(83 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 both 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 off-the-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 position 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. This is referred to as Exposure Control mode.
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 target 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 and fixation features.
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 each data line entry, patient and procedure ID, implant ID, step in process, and error messages received by the user during the procedure. This data can be archived to a CD upon demand at the end of the procedure and is anonymized.
This document is a 510(k) summary for the Navio® system, specifically addressing an expanded indication for use to include total knee arthroplasty (TKA). Since it's a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, rather than to prove absolute safety and effectiveness through extensive clinical trials.
Therefore, the information regarding acceptance criteria and statistical proof of meeting those criteria is limited and framed within the context of establishing substantial equivalence for an expanded indication.
Here's an analysis of the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table. Instead, it relies on the concept of "substantial equivalence" and the demonstration that the expanded use for TKA does not raise new issues of safety or effectiveness compared to the predicate device.
The reported device performance, in this context, is that the system could successfully assist in TKA procedures in simulated environments.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Performance of Navio system for TKA is equivalent to predicate Navio for UKR/PFA in terms of safety and effectiveness. | "Users included surgeons, physician's assistants, and technical support personnel who were able to successfully use the Navio system to place total knee implant systems per Blue Belt Technologies' and implant manufacturer's specifications after being adequately trained." |
| No new issues of safety or effectiveness are raised by the expanded TKA indication. | "Nonclinical testing was completed to verify that the use of the Navio system to assist with placement of total knee implants does not raise any new issues of safety or effectiveness." |
| The device functions as intended in surgical knee procedures (including TKA). | The testing concluded that the Navio system, when used for TKA, is "as safe and effective as the currently cleared Navio system." |
| The system accurately provides software-defined spatial boundaries for orientation and reference information for TKA. | The description confirms the system uses "intraoperative data collection... to create a model of the patient's femur and/or tibia" and "pre-defined boundaries generated during the planning process to control the motion of the surgical bur." |
| The system controls bone removal as intended for TKA, involving placement of cutting guides. | The system "controls the cutting action of the bur during the placement of the cutting guides." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "simulated-use testing included simulated knee (sawbones) and cadaver laboratory testing." It does not provide specific numbers for the cadaver lab or sawbones used. It does not mention any human clinical testing.
- Data Provenance: The testing was "Non-Clinical Testing (Bench)" and performed by "Blue Belt Technologies, Inc." This suggests it was likely internal testing. There is no information about the country of origin of the data or whether it was retrospective or prospective, as it was bench/simulated testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The document states, "Users included surgeons, physician's assistants, and technical support personnel who were able to successfully use the Navio system..."
- It does not specify the number of experts, nor their detailed qualifications (e.g., years of experience, specific certifications). It only broadly categorizes them.
- The "ground truth" in this context would be the "specifications" of Blue Belt Technologies and the implant manufacturer, which these users were tasked to follow.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any formal adjudication method for the test set. The statement "Users... were able to successfully use the Navio system to place total knee implant systems per Blue Belt Technologies' and implant manufacturer's specifications" implies that adherence to these specifications was the measure of success, but it does not detail how this "success" was adjudicated (e.g., by independent observers, a panel, etc.).
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 MRMC comparative effectiveness study was conducted or mentioned in this document. The submission is a 510(k) for an expanded indication, relying heavily on non-clinical bench testing and similarity to a predicate device, not a comparative effectiveness study involving human readers/users in a clinical setting against a control group.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Navio system is explicitly described as assisting the surgeon (human-in-the-loop). Therefore, a standalone (algorithm only) performance study would not be relevant and was not performed or mentioned. The system's function is to aid the surgeon, not to operate autonomously.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical testing appears to be based on:
- Manufacturer's Specifications: The ability of testers to "successfully use the Navio system to place total knee implant systems per Blue Belt Technologies' and implant manufacturer's specifications."
- Expected Surgical Plan Execution: The system's ability to create a model, plan the surgery, and control bone removal as described in the device description.
This is not "expert consensus" in the sense of multiple independent experts agreeing on a diagnosis or measurement, nor is it pathology or outcomes data. It's more akin to validation against defined engineering and procedural standards for surgical preparation.
8. The sample size for the training set
The document does not mention any machine learning or AI training sets. The Navio system described uses "established technologies of navigation" and "pre-defined boundaries generated during the planning process" to control the surgical bur. It's a navigation and burring system, not explicitly described as an AI/ML device in this context. Therefore, a "training set" in the context of AI is not applicable here.
9. How the ground truth for the training set was established
As no training set (in the AI/ML sense) is mentioned, this question is not applicable.
§ 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).