(372 days)
The Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), 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 Robotic Arm Interactive Orthopedic System (RIO), 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 .
- Restoris Porous Partial Knee System ●
Partial Knee Application is an upgrade to RIO-PKA (K112507). The features of this application are to improve overall performance of the system in supporting partial knee arthroplasty. Partial Knee Application is used with RIO which includes an optical detector, robotic arm, and guidance module. In addition, the application is designed to be used with a pre-operative planning laptop, as well as both reusable and disposable instrumentation.
The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, cutting system, and a robotic arm. The system's architecture is designed to support partial knee procedures. With application specific hardware and software, it provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation.
RIO's 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 document describes the MAKO Surgical Corporation's Partial Knee Application (PKA) device, which received 510(k) clearance from the FDA. The document summarizes various performance tests conducted to demonstrate the device's substantial equivalence to predicate devices.
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:
The document provides a table summarizing the validation and verification methods, their acceptance criteria, and the results, as shown below:
| Validation / Verification Method | Acceptance Criteria | Reported Performance (Results) |
|---|---|---|
| MICS Handpiece Functional Test | Intended to verify the MAKO Integrated Cutting System (MICS) requirements. | Pass |
| MICS Attachments Functional Test | Intended to verify that the straight sagittal saw blades met applicable specifications. | Pass |
| RIO Base Array Functional Test | Intended to verify that the Base Array assemblies when used with the Base Array Connector meet applicable specifications. | Pass |
| Bone Arrays and Clamps Functional Test | Intended to verify that the array movement is equal or less than the assembly requirement to a fixed position after cutting. | Pass |
| PKA Application Performance Test | Intended to verify that the real-time performance of the PKA application met applicable specifications. | Pass |
| Disposable Cutter Strength Testing | Intended to verify that the narrow saw blades met applicable specifications. | Pass |
| Bone Mineral Density (BMD) Application Functional Test | Intended to verify that the Bone Mineral Density function met applicable specifications. | Pass |
| Full System Run-through test | Intended to verify that the Partial Knee Application Software, and supporting instrumentation provides adequate functionality to be able to successfully complete a PKA procedure. | Pass |
| System Accuracy Test | The purpose of this test is to determine the overall system accuracy as a result of bone registration and bone resection accuracy. This protocol will use the verification results obtained from bone registration verification test and bone resection test and combine these results using a statistical approach. | Pass |
| PKA System Validation with MCK Implant system | Validate in a simulated-use environment that the integration of the Robotic Arm Interactive Orthopedic System (RIO) with the Partial Knee Application Software, MCK implant system and supporting instrumentation provides adequate functionality to successfully complete a Partial Knee Arthroplasty procedure and satisfies the customer requirements. | Pass |
| PKA System Validation with Restoris Porous Implant system | Validate in a simulated-use environment that the integration of the Robotic Arm Interactive Orthopedic System (RIO) with the Partial Knee Application Software, Restoris implant system and supporting instrumentation provides adequate functionality to successfully complete a Partial Knee Arthroplasty procedure and satisfies the customer requirements. | Pass |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document provides a list of tests and states "Pass" for each, but it does not specify the sample sizes used for any of the individual tests comprising the test set. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of data). The studies are described as "nonclinical performance testing" and "simulated-use environment," indicating they were likely conducted in a lab or pre-clinical setting rather than with human patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The validation tests, particularly the "Full System Run-through test" and the "PKA System Validation," mention assessing "adequate functionality" and satisfying "customer requirements," which would implicitly involve expert assessment, but details are not given.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the nature of the tests (functional and system accuracy), it's more likely that predefined technical specifications were used as criteria rather than a consensus among multiple human adjudicators for subjective assessments.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
The document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. The studies described are focused on the device's functional performance and accuracy, not on comparing the performance of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done:
The "Partial Knee Application (PKA)" is described as being "intended to assist the surgeon" and "provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation." The "RIO's robotic arm... can serve as surgeon's 'intelligent' tool holder or tool guide." This clearly indicates a design for "human-in-the-loop" operation. Therefore, a standalone (algorithm-only) performance study is not explicitly described or implied as being relevant given the device's assistive nature. However, certain functional tests (e.g., System Accuracy Test, PKA Application Performance Test) would evaluate the algorithm's performance independent of surgical action, but within the context of ultimately assisting a surgeon.
7. The Type of Ground Truth Used:
The ground truth for most of these tests appears to be based on engineering specifications and predefined performance metrics. For example, the "System Accuracy Test" aims to determine "overall system accuracy as a result of bone registration and bone resection accuracy." This implies a comparison against a known, accurate standard or measurement. For the "Full System Run-through test" and "PKA System Validation," the ground truth would be the successful completion of the PKA procedure according to established clinical protocols and "customer requirements" (likely derived from surgical best practices and outcomes) in a simulated environment. There is no mention of pathology or long-term outcomes data used as ground truth in these nonclinical tests.
8. The Sample Size for the Training Set:
The document does not provide any information regarding the sample size for a training set. As this device seems to be a complex robotic surgical assistance system, there would undoubtedly be internal development and training data used for its algorithms and software. However, such details are not disclosed in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established:
Similar to question 8, the document does not provide information on how the ground truth for any potential 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).