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The SNT DISPOSABLE BIOPSY NEEDLE is intended to be used for stereotaxic biopsy of brain tissue. This needle is only intended for use with the StealthStation™ Image Guided Surgery System and it's rigid needle guide holder. The biopsy needle is supplied sterile and is intended for single use only.

The SNT DISPOSABLE BIOPSY NEEDLE is intended to be used for stereotaxic biopsy of brain tissue. This needle is only intended for use with the StealthStation™ Image Guided Surgery System and it's rigid needle guide holder.

This document, K971247, is a 510(k) summary for a SNT Disposable Biopsy Needle, which was cleared on June 16, 1997. It describes the device's intended use and claims substantial equivalence to existing devices.

The information provided does not contain acceptance criteria or study data demonstrating device performance in the typical sense of quantitative metrics like sensitivity, specificity, or accuracy. This is a premarket notification for a medical device (a biopsy needle), not a diagnostic algorithm.

Based on the provided text, here’s an analysis of the requested information:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the given text. For mechanical devices like a biopsy needle, acceptance criteria would typically relate to physical properties, sterility, and functional performance (e.g., sharpness, tissue acquisition capability, compatibility with the guided system). The summary focuses on establishing equivalence rather than presenting performance data against specific criteria.

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

This information is not provided. As this is a biopsy needle, "test set" in the context of diagnostic algorithms does not apply. Testing for a medical device like this would involve mechanical, biocompatibility, and perhaps animal or cadaver studies, but no details of such studies or their sample sizes are mentioned.

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 and is not applicable to this type of device submission. Ground truth, in the context of diagnostic performance, is not discussed here.

4. Adjudication method for the test set

This information is not provided and is not applicable to this type of device submission.

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

This information is not provided and is not applicable. The device is a physical biopsy needle, not an AI-assisted diagnostic tool.

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

This information is not provided and is not applicable. The device is a physical biopsy needle, not a standalone algorithm.

7. The type of ground truth used

This information is not provided and is not applicable in the context of diagnostic ground truth. For a biopsy needle, relevant "ground truth" might pertain to successful tissue acquisition (verified by pathology) or accurate targeting (verified by imaging/histology), but no such studies are described.

8. The sample size for the training set

This information is not provided and is not applicable to this type of device submission. The concept of a "training set" applies to machine learning algorithms.

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

This information is not provided and is not applicable.

Summary of Device and Equivalence Claim:

• Device Name: SNT DISPOSABLE BIOPSY NEEDLE
• Intended Use: Stereotaxic biopsy of brain tissue, only for use with the StealthStation™ Image Guided Surgery System and its rigid needle guide holder. Supplied sterile and single-use.
• Predicate Device: Stereotatic biopsy needle manufactured by RADIONICS (used in their Nashold Biopsy Needle Kit).
• Key Difference from Predicate: The SNT needle uses an LED tracked by the STEALTHSTATION™ system for guidance, whereas the RADIONICS device uses stereotactic coordinates dialed into a guide holder on a headframe.
• Equivalence Claim: The SNT DISPOSABLE BIOPSY NEEDLE was claimed to be substantially equivalent to the RADIONICS needle and several other commercially available biopsy needles. A comparison was provided to support this claim.

Conclusion:

The provided 510(k) summary focuses on establishing substantial equivalence for a physical medical device (a biopsy needle) by comparing its features and intended use to existing, legally marketed devices. It does not include performance data or acceptance criteria that would typically be found in submissions for diagnostic AI algorithms, which are the context of the questions asked. Therefore, most of the requested information is not present in this document.

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