(30 days)
Interactive, image-guided means of localizing targets in surgical procedures. OTS 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 above device consists of a software module that allows a variable focused microscope to be used with OTS. The position and trajectory of the microscope's focal point is tracked using light emitting diodes (LEDs) attached to the microscope and viewed by a camera array in conjunction with digital communications with the microscope.
The provided text is a 510(k) summary for the Radionics OTS Microscope Module II. This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain information about acceptance criteria, detailed study designs, or performance metrics that would typically be found in a clinical study report.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, the effect size: Not mentioned.
- If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, and this device is an accessory for an optical tracking system, not a standalone diagnostic algorithm.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Based on the provided text, the device is an accessory (software module) that allows a variable-focused microscope to be used with Radionics Optical Tracking System (OTS). Its clearance is based on substantial equivalence to previously cleared devices (Radionics Microscope Module I and Zeiss Surgical Microscope Navigator System), rather than a detailed clinical performance study with acceptance criteria.
The 510(k) summary focuses on:
- Device Name: Radionics OTS Microscope Module II
- Common Name: Intraoperative Guidance Device
- Classification Name: Stereotaxic instrument (accessory)
- Intended Use: Interactive, image-guided means of localizing targets in surgical procedures. Indicated for use in cranial and spinal surgical procedures where anatomical landmarks are not clearly visible or where a desired target is close to critical structures.
- Substantial Equivalence: To Radionics Microscope Module I (K981213) and Zeiss Surgical Microscope Navigator System (K965139).
- Technological Characteristics: The device consists of a software module that allows a variable focused microscope to be used with OTS. The position and trajectory of the microscope's focal point are tracked using LEDs attached to the microscope, viewed by a camera array, and communicated digitally with the microscope. The technological characteristics are stated to be the same or similar to those found with the predicate device.
To obtain the detailed study information you are asking for, you would typically need to review the full 510(k) submission, which is not provided, or associated clinical trial documentation if any were required for clearance.
§ 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).