(113 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
- · Unicompartmental Knee Arthroplasty: Tibial transverse resection
The OrthAlign Plus® System is a 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 provided text describes modifications to an existing orthopedic surgical navigation system, the OrthAlign Plus® System (K153237), to add functionality for unicompartmental knee arthroplasty (UKA) tibial transverse resections. The submission claims substantial equivalence to its prior version (K140331) and the Aesculap OrthoPilot Next Generation (K141694).
However, the document does not contain specific acceptance criteria with numerical targets (e.g., minimum accuracy of X degrees or Y mm) or detailed results from a study demonstrating the device meets those criteria. Instead, it describes general categories of performance testing.
Therefore, I cannot populate the table with acceptance criteria and reported device performance as they are not explicitly stated with specific numerical values in the provided text. I also cannot provide detailed answers for many of the questions as the specific study details (e.g., sample sizes for test/training, expert qualifications, adjudication methods, MRMC studies) are not present.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Specific Targets) | Reported Device Performance (Specific Results) |
|---|---|
| Not explicitly stated in the document | Not explicitly stated with numerical results in the document |
| Example: Navigated resection plane angular accuracy: within X degrees of target | Example: Achieved Y degrees of angular accuracy for navigated resection plane |
| Example: Navigated resection plane depth accuracy: within Z mm of target | Example: Achieved W mm of depth accuracy for navigated resection plane |
Missing Information: The document states "System accuracy testing: bench testing with mechanical fixtures and foam models to verify navigated resection plane angular and depth accuracy." However, it does not provide the specific acceptance criteria (i.e., "within X degrees/mm of target") nor the actual measured performance results.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document mentions "bench testing with mechanical fixtures and foam models" for system accuracy and "cadaver with an advising surgeon" for usability validation, but no sample sizes for these tests are provided.
- Data Provenance: The cadaver study would typically be prospective for that specific test run, but the location/country of origin is not mentioned. Bench testing is laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "an advising surgeon" (singular) for the cadaver study.
- Qualifications of Experts: The qualification is "advising surgeon." No further details on experience level or specialization are provided.
4. Adjudication method for the test set
- Adjudication Method: Not specified. For the cadaver study, an "advising surgeon" was involved in validating usability, but the method for establishing ground truth or resolving discrepancies is not detailed. For bench testing, mechanical fixtures and foam models would likely have a pre-defined "ground truth" based on their design.
5. 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
- MRMC Study: No, an MRMC comparative effectiveness study involving human readers or AI assistance in that context was not mentioned or performed. The device is a surgical navigation system, not an imaging interpretation AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The described "System accuracy testing: bench testing with mechanical fixtures and foam models to verify navigated resection plane angular and depth accuracy" can be considered a form of standalone testing for the device's accuracy in measuring and displaying angles/positions. However, it's not a purely "algorithm-only" test as it involves hardware components interacting with physical models. The document doesn't explicitly delineate "algorithm-only" performance metrics separate from the integrated system.
7. The type of ground truth used
- Ground Truth Type:
- For system accuracy testing, the ground truth would be based on the known, precise measurements of the mechanical fixtures and foam models.
- For usability validation in cadaver, the "ground truth" relates to whether the system meets design input requirements for its functions, likely assessed by the advising surgeon against surgical standards.
8. The sample size for the training set
- Training Set Sample Size: Not applicable/not specified. This device is a surgical navigation system, which primarily relies on algorithms and hardware for real-time measurements rather than a "training set" in the machine learning sense for image recognition or similar AI applications. The algorithms are developed and calibrated, but a "training set" for performance evaluation is not referenced.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable/not specified. As above, the concept of a "training set" for this type of device is not directly addressed in the document. The algorithms would be designed and tested based on engineering principles and physical measurement accuracy.
§ 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).