(120 days)
The OrthAlign Plus System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty: Posterior.
Example orthopedic surgical procedures include but are not limited to:
- Total Knee Arthroplasty
- Total Hip Arthroplasty: Anterior/Posterior
The KneeAlign® 3 System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The KneeAlign® 3 System facilitates the accurate positioning of implants, relative to these alignment axes.
Example orthopedic surgical procedures include but are not limited to:
- Total Knee Arthroplasty
The HipAlign® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The HipAlign® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty: Posterior.
Example orthopedic surgical procedures include but are not limited to:
- Total Hip Arthroplasty: Anterior / Posterior
The OrthAlign Plus® System is an innovative non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format.
The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.
The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.
The OrthAlign Plus® System is usable for a total knee arthroplasty or total hip arthroplasty procedure. The System includes two optional configurations: the KneeAlign® 3 System usable for total knee arthroplasty only, and the HipAlign® System usable for total hip arthroplasty only. The OrthAlign Plus® System includes the singleuse OrthAlign Plus® Unit, a KneeAlign® 3 Instrument Set and a HipAlign® Instrument Set. The optional configurations include a modified version of the OrthAlign Plus® Unit and only one of the Instrument Sets.
The OrthAlign Plus System comprises a single use computer module, a reusable reference sensor, a reusable femoral jig, a reusable tibial jig, a reusable posterior hip jig and a reusable anterior hip jig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical and numerical representation of instruments and anatomy on the user display screen.
The optional KneeAlign® 3 and HipAlign® system configurations also comprise the single use computer module, reusable reference sensor and applicable reusable jigs. They utilize the same algorithms, sensor conversions, graphical and numerical representations and surgical techniques as the OrthAlign Plus® System.
The OrthAlign Plus® System, KneeAlign® 3 System, and HipAlign® System are computer-controlled surgical navigation systems for knee and hip arthroplasty procedures.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes general performance testing but does not explicitly state numerical acceptance criteria for accuracy, nor does it provide specific numerical results of device performance against such criteria. Instead, it broadly states that "Device performance testing confirms that the OrthAlign Plus® System can be used according to its intended use" and that the "testing regime demonstrates that the subject device is as safe, as effective, and performs as well as or better than the predicate devices."
The most specific performance mentioned is related to accuracy in measuring leg length and offset.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of Leg Length and Offset Measurement | Validated via simulated use testing in cadaver. Performance is demonstrated to be "as safe, as effective, and performs as well as or better than the predicate devices." |
| Software Verification and Validation | Ensured integrity of code, functionality, and reliability in various use sequences. |
| System Hardware Verification/Validation | Ensured electronics hardware meets mechanical requirements. |
| Electrical Safety | Compliant with IEC 60601-1:2005 + Corr. 1 (2006) + Corr. 2 (2007) + AM1 (2012) or IEC 60601-1:2012. |
| Electromagnetic Compatibility | Compliant with IEC 60601-1-1: 2007. |
| Instrumentation Cleaning, Sterilization, and Shipping Validations | Validated for specified processes. |
| Navigation Device Sterilization, Packaging, Shelf Life, Environmental Conditions, and Shipping Validations | Validated for specified ranges of conditions. |
| Reference Sensor Verification/Validation | Ensured unit meets requirements for use environment and stresses. |
| System Components Biocompatibility Assessment | Per ISO 10993-1 (2009). |
| Customer Requirements Validation | Validated with an advising surgeon in a simulated use environment. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The simulated use testing for validation of intraoperative change in leg length and offset involved 18 data points on 5 hips.
- Data Provenance: The study was a prospective cadaver validation conducted in a simulated operating room environment. The country of origin is not explicitly stated but is implied to be in the country where OrthAlign, Inc. operates (USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: One "advising surgeon" was involved in "Customer requirements validation" and a "surgeon" conducted the procedures in the simulated use testing. It's not explicitly stated how many experts established the ground truth itself, but a surgeon was central to the simulated use.
- Qualifications of Experts: The document mentions an "advising surgeon" and a "surgeon" conducting procedures. Specific qualifications (e.g., years of experience, subspecialty) are not provided.
4. Adjudication Method for the Test Set:
- The document does not explicitly describe an adjudication method involving multiple reviewers for establishing ground truth. The ground truth for the simulated use testing was "radiographic evaluation of the leg length and offset changes."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No, an MRMC comparative effectiveness study was not explicitly described. The device is a "computer-assisted surgical navigation system" intended to assist the surgeon, but the study focuses on the device's accuracy in cadaveric models rather than a comparative effectiveness study of surgeons with and without the device. Therefore, no effect size of human reader improvement with AI assistance is provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- The document describes "System accuracy testing: bench testing with mechanical fixtures and foam models to verify leg length and offset and updated scale reader measurement accuracy." This bench testing likely represents a form of standalone testing of the algorithm's accuracy in a controlled environment, separate from the cadaver study which involves a surgeon. However, it's not explicitly labeled as "standalone performance."
7. The Type of Ground Truth Used:
- For the validation of intraoperative change in leg length and offset, the ground truth used was radiographic evaluation of the leg length and offset changes.
8. The Sample Size for the Training Set:
- The document does not specify a sample size for a training set. This submission is for a modification to a previously cleared device (K130387) and focuses on validation against its own intended use and substantial equivalence to predicates. It doesn't detail the development and training process for the algorithms.
9. How the Ground Truth for the Training Set Was Established:
- As a training set is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided in the document.
§ 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).