Search Results

The Intellijoint HIP Generation 2B System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified.

The Intellijoint HIP Generation 2B System is indicated for patients undergoing orthopedic surgery, and where the use of stereotactic surgery is considered safe and effective. The surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning. Example orthopedic surgical procedures include, but are not limited to:

• Total Hip Arthroplasty

• Minimally Invasive Hip Arthroplasty

• Revision Hip Arthroplasty

The Intellijoint HIP® Generation 2B System is an imageless optical navigation system intended for use in orthopedic surgery. The device provides intra-operative assessment of patient leg length, offset, anterior-posterior change, hip center of rotation change, and acetabular cup angle during Total Hip Arthroplasty procedures. The system is composed of an infrared Camera, Tracker, computer workstation, software, and bone fixation instruments/hardware.

The Intellijoint HIP® Generation 2B System is an update to the Intellijoint HIP® System previously cleared in 510(k) K162364. This submission provides the addition of revision hip arthroplasty (RHA) procedures to the indications for use, and the use of either linear or non-linear acetabular cup impactors. Other minor modifications made to the device are also provided.

"The Intellijoint HIP Generation 2B System is an optical navigation system for orthopedic surgery. The manufacturer submitted a 510(k) premarket notification to the FDA to gain clearance for updates to the Indications for Use, specifically the addition of revision hip arthroplasty (RHA) procedures and the use of linear or non-linear acetabular cup impactors. Below is an outline of the acceptance criteria and the study that proves the device meets the acceptance criteria.

1. A table of acceptance criteria and the reported device performance:

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

The document does not explicitly state the numerical sample size for the anatomical phantom or cadaver studies regarding the number of simulated procedures or specimens used.

• Anatomical Phantom Simulated Use and Clinical Accuracy: Bone models were used.
• Cadaver Simulated Use: Human specimens (cadavers) were used.
  The data provenance is prospective, as these were simulated use tests conducted by orthopedic surgeons. The country of origin of the data is not specified in the provided text.

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

• Experts: Orthopedic surgeons were involved in the simulated use testing, both on bone models and cadavers. The number of surgeons is not specified.
• Qualifications: They are referred to as "orthopedic surgeons," implying expertise in orthopedic surgical procedures. The duration of their experience is not mentioned.

4. Adjudication method for the test set:

The document does not describe an adjudication method for the test set. It states that accuracy was assessed by comparing simulated use measurements with ground truth values, but it does not specify if multiple experts independently made measurements or how discrepancies were resolved.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed. The Intellijoint HIP Generation 2B System is an optical navigation system that provides intra-operative measurements to a surgeon; it is not an AI-assisted diagnostic or interpretation tool in the typical sense that would be evaluated with an MRMC study for improved human reader performance. Its function is to provide measurement data to the surgeon, assisting with component selection and positioning.

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

The device's performance was evaluated with human-in-the-loop, as the "simulated use testing was performed on bone models by orthopedic surgeons" and "in a cadaver lab... operated by a surgeon." The system is designed to provide intra-operative measurements to a surgeon to aid in selection and positioning. Therefore, a standalone (algorithm-only) performance evaluation would not be applicable or relevant to its intended use, which is as a surgeon-assisted tool. The software functional and unit tests may have involved algorithm-only verification of calculations, but this is distinct from clinical performance assessment.

7. The type of ground truth used:

For the "Anatomical Phantom Simulated Use and Clinical Accuracy" test, ground truth values were established against which the simulated use measurements were compared. The exact method for establishing these ground truth values is not explicitly described but implies predefined, accurate measurements on the bone models.

8. The sample size for the training set:

The document describes performance testing for an update to an already cleared system. It does not provide information about a training set, as this device functions as a real-time intra-operative measurement tool rather than a machine learning model that requires a training set.

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

As no training set is described for this device's functionality, this question is not applicable."

Ask a specific question about this device