(72 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 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 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 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.
Based on the provided text, the Mako Partial Knee Application is a Class II medical device, product code OLO, regulated under 21 CFR 882.4560 (Stereotaxic Instrument). This device is intended to assist surgeons by providing software-defined spatial boundaries for orientation and reference to anatomical structures during orthopedic procedures, specifically unicondylar knee replacement and/or patellofemoral knee replacement. The 510(k) submission (K170584) claims substantial equivalence to the predicate device, Mako Partial Knee Application cleared via K112507.
The primary change described is the implementation of an alternate online portal for case management and file transfer, known as eRequest LifeCycle, for use during the preoperative planning phase. The performance data focuses on verifying and validating this new component's functionality and integration into the existing Mako System.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Purpose of Test) | Reported Device Performance (Validation/Verification Results) |
|---|---|
| Product Specification Verification: Verify that PKA fields and values implemented into the eRequest application must match the THA Product Specifications. | Pass |
| eRequest - Full System Run Through for PKA Application: Verify the integration of the eRequest LifeCycle into the Mako System provides adequate functionality to successfully complete the pre-operative planning workflow. | Pass |
| eRequest LifeCycle PKA Validation: 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 the sample size (e.g., number of cases or simulations) used for each test. The studies appear to be focused on the new eRequest LifeCycle portal and its integration. The data provenance is also not specified; it is implied to be internal testing by the manufacturer rather than retrospective or prospective clinical data from external sources.
3. Number of Experts and their Qualifications for Ground Truth
The document mentions "appropriate user" for the eRequest LifeCycle PKA Validation but does not specify the number or qualifications of experts (e.g., radiologists, orthopedic surgeons) used to establish ground truth or validate the functionality. This type of testing appears to be functional validation rather than diagnostic performance assessment requiring expert review.
4. Adjudication Method for the Test Set
No details regarding an adjudication method (e.g., 2+1, 3+1) are present. Given the nature of the tests ("Pass" outcomes for functional verification/validation), human adjudication of complex diagnostic interpretations is not indicated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The submission focuses on the substantial equivalence of an updated component (eRequest LifeCycle portal) rather than demonstrating an improvement in human reader performance with or without AI assistance. This device is an orthopedic surgical robotic system, not an AI-powered diagnostic imaging tool that would typically involve MRMC studies for reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
While the device itself is a "stereotaxic instrument" with a "robotic arm" and "operating software," the performance data presented pertains specifically to the eRequest LifeCycle portal. The tests described are functional verification and validation of this portal's integration and workflow capability. There is no mention of a standalone algorithm performance study in the context of diagnostic accuracy, which would be typical for AI-based image analysis algorithms. The "standalone" performance here relates to the technical functioning of the software component.
7. Type of Ground Truth Used
The "ground truth" for these tests appears to be defined by the "THA Product Specifications" (for Product Specification Verification) and the "pre-operative planning workflow" and "customer requirements" (for eRequest - Full System Run Through and eRequest LifeCycle PKA Validation). This means the ground truth is established by design specifications and user requirements, not clinical outcomes, pathology, or expert consensus on patient data.
8. Sample Size for the Training Set
This information is not applicable and not provided. The described changes are related to a software portal for case management and file transfer, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning for image analysis or prediction tasks. The "training" here relates to software development and testing, where test cases would be used, but not in the context of a machine learning training set for learning from data.
9. How the Ground Truth for the Training Set Was Established
As above, this information is not applicable. The "ground truth" for the functional tests was internal product specifications and defined workflow requirements, not clinical data requiring expert annotation or similar for machine learning purposes.
§ 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).