(21 days)
The Optical Tracking System (OTS) is a graphical planning tool that allows for pre-operative and operative planning of cranial and spinal surgical procedures. The OTS is indicated for use in cranial and spinal surgical procedures in which anatomical structures are not clearly visible or where a desired target is close to critical regions. Examples of such procedures using OTS with the Non-Invasive DRF include, but are not limited to: Catheter shunt placement Craniotomies Tumor resections Skull lesioning Vascular malformations Various ENT procedures
The above device consists of a headband that secures a light array to the patient. When coupled with the OTS workstation, the device allows for preoperative and operative planning of surgical procedures through workstation images. The device allows a light array to be secured to a patient non-invasively. Like its Cranial DRF and Spinal DRF predicates it is intended to maintain registration of the system during surgical procedures.
The provided text describes a 510(k) summary for the Radionics Non-Invasive Dynamic Reference Frame (DRF) for use with Radionics Optical Tracking System (OTS), but it does not contain the specific details required to answer all parts of your request.
The document primarily focuses on establishing substantial equivalence to a predicate device and obtaining marketing clearance. It does not include a detailed study report with acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert qualifications for the new device.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Cannot be provided based on this document. The text states that the "technological characteristics are the same or similar to those found with the predicate device," implying that performance is expected to be similar, but no specific acceptance criteria or performance metrics for the new device are reported.
2. Sample size used for the test set and the data provenance:
- Cannot be provided based on this document. No test set or study details are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided based on this document. No ground truth establishment related to a test set is discussed.
4. Adjudication method for the test set:
- Cannot be provided based on this document. No test set or adjudication process is described.
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:
- Cannot be provided based on this document. This device is a hardware component (a headband securing a light array) for an intraoperative guidance system, not an AI-powered diagnostic or interpretive tool that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided based on this document. Again, this is a hardware device. The "algorithm" or "software" would be part of the Optical Tracking System (OTS), and its standalone performance is not detailed here. The focus is on the Non-Invasive DRF itself.
7. The type of ground truth used:
- Cannot be provided based on this document. No specific ground truth type is mentioned for any performance evaluation of this device.
8. The sample size for the training set:
- Cannot be provided based on this document. There is no mention of a "training set" as this is a hardware accessory, not a machine learning model.
9. How the ground truth for the training set was established:
- Cannot be provided based on this document. Not applicable for this type of device and information provided.
In summary: The provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence. It does not include the detailed scientific study results, performance data, or ground truth establishment information that would typically be found in a study report addressing acceptance criteria.
§ 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).