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The TSolution One® Surgical System Model 210 is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of 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® Surgical System Model 210 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® Surgical System Model 210 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® Surgical System Model 210 facilitates accurate positioning of THA implants, relative to these alignment axes.

The TSolution One® Surgical System Model 210 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 about a 510(k) premarket notification for the TSolution One® Surgical System Model 210, a robotic surgical system for total hip arthroplasty (THA). The document primarily focuses on demonstrating substantial equivalence to a predicate device (TSolution One® Cup1 Surgical System, K162195) rather than providing detailed acceptance criteria and a study dedicated to proving the device meets those criteria with specific performance metrics as typically expected for complex AI/ML devices.

However, based on the information provided, I can infer the acceptance criteria within the context of this 510(k) submission as the successful completion of verification and validation activities demonstrating the device functions as intended and does not raise new safety or efficacy issues compared to its predicate.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a sample size for any test set or the data provenance. The verification and validation activities are described broadly as "Software Testing" and "Support Surgical Instrument Testing," implying internal testing rather than a clinical study with real patient data.

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)

The document does not mention the use of experts to establish ground truth for a test set. This type of information is typically not included in a 510(k) summary focused on substantial equivalence for a surgical robotic system unless a specific clinical study with expert reviews was conducted to prove a clinical endpoint.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not mention any adjudication method.

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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in the provided document. The device is a robotic system for performing surgery based on a presurgical plan, not an AI-assisted diagnostic tool that helps human readers.

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

The document implies that the "Software Testing" and "Support Surgical Instrument Testing" evaluate the system's performance in a standalone capacity (as an algorithm and robotic system functioning as intended) without explicit human-in-the-loop performance described in the context of effectiveness evaluation. However, the device itself is "under the direction of the surgeon," indicating a human-in-the-loop for actual surgical procedures. The testing described focuses on the proper functioning of the software and instruments.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used for its internal verification and validation activities. Given the nature of a surgical robotic system, it's likely based on engineering specifications, kinematic accuracy, planned surgical outcomes (e.g., bone preparation dimensions) against actual robotic execution, and functional tests.

8. The sample size for the training set

The document does not describe any "training set." This device is a robotic system with software for planning and execution, not an AI/ML system that undergoes a training phase with a dataset in the way a diagnostic algorithm would.

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

As there is no mention of a training set, there is no information on how its ground truth would have been established.

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