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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. TPLANTM 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 text describes a 510(k) premarket notification for the TSolution One™ w/ACG Surgical System, a robotic surgical system for total hip arthroplasty (THA). The document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and performance testing.

However, the document does not contain the level of detail required to fulfill all aspects of your request, particularly regarding specific acceptance criteria values, sample sizes for test sets where performance metrics are quantified, the number and qualifications of experts, adjudication methods, details of MRMC studies, or the provenance of detailed data. The "Performance Data" section lists "Benchtop Accuracy Testing" as verifying overall system accuracy against specified requirements, but it does not provide the specific numerical acceptance criteria or the reported device performance against those criteria. It only states "PASS".

Based on the provided text, here's what can be extracted and what cannot:

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

Important Note: The document states "Benchtop Accuracy Testing" verifies accuracy in "meeting specified requirements" but does not explicitly state what those numerical requirements are (e.g., a specific tolerance in mm or degrees) or the measured accuracy. It only indicates "PASS."

2. Sample sizes used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated for any of the listed tests (Software, Usability, Benchtop Accuracy, Cadaver).
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The cadaver testing is a simulated use environment, which is a type of prospective lab-based testing.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified. Given the nature of these tests (software functionality, usability, benchtop accuracy, cadaver workflow), it's likely that a predefined protocol and objective measurements were used for "PASS/FAIL" rather than expert adjudication in the sense of consensus reading of medical images.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. This type of study is typical for AI-assisted diagnostic devices to measure improvement in human reader performance. This device is a robotic surgical system, not a diagnostic AI.

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

• Standalone Performance: The "Benchtop Accuracy Testing" would be the closest to a standalone performance evaluation, as it aims to verify the "overall system (TPLAN presurgical planning, and TCAT surgical system) accuracy." However, the exact metrics and whether this is "algorithm only" are not detailed. The system, by its description, always involves a human surgeon "under the direction of the surgeon" and implementing a "presurgical software plan." Thus, a purely standalone algorithm evaluation in the sense of a diagnostic AI is not applicable.

7. The type of ground truth used

• Ground Truth Type:
  • For "Software Testing" and "Usability Testing": Implied ground truth is the predefined functional specifications and user requirements for the system.
  • For "Benchtop Accuracy Testing": Implied ground truth would be precise measurements from a known reference standard (e.g., phantom, jig) against which the system's output is compared. The "specified requirements" define this ground truth.
  • For "Cadaver Testing": Implied ground truth would be successful completion of the THA procedure workflow as per established surgical protocols and meeting "customer requirements" in a simulated environment.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This document describes a robotic surgical system, not a machine learning model that requires a distinct training set. The "software" mentioned refers to the system's control software and planning software, which are developed through traditional software engineering processes, not trained on a data set in the AI sense.

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

• Training Set Ground Truth: Not applicable, as it's not a machine learning model that undergoes training on a data set with established ground truth.

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