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The Medical Biopsy Automatic Cutting Needle is intended for use in obtaining samples of tissues or lesions.
Medical Biopsy's Automatic Biopsy Needle is intended for use in obtaining samples of tissues or lesions from the Breast, Kidney, Prostate and Liver.

Device Description

The Medical Biopsy Automatic Cutting Needle is a two-piece design consisting of a cannula and an obturator (stylet). The needles are made of 304 Stainless Steel. Etched markings have been incorporated along the shaft of both the cannula and the obturator, at intervals of 1cm, to guide depth of insertion. The distal end of the stylet is notched for tissue retention. The proximal end of the Automatic Cutting Needle incorporates a plastic fitting for attachment to the "gun" portion of the Biopsy System, which houses, guides and manipulates the Automatic Cutting Needle during use. This "gun" component is sold separately by another company and is not covered within this 510(k) Premarket Notification.

AI/ML Overview

This document is a 510(k) summary for the Medical Biopsy Automatic Cutting Needle, intended for use in obtaining tissue samples. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria, device performance studies, or ground truth establishment in the context of AI/ML evaluation.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what information could and could not be extracted:

Acceptance Criteria and Study Details

Information Item	Found in Document
1. Table of acceptance criteria and reported device performance	Not found. The document is a 510(k) summary demonstrating substantial equivalence to a predicate device (Manan Pro-Mag Automatic Biopsy Device). It lists characteristics (two-piece design, intended use, sizes, material, etched markings) that are similar to the predicate device but does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or report quantitative device performance data against such criteria.
2. Sample size used for the test set and data provenance	Not found. The document does not describe any clinical study or test set for evaluating the device's performance against specific criteria. It only references a predicate device for comparison of characteristics.
3. Number of experts used to establish ground truth and their qualifications	Not found. No ground truth establishment is described as there's no performance study detailed.
4. Adjudication method for the test set	Not found. No test set or adjudication method is mentioned.
5. MRMC comparative effectiveness study and effect size	Not found. This document predates common AI/ML applications in medical devices and does not describe any AI/ML components or MRMC studies.
6. Standalone performance study (algorithm only)	Not found. This document predates common AI/ML applications in medical devices and does not describe any AI/ML components or standalone algorithm performance.
7. Type of ground truth used	Not found. No ground truth is described.
8. Sample size for the training set	Not found. The device is a physical instrument, not an algorithm that requires a training set.
9. How the ground truth for the training set was established	Not found. The device is a physical instrument, not an algorithm that requires a training set.

Key takeaway from the document:

The 510(k) summary demonstrates that the Medical Biopsy Automatic Cutting Needle is substantially equivalent to the Manan Pro-Mag Automatic Biopsy Device (K914874) based on shared design characteristics, intended use, available sizes, materials, and features (etched markings). The document focuses on showing that the new device is as safe and effective as the predicate device without providing detailed performance metrics or clinical study data that would be typical for many AI/ML-driven device approvals today.

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