(184 days)
The Stryker Navigation System - Hip 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 surgery may be appropriate, and where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.
The system must be used within the operating theatre and should be operated only by trained personnel such as orthopedic surgeons and clinic staff.
The Stryker Navigation System - Hip Module supports, but is not limited to the following surgical procedures
- Any form of Total Hip Athroplasty (THA), e.g. open of minimal-invasive ●
- Precisely position instruments, implants and bony tissue during orthopedic . surgery, such as operations performed with Hip and bones in the upper extremities
- Revisions .
The Stryker Navigation System – Hip Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.
The provided 510(k) summary for Ko22365, the Stryker Navigation System - Hip Module, does not contain a study demonstrating acceptance criteria or specific device performance metrics in the way a contemporary AI/ML medical device submission would. This submission predates the widespread use of AI/ML in medical devices and the current emphasis on rigorous performance studies for such devices.
The document primarily focuses on establishing substantial equivalence to existing, legally marketed image-guided surgery systems. It asserts that the device does not raise new safety or efficacy concerns.
Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Efficacy (General) | "The Stryker Navigation System does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed." This is a statement of substantial equivalence, implying that its safety and efficacy are considered comparable to predicate devices, rather than a quantifiable performance metric against a specific acceptance criterion. The document does not provide specific performance data to support this claim in a measurable way. |
| Intended Use Equivalence | "The Stryker Navigation System is equivalent in intended use... to existing image guided surgery systems being marketed by companies such as Stryker, Sofamor Danek, and BrainLab." This is a qualitative statement of equivalence. |
| Functional Capabilities (Implicit from Indications for Use) | Supports: |
- Any form of Total Hip Arthroplasty (THA)
- Precisely position instruments, implants and bony tissue during orthopedic surgery (Hip and upper extremities)
- Revisions |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided: The document does not describe a specific "test set" or a performance study with a defined sample size for evaluating acceptance criteria. The basis for clearance is substantial equivalence to predicate devices, not a direct performance study against objective criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: As there is no described test set or ground truth establishment process, this information is not available.
4. Adjudication method for the test set
- Not Applicable / Not Provided: No test set or adjudication method is described.
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: This is a navigation system, not an AI/ML diagnostic or assistive device in the context of "human readers" interpreting images. No MRMC study is mentioned.
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" designed to be used with human operators (surgeons and staff) within the operating theatre. It is not an "algorithm only" device in the sense of an AI/ML standalone diagnostic. Its performance is intrinsically linked to its use in a clinical setting by trained personnel.
7. The type of ground truth used
- Not Applicable / Not Provided: There is no mention of ground truth in the context of validating performance parameters against a specific dataset. The "ground truth" for a surgical navigation system, in a broader sense, would be the actual anatomical positions and planned trajectories, and the accuracy with which the system guides instruments to those positions. However, the document does not include performance data on this.
8. The sample size for the training set
- Not Applicable: This is an image-guided navigation system, not an AI/ML algorithm that is "trained" on a dataset in the modern sense. It uses existing imaging data (likely CT or MRI) to create 3D models for surgical planning and guidance.
9. How the ground truth for the training set was established
- Not Applicable: As above, this device predates typical AI/ML training paradigms. Its "knowledge" is embedded in its engineering and software based on principles of image processing, registration, and spatial tracking, not "ground truth" from a labeled training set.
§ 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).