(85 days)
The NextAR™ TKA Platform is intended to be used to support the surgeon during total knee replacement procedures by providing information on bone resections, ligaments behaviour, instruments and implants positioning.
The NextAR™ TKA Platform is intended to be used in combination with NextAR™ stereotaxic instruments and general surgical instruments to implant the GMK® Sphere Total knee system and perform ligament balancing. As an optional display, the smart glasses can be used auxiliary to the NextAR™ Platform to view the same 2D stereotaxic information as presented by the NextAR™ Platform.
The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.
The MyKnee® NextAR™ cutting guides include a camera/target holder and a PSI MyKnee® cutting guide both for tibia and femur. The MyKnee® cutting guides must be used as anatomical cutting blocks specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting. The use of MyKnee® NextAR™ cutting guides are applicable only for the "PSI-based" approach. MyKnee® NextAR™ TKA cutting guides are for single use only.
The NextAR™ stereotaxic instruments are intended to be used to support the surgeon during specific orthopedic surgical procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning. The NextAR™ stereotaxic instruments, when registered with the MyKnee® NextAR™ TKA cutting guides, provide reference to a patient's rigid anatomical structures, such as the femur and tibia, that can be identified relative to pre-operative CT based planning.
The NextAR™ TKA Platform is a CT based computer-assisted surgical navigation platform used in total knee replacement surgery and includes the following components:
- navigation software which displays information to the surgeon in real-time;
- Augmented Reality glasses:
- optical tracking system;
- PC based hardware platform;
- MyKnee NextAR Cutting Blocks (PSI) - now an option
- Reusable surgical instruments for total knee replacement procedures.
NextAR™ TKA Platform PSI based is available on the US market via the clearance - K193559.
The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the markers. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of bones and instrumentation relative to preoperative data in real-time while performing the surgical procedure. The tracking sensors are provided sterile.
The NextAR™ TKA Platform PSI based and PSI free, aid the surgeon in executing the surgical plan by visualizing all of the information in real time via a monitor.
The approach currently cleared via K193559, is to utilize the NextAR™ TKA Platform - PSI for the placement of the implants by cutting the bones using the MyKnee® NextAR™ Cutting Blocks.
The subject of this submission is to add an optional approach for the surgeon to utilize the NextAR™ TKA Platform PSI free for the placement of the implants by cutting the bones using navigated, reusable surgical instrumentation (provided non-sterile). The registration of the CT scan on the patient's anatomy is performed by executing the NextAR registration algorithm.
The same reusable surgical instrumentation (provided non-sterile) that is guided by the tracking sensors can be used also for recut. Although the position of the implants can be validated to assess the correct execution of the planning; the surgeon can change the surgical plan intraoperatively by analyzing the 3D models of the patient, the CT scan, and the 3D geometry of the implants.
With this submission we are presenting the NextAR™ TKA Platform extension (PSI free) intended to be used in combination with NextAR™ stereotaxic instruments and general surgical instruments to implant the GMK® Sphere Total knee system and perform ligament balancing.
The surgeon can choose the desired approach, PSI-based (clearance - K193559) or PSI-free under submission.
Here's a breakdown of the acceptance criteria and study information for the NextAR™ TKA Platform, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not provide a specific table of numerical acceptance criteria with corresponding performance data. Instead, it broadly states that "performance testing to evaluate mechanical and optical properties" was conducted and "device accuracy" is a shared characteristic with the predicate.
The main performance evaluation cited for this submission is a cadaver study. The summary also mentions that "software validation" was conducted.
| Acceptance Criteria Category | Reported Device Performance (as implied by the document) |
|---|---|
| Device Accuracy | Comparable to the predicate device (NextAR™ TKA Platform K193559). The cadaver study implicitly aims to demonstrate clinical accuracy for bone resections, ligament behavior, instrument, and implant positioning. |
| Software Validation | Conducted successfully. No specific metrics or acceptance criteria detailed in this summary. |
| Mechanical Properties | Performance testing conducted. No specific metrics or acceptance criteria detailed in this summary. |
| Optical Properties | Performance testing conducted. No specific metrics or acceptance criteria detailed in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document explicitly mentions a "cadaver study" but does not specify the number of cadavers or the sample size used in this study.
- Data Provenance: The cadaver study would typically be considered prospective data collection for the purpose of the study. The country of origin of the data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts used to establish the ground truth for the cadaver study or their qualifications. For a surgical navigation system, ground truth would typically involve precise measurements or assessments by orthopedic surgeons or specialized technicians.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set in the cadaver study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or described in this 510(k) summary. This type of study is more common for diagnostic AI tools where human interpretation of images is a primary outcome. The NextAR™ TKA Platform is a surgical navigation system, where the AI assists the surgeon directly during the procedure, rather than for diagnostic reading.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not explicitly state whether a standalone performance study of the algorithm without human-in-the-loop was conducted. However, the nature of a surgical navigation system inherently involves human interaction. Performance testing (e.g., "device accuracy") would likely involve assessing the algorithm's output in the context of simulated or actual surgical use with human interaction. The "software validation" would cover the algorithmic performance in a controlled environment.
7. Type of Ground Truth Used
For the cadaver study, the ground truth would typically be established through direct, precise intraoperative measurements (e.g., using a coordinate measuring machine, highly accurate goniometers, or other measurement tools) to ascertain the actual bone resections, implant positions, and ligament balance achieved, which are then compared to the planned surgical outcomes and the guidance provided by the NextAR™ TKA Platform. The document does not explicitly state the specific method for ground truth establishment, but for this type of device, it would involve direct physical measurements.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size of a training set. This submission is for an "extension" (PSI-free approach) to an already cleared device (K193559). While the original development of the navigation software likely involved significant data for training machine learning components (if any), this particular 510(k) does not detail it.
9. How Ground Truth for the Training Set Was Established
Since the document does not provide information on a training set, it consequently does not describe how ground truth for a training set was established.
§ 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).