(101 days)
ILUMARK Navigation Markers are intended to be used as image guided surgery system accessory to aid in auto-registration and localization of rigid patient anatomical structure in either open or percutaneous image guided surgery procedures. It is indicated for any medical condition in which the use of an image guided surgery system may be considered to be appropriate.
ILUMARK Navigation Markers can be used in following procedures:
- Stereotactic brain surgery .
- Endoscopic Sinus Surgery .
- . Pedicle Screw Placement
- Reconstructive orthopedic surgery .
- Soft tissue treatment .
ILUMARK Navigation Markers are used as accessories with image quided surgery systems. The Navigation Markers define specific locations on instruments and reference geometries. A camera system, as part of an image guided surgery system uses the location information to determine the orientation and location of an instrument relative to other instruments or reference geometries. A computer system visualizes the orientation and location of the instrument based on pre-operative data or a computer calculated model of the patients anatomy.
This 510(k) premarket notification for ILUMARK Navigation Markers does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document focuses on demonstrating substantial equivalence to already legally marketed devices, rather than providing new performance data where acceptance criteria would typically be established and tested.
Here's a breakdown of why this information is missing and what the document does provide:
- No Acceptance Criteria or Performance Study: The purpose of a 510(k) submission for this type of device (accessories to image-guided surgery systems) is often to establish that it is "substantially equivalent" to predicate devices already on the market. This means the manufacturer claims their device has the same intended use, fundamental technological characteristics, and safety and effectiveness as the predicate. They typically don't need to conduct a new clinical or performance study that sets and meets novel acceptance criteria.
Therefore, I cannot populate the requested table or answer the specific questions related to acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment for a performance study because such a study is not part of this 510(k) submission.
What the document does state regarding equivalence:
The document explicitly states:
- Section 3. Substantial Equivalence: "ILUMARK's navigation Markers are substantial equivalent based upon their intended use, design, dimensional and materials characterization to other legally marketed devices from different manufacturers, e.g. NDI passive Spheres from Northern Digital Inc., #K033621 and Disposable Reflective Marker Spheres from BrainLAB Ag #K100038."
- Section 7. Conclusion: "Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that ILUMARK's Navigation Markers are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act."
In summary, for the provided document:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence rather than new performance data against specific criteria.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no performance study data is presented.
- 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 applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. This device is a physical navigation marker, not an AI or imaging diagnostic tool that would involve human "readers."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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).