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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. 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."

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.

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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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