(87 days)
The Operativ Navigation Pin is indicated for use as temporary fixation pin to attach an orthopedic stereotaxic tracker holder to bone which allows the tracker to be referenced by the computer during a total knee arthroplasty.
The Navigation Pin is a partially threaded stainless steel (ASTM F138-08) pin with lengths of 100mm and 150mm. It has a diameter of 3mm. The Navigation Pins are driven into bone using a drill and collet driver. The pins hold the Stryker Navigation OrthoLock stereotaxic accessory device (6007-003-000) in place during a computer navigated total knee replacement. The Navigation Pins are placed in the distal femur and proximal tibia. Two pins are used for each Stryker Navigation OrthoLock stereotaxic accessory device (6007-003-000), one device for the femur and one for the tibia. The Navigation Pins are removed once the total knee replacement is completed. They are not meant for implanting.
This document describes the Navigation Pin by Operativ. The 510(k) summary focuses primarily on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance results for the Navigation Pin itself. The device is a sterile, single-use, partially threaded stainless steel pin designed for temporary fixation of an orthopedic stereotaxic tracker holder to bone during computer-navigated total knee replacement surgery.
Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in the provided text.
Here's an analysis based on the given information:
1. Table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with reported device performance metrics in the way one would expect for a diagnostic or AI device study. The entire submission is built around demonstrating substantial equivalence to a predicate device, Zimmer CAS Fixation Pins (K100599), based on material, design, and intended use.
The "performance" is implicitly deemed acceptable if it matches the predicate device. The key characteristics compared are:
| Feature | Navigation Pin (Operativ) | Predicate Device (Zimmer CAS Fixation Pins, K100599) |
|---|---|---|
| Material | Partially threaded stainless steel (ASTM F138-08) | Partially threaded stainless steel (ASTM F138-08) |
| Diameter | 3mm | 3.2mm |
| Lengths | 100mm, 150mm | 80mm, 150mm |
| Insertion Method | Driven into bone using a drill and collet driver | Same technique |
| Location | Distal femur and proximal tibia | Distal femur and medial proximal tibia |
| Function/Intended Use | Hold Stryker Navigation OrthoLock stereotaxic accessory device during total knee replacement | Hold proprietary stereotaxic device during total knee replacement |
| Fixation Mechanism | Threads act like a screw, driven into both sides of cortical bone | Threads act like a screw, driven into both sides of cortical bone |
| Removal | Removed once total knee replacement is completed | Removed once total knee replacement is completed |
The "acceptance criteria" here are essentially the demonstration that the Operativ Navigation Pin is acceptably similar to the predicate device in terms of material, design, and intended use, and that any differences (such as slight variations in diameter and length) do not raise new questions of safety or effectiveness. No specific quantitative performance metrics (e.g., pull-out strength, bending stiffness) or thresholds are mentioned as "acceptance criteria" with corresponding "reported performance."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the document. This is a medical device 510(k) submission, not a study involving a test set of data points or images for a diagnostic algorithm. The "test" for this device involved comparing its physical and functional characteristics to a legally marketed predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. "Ground truth" in the context of this 510(k) submission refers to the established safety and efficacy of the predicate device, which is assumed to be true based on its prior market clearance. There were no human experts evaluating a "test set" in the context of ground truth for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. No adjudication method was used as there was no test set of data requiring expert consensus or review.
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
This information is not applicable and not provided. An MRMC study is relevant for diagnostic imaging devices often involving AI. The Navigation Pin is a mechanical fixation pin, not a diagnostic or AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a physical pin, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" is typically the established safety and effectiveness of the legally marketed predicate device. The manufacturer demonstrated that their device is substantially equivalent to this predicate based on material, design, and intended use. There is no external "ground truth" established through clinical data, pathology, or outcomes specifically for the Navigation Pin outside of its comparison to the predicate.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" for a physical medical device like this pin. This concept is relevant for AI/ML algorithms.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there is no training set, there is no ground truth established for it.
§ 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).