(52 days)
The NAVIO system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The NAVIO system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement (UKR), patellofemoral arthroplasty (PFA), and total knee arthroplasty (TKA).
The NAVIO system is indicated for use with cemented implants only.
The NAVIO system is a computer-assisted orthopedic surgical navigation and surgical burring system. The system uses established technologies of navigation, via a passive infrared tracking camera, to aid the surgeon in establishing a bone surface model for the target surgery and in planning the surgical implant location, based on intraoperatively-defined bone landmarks and known geometry of the surgical implant. The NAVIO system then aids the surgeon in executing the surgical plan by using a standard offthe-shelf surgical drill motor and bur (Anspach eMax2 Plus System, cleared via K080802), which has been adapted using a tracking system.
The surgical bur is inserted into a handpiece, which allows the bur to move within the handpiece. The NAVIO system software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved in two ways:
- . Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the NAVIO system retracts the bur inside the guard, disabling cutting.
- . Speed control regulates the signal going to the drill motor controller itself and will limit the speed of the drill if the target surface is approached. This mode of operation is useful in shaping surfaces of the condyle as well as placing post holes and fixation features for femoral and tibial cut guides.
Additionally, the surgeon can disable both controls and operate the NAVIO system handpiece as a standard navigated surgical drill. The surgeon must press on a footpedal to activate the surgical bur and enable cutting in all modes.
This FDA 510(k) summary for the NAVIO Surgical System (K191223) states that no human clinical testing was conducted to determine the safety and effectiveness of the updated device. Therefore, a study proving the device meets acceptance criteria as typically understood for clinical performance (e.g., accuracy against a medical outcome or expert ground truth) has not been provided in this document.
Instead, the submission relies on non-clinical (bench) testing to demonstrate performance and establish substantial equivalence to a predicate device (NAVIO Surgical System, K180271). The acceptance criteria and "reported device performance" would therefore relate to engineering specifications and functional verification rather than clinical outcomes.
Here's an attempt to answer your questions based only on the provided document, acknowledging the limitations due to the absence of clinical study data:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with numerical performance targets or reported results in the traditional sense of a clinical study. It states that the device "meets the same accuracy specifications required for the predicate device." Without the predicate device's specific acceptance criteria documented here, we can only infer the type of performance evaluated.
| Acceptance Criteria Category | Reported Device Performance (as stated or implied) |
|---|---|
| Functional Performance | "Performed as intended" (for updated TKA instrument kit, distal femur punches, updated labeling, new implant database, and software modifications). |
| Accuracy | "Meets the same accuracy specifications required for the predicate device." (Specific numerical accuracy values are not provided in this document.) |
| Safety | "Does not raise any new questions of safety." |
| Effectiveness | "Does not raise any new questions of... effectiveness." "Continues to be as safe and effective as the predicate NAVIO system (K180271)." |
| Software Functionality | Verified through "software code reviews" and "verification testing" ensuring updates to workflow, user interface, and infrastructure perform as intended. |
| Labeling Compliance | Verified through "labeling verification and validation testing." |
| Usability | Evaluated through "summative usability testing." |
The "study that proves the device meets the acceptance criteria" referred to in the document is a set of Non-Clinical Testing (Bench) activities, specifically:
- Software code reviews
- Bench testing
- Summative usability testing
- Labeling verification and validation testing
2. Sample Size Used for the Test Set and Data Provenance
Given that no human clinical testing was conducted, there is no "test set" in the context of patient data for this submission. The "test set" would refer to the artifacts and software modules tested during the non-clinical verification and validation activities. The document does not specify the number of instruments, software versions, or test cases used in this non-clinical testing.
- Data Provenance: Not applicable in the context of patient data. The testing was likely conducted internally by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable as there was no test set derived from human patient data for which medical ground truth would be established by experts. Non-clinical testing typically relies on engineering specifications and gold-standard measurements or reference implementations to verify functionality and accuracy.
4. Adjudication Method for the Test Set
This is not applicable as there was no test set derived from human patient data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, as stated: "No human clinical testing was conducted to determine safety and effectiveness of the NAVIO system."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a "computer-assisted orthopedic surgical navigation and surgical burring system," implying a human-in-the-loop system. The non-clinical testing focused on verifying the changes to this system. While specific algorithm-only performance metrics are not detailed, the "software code reviews" and "bench testing" would inherently evaluate the algorithms' functionality according to their design specifications, which is a form of standalone evaluation in an engineering context. However, it's not a standalone clinical performance evaluation.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" would be:
- Engineering Specifications: For functional performance and accuracy.
- Predicate Device Performance: The primary "ground truth" or benchmark is that the updated device "meets the same accuracy specifications required for the predicate device."
- Design Requirements: For software functionality and usability.
- Regulatory Requirements: For labeling verification.
8. The Sample Size for the Training Set
This is not applicable as the NAVIO Surgical System is a navigation and surgical burring system, not an AI/ML device that requires a "training set" for model development in the sense of supervised learning on patient data. The software updates mentioned (workflow, UI, infrastructure) refer to enhancements of the existing system's operational aspects.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no mention of a "training set" in the context of AI/ML model development.
§ 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).