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The BL Navigated Biopsy Needle is indicated for stereotactic biopsy of cranial tissue using BrainLab AG's VectorVision navigation system. The Navigated Biopsy Needle is a pre-sterilized, single-use, side-cutting needle where the cutting action is achieved by rotation of an inner cannula within an outer cannula.

BL Navigated Biopsy Needle contains a calibrated biopsy cannula that is used with a compatible image guided surgery navigation system in stereotactic biopsy of cranial tissue. The device is compatible with specified BrainLab navigation systems (see intended use section below). Like the predicate device, the BL Navigated Biopsy Needle is a pre-sterilized, single-use, stainless steel device and uses a side-cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula.

BL Navigated Biopsy Needle's components include a navigable biopsy cannula, a biopsy cannula stop with screw, a stop adjustment tool and an aspiration tube.

The provided text describes a 510(k) premarket notification for the "Navigable Brain Biopsy Cannula Set" (K140705). This document focuses on demonstrating substantial equivalence to predicate devices, rather than on a study proving the device meets specific acceptance criteria in the context of AI/algorithm performance. The device described is a physical medical instrument (a biopsy needle), not an AI or software-based device.

Therefore, many of the requested criteria about AI/algorithm performance studies (e.g., sample size for AI test/training sets, ground truth establishment for AI, MRMC studies for AI, standalone AI performance) are not applicable to the information contained in this 510(k) summary.

However, I can extract the relevant information regarding the performance testing conducted for this physical device.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical "acceptance criteria" for the performance tests in a table format, nor does it provide quantitative performance metrics beyond confirming the tests were conducted and the device "performs as intended."

Reported Device Performance:

• Tissue extraction testing: Verified the ability of the device to sample tissue.
• Navigation testing: Verified compatibility and accuracy with specified navigation systems (BrainLab AG's VectorVision navigation system).
• Real-time shelf life testing: Verified no change in visual attributes, dimensional characteristics, or tensile strength after 5 years of real-time storage.
• Biocompatibility testing:
  • Cytotoxicity: Performed in accordance with ISO 10993-5.
  • Pyrogen Testing: Performed in accordance with ANSI/AAMI ST72:2011.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any of the performance tests (tissue extraction, navigation, shelf life, or biocompatibility).
• Data Provenance: Not specified. These appear to be bench tests, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. The ground truth for this physical device's performance tests would be based on objective measurements and established standards (e.g., tissue presence in a sample, accurate navigation tracking, material integrity, biocompatibility standards), not expert consensus on images or interpretations.

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

• Not applicable for the type of bench testing 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

• No, an MRMC study was not done. This device is a physical biopsy cannula, not an AI or software diagnostic tool, so such a study is not relevant.

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

• No, a standalone algorithm performance study was not done. This device is a physical biopsy cannula.

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

• Tissue extraction testing: The ground truth would likely be the physical presence and integrity of the tissue sample obtained.
• Navigation testing: The ground truth would be the known, actual position or trajectory of the cannula compared to the system's displayed position, verified through metrology or other accurate measurement methods.
• Shelf life testing: Ground truth would be objective measurements of material properties (visual, dimensional, tensile strength) against baseline or established specifications.
• Biocompatibility testing: Ground truth is defined by the standards (ISO 10993-5, ANSI/AAMI ST72:2011) which specify thresholds for cytotoxicity and endotoxin levels.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI or machine learning algorithm requiring a training set.

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

• Not applicable. As above, this is a physical device, not an AI/ML algorithm.

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