(139 days)
Zimmer Knee Ortho Guidance Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any knee orthopedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example orthopedic procedures for these instruments include, but are not limited to: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty (Primary and Revision) Minimally Invasive Knee Orthopedic Procedures
This submission is for Zimmer orthopedic manual knee instruments modified to accept an Medtronic Image Guidance System (IGS) array and to be used with the Medtronic StealthStation® System
Here's an analysis of the provided 510(k) summary for the Zimmer Ortho Guidance Systems - Knee Instruments:
The provided document describes a 510(k) premarket notification for Zimmer Ortho Guidance Systems - Knee Instruments. These instruments are accessories intended to be used with the Medtronic StealthStation® Image Guidance System.
Based on the information provided in the 510(k) summary, the device is a manual knee instrument modified to accept an Medtronic Image Guidance System (IGS) array. This is not an AI/ML powered device, therefore, many of the requested criteria related to AI/ML device studies (such as MRMC studies, stand-alone performance, training set details, and expert ground truth establishment for AI performance) are not applicable.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Substantial Equivalence:
The primary acceptance criteria for this 510(k) submission was to demonstrate substantial equivalence to a legally marketed predicate device. This involved showing that the new device has the same intended use, similar technological characteristics, and does not raise different questions of safety and effectiveness compared to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | "Zimmer Knee Ortho Guidance Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any knee orthopedic medical condition in which the use of stereotaxic surgery may be appropriate... Example orthopedic procedures for these instruments include, but are not limited to: Total Knee Arthroplasty (Primary and Revision), Unicompartmental Knee Arthroplasty (Primary and Revision), Minimally Invasive Knee Orthopedic Procedures." |
The document states: "Both the predicate and proposed devices are indicated for use with Image Guidance Surgery systems. Both are accessory instruments." |
| Technological Characteristics (Material, Design, Energy, Performance, etc.) | The device is described as "Zimmer orthopedic manual knee instruments modified to accept an Medtronic Image Guidance System (IGS) array and to be used with the Medtronic StealthStation® System." The document implies that the core function of the knee instrument remains the same, with the modification being its compatibility with the image guidance system. |
| Safety & Effectiveness | No specific performance metrics for safety or effectiveness are provided, as the submission relies on substantial equivalence and the predicate's established performance. The document states: "No testing was needed for these devices. QSR validation and verification will be conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems." And "Clinical data and conclusions were not needed for these devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable (N/A): No formal test set, clinical data, or performance studies are described in this 510(k) summary for the device itself. The submission states, "No testing was needed for these devices." and "Clinical data and conclusions were not needed for these devices." This indicates that the substantial equivalence was based on design comparison and intended use, rather than a performance study requiring a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable (N/A): As no test set performance study was conducted, there were no experts required for ground truth establishment.
4. Adjudication Method for the Test Set
- Not Applicable (N/A): No test set performance study was conducted.
5. If an MRMC Comparative Effectiveness Study was Done
- No: This is not an AI/ML device, and no MRMC study was described. The device is a physical surgical instrument.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
- No: This is not an AI/ML algorithm; it is a surgical instrument. Therefore, a standalone algorithm performance study is not relevant or applicable.
7. The Type of Ground Truth Used
- Not Applicable (N/A): No ground truth was established for device performance as part of this 510(k) submission. The FDA cleared the device based on substantial equivalence to the predicate device (Catheter Introducer for the StealthStation System, K022126). The "ground truth" for clearance was the established safety and effectiveness of the predicate device in conjunction with the image guidance system.
8. The Sample Size for the Training Set
- Not Applicable (N/A): There is no AI/ML component described, therefore no training set was used.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable (N/A): There is no AI/ML component described, therefore no training set or associated ground truth establishment process.
In summary, the 510(k) for the Zimmer Ortho Guidance Systems - Knee Instruments relied on demonstrating substantial equivalence to a predicate device rather than conducting new performance studies. Therefore, most of the detailed questions regarding study design, sample sizes, and ground truth establishment (which are common for AI/ML or novel device performance studies) are not applicable in this context.
§ 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).