(57 days)
The TSolution One™ w/ACG+ Surgical System is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physicial planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the surgeon, precisely implements the presurgical software plan.
The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/ reaming/impacting techniques for femoral canal and acetabular cup preparation in primary cementless total hip arthroplasty (THA) using a posterior approach.
The TSolution One w/ACG+ Surgical System is indicated for orthopedic procedures in which the broaching, reaming and impacting techniques used in primary cementless total hip arthroplasty (THA) using a posterior approach may be considered to be safe and effective and where references to rigid anatomical structures may be made. The TSolution One™ w/ACG+ Surgical System is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One™ w/ACG+ Surgical System facilitates accurate positioning of THA implants, relative to these alignment axes.
The TSolution One™ w/ACG+ Surgical System is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require a total hip arthroplasty (THA) procedure. This device is intended as an alternative to manual template planning, broaching, reaming and impacting techniques for the preparation of femoral canal and acetabular cup for patients requiring a primary THA procedure. The system consists of the TPLAN™ Preoperative Planning Workstation and TCAT™, a robotic system composed of an electromechanical arm, arm base including control electronics and computer, display monitor, and miscellaneous accessories such as cutters, drapes, irrigation sets, probes, and markers. TPLAN™ and TCAT™ when used according to the instructions for use, make precision femoral canal and acetabular cup preparation possible before and during THA surgical procedures.
The provided document is a 510(k) summary for the TSolution One™ w/ACG+ Surgical System, which is a robotic surgical system for Total Hip Arthroplasty (THA). This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not detail specific acceptance criteria or a dedicated study proving device performance against those criteria in the way typically expected for an AI/algorithm-driven device's clinical performance.
Instead, the performance data section outlines verification and validation activities conducted to assess modifications and improvements to the system. These activities include Software Testing, Usability Testing, Benchtop Accuracy Testing, and Cadaver Testing. The results for all these activities are simply reported as "PASS."
Therefore, based on the provided document, I cannot fulfill all parts of your request as it pertains to a detailed description of acceptance criteria met by a specific study with clearly defined metrics, sample sizes, and ground truth methodologies for an AI/algorithm.
However, I can extract the information that is present:
1. Table of acceptance criteria and the reported device performance:
The document does not provide a table of explicit, quantitative acceptance criteria for clinical performance (e.g., accuracy, precision of cuts against target) or reported numerical performance metrics. Instead, it lists verification/validation activities and reports them as "PASS."
| Verification / Validation Activity | Purpose | Reported Device Performance |
|---|---|---|
| Software Testing | Verify TPLAN presurgical planning and TCAT surgical system software function as intended to successfully complete THA procedure including Acetabular Cup Guidance | PASS |
| Usability Testing | Verify TPLAN presurgical planning and TCAT user interface functions as intended to successfully complete THA procedure including Acetabular Cup Guidance and meet user needs. | PASS |
| Benchtop Accuracy Testing | Verify overall system (TPLAN presurgical planning, and TCAT surgical system) accuracy in meeting specified requirements. | PASS |
| Cadaver Testing | Validate that the workflow of the TSolution One™ wACG+ Surgical System including THA software as well as tools and accessories in a simulated use environment functions as intended to successfully complete a THA procedure including Acetabular Cup Guidance and meets customer requirements. | PASS |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not specified for any of the testing activities beyond "cadaver testing."
- Data Provenance: Not specified. The document is a 510(k) summary submitted to the FDA in the USA, but it does not detail where the studies were conducted or the origin of any data used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not specified. The document does not mention any expert involvement in establishing "ground truth" for quantitative performance metrics. For cadaver testing, it mentions validating workflow and meeting "customer requirements," which might imply expert input, but details are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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:
- No. The document describes a robotic surgical system, not an AI diagnostic or assistance tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The TSolution One™ system is described as a "robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan." This indicates it's a human-in-the-loop system where the surgeon directs the robot based on the presurgical plan. While software testing verifies the algorithm's function, it's not discussed as a standalone diagnostic or interpretative algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For "Benchtop Accuracy Testing," the ground truth implicitly refers to "specified requirements," which would likely be engineering or design specifications for accuracy.
- For "Cadaver Testing," the ground truth relates to the system's ability to "successfully complete a THA procedure" and meet "customer requirements," which would involve surgical outcomes in a simulated environment.
- No specific mention of expert consensus, pathology, or long-term outcomes data as ground truth.
8. The sample size for the training set:
- Not specified. The document doesn't discuss a "training set" in the context of machine learning model development. The system involves validated control software and hardware, but details regarding its development, training data, or methodology are not provided.
9. How the ground truth for the training set was established:
- Not applicable, as a "training set" for a machine learning model is not discussed in this 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).