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The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Mako System is indicated for use in total hip arthroplasty procedures in which:

• the use of stereotactic surgery may be appropriate, and
• where reference to rigid anatomical bony structures can be identified relative to a CT-based model of the anatomy;

including revision total hip arthroplasty procedures where:

• the primary acetabular component is well-fixed to the pelvic anatomy, and
• the acetabular component can be revised with either a cup or cup and wedge augment construct.

These procedures include: Total Hip Arthroplasty (THA)

The Mako System with the subject Mako Total Hip Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, camera, a computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.

The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides haptic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement and interpretive / intraoperative navigation of the patient's anatomy.

Once configured for a specific application, the Mako robotic-arm can serve as the surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.

The provided FDA 510(k) summary document for the Mako Total Hip Application 5.0 indicates that no clinical studies were performed. Instead, the device was evaluated through non-clinical performance testing. The document focuses on demonstrating substantial equivalence to a predicate device (Mako Total Hip Application, cleared via K193128) based on these non-clinical tests.

Therefore, the following information, which typically relates to clinical studies and the use of expert adjudicated ground truth, is not available within this document:

• Acceptance Criteria and Reported Device Performance (Table): While performance testing was done, specific numerical acceptance criteria and reported device performance (e.g., accuracy metrics with thresholds) are not detailed in this summary. The summary states "performance testing demonstrates that the characteristics of the subject Mako Total Hip Application are equivalent to the characteristics of the predicate device," but does not provide quantitative results for these tests.
• Sample size for the test set and data provenance: No clinical test set.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no external expert ground truth was established for a clinical test set.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as no human reader studies were conducted.
• Standalone (algorithm only without human-in-the-loop performance) study: The device is a system with human-in-the-loop (surgeon assistance). While non-clinical accuracy tests were performed, these are not presented as "standalone algorithm performance" in the context of typical AI medical device evaluation.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical test set. For the non-clinical tests, physical measurements and system specifications would serve as the "ground truth."
• Sample size for the training set: Not applicable, as this is not a traditional AI/ML device relying on a large training data set in the sense of image recognition or predictive analytics. The software itself is developed and tested, but a "training set" as commonly understood in AI is not mentioned.
• How the ground truth for the training set was established: Not applicable.

However, the document does list the types of non-clinical performance testing performed:

• Software testing
• Bone registration accuracy verification
• Bone resection accuracy verification
• System verification
• Simulated-Use Cadaveric Surgeon Validation

The document concludes that "performance testing demonstrates that the characteristics of the subject Mako Total Hip Application are equivalent to the characteristics of the predicate device," and that "The subject device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness."

Therefore, based on the provided text, while non-clinical performance tests were conducted to demonstrate substantial equivalence, the specific quantitative acceptance criteria and detailed performance metrics that would typically comprise the requested table and clinical study details are not explicitly stated in this 510(k) summary.

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