(99 days)
Intended Use: The Stryker Navigation System - Cranial Module 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 intra-operative guidance where a reference to a rigid anatomical structure can be identified.
Indications for Use: The system should be operated only by trained personnel such as surgeons and clinic staff. The Cranial Navigation system supports, but is not limited to, the following surgical procedures: ENT Procedures (Endoscopic Sinus Surgery (ESS), Intranasal procedures, Ear implant procedures), Neuro Procedures (Cranial biopsies, Puncture of abscesses, Craniotomies, Craniectomies, Resection of tumors and other lesions, Removal of foreign objects, Skull base procedures, Transnasal neurosurgical procedures, Transphenoidal pituitary surgery, Shunt placement, including pediatric shunt placement, Placement of electrodes for recording, stimulation and lesion generation, Craniofacial procedures, Skull reconstruction procedures, Orbital cavity reconstruction procedures).
Stryker Navigation System - Cranial Module is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. The Stryker Navigation Cranial Module is a combination of the previously cleared Stryker Navigation System - Neuro Module and ENT Module with the addition of new features. The Cranial module will include automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.
This 510(k) submission for the Stryker Navigation System - Cranial Module does not contain the information requested regarding acceptance criteria and a study to prove the device meets these criteria.
Instead, this document is a 510(k) summary and the FDA's clearance letter, focusing on establishing substantial equivalence to previously marketed predicate devices. It states that the device "does not raise any new safety and efficacy concerns" and is "substantially equivalent" to existing devices.
Therefore, I cannot provide the specific details you requested because they are not present in the provided text.
Here is what I can infer from the document regarding the justification for market clearance, which effectively substitutes the lack of a detailed performance study in this type of submission:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The implicit acceptance criterion is "substantial equivalence" to predicate devices in terms of intended use, safety, and effectiveness.
- Reported Device Performance: Not provided as a series of test results. The performance is implied to be similar to the predicate devices.
2. Sample size used for the test set and the data provenance
- No specific test set or data provenance is mentioned as this is a substantial equivalence claim, not a de novo performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as there is no specific test set or ground truth establishment described for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- No MRMC study or AI assistance is mentioned. This is a navigation system, not an AI-driven diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a planning and intraoperative guidance system for computer-assisted surgery, inherently designed for human-in-the-loop use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. Ground truth as typically understood for diagnostic or image analysis performance studies is not relevant here, as the device's efficacy is based on similarity to established devices.
8. The sample size for the training set
- Not applicable. No new algorithm training is described.
9. How the ground truth for the training set was established
- Not applicable.
In summary: The provided document is a 510(k) (premarket notification) where the manufacturer, Stryker Instruments, is seeking clearance for their Navigation System - Cranial Module based on substantial equivalence to already legally marketed predicate devices. This type of submission generally does not require a new, extensive clinical trial or performance study against specific acceptance criteria if the new device is deemed sufficiently similar to existing ones. The "study" proving it meets acceptance criteria, in this context, is the comparison to predicate devices and the assertion that it "does not raise any new safety and efficacy concerns."
§ 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).