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This device is intended to be used with an ultrasound endoscope for delivery of injectable materials into tissues during endoscopic procedures and fine needle aspirations (FNA) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.

The Endoscopic Ultrasound Needle is offered in various needle gauges for injection or aspiration. This device is used in conjunction with an ultrasound endoscope to gain access to the target site. The needle which is dimpled for ultrasonic visualization is advanced into the target site for injection of therapeutic materials or aspiration. The device allows for adjustment of the length of the sheath and needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet to aid in inserting the needle which is removed for injection and aspiration. The device is supplied sterile and intended for single use only.

The provided document describes a 510(k) Summary for the Cook Endoscopy EchoTip Ultra Ultrasound Needle, submitted to the FDA in 2009. This document is a premarket notification for a medical device seeking to demonstrate substantial equivalence to previously cleared predicate devices. It largely focuses on the device's technical specifications, intended use, and its equivalence to other legally marketed devices, rather than a clinical study evaluating its performance against specific acceptance criteria.

Therefore, much of the requested information regarding detailed acceptance criteria, specific device performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from this document as it is not a clinical study report.

However, I can extract the following based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:

• "Performance testing performed under simulated use conditions demonstrates that the Endoscopic Ultrasound Needle met the performance requirements of the expanded indications for use."

This indicates that internal performance requirements were established and met under simulated conditions for the expanded indications. However, the specific acceptance criteria (e.g., minimum tensile strength, maximum deflection, aspiration efficiency, injection rate) and the numerical results for these criteria are not provided in this summary. The "reported device performance" is a general statement of compliance.

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

• Sample Size for Test Set: Not specified. The document mentions "performance testing," but does not provide details on the number of devices or simulated scenarios tested.
• Data Provenance: The testing was "performed under simulated use conditions," implying laboratory or bench testing rather than clinical data. No country of origin is specified for the simulated use data, nor is it explicitly stated as retrospective or prospective (though simulated testing is inherently prospective in its design).

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

• Not applicable. This document describes simulated performance testing, not a clinical study where ground truth would be established by experts.

4. Adjudication Method for the Test Set:

• Not applicable. As this was simulated performance testing, not a study involving human interpretation of data, an adjudication method for a test set is not relevant here.

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

• No. The document does not describe an MRMC study. Its focus is on demonstrating substantial equivalence through technical and simulated performance, not on comparative effectiveness with human readers.

6. If a Standalone (Algorithm Only) Performance Was Done:

• Not applicable. This device is a physical medical instrument (an ultrasound needle), not an algorithm or AI. Therefore, standalone algorithm performance is not relevant. The performance mentioned refers to the physical device's characteristics.

7. The Type of Ground Truth Used:

• Not applicable / N/A. For simulated use performance testing of a physical device, "ground truth" in the sense of expert consensus or pathology is typically not established. The ground truth refers to the expected physical performance standards the device is designed to meet, validated through engineering specifications and experimental measurements.

8. The Sample Size for the Training Set:

• Not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or algorithms.

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

• Not applicable. There is no training set for this type of device.

Summary Limitations:

It is crucial to understand that 510(k) summaries are for demonstrating substantial equivalence to existing devices, not necessarily for proving novel clinical efficacy or diagnostic accuracy through extensive clinical trials. The "clinical evidence" mentioned generally refers to information supporting the safety and effectiveness of the device type for the proposed indications, often referencing scientific literature or previous uses of similar devices, rather than a specific, new clinical trial conducted for this particular submission. The document explicitly states: "The Clinical Evidence supports the substantial equivalence of this device for the new indications for use." This supports the claim that the expanded indications do not pose new safety or effectiveness concerns beyond what is understood for the predicate devices.

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