(59 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:
• Total Knee Arthroplasty (TKA)
The implant systems compatible with the system:
- · Triathlon Total Knee System (CR/CS/PS cemented and cementless primary)
- · Triathlon Total Knee System (TS inserts 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/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.
The provided text focuses on the FDA's 510(k) clearance for the Mako Total Knee Application (K172219), stating its substantial equivalence to a predicate device (K170581). This document does not contain the detailed acceptance criteria or the specific results of a study that proves the device meets those criteria in the format typically used for AI/ML device performance evaluation (e.g., sensitivity, specificity, or clinical outcome measures, MRMC studies, etc.). Instead, it describes performance testing in the context of a robotics-assisted surgical system.
However, based on the information provided, we can infer some aspects and construct a response within the given limitations.
Here's an attempt to answer your questions based only on the provided text, highlighting what information is not available:
Acceptance Criteria and Device Performance for MAKO Total Knee Application (K172219)
The provided document describes a 510(k) submission for the MAKO Total Knee Application. Unlike AI/ML medical devices that often have specific performance metrics like sensitivity and specificity measured against a ground truth, this device is a surgical assistance system (stereotaxic instrument). Its "performance" revolves around its ability to provide accurate spatial guidance and integrate with specific implants, demonstrating substantial equivalence to a previously cleared device.
Since the document is a 510(k) clearance letter and summary, it primarily focuses on establishing "substantial equivalence" to a predicate device, rather than detailing a study with explicit quantitative acceptance criteria for each specific metric typically seen in AI/ML validation.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide a table with explicit numerical acceptance criteria for statistical metrics (like sensitivity/specificity for diagnostic AI) or detailed performance results in that format. Instead, the performance evaluations mentioned are designed to demonstrate the system's accuracy and functionality for its intended surgical guidance purpose. The "acceptance" is implicitly tied to demonstrating functionality and accuracy comparable to the predicate device.
| Category | Acceptance Criteria (Inferred from document) | Reported Device Performance (Inferred from document) |
|---|---|---|
| Functional Accuracy | The system must accurately provide software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. This includes accurate pre-surgical planning, implant placement, and interpretive/intraoperative navigation. (Implied: comparable to predicate device performance). | "Cutting Accuracy Verification" was performed. "Full system Cadaver Validation" was performed. The "Performance testing has demonstrated that the characteristics of the Mako Total Knee Application are equivalent to the predicate device, and that the device is as safe and as effective as the predicate device..." |
| Safety | The device must not raise different questions of safety or effectiveness compared to the predicate device. | "Performance testing has demonstrated... that the device is as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness, and therefore, supports a determination of Substantial Equivalence." |
| Compatibility | The system must be compatible with the specified implant systems (e.g., Triathlon Total Knee System, Kinetis Total Knee System). | The device is explicitly stated to be compatible with: Triathlon Total Knee System (CR/CS/PS cemented and cementless primary), Triathlon Total Knee System (TS inserts cemented primary), and Kinetis Total Knee System (CR/UC). (This was a specific modification addressed in this 510(k) via compatible implants and labeling updates). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "Cutting Accuracy Verification" and "Full system Cadaver Validation." The specific number of cases or cadavers used for these tests is NOT provided.
- Data Provenance: The document does not specify the country of origin. The validation involved "Cadaver Validation," implying a laboratory or simulated surgical environment. The studies are non-clinical performance testing. It does not state whether it was retrospective or prospective in a clinical setting, as it's a non-clinical, pre-market submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Provided. For a surgical robotic system's "accuracy" and "functional performance," the ground truth is often established by engineering specifications, physical measurements, and comparison against established surgical methodologies or predicate device performance, rather than expert human interpretation of images like in diagnostic AI. The document does not refer to "experts" establishing a ground truth in the context of image labeling or diagnosis.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers are interpreting data (like medical images) and their interpretations need to be reconciled to form a ground truth. This type of method is not mentioned for the non-clinical performance testing of a surgical robot.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is relevant for diagnostic or AI-assisted diagnostic devices where the performance of human readers (with and without AI assistance) is compared. This document describes a surgical robotic system for guiding procedures. The type of testing performed (Cutting Accuracy, Cadaver Validation) is not an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Partially Applicable, but not in the typical AI sense. The system works as a "surgeon's intelligent tool holder or tool guide." The "Cutting Accuracy Verification" would be a standalone test of the system's precision based on its programming and mechanics. However, its ultimate function is always "human-in-the-loop" as it assists a surgeon. The term "algorithm only" is less fitting for a hardware-software integrated robotic system where the algorithm drives the physical guidance. The non-clinical tests would evaluate the system's mechanical and computational accuracy.
7. The Type of Ground Truth Used
- Engineering Specifications / Physical Measurement / Pre-defined Anatomical Models. For "Cutting Accuracy Verification," the ground truth would be based on precise measurement of cuts against intended/programmed cuts or anatomical landmarks. For "Cadaver Validation," the ground truth would relate to the successful and accurate completion of surgical steps (e.g., implant alignment, bone preparation) as determined by established surgical principles and post-procedure measurements on the cadaver. It is based on CT-based models of anatomy which the system uses for reference.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. This device is a stereotaxic instrument that uses pre-operative CT data for planning and intraoperative guidance, not a machine learning algorithm that is "trained" on a large dataset of patient images in the way many AI/ML diagnostic tools are. Its "training" is in its engineering design and calibration.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As noted above, this device does not have a "training set" in the common machine learning sense. Its "knowledge" is embedded in its design, calibration, and the anatomical information derived from patient-specific CT scans.
§ 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).