(184 days)
The Restoris 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 Restoris 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.
Restoris PKA is an upgrade to the Tactile Guidance System v2.0, a.k.a RIO, which was cleared via K081867. The features of this application are to improve overall performance of the system in supporting unicondylar and/or patellofemoral knee replacement. Restoris PKA 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.
Restoris PKA 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 use with Restoris PKA, can serve as a surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with softwaredefined spatial boundaries.
Here's a breakdown of the acceptance criteria and study information for the Restoris Partial Knee Application (PKA) as described in the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document summarizes the testing and indicates that "All acceptance criteria were satisfied" or "The testing successfully met the acceptance criteria specified in the validation protocol." However, the specific quantitative acceptance criteria themselves are not explicitly listed in this summary document. The document focuses on the conclusion that the criteria were met.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Verification Testing | |
| Integration Verification | All acceptance criteria were satisfied; complete integration of Restoris PKA with RIO platform confirmed. |
| Registration Accuracy | All acceptance criteria were satisfied; successful bone registration using Restoris PKA was confirmed. |
| Validation Testing | |
| Usability (Simulated-use) | Acceptance criteria were met; confirmed that Restoris PKA and RIO platform meet user needs. |
| Overall System Performance | The testing successfully met the acceptance criteria specified in the validation protocol; further confirmed meeting user needs. |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Verification Testing (Integration & Registration):
- Sample Size: Sawbone models were used for both the integration and registration verification tests. The exact number of sawbone models is not specified.
- Data Provenance: Retrospective (synthetic models).
-
Validation Testing (Usability):
- Sample Size: Two (2) cadaveric specimens were used.
- Data Provenance: Prospective (cadaveric specimens).
-
Validation Testing (Overall System Performance):
- Sample Size: Three (3) cadaveric specimens were used.
- Data Provenance: Prospective (cadaveric specimens).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Verification Testing: Not applicable, as testing was against predefined system specifications or expected outcomes.
- Validation Testing (Usability): Three (3) users participated in completing the procedure. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not explicitly stated. They are generally referred to as "users," implying they are likely surgeons or trained medical professionals using the device in a simulated environment.
- Validation Testing (Overall System Performance): One surgeon performed the procedure, and four (4) independent reviewers assessed the outcome. The specific qualifications of these surgeons/reviewers are not explicitly stated.
4. Adjudication Method for the Test Set
- Verification Testing: Not applicable, as outcomes were likely assessed against objective technical specifications.
- Validation Testing (Usability): The method of adjudication for the "acceptance criteria" being met is not detailed beyond the conclusion that they were met. It's implied to be based on the experience of the 3 users.
- Validation Testing (Overall System Performance): One surgeon performed the procedure, and four (4) independent reviewers assessed it. The specific adjudication method among the four reviewers (e.g., 2+1, 3+1, simple majority) is not specified. It just states they independently reviewed the procedure.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- A MRMC comparative effectiveness study, comparing human readers with and without AI assistance, was not explicitly described in this 510(k) summary. The studies described focus on the device's performance in guiding a surgeon directly during a procedure, not on a diagnostic reading task. The device assists the surgeon rather than providing interpretations for readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, in part. The Verification Testing for "registration with the Restoris PKA satisfies the specified accuracy requirements" using "the software's improved bone model imaging algorithm" can be considered a form of standalone testing for a specific algorithmic component (registration accuracy). However, the overall device (Restoris PKA) is intended for human-in-the-loop surgical assistance, so the primary validation is in that context.
7. The Type of Ground Truth Used
- Verification Testing (Integration & Registration): The ground truth was likely based on pre-defined engineering or system specifications and benchmarks for integration functionality and accuracy of registration.
- Validation Testing (Usability & Overall System Performance): The ground truth for these cadaveric studies would be the successful and accurate completion of the simulated surgical procedure as assessed by the participating surgeons/reviewers against clinical standards and the stated "needs of the user" for unicondylar and/or patellofemoral knee replacement. This is a form of expert assessment of procedural correctness and outcome.
8. The Sample Size for the Training Set
- The 510(k) summary does not provide any information regarding a specific training set or its sample size for the Restoris PKA. This document describes verification and validation testing, not the development or training of an AI model in the conventional sense. The device "assists a surgeon with presurgical planning and interpretive/intraoperative navigation" using "patient CT data," implying it's a guidance system built upon established biomechanical models and image processing, rather than a deep learning model requiring a distinct training dataset for its core function.
9. How the Ground Truth for the Training Set Was Established
- As no training set is described, there's no information on how its ground truth might have been 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).