K030764 submission.
In summary, K051724 is a re-submission due to ownership transfer and explicitly states identity to the predicate device (Z-Box, K030764). Therefore, all performance studies, acceptance criteria, and related methodological details refer to the K030764 submission, which is not provided here.
§ 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).