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The TCAT™/TPLAN™ Surgical System is intended for use as a device which 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 techniques for femoral canal preparation in primary total hip arthroplasty (THA).

The TCAT™/TPLAN™Surgical System is indicated for orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

The TCAT™ TPLAN™ 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, and reaming techniques for the preparation of bone for patients requiring a 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 bone preparation possible before and during THA surgical procedures.

The provided document is a 510(k) summary for the TCAT™/TPLAN™ Surgical System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance statistics for the new device.

Therefore, the information requested cannot be fully extracted from this document as it does not contain a study specifically designed to establish acceptance criteria and prove the device meets them in the way a clinical trial or a detailed performance validation study would for a novel device. The document emphasizes comparison to a predicate device.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is missing:

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

This information is not explicitly provided in the document. The document states that "The TCAT™ Surgical System has been evaluated with non-clinical performance testing for the following modifications and or improvements" and lists various components. It also mentions "Bench and simulated use tests included functional software testing... and hardware, functional software, user interface, instrument/tool and sterile disposable accessory testing and simulated clinical use of new and changed instrument /tools for the TCAT™/TPLAN™ Surgical System." However, specific numerical acceptance criteria (e.g., accuracy, precision thresholds) and the corresponding reported performance values for the TCAT™/TPLAN™ Surgical System are not detailed.

Table: Acceptance Criteria and Reported Device Performance (Information Not Available in Document)

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

This information is not explicitly provided. The document mentions "non-clinical performance testing" and "Bench and simulated use tests" but does not detail the sample sizes (e.g., number of test cases, number of simulated surgeries) or the provenance of any data used for these tests. It is implied these are laboratory/bench tests, not patient data studies.

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)

This information is not explicitly provided. Since the document describes "non-clinical performance testing" and "simulated use tests," it's unlikely that experts were used in the context of establishing a clinical ground truth for a test set in the way a diagnostic AI would require. The ground truth for engineering or functional tests would typically be established by design specifications and measurement tools.

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

This information is not explicitly provided. Given the nature of the described tests (bench and simulated use for functional software and hardware), a clinical adjudication method is not relevant or would not be described in this context.

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, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The TCAT™/TPLAN™ Surgical System is described as a robotic system that implements a presurgical plan, not an AI to assist human readers in, for instance, image interpretation. The comparison is between the robotic system and manual planning/broaching/reaming techniques, not between human readers with and without AI assistance for interpretation tasks.

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

This concept is partially applicable but not fully detailed. The device consists of a planning software (TPLAN™) and a robotic surgical tool (TCAT™). The "algorithm only" performance would relate to the precision and accuracy of the robotic arm's movements in executing the presurgical plan. The document states that "the robotic surgical tool... precisely implements the presurgical software plan" and mentions "functional software testing" and "hardware... testing." While this suggests standalone performance evaluation of the system's components, specific metrics and studies are not detailed. The system is still "under the direction of the surgeon," implying continued human involvement.

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

The document does not specify the type of ground truth used for performance validation. For a surgical robotic system, ground truth for bench tests would typically refer to highly accurate physical measurements of movement, accuracy, and precision against known targets or reference points. It would not typically involve expert consensus, pathology, or outcomes data in the context of this 510(k) submission's described testing.

8. The sample size for the training set

This information is not applicable or not provided. This document describes approval for a medical device (a surgical system), not an AI model trained on a dataset. Therefore, there is no "training set" in the context of machine learning. The term "training set" is generally used for machine learning algorithms, which is not the primary focus of this device's validation as presented in this 510(k).

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

This question is not applicable as there is no mention of a "training set" for a machine learning model.

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