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The device 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. The Endoscopic Ultrasound Aspiration Needle consists of an Aspiration Needle and negative suction device. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 2 years.

The provided text describes a 510(k) summary for a medical device and does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details for an AI/ML powered device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through:

• Comparison of technological characteristics: This involves a table (Table 7.1) comparing various features of the proposed device (Adapt Endoscopic Ultrasound Aspiration Needle) and the predicate device (Endoscopic Ultrasound Aspiration Needle, K172309).
• Performance data (bench testing): A list of bench tests performed to ensure the device works as intended. These tests are:
  • Smooth Actuation of Handle
  • Leakage
  • Ultrasound Visibility
  • Puncture Force
  • Stiffness
  • Durability
  • Stylet Removal Force
  • Locking Force of Handle
  • Tensile Strength
• Shelf-life and packaging integrity testing: Based on accelerated aging and ISO standards.
• Sterilization validation: In accordance with ISO 11135.
• Biocompatibility evaluation: In accordance with ISO 10993-1 and FDA guidance, including tests for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, and Hemolysis.

The text explicitly states that no animal study and no clinical study were included in the submission. This implies that no human-in-the-loop performance, standalone algorithm performance, or clinical effectiveness data would be available from this document.

Therefore, I cannot fulfill your request for the specific information you asked for, as the provided text pertains to a traditional medical device (an aspiration needle) and its regulatory submission, not an AI/ML powered device with related performance metrics.

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