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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:

2. Sample size used for the test set and the data provenance:

• The document describes non-clinical testing. It does not mention "test sets" in the context of patient data or clinical images.
• For dimensional analysis, navigational accuracy, and biocompatibility tests, the sample sizes are not specified within this document. These would typically involve a certain number of manufactured units or material samples.
• Data provenance (country of origin, retrospective/prospective) is not applicable in the context of these non-clinical, in-vitro/bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable. The "ground truth" for these non-clinical tests would be defined by engineering specifications (for dimensional/navigational accuracy) and established ISO/ASTM standards (for biocompatibility tests). There's no mention of human expert adjudication for these tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable, as there is no human adjudication described for these non-clinical tests.

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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not described or performed according to this FDA 510(k) summary. This device is a surgical navigation system component, not an AI-assisted diagnostic tool for image interpretation by human readers. The purpose of this submission was to introduce a titanium version of the Pointer tool and demonstrate its substantial equivalence through non-clinical testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a physical instrument (Pointer tool) used with a surgical navigation system, enabling human-in-the-loop guidance. It is not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the non-clinical tests:
  • Dimensional analysis: Engineering specifications (tolerances).
  • Navigational accuracy: Referencing known physical standards/measurements, aiming for accuracy "as accurate as the predicate device."
  • Biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Endotoxin): Established biological testing standards and acceptable limits defined by regulatory guidelines (e.g., ISO 10993 series).

8. The sample size for the training set:

• Not applicable. This document describes non-clinical testing of a physical device component, not the development or validation of an AI algorithm with training data.

9. How the ground truth for the training set was established:

• Not applicable, for the same reason as above.

Summary of what the document focuses on:

The document describes a 510(k) submission for a minor change (new material for a component) to an existing "Stereotaxic Instrument." The primary "study" is a set of non-clinical, bench and biocompatibility tests designed to demonstrate that the new titanium Pointer tool is substantially equivalent to previously cleared devices. This equivalence is based on similar design, dimensions, tracking mechanisms, reprocessing procedures, and importantly, acceptable performance in direct measurements (dimensional, navigational accuracy) and biocompatibility for the new material. The device itself is a surgical navigation tool, not an AI-based diagnostic or interpretative system intended to assist or enhance human reader performance in areas like image analysis.

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