(30 days)
The Optical Tracking System (OTS) with Surface Matching Module is a graphical planning tool that allows for pre-operative and operative planning of cranial and spinal surgical procedures. The OTS with Surface Matching Module is indicated for use in cranial and spinal surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.
The OTS with Surface Matching Module is a graphical planning tool that allows for preoperative and operative planning of cranial and spinal surgical procedures. The Surface Matching Module offers an alternate method of registering the patient to their scans. The OTS with Surface Matching Module, addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available OTS, and Stealth Station Image-Guided Surgery System with SurfaceMerge registration option. Like the commercially available OTS, the OTS with Surface Matching Module offers the following functionality:
- Ability to plan frameless stereotactic surgical procedures from scanned images;
- Ability to plan stereotactic procedures performed with a Radionics CRW framed . system;
- . Display of image slices in 3D reconstructed space;
- Ability to display probe tip position in 2D and 3D displays;
- Ability to display "real-time" position of the probe in 2D image space;
- Ability to reconstruct oblique slices;
- . Use of Pointer (probe) as a Mouse to operate program.
The provided 510(k) summary for the "Optical Tracking System with Surface Matching Module" does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. Modern 510(k) submissions typically include more explicit performance data.
Based on the available text, here's what can be extracted and inferred, along with what is explicitly stated as not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states, "The RSA Surface Matching system testing rigorously tests the features of the software. The results of the testing indicate that the OTS with Surface Matching Module is safe and reliable for its intended use." However, specific numerical acceptance criteria (e.g., accuracy, precision thresholds) and the corresponding reported performance data are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "system testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The summary does not detail how ground truth was established for "system testing."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
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:
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. This device is an image-guided surgery system, not an AI for image interpretation by human readers. It's a tool for surgeons.
- Effect size of human improvement: Not applicable given the type of device and lack of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device is an "Optical Tracking System with Surface Matching Module," which is inherently designed for human-in-the-loop surgical guidance. Therefore, a standalone (algorithm only) performance assessment in the context of interpretation AI is not applicable or described for this type of device. Its "standalone" function would be its ability to accurately track and register, but specific metrics are not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The specific type of ground truth used for the "system testing" is not provided. For a tracking and registration system, ground truth might involve physical phantoms with known fiducial locations or highly accurate alternative measurement systems, but this is not detailed.
8. The sample size for the training set:
The term "training set" in the context of machine learning (AI) is not used, and no such details are provided. It's unlikely this device, from 1998, utilized a machine learning approach that would necessitate a "training set" in the modern sense. The "Surface Matching Module" likely uses classical image processing and registration algorithms.
9. How the ground truth for the training set was established:
As no training set (in the machine learning sense) is mentioned, this information is 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).