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This device is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal and extramural lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.

The EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) is an endoscopic ultrasound needle consisting of a needle assembly and syringe. The needle assembly is comprised of a handle, sheath, stylet and needle cannula. This device is available in one 22Ga needle size.

Here's a breakdown of the acceptance criteria and the study information for the EchoTip® AcuCore™ Ultrasound Biopsy Needle, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: It's important to note that the document extensively references "acceptance criteria" but rarely provides specific quantitative values for these criteria. It generally states that "All test articles met the acceptance criteria" or "meets the relevant acceptance criteria."

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

• Test Set Sample Size: The document does not specify the exact sample sizes for each non-clinical test. It refers to "All test articles" meeting the acceptance criteria, suggesting a finite number of devices were tested for each performance characteristic.
• Data Provenance: The studies were retrospective in the sense that they were conducted by the manufacturer (Cook Ireland Ltd.) for regulatory submission to demonstrate substantial equivalence. The data is from internal testing (Cook), rather than from external clinical trials on human subjects. The country of origin for the manufacturing and potentially the testing is Ireland, as indicated by "Cook Ireland Ltd."

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

• Not Applicable. The document describes non-clinical performance testing (e.g., puncture force, suction) and simulated use testing in a laboratory setting. There is no mention of a "test set" requiring expert ground truth establishment in the context of diagnostic accuracy, as this is a medical device for biopsy, not an AI or diagnostic imaging system. Therefore, no experts were used for this purpose in this context.

4. Adjudication Method for the Test Set:

• Not Applicable. As the performance testing is non-clinical and objective (e.g., measuring force, length), an adjudication method (like 2+1 or 3+1 used for expert discrepancies) is not relevant. The results are based on direct measurements and pre-defined acceptance thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or AI systems where human readers interpret medical images/data, and the AI's impact on their performance (with vs. without AI assistance) is evaluated. The EchoTip® AcuCore™ is a physical biopsy needle, and its performance is assessed through mechanical, functional, and simulated use testing, not through human reader interpretation of data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not Applicable. This question typically pertains to AI algorithms. The EchoTip® AcuCore™ is a physical medical device (biopsy needle), not an algorithm, so the concept of "standalone performance" in this context is not relevant. The device's performance is inherently tied to its use by a human clinician.

7. The Type of Ground Truth Used:

• The "ground truth" for the non-clinical tests was established by engineering specifications, material science standards, and established physical performance benchmarks. For example, the puncture test would have a "ground truth" derived from target tissue models (e.g., worst-case material representative of liver and pancreatic tissue) and measured force, while the extension length test would have a "ground truth" based on the design specifications and measurements. Biocompatibility relies on established regulatory standards and biological testing outcomes.
• For the "Indications for Use" change, the "ground truth" for the justification essentially relies on alignment with market standards (other cleared devices like Boston Scientific's Acquire) and the fact that procedural steps/risks were not identified as new by the internal quality system.

8. The Sample Size for the Training Set:

• Not Applicable. This question is relevant for machine learning algorithms. The EchoTip® AcuCore™ is a physical medical device and does not involve AI or machine learning, so there is no "training set."

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

• Not Applicable. As there is no training set for this device, the question of how its ground truth was established is not relevant.

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The Endoscopic Ultrasound Aspiration Needle is designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope in adult patients only.

The proposed Endoscopic Ultrasound Aspiration Needle is a sterile single-use device, designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope.

It consists of three parts, Aspiration Needle, Syringe and Stopcock. The aspiration needle is offered with multiple types with different dimension, needle tip design and needle material. Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample.

There are 12 specifications, the difference is the diameter, material and tip design of needle.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10t and placed in a sterility maintenance package to ensure a shelf life of 2 years.

This document is a 510(k) summary for the Endoscopic Ultrasound Aspiration Needle, which is a medical device. It does not contain information about the acceptance criteria or a study proving the device meets performance criteria for an AI/ML powered device. The document focuses on regulatory approval for this specific type of medical device by demonstrating substantial equivalence to predicate devices, not on proving performance through specific metrics associated with AI/ML.

Therefore, I cannot provide the requested information. The document does not describe:

• Acceptance criteria in terms of AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
• A study that proves the device meets such acceptance criteria.
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth types related to an AI/ML algorithm.
• Training set sample size or how ground truth for a training set was established.

This document describes a traditional medical device approval process based on comparison to existing legally marketed devices, not an AI/ML product.

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