(58 days)
The Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with 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 unicondylar knee replacement and/or patellofemoral knee replacement.
The Implant systems with which the system is compatible:
• Restoris Multicompartmental Knee System
The Mako System with the Partial 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 stereotactic/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.
The Mako robotic arm, once configured for a specific application, can serve as 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.
This document is a 510(k) summary for the Mako Partial Knee Application, a medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the typical sense of an AI/ML device performance study with traditional metrics like sensitivity, specificity, or AUC.
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Mako Surgical's Partial Knee Application cleared via K142530), based on technological characteristics and functional performance testing.
Therefore, I cannot extract the requested information regarding acceptance criteria, study design, ground truth establishment, or human reader performance for an AI/ML system from this document. The "Performance Data" section describes non-clinical performance testing for a robotic surgical assistance system, not an AI/ML diagnostic or prognostic tool.
Here's a breakdown of why the requested information cannot be provided based on the input document:
- Acceptance Criteria and Reported Device Performance (Table): Not present. The document discusses "performance testing" but not in the context of quantitative metrics for an AI/ML model. It lists activities like "Sub-system level software functional testing" and "Resection accuracy verification," but no specific numerical acceptance criteria or results are given.
- Sample Size and Data Provenance (Test Set): Not applicable in the context of AI/ML validation data. The performance testing mentions "Full system cadaver validation," which implies a small, non-human sample for mechanical/software function verification, not a large patient-data test set.
- Number/Qualifications of Experts for Ground Truth: Not applicable. Ground truth, in the AI/ML sense, refers to labeling of patient data, which is not described.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not mentioned or implied. This device is a surgical assistance system, not an imaging interpretation AI for human reader improvement studies.
- Standalone (Algorithm-only) Performance: Not applicable as it's a robotic system with human interaction.
- Type of Ground Truth: Not applicable in the AI/ML data labeling sense. The "ground truth" for this device's performance would be the physical accuracy of the robotic arm's movements and resections compared to a planned trajectory.
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that learns from a training set of data in the typical sense. Its software is programmed to assist with surgical procedures.
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document describes a robotic surgical assistance system that aims to demonstrate substantial equivalence through a series of non-clinical performance and functional tests, rather than an AI/ML system that undergoes a clinical validation study with specific performance metrics and patient data.
§ 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).