(49 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 Make System is indicated for use in surgical knee and hip 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
· Total Hip Arthroplasty (THA)
The Mako System with the Total Hip 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 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.
The Mako Total Hip 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 device is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures, specifically Total Hip Arthroplasty (THA).
The device in question is a modification of a previously cleared device (K141989), with the modification being "An alternate online portal for case management and file transfer known as eRequest LifeCycle is being implemented for use during the preoperative planning phase of the Mako Total Hip Application." Therefore, the validation and verification focused on ensuring that this new portal and its integration did not negatively impact the existing functionalities or introduce new risks.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Product Specification Verification | THA fields and values implemented into the eRequest application must match the THA Product Specifications. | Pass |
| eRequest – Full System Run Through for THA Application | The integration of the eRequest Lifecycle into the Mako System provides adequate functionality to successfully complete the pre-operative planning workflow. | Pass |
| eRequest LifeCycle THA Validation | In a simulated-use environment, with appropriate user, the implementation of eRequest LifeCycle into the Mako System provides adequate functionality to successfully complete the pre-operative workflow and satisfies the customer requirements. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The tests described are functional verification and validation steps for software integration rather than clinical performance studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish a "ground truth" for the test set. The validation appears to be based on product specifications and user requirements, likely assessed by internal development and quality assurance teams, potentially with input from clinical users or subject matter experts in surgical workflows, but this is not detailed.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (such as 2+1 or 3+1). The tests are described as "Pass/Fail" based on whether the acceptance criteria were met.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. The device is a surgical planning and guidance system for Total Hip Arthroplasty (THA), and the specific tests mentioned focus on the software integration of a new case management portal. There is no information provided regarding studies on human reader performance with or without AI assistance for this device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
A standalone algorithm-only performance study was not explicitly done or detailed in the provided text. The device is inherently a "human-in-the-loop" system, assisting surgeons. The testing focused on the functionality of the new eRequest LifeCycle within the overall Mako System, which is for pre-operative planning.
7. Type of Ground Truth Used
The "ground truth" for these tests appears to be product specifications, documented pre-operative planning workflows, and customer requirements. These are largely functional and performance specifications for the software system and its integration, rather than clinical ground truth like pathology, expert consensus on imaging, or outcomes data.
8. Sample Size for the Training Set
The document does not specify any sample size for a training set. Given the nature of the modification (a new online portal for case management), this is unlikely to involve a machine learning model that requires a training set in the conventional sense. The "training" here would refer to software development and testing cycles rather than data-driven model training.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of the device's modification, the document does not describe how ground truth for a training set was established.
§ 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).