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Used for soft tissue biopsy through the accessory channel of an ultrasound endoscope.

The Wilson-Cook Modified Ultrasound Biopsy Needle is used for soft tissue biopsy through the accessory channel of an ultrasound endoscope. This device is supplied sterile and intended for single use only.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets criteria in the typical format of a modern performance study. Instead, it describes a "Special 510(k)" for a device modification, relying on substantial equivalence to predicate devices and internal design verification.

Here's an analysis based on the information provided, highlighting the absence of typical performance study data for AI devices:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." However, it does not quantify these acceptance criteria or the specific results. The criteria are likely related to mechanical function, dimensional accuracy, sterilization effectiveness, and biocompatibility, rather than diagnostic accuracy as would be seen with an AI device.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the provided text for a device's diagnostic performance. The document only generically confirms that internal design verification met pre-determined criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Design Verification" activities were conducted, including "dimensional and functional testing." However, it does not specify the sample size of devices or materials tested, nor does it provide information on the provenance of any data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to the type of device and study described. This is a biopsy needle, and the "ground truth" for its performance would be its ability to collect tissue, its mechanical integrity, and its biocompatibility, not a diagnostic interpretation that would require expert consensus.

4. Adjudication Method for the Test Set

Not applicable. There is no diagnostic "test set" in the context of expert adjudication for this medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices to assess how AI assistance impacts human reader performance. The device described is a physical biopsy needle, not an AI diagnostic tool.

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

No, a standalone performance study was not done. This concept is for AI algorithms, and the Wilson-Cook Ultrasound Biopsy Needle is a physical medical instrument.

7. The Type of Ground Truth Used

The ground truth implicitly used for this device's performance would be:

• Mechanical and Dimensional Specifications: Verification that the device's dimensions and mechanical properties (e.g., ability to cut, deploy, retract) meet engineering drawings and functional requirements.
• Biocompatibility Standards: Confirmation that the materials meet established biocompatibility requirements through testing and/or documented history of safe use.
• Sterility Testing: Verification that the device is sterile.

There is no mention of pathology, outcomes data, or expert consensus in relation to diagnostic performance, as the device's function is to obtain a biopsy, not to interpret it.

8. The Sample Size for the Training Set

Not applicable. This device is a physical instrument, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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