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The DigiMatch™ ROBODOC® 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 intra-operative 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 DigiMatch ROBODOC 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 DigiMatch™ ROBODOC® Surgical System consists of the 510(k)-cleared (K960685) ORTHODOC® Preoperative Planning Workstation (ORTHODOC), and a Robot composed of an electromechanical arm, electronics control cabinet, display monitor and miscellaneous accessories (ROBODOC). The System (ORTHODOC and ROBODOC) is a threedimensional graphical preoperative planner and implementation tool and is indicated as an alternative to template planning and manual broaching for treatment of patients who require primary total hip arthroplasty (THA). The ORTHODOC component of the System allows a surgeon to preoperatively assess a patient's femoral anatomy and state of hip disease, select an optimally sized femoral stem implant from a library of prostheses, and determine where the implant should be positioned within the femur. Then ROBODOC component of the System, under direct control by the surgeon, will precisely implement the preoperative plan.

The provided text describes the DigiMatch™ ROBODOC® Surgical System and its premarket notification (K072629) to the FDA. However, the document does not explicitly state specific quantitative acceptance criteria for performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices and proving safety and efficacy through various studies.

The closest to "acceptance criteria" is the demonstration of "equivalence in Harris Hip Scores" in the clinical trials, implying that the device's performance should be at least as good as manual methods in this regard. The non-clinical studies focus on accuracy and biological response.

Here's a breakdown of the requested information based on the provided text, with caveats where information is not explicitly stated:

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample Size used for the test set and the data provenance:

   • Cadaver Study: Sample size not specified. Data provenance: Not explicitly stated, but typically cadaver studies are conducted in a controlled lab environment.
   • Animal Study: 20 male greyhounds. Data provenance: Not explicitly stated, but typically animal studies are conducted in a controlled lab environment.
   • First U.S. Trial (Clinical): Sample size for ROBODOC group and manual control group not specified. Data provenance: U.S., prospective clinical trial.
   • Second U.S. Trial (Clinical): Sample size for ROBODOC group and manual control group not specified. Data provenance: U.S., prospective clinical trial (IDE # G000071).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not specify the number of experts or their qualifications for establishing ground truth for any of the studies (cadaver, animal, or clinical). For clinical trials, "Harris Hip Scores" are typically evaluated by orthopedic surgeons or trained clinicians. Histological examinations would involve pathologists.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   The document does not specify any adjudication methods (e.g., 2+1, 3+1 consensus) for establishing ground truth in any of the studies.

4. 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, an MRMC study was NOT done. The studies described compare the robotic system (ROBODOC) to manual techniques for hip arthroplasty, not human readers with or without AI assistance in an imaging interpretation context. The device is a surgical system that implements a plan, not an AI diagnostic tool that assists human interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Yes, in essence, the "ROBODOC" component operates in a standalone manner in terms of implementing the presurgical plan. The document states: "The ROBODOC component of the System, under direct control by the surgeon, will precisely implement the preoperative plan." While under "direct control by the surgeon," the precision and execution of the plan by the robot itself is an algorithmic function. The performance of the robotic cutting was evaluated against manual cutting in cadaver and animal studies, and clinicallly, its implementation of the plan led to equivalent Harris Hip Scores.

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

   • Cadaver Study: "Accuracy of cutting the femur" and "measurement of the gap between the bone and implant." Implies objective measurements.
   • Animal Study: "Accuracy of cutting the femur," "histological examinations of the cavity/implant interface" (pathology), and observation of "fracture or osteotomy."
   • Clinical Studies (First & Second U.S. Trials): "Fit and alignment of the femoral implant" (likely based on imaging and surgical assessment) and "Harris Hip Scores" (patient-reported outcomes and clinical assessment of hip function).

7. The sample size for the training set:
   The document does not specify any separate "training set" for the DigiMatch™ ROBODOC® Surgical System. The device's "training" and validation would have occurred during its development and prior testing, which is not detailed here. The studies mentioned (cadaver, animal, clinical) serve as validation/test sets to demonstrate safety and effectiveness for regulatory approval.

8. How the ground truth for the training set was established:
   As no specific "training set" is described for the device's algorithmic development, this information is not available in the provided text. The ORTHODOC component is described as being "510(k)-cleared (K960685)," indicating prior regulatory review, but details of its development and ground truth establishment are not in this K072629 summary.

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