(86 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 acceptance criteria and a study proving the device meets these criteria for the Navio™ system, specifically for its expanded indication of placing inlay patellofemoral implants.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" for the expanded indication seem to be demonstrating that the accuracy for inlay patellofemoral implant placement is comparable to or better than the accuracy previously established for onlay patellofemoral components with the predicate device.
| Acceptance Criteria Category | Specific Metric/Description | Reported Device Performance (Navio for Inlay Patellofemoral) |
|---|---|---|
| Accuracy of Implant Placement | Onlay Patellofemoral component RMS placement error along any single axis averaged: 0.884 mm and 1.013° (Predicate device performance established in K140596, serving as benchmark for "same placement accuracies"). | Inlay Patellofemoral component RMS placement error along any single axis averaged: 0.462 mm and 1.028° |
| Safety and Effectiveness | No new issues of safety or effectiveness. | Non-clinical testing demonstrated no new issues of safety or effectiveness. |
| Functionality | Successfully use the Navio system and place inlay patellofemoral implants per specifications. | Users were able to successfully use the Navio system and place inlay patellofemoral implants. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number. The testing involved "simulated knees (sawbones) and cadaver lab testing." The number of sawbones or cadavers used is not specified.
- Data Provenance: The testing was "nonclinical testing" and involved "simulated-use testing included testing in simulated knees (sawbones) and cadaver lab testing." This implies prospective, controlled lab experiments rather than retrospective patient data. The country of origin is not explicitly stated, but given the FDA submission, it's likely U.S.-based or regulated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated. The text mentions "Users included surgeons, physician's assistants, and technical support personnel." It doesn't specify how many of each, nor how many were involved in establishing "ground truth" (which seems to be implicitly defined by the system's ability to achieve specified placement accuracy and these users' successful operation of the device).
- Qualifications: "Surgeons," "physician's assistants," and "technical support personnel" who were "adequately trained" on the Navio system. Specific years of experience or board certifications are not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly described. The determination of "successful" placement was "per Blue Belt Technologies' specifications and implant manufacturer's specifications." This suggests an objective measurement against predefined targets rather than a human consensus-based adjudication for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. The study described is a non-clinical, performance-based test, not an MRMC study comparing human readers with and without AI assistance. The device is a surgical navigation system, not an AI for image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not directly applicable in the typical sense for an image-analysis AI. The Navio system inherently involves "human-in-the-loop" as it's a surgical assistance system ("intended to assist the surgeon"). The accuracy measurements (RMS placement error) represent the system's performance when used by a human. However, the control algorithms for bur retraction/speed are standalone in their operation relative to the software-defined spatial boundaries. The accuracy numbers reported (0.462 mm and 1.028°) reflect the end-to-end performance of the system in achieving the planned surgical outcome, which is highly dependent on the algorithm's control.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the device's performance (specifically the placement accuracy) was based on objective measurements against predefined specifications. This is derived from the "Blue Belt Technologies' specifications and implant manufacturer's specifications." For surgical navigation systems, this usually involves measuring the deviation of the actual performed cut or implant placement from the pre-planned surgical model within controlled lab settings (e.g., using metrology tools or comparing post-procedure scans to planned models).
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable/not provided. This document describes a 510(k) submission for a medical device (surgical navigation system), which is a defined hardware/software product. It is not an AI model that undergoes "training" in the machine learning sense with a distinct training dataset. The device's "training" in a developmental context would involve iterative design, development, and testing cycles, but not a "training set" of data in the way an AI algorithm uses for learning.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as this is not a machine learning AI model with a training set. The "ground truth" for the device's design and development would have been established through engineering specifications, biomechanical data, anatomical models, and surgical requirements derived from established medical knowledge and clinical practice.
§ 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).