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The NextAR™ Knee Platform is intended to be used to support the surgeon during total knee replacement procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning.

The NextAR™ Knee Platform is intended to be used in combination with NextAR™ stereotaxic instruments and general surgical instruments to implant the GMK® Sphere Total knee system ligament balancing. As an optional display, the smart glasses can be used auxiliary to the NextAR™ to view the same 2D stereotaxic information as presented by the NextARTM 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 MyKnee® PPS NextAR™ blocks include a PSI MyKnee® pin positioners block both for tibia and femur. The MyKnee® PPS NextAR™ blocks must be used as anatomical Pin positioners blocks 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 or MyKnee® PPS NextAR™ blocks are applicable only for the "PSIbased" approach. MyKnee® NextAR™ cutting guides or MyKnee® PPS NextAR™ blocks are for single use only.

The NextAR™ stereotaxic instruments are intended to be used to surgeon during specific orthopedic surgical procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning. The NextAR™ Knee stereotaxic instruments, when registered with the MyKnee® NextAR™ Knee cutting guides, provide reference to a patient's rigid anatomical structures, such as the femur and tibia, that can be identified relative to preoperative 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) an option;
• MyKnee NextAR Pin Positioners (PPS) - an option; and
• Reusable surgical instruments for total knee replacement procedures.

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. In NextAR TKA MyKnee PPS, subject of the submission, the placement of the sensor is performed by the use of reusable metal instrumentation used in the PSI free version (NextARTM TKA Platform, K202152).

The NextAR™ TKA Platform PSI based, PSI free and now NextAR™ TKA MyKnee PPS aid the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor. Utilizing the approach NextAR™ TKA Platform PSI based (K193559) the placement of the implants is performed by cutting the bones using MyKnee® NextAR™ Cutting Blocks and, optionally, utilizing the approach NextAR™ TKA Platform PSI free (K202152), the placement of the implants is performed by cutting the bones using navigated reusable surgical instrumentation where the registration of the CT scan of the patient's anatomy is performed by executing the NextAR registration algorithm. Now, NextAR™ TKA MyKnee PPS fuses from both PSI and PSI free method. NextAR PPS helps the surgeon to place the metal fixation for the sensor and the pins to place the standard or micrometric cutting guides to reproduce the preoperative planning.

Same reusable surgical instrumentation (provided non-sterile) 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.

The MyKnee® NextAR™ Pin Positioners, manufactured from medical grade nylon, are single use patient-specific blocks which are designed from patient CT images. They are intended to position the pins for placement of the standard instruments and for the infrared technology. The blocks are provided sterile via gamma irradiation or non-sterile.

The surgeon can choose the desired approach, PSI-based (clearance - K193559), PSI-free (clearance - K202152), or PPS now under submission.

Here's a summary of the acceptance criteria and the study information for the NextAR™ TKA Platform My Knee PPS device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Software validation.
• In vitro validation.
• Biocompatibility (per ISO 10993-1:2009).
• Sterilization validation.
• Shelf-life testing.
• Electrical safety (per IEC 60601-1:2005, COR1:2006, COR2:2007, Amd1:2012).
• Electromagnetic compatibility (per IEC 60601-1-2:2014).
• Mechanical and optical properties performance. | - Device Accuracy: The device has similar characteristics to its predicate devices, which also include orientation and positioning of bone resections. The "in vitro validation" likely addressed this, confirming its performance is comparable.
• Software Validation: Performed.
• In Vitro Validation: Performed.
• Biocompatibility: Accepted during predicate submissions (K193559 and K202152) and deemed unchanged.
• Sterilization Validation: Accepted during predicate submissions and deemed unchanged.
• Shelf-Life Testing: Accepted during predicate submissions and deemed unchanged.
• Electrical Safety: Accepted during predicate submissions and deemed unchanged.
• Electromagnetic Compatibility: Accepted during predicate submissions and deemed unchanged.
• Mechanical and Optical Properties Performance: Accepted during predicate submissions and deemed unchanged. |

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample size used for the test set (e.g., number of patients, number of anatomical models). It only mentions that "in vitro validation" was performed.

Data provenance is not explicitly stated in terms of country of origin. The studies are described as "in vitro validation," suggesting lab-based testing rather than studies involving human patients. Therefore, it's likely retrospective or prospective testing on inanimate objects/models, not patient data in the typical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The studies listed are primarily technical validations (software, in vitro, safety, etc.), which may not inherently require expert human review to establish ground truth in the same way clinical diagnostic studies might.

4. Adjudication Method for the Test Set:

This information is not provided in the document. It's improbable that an adjudication method (like 2+1 or 3+1) was used, as the listed studies are technical validation tests rather than diagnostic performance studies requiring human interpretation of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or described in the provided text. The device is a surgical navigation platform, not a diagnostic imaging AI tool in the typical sense of MRMC studies.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance study (algorithm only) was implicitly done through the "software validation" and "in vitro validation" studies. These types of studies typically evaluate the technical performance of the device/algorithm itself, independently of a human operator, to ensure its accuracy and functionality.

7. The Type of Ground Truth Used:

The document doesn't explicitly state the "type of ground truth" in a singular specific manner. However, for the technical validations:

• Software Validation: Ground truth would be defined by the expected behavior and calculations of the software as per its design specifications.
• In Vitro Validation: Ground truth would be established by precise measurements taken from physical models or phantoms using highly accurate reference instruments, against which the device's measurements/guidance are compared.
• Device Accuracy (Orientation and Positioning): For this aspect, the ground truth would be extremely precise, independently verified knowledge of the true orientation and position of relevant anatomical structures or measuring points, against which the NextAR™ system's reported values are compared. This is usually achieved with high-precision metrology equipment in a lab setting.

8. The Sample Size for the Training Set:

The document does not provide any information on the sample size for a training set. This device is a navigation system that uses pre-operative CT data for planning. While it might involve algorithms that were developed using training data (e.g., for image segmentation or registration), the provided 510(k) summary does not disclose details about such training sets.

9. How the Ground Truth for the Training Set Was Established:

As no training set information is provided, how its ground truth was established is also not described in the document.

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