(301 days)
The Stryker Navigation System – Knee Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.
The Knee Module is a part of the product series of the Stryker Navigation System. The system comprises a knee joint kinematics analysis module based on a wireless videooptical tracking localization device for the use in primary total knee arthroplasty.
The Stryker Navigation System provides precise stereotactic determination of surgical targets using a stereotactic methodology. The three principle features include computer calculation of stereotactic coordinates from the diagnostic images, measurement of stereotactic coordinates within the surgical field, high-resolution computer display of diagnostic images with stereotactic coordinates indicated. The system is comprised of hardware and software components.
The provided text is a 510(k) summary for the Stryker Navigation System - Knee Module. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details on novel performance studies with acceptance criteria and detailed study designs.
Therefore, much of the requested information regarding specific acceptance criteria, detailed study designs (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance), and ground truth establishment is not available in the provided document.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Device Performance
The document does not specify quantitative acceptance criteria or reported device performance metrics in a table format. The primary "acceptance criteria" for a 510(k) submission are typically demonstrating substantial equivalence to a predicate device in terms of intended use, safety, and effectiveness.
The document states:
"The Stryker Navigation System does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed."
This general statement serves as the qualitative "performance" against the implicit "acceptance criteria" of being equally safe and effective as the predicate.
Study Details (Missing from document)
Given that this is a 510(k) submission focused on substantial equivalence, a full de novo clinical study with detailed performance metrics and acceptance criteria is typically not provided unless the device presents novel technology or significant new risks. The document does not describe such a study.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 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 mentioned. This type of study would be more relevant for AI diagnostic tools, not a surgical navigation system of this era.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned as a formal standalone study. The system provides "precise stereotactic determination of surgical targets." Its effectiveness is implicitly tied to this precision, but specific quantitative standalone performance studies are not described.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Key Information from the Document:
- Device Type: Surgical Navigation System – Knee Module.
- Intended Use: Planning and intraoperative guidance system for open or percutaneous computer-assisted surgery for knee joint conditions.
- Substantial Equivalence: The document asserts substantial equivalence to existing image-guided surgery systems marketed by Stryker, Medtronic, Brainlab, and Aesculap. This is the primary "proof" for the 510(k) submission.
- Safety and Efficacy: The system "does not raise any new safety and efficacy concerns" compared to predicate devices.
- Features: Wireless video-optical tracking localization device, computer calculation of stereotactic coordinates from diagnostic images, measurement of stereotactic coordinates within the surgical field, high-resolution computer display of diagnostic images with stereotactic coordinates.
In summary, the provided 510(k) summary focuses on demonstrating equivalence to predicate devices, and therefore does not contain the detailed performance study information typically associated with a de novo or PMA submission, or more recent AI/software as a medical device (SaMD) submissions that often include such specific performance data.
§ 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).