(72 days)
The Mako System is intended to assist the surgeon in providing software 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:
- · Total Knee Arthroplasty (TKA)
The implants systems compatible with this system: - · Triathlon Total Knee System (CR/CS/PS cemented Primary)
- · Kinetis Total Knee System (CR/UC)
The Mako System with the 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 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.
Here's a breakdown of the acceptance criteria and study information for the Mako Total Knee Application, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses primarily on verifying the integration of a new online portal (eRequest LifeCycle) into an existing device (Mako Total Knee Application, cleared via K143752). Therefore, the acceptance criteria are related to the successful functionality and integration of this change, rather than new performance criteria for the core surgical application itself.
| Acceptance Criteria (Purpose) | Reported Device Performance (Validation/Verification Results) |
|---|---|
| Verify that TKA fields and values implemented into the eRequest application must match the TKA Product Specifications. | Pass |
| Verify the integration of the eRequest Lifecycle into the Mako System provides adequate functionality to successfully complete the pre-operative planning workflow. | Pass |
| Validate in a simulated-use environment, with appropriate user, that 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 document does not explicitly state a specific numerical "sample size" in terms of cases or patients for the test set. The validation appears to be functional and simulated-use testing.
- Test Set Sample Size: Not explicitly stated as a number of cases/patients. The testing involved verifying product specifications and running through the eRequest system in a "simulated-use environment" with an "appropriate user."
- Data Provenance: Not applicable in the context of clinical data for this type of submission. The testing is for the integration and functionality of a software component (eRequest Lifecycle) within an existing device, not for clinical performance on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The "ground truth" for these tests relates to the proper functioning of the software and its adherence to product specifications and user requirements, not clinical diagnoses or outcomes adjudicated by medical experts.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the testing (product specification verification and functional run-throughs), a formal adjudication method by multiple experts is unlikely to have been employed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The submission focuses on a modification (integration of eRequest LifeCycle) to an existing cleared device (Mako Total Knee Application K143752). The studies are functional and simulated-use tests for this integration, not clinical comparative effectiveness studies showing human reader improvement with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone performance study was not done. The Mako System, by definition, is designed to "assist the surgeon" and serves as a "surgeon's 'intelligent' tool holder or tool guide." Its primary function involves human interaction for pre-surgical planning, implant placement, and intraoperative navigation. The software (eRequest LifeCycle) is part of the pre-operative planning workflow that supports the human surgeon.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the verification and validation tests in this submission appears to be:
- Product Specifications: For the "Product Specification Verification" test.
- Intended Functionality/Workflow Success: For the "eRequest – Full System Run Through" and "Planning Workflow - TKA Validation" tests, ensuring the system performs as designed and meets user/customer requirements in a simulated environment.
8. Sample Size for the Training Set
This information is not applicable and not provided. The submission is for a modification to an existing device, involving the integration of a new online portal (eRequest LifeCycle) for case management and file transfer. This is not an artificial intelligence/machine learning model where a "training set" of data would be used to develop an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no mention of a training set for an AI/ML algorithm in this submission.
§ 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).