(88 days)
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 RIO 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 o
- Acetabular reaming during total hip arthoplasty (THA) o
The main platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, drill system, and a robotic arm. The system's architecture is designed to support two main surgical applications: knee procedures (per the predicate device K081867) and hip procedures (per RIO-Hip described in this 510(k) submission). 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. The robotic arm, once configured for a specific application (knee or hip), 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 describes the 510(k) summary for the MAKO Surgical Corp.'s Robotic Arm Interactive Orthopedic System - Hip (RIO-Hip). It indicates that performance data was collected but primarily focuses on claiming substantial equivalence to predicate devices rather than detailing specific acceptance criteria and a comprehensive study report with quantified performance metrics.
Based on the provided text, here is the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| System Accuracy & Functionality | Satisfy all required acceptance criteria for setup, registration, and overall accuracy and functionality in supporting acetabular reaming during THA. | "The results of these tests satisfied all required acceptance criteria and were found to support substantial equivalence of the RIO-Hip to the predicate devices." (No specific numerical performance metrics are provided). |
| Intended Use Validation | Validate the system's intended use with cadaveric material by evaluating postoperative x-rays. | "Further testing was performed with RIO-Hip using cadaveric material where postoperative x-rays were obtained and evaluated in order to validate the system's intended use. The results... were found to support substantial equivalence of the RIO-Hip to the predicate devices." (No specific numerical performance metrics or validation criteria are provided). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set:
- Sawbone Models: Used for "system level verification testing" to evaluate setup, registration, and overall accuracy/functionality. The specific number of sawbone models is not provided.
- Cadaveric Material: Used for "further testing" to validate the system's intended use. The specific number of cadaveric specimens is not provided.
- Data Provenance: The studies were conducted in a laboratory setting by MAKO Surgical Corp. The country of origin is not explicitly stated but can be inferred as the USA (Florida) where the company is located. The studies appear to be prospective in nature, as they were conducted specifically for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test set. The validation for the cadaveric study involved evaluating "postoperative x-rays," but it doesn't specify who performed this evaluation or what their qualifications were.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method for the test set, such as 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. No information is provided about human readers improving with or without AI assistance, as the device is a robotic arm system for surgical assistance, not an AI for image interpretation or diagnosis.
6. Standalone Performance Study (Algorithm Only):
Yes, a standalone performance study was done for the device. The "System level verification testing" with sawbone models and "further testing" with cadaveric material directly assessed the performance of the RIO-Hip system. The description "algorithm only" is a bit of a misnomer here, as the device is an interactive robotic system, not just a diagnostic algorithm. However, its accuracy and functionality were tested independently of additional human interpretation in these studies.
7. Type of Ground Truth Used:
- Sawbone Models: The ground truth would have been based on the engineered specifications and known anatomical landmarks of the sawbone models, likely established through precise measurements and design data.
- Cadaveric Material: The ground truth for the cadaveric study would likely have been established through detailed anatomical measurements/assessments against established surgical goals and possibly validated by an expert (though not explicitly stated in the document). The "postoperative x-rays" were used for evaluation, implying a comparison against an expected or desired outcome.
8. Sample Size for the Training Set:
The document does not provide any information regarding a training set or its sample size. The focus is on validation testing rather than AI model training data.
9. How the Ground Truth for the Training Set Was Established:
As no information about a training set is provided, there is no information on how its ground truth 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).