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The Manan Techna-Cut biopsy needle is intended for use in obtaining biopsy material from tissues such as the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.

The Manan Techna-Cut biopsy needle is a cutting biopsy needle based upon the Menghini cutting tip geometry. A syringe is included with the syringe used is a locking syringe. The Manan Techna-Cut biopey needle is intended for use in obtaining biopsy material from tissues such as the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.

The provided text does not contain detailed information about the acceptance criteria or a study that specifically proves the device meets those criteria for the Manan™ Techna-Cut Biopsy Needle. The 510(k) summary focuses on establishing substantial equivalence to a predicate device (Manan Medical Products Techna-Cut Biopsy Needle, K943651).

The information provided is primarily for regulatory clearance based on substantial equivalence, which often relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than explicit performance acceptance criteria from a specific study.

Therefore, many of the requested fields cannot be filled based on the given document.

Here's an attempt to extract and infer information, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated in the document. Substantial equivalence for this type of device typically implies that its performance (e.g., ability to obtain biopsy material, safety profile) is comparable to the predicate device.

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

Not specified. The 510(k) summary does not describe a new clinical or performance study with a distinct test set. Substantial equivalence is often based on design similarities, materials, and intended use as compared to the predicate device.

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

Not applicable, as no specific test set requiring expert ground truth is described in the provided document.

4. Adjudication method for the test set

Not applicable, as no specific test set requiring adjudication is described in the provided document.

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

Not applicable. This device is a biopsy needle, not an AI-assisted diagnostic tool, and the document does not mention any MRMC studies or AI involvement.

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

Not applicable. This device is a biopsy needle, not an algorithm.

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

Not explicitly stated. For a reusable surgical instrument like a biopsy needle cleared via 510(k), ground truth often relates to successful tissue acquisition and histological analysis to confirm the presence of viable tissue, and clinical outcomes for safety. The document implies that the device's ability to obtain biopsy material from specified tissues is central, suggesting that histological confirmation would be the ultimate ground truth in any performance evaluation.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is a physical medical device, not a machine learning model.

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

Not applicable.

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