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Ortho Guidance Precision Knee Software:
The Stryker guidance systems, with the Ortho Guidance Precision Knee Software, are intended as a planning and intraoperative quidance system to enable open computer-assisted surgerv. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.

Ortho Guidance Express Knee Software:
The Stryker quidance systems, with the Ortho Guidance Express Knee Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.

Ortho Guidance Versatile Hip Software:
The Stryker guidance systems, with the Ortho Guidance Versatile Hip Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery.

The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.

The systems are indicated for conditions of the hip joint in which the use of computer-assisted surgery may be appropriate.

The system is indicated for the following surgical procedures:

• Total Hip Arthroplasty (THA)

• Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery

• Revisions

Q Guidance System:
The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. When used with the Ortho Guidance Precision Knee, Express Knee, or Versatile Hip Software, the Q Guidance System is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the femur, tibia, or long bone can be identified.

The system is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. It allows for the localization of surgical instruments, and visualization of their position relative to patient specific anatomical landmark information, assisting the surgeon in performing the intervention at a high level of precision. The system uses active optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model. The computed model is based on an intraoperative anatomy survey of the pelvis and/or leg.

Here's a breakdown of the acceptance criteria and the study information for the Stryker Q Guidance System and its associated software, based on the provided document:

Acceptance Criteria and Device Performance

The study that proves the device meets the acceptance criteria is a non-clinical design verification and validation testing campaign.

Study Details

1. Sample size used for the test set and the data provenance:

   • The document does not specify a numerical sample size for the test set regarding the accuracy measurements. It mentions that testing was performed internally by the manufacturer.
   • Data Provenance: The data appears to be from internal testing conducted by Stryker Leibinger GmbH & Co. KG, located in Germany. The tests involved cadaver labs or simulated use, suggesting controlled laboratory environments rather than real-world patient data. The provenance is therefore prospective in a simulated environment.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number or qualifications of experts used to establish ground truth for the numerical accuracy tests (e.g., fiducial trueness, system accuracy). These types of measurements are typically established using highly precise metrological equipment as the ground truth.
   • For "Intended Use/User Needs" testing, "intended users" were involved in cadaver labs or simulated use tests. However, the exact number and qualifications (e.g., specific surgical experience) of these "intended users" (e.g., surgeons) are not specified.

3. Adjudication method for the test set:

   • The document does not describe a formal adjudication method for the test set results. The accuracy metrics are quantitative measurements against an established standard. The user needs validation was presumably based on observation and feedback from the intended users.

4. 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 done or reported. The device is a surgical guidance system, not an AI diagnostic tool that assists human readers in interpreting medical images. The testing described focuses on the system's accuracy in tracking and guiding surgical instruments.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, standalone performance was assessed. The accuracy measurements for fiducial trueness and system point/angular accuracy represent the direct, standalone performance of the tracking and guidance algorithms. The "Intended Use/User Needs" validation also assessed the integration and utility with a human user.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the accuracy metrics (e.g., trueness for fiducials, system accuracy), the ground truth is implicitly defined by metrological standards and highly precise measurement systems, which assess the physical displacement and angulation of tracked objects.
   • For "Intended Use/User Needs," the ground truth involves user feedback and achievement of functional requirements observed in cadaver labs or simulated environments.

7. The sample size for the training set:

   • The document does not specify a numerical sample size for the training set. This is a navigation system primarily based on optical tracking and software for workflow and display, rather than a machine learning model that requires a discrete "training set" of patient data in the conventional sense. The "training" of such a system would involve extensive engineering, calibration, and iterative development based on design parameters and physical principles.

8. How the ground truth for the training set was established:

   • As this is not a machine learning-based device that would typically have a "training set" with explicit ground truth labels, the concept of ground truth for a training set in the AI sense does not directly apply here. Instead, during development and "training" of the underlying algorithms and hardware, ground truth is established through:
     • Physical calibration standards: For optical tracking, this involves precise optical benches and measurement devices to calibrate camera parameters, fiducial patterns, and spatial relationships.
     • Engineering specifications and simulations: Ground truth for software logic and mechanical tolerances is derived from engineering design requirements and validated through simulations.
     • Iterative testing and refinement: Early prototypes and software versions undergo extensive testing against known inputs and expected outputs to refine performance.

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Ortho Guidance Precision Knee Software:

The Stryker Ortho Q Guidance System, with the Ortho Guidance Precision Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system is indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.

Ortho Guidance Express Knee Software:

TThe Stryker Ortho Q Guidance System, with the Ortho Guidance Express Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system is indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.

Ortho Guidance Versatile Hip Software:

The Stryker Ortho Q Guidance System, with the Ortho Guidance Versatile Hip Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure, such as but not limited to the pelvis or femur, can be identified. The system is indicated for conditions of the hip joint in which the use of computer-assisted surgery may be appropriate. The system is indicated for the following surgical procedures:

• Total hip arthroplasty (THA)

• Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery

• Revisions

Ortho Q Guidance System:

The Stryker Ortho Q Guidance System is intended as an aid for precisely locating anatomical structures in open computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the skull, vertebra, or long bone can be identified.

The purpose of this Traditional 510(k) submission is to seek clearance for 3 new software applications and 1 new guidance system. The applications have been created for functionality on the new guidance system in scope of this submission. The subject devices in scope of this submission are outlined in Table 6-1 with the predicate information in Table 6-2. The devices in scope of this submission, Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, and the Ortho Q Guidance System work within an ecosystem with a host of other existing smart devices and accessories that will be demonstrated to be compatible with the subject devices but are not in scope of this submission.

The Ortho Guidance Precision Knee Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Precision Knee System. The Ortho Guidance Express Knee Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Express Knee System. The Ortho Guidance Versatile Hip Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Versatile Hip System.

The system is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. It allows for the localization of surgical instruments, and visualization of their position relative to patient specific anatomical landmark information, assisting the surgeon in performing the intervention at a high level of precision. The system uses active optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model. The computed model is based on an intraoperative anatomy survey of the pelvis and/or leg.

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