(120 days)
BrightMatter Guide is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The user should consult the "Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs.
The BrightMatter Pointer is intended to be used for anatomy palpation and as a pointing tool to enable spatial localization and identification by BrightMatter Guide navigational systems.
BrightMatter Guide is a planning and image guided surgical system that enables computer assisted surgery where use of stereotactic image guidance may be considered appropriate. The BrightMatter Pointer is a handheld passive instrument which can be used for anatomy palpation using its tip. This tool can be tracked using passive reflective markers in order for BrightMatter Guide to identify and spatially track its location. There are rigid features on the subject device where the markers (passive spheres) that reflect infrared (IR) signals can be attached. The markers are arranged in a unique pattern on the device so that the BrightMatter Guide can differentiate it from other instruments. The Pointer portion of the device is provided non sterile and requires steam sterilization before use. The passive reflective markers are single-use.
The BrightMatter Pointer is made of either titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) or 17-4 stainless steel conforming to ASTM A564 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.
The provided text describes a 510(k) premarket notification for a medical device called "BrightMatter Guide with BrightMatter Pointer." This document focuses on demonstrating the substantial equivalence of the new titanium version of the "Pointer tool" to previously cleared predicate devices. It outlines non-clinical testing performed to show this equivalence, rather than a clinical study establishing the device's efficacy against specific performance criteria for AI-assisted human reading.
Therefore, many of the requested details, such as those related to AI effectiveness studies, multi-reader multi-case studies, ground truth establishment for training and test sets, and sample sizes for training/test sets as they pertain to clinical performance, are not explicitly present in the provided document. The "acceptance criteria" discussed are primarily related to non-clinical performance and biocompatibility to prove substantial equivalence, not clinical efficacy or an improvement in human reader performance with AI.
Here's an attempt to extract and infer information based on the document, focusing on what is available regarding acceptance criteria and the non-clinical study:
Acceptance Criteria and Device Performance (Non-Clinical)
The document does not present clinical acceptance criteria for demonstrating improved diagnostic performance (e.g., sensitivity, specificity for a particular disease) or human reader performance. Instead, the acceptance criteria are focused on non-clinical performance and biocompatibility to prove substantial equivalence of a new material (titanium) for an existing device component (Pointer tool).
1. Table of Acceptance Criteria (Non-Clinical) and Reported Device Performance:
| Test | Purpose (Acceptance Criteria Implicit in Purpose) | Reported Performance / Results (Meets Acceptance) |
|---|---|---|
| Dimensional analysis | Comparison of measured dimensions to ensure tolerances are within acceptable limits. | Measurements found within acceptable tolerances. If outside tolerance, navigational accuracy testing was performed (implies acceptable accuracy maintained). |
| Navigational accuracy | Accuracy of navigational components evaluated to ensure performance of the system. | Accuracy testing demonstrated the subject device was as accurate as the predicate device. |
| Cytotoxicity | Cytotoxicity of the device evaluated to demonstrate biocompatibility. | Testing demonstrated the device is not cytotoxic. |
| Sensitization | Sensitization of the device evaluated to demonstrate biocompatibility. | Testing demonstrated the device is not sensitizing. |
| Irritation | Irritation of the device evaluated to demonstrate biocompatibility. | Testing demonstrated the device is not an irritant. |
| Pyrogenicity | Material mediated pyrogenicity evaluated to demonstrate the absence of a febrile response in an in vivo model. | Testing demonstrated the device is non-pyrogenic. |
| Endotoxin (LAL test) | Amount of gram negative bacteria evaluated to demonstrate endotoxin units are within acceptable limits. | Endotoxin units were found to be |
§ 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).