(208 days)
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 surgical knee 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. These procedures include:
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· Total Knee Arthroplasty (TKA)
The implant systems compatible with the system: -
· Triathlon Total Knee System (CR/CS/PS/PSR cemented and cementless primary)
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· Triathlon Total Knee System (TS inserts cemented primary)
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· Kinetis Total Knee System (CR/UC)
The Mako System with the subject Mako Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, 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 document is a 510(k) summary for the Mako Total Knee Application, which describes modifications to an existing device. It discusses the device's intended use and technical characteristics compared to a predicate device, as well as performance testing conducted. However, it does not contain specific acceptance criteria, detailed study results, or the other specific information requested in your prompt regarding dataset details, expert qualifications, and comparison to human performance with AI assistance.
Therefore, I cannot populate the requested table and answer many of your specific questions based solely on the provided text. The document states that "performance testing demonstrates that the characteristics of the subject Mako Total Knee Application are equivalent to the characteristics of the predicate device," but it does not provide the specific metrics or acceptance criteria used to make this determination, nor does it present the detailed results from the "Simulated-use cadaveric surgeon validation" or "Knee alignment clinical outcomes data review."
Below is a table where I have filled in what little information is directly available and indicated where requested information is not present in the provided text.
Acceptance Criteria and Device Performance Study Details for Mako Total Knee Application (K193515)
| Category | Information from Document |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Acceptance Criteria: Not explicitly stated in the provided document. The document refers to demonstrating equivalence to a predicate device and states that "performance testing demonstrates that the characteristics of the subject Mako Total Knee Application are equivalent to the characteristics of the predicate device." However, the specific quantitative acceptance criteria for this equivalence are not provided. |
| Reported Device Performance: Not explicitly detailed with quantitative metrics in the provided document. The document states that "performance testing demonstrates that the characteristics of the subject Mako Total Knee Application are equivalent to the characteristics of the predicate device" and that the device is "as safe and as effective as the predicate device." Specific measured performance metrics are not given. | |
| 2. Sample Size (Test Set) & Data Provenance | The document mentions "Simulated-use cadaveric surgeon validation" and "Knee alignment clinical outcomes data review" as performance testing. However, the sample size for the test set (number of cadavers or cases) is not specified. The data provenance (e.g., country of origin, retrospective/prospective) is not specified. |
| 3. Number & Qualifications of Experts (Ground Truth) | Not specified in the provided document. The "Simulated-use cadaveric surgeon validation" implies involvement of surgeons, but their number, qualifications, or their role in establishing ground truth (vs. performing the validation) are not detailed. An "Mako TKA User Guides" is mentioned for labeling. |
| 4. Adjudication Method (Test Set) | Not specified in the provided document. |
| 5. MRMC Comparative Effectiveness Study & Effect Size | No multi-reader multi-case (MRMC) comparative effectiveness study explicitly mentioned, nor is an effect size for human readers with/without AI assistance provided. The device is a stereotactic instrument with a robotic arm, providing haptic guidance and assisting surgeon with pre-surgical planning and intraoperative navigation. It's a tool for the surgeon, rather than an AI-driven diagnostic aid that improves human interpretation directly in a traditional MRMC sense. |
| 6. Standalone (Algorithm Only) Performance Study | Not explicitly mentioned as a standalone performance study. The device's description focuses on its function with a surgeon ("assist the surgeon," "serve as the surgeon's 'intelligent' tool holder or tool guide"). |
| 7. Type of Ground Truth Used | Not explicitly specified. Given the context of "Simulated-use cadaveric surgeon validation" and "Knee alignment clinical outcomes data review," the ground truth would likely relate to anatomical accuracy, implant positioning accuracy, or surgical outcome measures, but the precise definition of "ground truth" (e.g., highly accurate imaging, post-surgical assessment, expert consensus on optimal placement) is not detailed. |
| 8. Sample Size (Training Set) | Not specified in the provided document. The document doesn't explicitly discuss an AI model being 'trained' in the conventional sense, but rather a system that uses CT data and provides haptic guidance. |
| 9. How Ground Truth for Training Set Was Established | Not specified in the provided document. There's no mention of a traditional 'training set' or how its ground truth would have been established. The system uses "patient CT data" for planning, which implies the CT data itself serves as the basis for the anatomical model rather than a 'ground truth' that needs to be established for learning. |
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).