(77 days)
The Navitrack® System – OS Knee Universal is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intraoperatively. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.
Identically as in the predicates, the Navitrack System - OS Knee Universal device consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Knee Replacement (TKR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to each of the femur and tibia, such to allow the ability to track and display to the user their respective positions intra-operatively. The femur and tibia are displayed to the user in the form of their main alignment axes. The alignment axes are determined and recorded intraoperatively by identifying the key anatomical references that are used clinically to align and position the TKR components. The instruments are schematically represented. The main modifications to the predicates are to incorporate a new set of instruments with universal implant instrument interface features along with corresponding software changes such that the application can be compatible to track a variety of TKR implant lines.
The provided text describes the Navitrack® System - OS Knee Universal and its substantial equivalence to predicate devices, but it does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria.
The document states: "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicates." However, it does not provide the results of these tests, the specific metrics used, or the thresholds for "adequate" performance.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicates." (No specific metrics or numbers provided.) |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: Not specified.
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)
- Not applicable as the document does not describe a clinical study with expert ground truth establishment. The "non-clinical tests" likely refer to bench testing or simulation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable.
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
- No MRMC study was described. The device is a navigation system, not an AI diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document mentions "non-clinical tests" to verify accuracy and performance "adequate for its intended use and not reduced in comparison to the predicates." This implies standalone testing of the system's accuracy, but no details of the test or results are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. For non-clinical tests of a navigation system, ground truth would likely involve highly precise measurement instruments (e.g., coordinate measuring machines, optical tracking systems with known accuracy) to establish the true position/orientation of anatomical landmarks or instruments.
8. The sample size for the training set
- The document does not describe a machine learning model that would require a "training set" in the typical sense. This device is a computer-assisted surgical navigation system based on established principles of optical tracking and anatomical landmark registration, not a deep learning model requiring vast training data.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).