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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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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.

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.

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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 behavior, instrument and implant positioning.

The NextAR™ TKA Platform is intended to be used in combination with NextARTM stereotaxic instruments, the MyKnee® NextAR™ cutting guides, 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. MyKnee® NextAR TKA cutting guides 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™ 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; and
• reusable surgical instruments for total knee replacement procedures.

The system operates on the common principle of stereotaxic technology in which passive markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the markers to avoid intraoperative registration of bony landmarks. 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 aids the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor. The placement of the implants is performed by cutting the bones using MyKnee® NextAR™ Cutting Blocks while reusable surgical instrumentation (provided non-sterile) guided by the tracking sensors can be used 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™ Cutting Blocks, manufactured from medical grade nylon, are single use patient-specific blocks which are designed from patient MRI or CT images. The blocks are designed to be used in standard medial or lateral parapatellar surgical approaches with each set comprised of a femoral block, a tibial block, and two bone models of the patient's femur and tibia (optional). The femoral cutting blocks are provided in right and left configurations in sizes 1 to 7 and 1+ to 6+ and the tibial cutting blocks are provided in right and left configurations in sizes 1 to 6. The blocks are provided sterile via gamma irradiation or non-sterile.

The FDA 510(k) summary for the NextAR™ TKA Platform (K193559) provides details on the device's acceptance criteria and the studies conducted to prove its performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a single, consolidated format. However, it mentions various types of testing and states that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." The "Discussion" section also states, "Minor differences in the optical tracking systems and use of patient specific instrumentation are addressed by performance testing." This implies that the performance testing confirmed the device met established criteria for those specific aspects.

Based on the information provided, we can infer some of the areas where acceptance criteria would have been applied:

2. Sample Size for Test Set and Data Provenance

The document explicitly mentions a "cadaver study" as part of the performance data.

• Sample Size for the Test Set: Not explicitly stated in the provided text.
• Data Provenance: The cadaver study would involve human remains, but the exact country of origin or whether it was retrospective/prospective in the context of data collection for this specific study is not detailed. However, cadaver studies are inherently prospective for the purpose of testing the device.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly mention the number of experts, their qualifications, or their role in establishing ground truth specifically for the reported studies (e.g., cadaver study). For a device like this, ground truth would likely be established through precise anatomical measurements or post-hoc imaging.

4. Adjudication Method for the Test Set

The document does not detail any adjudication method (e.g., 2+1, 3+1) for the test set. Adjudication methods are typically associated with human interpretation of medical images or data, which is not the primary focus for establishing the technical accuracy of a navigation system in a cadaver study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention of an MRMC comparative effectiveness study, or the effect size of human readers improving with AI vs. without AI assistance, is made. This device is a surgical navigation platform, not an AI-assisted diagnostic tool that heavily relies on human reader interpretation of images. The smart glasses are described as an auxiliary display, not an AI-driven interpretive aid for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The performance testing, particularly the "performance testing to evaluate mechanical and optical properties" and elements of the "cadaver study," would inherently involve evaluating the standalone performance of the algorithm and system components. The software validates the navigation software's ability to display information to the surgeon accurately. The cadaver study would assess how accurately the system guides the surgeon, implying that the system's output (measurements, guidance) is evaluated independently of a human's ultimate judgment during the assessment phase of the study, though a human surgeon performs the actions based on the guidance.

7. Type of Ground Truth Used

For the specific performance testing of this surgical navigation platform, especially in the cadaver study, the ground truth would likely be established using precise direct physical measurements (e.g., with highly accurate measurement tools or CMMs) or potentially post-operative imaging with precise measurements of the cadaver bones to verify the accuracy of resections and implant positioning as guided by the system. The "pre-operative CT based planning" is used by the device, and the device ensures "reference to a patient's rigid anatomical structures... that can be identified relative to pre-operative CT based planning." Therefore, the ground truth would be tied back to the anatomical accuracy relative to these plans.

8. Sample Size for the Training Set

The document does not provide information about a specific "training set" sample size. This type of device relies on established biomechanical principles and image processing of CT scans for its planning and navigation, rather than a deep learning model that requires a discrete training set in the conventional sense. The software is validated, but not "trained" in an iterative machine learning fashion on a large dataset of patient outcomes.

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

As no specific training set for a machine learning model is mentioned, the method for establishing its ground truth is not applicable or detailed in this summary. The system's foundational data (e.g., anatomical models, instrument specifications) are established through engineering design, scientific principles, and preclinical testing.

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