(117 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 and patellofemoral arthroplasty.
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 to plan the surgical implant location based on predefined bone landmarks and known configuration of the surgical implant. The Navio system then aids the surgeon in executing the surgical plan by using a standard off-the-shelf surgical drill motor and bur (eMax 2 Plus System (K080802)), which has been adapted using a tracking system. The surgical bur is located in a handpiece which allows the bur to move within the handpiece. In the Navio system the software controls the position of the tip of the surgical bur relative to the end of a guard attached to the handpiece and prohibits the bur from cutting bone as it approaches the planned target surface. As the planned surface is reached the tip of the bur is fully retracted within the guard.
An alternate mode of operation is the speed control mode. In this mode the speed of the bur is controlled and the bur stops as the planned surface is reached. In this mode of operation the bur does not retract into the guard. This mode of operation is useful in shaping surfaces of the condyle as well as placing post holes.
The Navio computer system maintains a log of the patient data and procedure data. Each entry is date and time stamped. Data log entries include date and time stamp for data line entry, patient and procedure ID, implant ID, step in process, and error messages. This data can be archived to a CD upon demand at the end of the procedure.
The provided text describes the Navio™ system, an orthopedic stereotaxic instrument for computer-assisted knee procedures. The submission is a Traditional 510(k) for expanded indications to include patellofemoral arthroplasty (PFA).
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define acceptance criteria in terms of specific performance metrics or thresholds (e.g., accuracy, precision) for the device. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical testing.
The "reported device performance" is primarily qualitative, stating that the device is "as safe and effective and performs as well as the Blue Belt Technologies NavioPFS™ (K121936) or the MAKO Surgical Corp. Tactile Guidance System v2.0 (K081867)."
Therefore, a table of acceptance criteria and reported device performance as explicitly stated in quantified terms is not present in the provided document. The acceptance was based on the successful completion of nonclinical tests and a demonstration of equivalency in technological characteristics and workflow to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified quantitatively. The "clinical simulation (usability testing)" and "simulated-use testing included testing in simulated knees (sawbones) and cadaver lab testing" do not provide specific numbers for the test set or the number of simulated knees/cadavers used.
- Data Provenance: The testing was non-clinical. The document does not mention the country of origin for the cadaver lab testing or if any specific demographic data was considered for the sawbones. It's retrospective in the sense that no new human clinical trials were conducted to generate prospective clinical data for this specific submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated. The document mentions "Users included surgeons, physician's assistants, and technical support personnel" for usability testing. It does not quantify how many of each were involved or what their specific role was in establishing "ground truth," which implies a reference standard rather than just users.
- Qualifications of Experts: General qualifications are provided: "surgeons, physician's assistants, and technical support personnel." Specific experience levels (e.g., "radiologist with 10 years of experience") are not detailed.
4. Adjudication Method for the Test Set
Not applicable/Not specified. Since the testing was non-clinical (simulated-use, cadaver, bench) and primarily focused on verifying design, software, and usability, a formal adjudication method typically seen in clinical trials with multiple human readers for diagnostic accuracy is not described. The document states that users "were able to successfully use the Navio system and place implants per Blue Belt Technologies' specifications," implying an internal assessment rather than an adjudicated consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No human clinical tests were conducted to determine safety and effectiveness of the Navio system." Therefore, no MRMC comparative effectiveness study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
The device itself is an "Orthopedic Sterotaxic Instrument" designed to "assist the surgeon" and is described as a "computer-assisted orthopedic surgical navigation and surgical burring system." Its function inherently involves human interaction, as it controls a surgical bur based on a plan developed by the surgeon with the system's aid. Therefore, a standalone (algorithm only without human-in-the-loop performance) study would not be applicable for this type of device, as its core function is to augment a human surgeon's actions. The non-clinical testing focused on the system's performance in aiding a user.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" implicitly refers to:
- Blue Belt Technologies' specifications: Implants were placed "per Blue Belt Technologies' specifications."
- Planned target surface: The system controls the bur relative to a "planned target surface."
- Bone Model Refinement: The system aids in creating a model, and the burring is controlled based on this model and planned surfaces.
This suggests that the ground truth was primarily based on the predefined surgical plan and specifications established by the device's design and intended surgical outcomes, potentially verified against physical measurements in simulated and cadaveric models. It does not refer to external pathology reports or long-term patient outcomes for this type of non-clinical evaluation.
8. The Sample Size for the Training Set
Not applicable/Not specified. This device is a surgical navigation and burring system, not an AI/ML algorithm that requires a "training set" in the traditional sense of machine learning for image analysis or diagnosis. The software's functionality is based on established engineering principles for navigation and robotic control, not learning from a dataset of cases.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no "training set" in the context of supervised machine learning for this device. The software logic and control parameters are designed and verified against engineering specifications and real-world biomechanical principles, not trained on a dataset of ground-truthed "examples."
§ 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).