(17 days)
The iMNS Medacta Navigation System is intended to be used to support the surgeon during specific orthopedic surgical procedures by providing information on bone resections, instrument and implant positioning during joint replacement.
The iMNS Medacta Navigation System provides computer assistance to the surgeon based on anatomical landmarks and other specific data obtained intra-operatively that are used to place surgical instruments.
Examples of some surgical procedures include but are not limited to: Total Knee Replacement Minimally Invasive Total Knee Replacement
The iMNS Medacta Navigation System is a device for computer aided navigation of surgical instruments used in total knee replacement surgery. The system works on the common principle of stereotaxic technology in which passive markers are securely mounted on the patient's bones and an infrared camera is used to monitor the spatial location of those marker and and information is used to locate the anatomical landmarks such as centers of rotation of the femur head, knee and ankle intraoperatively. These measurements are displayed on a computer screen in real time. The instruments are then outfitted with the passive markers to improve the positioning of the cutting guides. The information from the system with the "navigated" instruments assists the surgeon in optimally conducting the bone resections and positioning of the orthopedic surgical implants. The surgeon maintains control of the surgery and makes any decisions required with regard to bone resections and implant positioning but the iMNS Medacta Navigation System provides real time support and information throughout the surgery.
The iMNS Medacta Navigation System consists of the following key components:
- . An acquisition system composed of two infrared cameras equipped with infrared light emitting diodes (LED) to track the position of the passive markers,
- . A computer running the proprietary Medacta software and a monitor,
- . Interface devices of a keyboard, foot pedal and optional mouse to control the system, and
- Manual reusable surgical instruments. .
The software application called Evolis Global Femur First is designed to work with Medacta's Evolis Total Knee System, cleared under K081023. The manual reusable surgical instruments include instruments specifically designed for navigated surgery and other standard surgical instruments needed to conduct total knee replacement.
The provided text describes performance testing for the iMNS Medacta Navigation System. However, it does not contain specific acceptance criteria, reported device performance metrics, or details about the study design that would allow for a comprehensive answer to all parts of your request.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "The testing met all acceptance criteria." |
Missing Information: Specific quantitative or qualitative acceptance criteria were not provided in the document. Therefore, actual reported performance metrics cannot be listed. The document only states that "all acceptance criteria" were met.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document refers to "simulated user setting" and "a surgeon," but no details on the number of cases or the nature of the data (retrospective/prospective, country of origin) are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "a surgeon" – implies at least one, but the exact number isn't quantified.
- Qualifications of Experts: Only "surgeon" is mentioned. Further specific qualifications (e.g., years of experience, subspecialty) are not provided.
4. Adjudication method for the test set:
- Adjudication Method: Not specified. With only "a surgeon" mentioned, it's unlikely a formal adjudication method like 2+1 or 3+1 was necessary or described for a single user evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This device is a navigation system for surgery, not an AI diagnostic tool involving human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The description emphasizes that the system "assists the surgeon" and "the surgeon maintains control." It provides "real-time support and information throughout the surgery." This strongly indicates that it is a human-in-the-loop system, and a standalone algorithm-only performance assessment would not be relevant or described as such.
7. The type of ground truth used:
- Type of Ground Truth: The context suggests that the ground truth for "design validation" was based on whether "the system meets user needs and intended uses" in a "simulated user setting." For a surgical navigation system, this would typically involve assessing the accuracy of anatomical landmarks, cutting guides, and implant positioning relative to surgical plans or anatomical references, often determined by the evaluating surgeon's assessment of surgical outcomes in the simulated environment. No pathology or outcomes data from actual patients are mentioned for this validation.
8. The sample size for the training set:
- Training Set Sample Size: Not specified. The document describes "design verification" and "design validation" but does not detail a separate "training set" for a machine learning model, as this is a computer-aided navigation system based on stereotaxic technology, not a deep learning AI model that requires extensive training data in the typical sense.
9. How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable/not specified, as the system does not appear to be a machine learning model that learns from a "training set" with established ground truth in the conventional sense. The system's functionality is based on established stereotaxic principles and proprietary software logic.
In summary, the provided document describes a computer-aided surgical navigation system and its regulatory clearance process. While it states that performance testing was conducted and all acceptance criteria were met, it lacks the detailed quantitative and qualitative results, study design specifics, sample sizes, and expert qualifications often found for AI/ML-based diagnostic devices. This is likely because the device is a navigation system based on established principles, rather than a machine learning algorithm requiring extensive data-driven validation for diagnostic accuracy.
§ 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).