(90 days)
The Navitrack™ System is a stereotaxic instrument indicated for use in precisely positioning instruments or implants during orthopedic surgery, such as operation perform within spinal structures.
The main components of the Navitrack™ system are: Computer Workstation and device display, Localization System, and Tools and instruments. The computer workstation runs the software and is linked to position sensors fixed on surgical tools. The localization system consists of a Position Sensor Unit (Magnetic Field Digitizer) and the Navitrack™ Software, using electromagnetic transmitters and receivers to measure six degrees of freedom for tool position and attitude. Electromagnetic receivers are fixed to surgical tools, and a positioning sensor on a reference clamp is attached to the bone to be instrumented to follow bone structure movements.
The provided text describes the Navitrack™ Computer-Assisted Surgery System and its 510(k) submission. However, it does not contain specific details about acceptance criteria, the study design, sample sizes, ground truth establishment, or expert qualifications as requested. The document states that "Performance tests were done on the Navitrack™ System. These tests along with clinical studies demonstrate that the Navitrack™ System is safe and accurate in performing the stated intended use. The results of those tests and studies are attached to this submission," but the attached results are not included in the provided text.
Therefore, I cannot provide the detailed information requested in the format of a table or specific answers to most of the questions using only the provided text.
Based on the available text, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance:
- This information is not explicitly provided in the given text. The document states that "Performance tests were done on the Navitrack™ System" and that these tests "demonstrate that the Navitrack™ System is safe and accurate in performing the stated intended use," but no specific criteria or quantitative performance metrics are listed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the given text.
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 provided in the given text. The study mentions "clinical studies" but no details on expert involvement or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the given text.
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:
- The document describes the Navitrack™ System as a "Computer-Assisted Surgery System" and a "stereotaxic instrument" that "enables the surgeon to review radiology images... This system also enables the surgeon to virtually manipulate bone structures... in order to perform pre-operative planning." While it's a computer-assisted system, there is no mention of an MRMC study, "human readers," or "AI" in the context of the requested comparative effectiveness study. The term "AI" itself was not commonly used in regulatory submissions in 1998 in the same way it is today for specific performance evaluations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is described as assisting the surgeon by "virtually displaying simultaneously the surgical tools and the structure of interest." This implies a human-in-the-loop system. The text doesn't specify if a standalone performance evaluation of the "algorithm only" was conducted. Given the nature of a computer-assisted surgery system, standalone performance without a surgeon would likely be irrelevant or not the primary evaluation metric.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not provided in the given text. The document refers to "clinical studies" but does not detail how ground truth was established within those studies.
8. The sample size for the training set:
- This information is not provided in the given text. The document does not discuss a "training set" in the context of "AI" or machine learning algorithms, which is generally associated with such terminology.
9. How the ground truth for the training set was established:
- This information is not provided in the given text.
§ 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).