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The Endobronchial Ultrasound Aspiration Needle is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree.

The proposed device Endobronchial Ultrasound Aspiration Needle is a sterile, single-use bronchoscopic device, is designed to sample targeted submucosal and extramural lesions of the tracheobronchial tree. The Endobronchial Ultrasound Aspiration Needle consists of an Aspiration Needle, Adaptors and Negative suction device (Stopcock and Syringe). Wherein, the Aspiration Needle consists of a handle, sheath, needle, and stylet. The handle is connected to the channel port of a bronchoscope via the proper adaptor. The needle is deployed in the sheath and projected from the sheath to penetrate the target lesion to serve sample by advancement of handle. The stylet is in place in order to provide protection to the inside of the needle tube and sheath during device passage, and also used to expel the sample after the procedure. The adaptors are provided different bronchoscopes with compatibility and attached onto the channel port as the middleware between a bronchoscope and the aspiration needle. The negative suction device is connected to the proximal end of the handle to aspirate the removed tissue.

The Endobronchial Ultrasound Aspiration Needle has echogenic features and is visible under ultrasound at the distal end to facilitate real time visualization of the device under ultrasound.

The proposed device has six models, and the main differences of these models are diameter and tip type of the needle. The Endobronchial Ultrasound Aspiration Needle offers 19G, 22G, 25G needles by size or gauge to respond various clinical options of accessing and sampling. There are two kinds of different tip design (bevel and trident) of needles for FNA (Fine Needle Aspiration) and FNB (Fine Needle Biopsy). The device is identified as is Areus™ Endobronchial Ultrasound Aspiration Needle and Trident™ Endobronchial Ultrasound Aspiration Needle by trade name.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10th and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The provided text describes the Micro-Tech (Nanjing) Co., Ltd. Endobronchial Ultrasound Aspiration Needle (AreusTM and TridentTM) and its equivalence to a predicate device. However, the document does not contain specific acceptance criteria nor detailed study results with performance metrics that would allow for the construction of a table comparing acceptance criteria to reported device performance.

Instead, the document broadly states that the device "met the predetermined acceptance criteria" without listing those criteria or the precise performance values attained for each. It focuses on demonstrating substantial equivalence through various non-clinical tests.

Therefore, I cannot fulfill all parts of your request with the provided information. I can, however, extract the information that is present in the document.

Missing Information:

• Specific acceptance criteria values: The document states that criteria were met but doesn't define them.
• Reported device performance values: Similarly, specific performance numbers are not provided, only a general statement that they "met" the criteria.
• Details on the "study" itself: No specific study names or designs are outlined, beyond mentioning various bench tests and validation activities.
• Sample size used for the test set: Not specified.
• Data provenance for the test set: Not specified (e.g., country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth: Not applicable, as the tests were non-clinical/bench tests, not involving human interpretation of medical images or data.
• Adjudication method for the test set: Not applicable for non-clinical tests.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not done/not applicable, as it's a device, not an AI diagnostic tool.
• Standalone (algorithm only) performance: Not applicable, as it's a physical medical device.
• Type of ground truth used (for test set, if applicable): Not applicable for non-clinical/bench tests.
• Sample size for the training set: Not applicable, as it's a physical medical device, not an AI algorithm requiring a training set.
• How ground truth for the training set was established: Not applicable.

Here's a summary of the information that is available in the document regarding the device's testing and compliance:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, specific numerical acceptance criteria and reported device performance values are not provided in this document. The document states:

"The results of all the performance testing demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device Vizishot 2 Flex."

The following types of tests were performed:

• Dimension
• Sheath and Needle Insertion and Withdrawal force
• Stylet Insertion and Withdrawal Force
• Puncture Force
• Ultrasound Visibility
• Locking Force of Handle Portion
• Adjustment Length
• Attach and Detach Adaptor to Scope
• Tensile Strength
• Durability
• Aspiration Capability
• Transmission Force
• Needle Deformation Angle

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

• Sample size for the test set: Not specified in the document.
• Data provenance: Not applicable. These were non-clinical bench tests performed on the device itself.

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

• Not applicable. The ground truth for these non-clinical, physical performance tests would be based on engineering specifications and measurement standards, not medical expert consensus.

4. Adjudication method for the test set

• Not applicable. This is for non-clinical, physical performance tests.

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

• No. This is a physical medical device (Endobronchial Ultrasound Aspiration Needle), not an AI-powered diagnostic tool, so an MRMC study is not applicable.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• For the non-clinical bench tests, the "ground truth" would be the engineering specifications and established test methods/standards (e.g., measurements against dimensional tolerances, force thresholds, durability cycles). For biocompatibility, it's compliance with ISO 10993-1. For sterilization, it's compliance with ISO 11135. For shelf-life/packaging, it's compliance with ASTM F1980-16, ISO 11607-1, and ISO 11607-2.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI algorithm.

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

• Not applicable. This is a physical medical device, not an AI algorithm.

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