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The ViziShot FLEX has been designed to be used with ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose of the than its intended use.

The ViziShot FLEX is intended for use with compatible ultrasound endoscopes for Transbronchial Needle Aspiration (TBNA) of submucosal and extramural lesions of the tracheobronchial tree. The device is supplied sterile and intended for single patient use.

The device consists of a handle, sheath, needle, and stylet. The sheath and needle are attached to the handle, and the removable stylet is located within the needle. Note that although the device has a component called a needle, the device is often referred to as a needle as well.

Prior to a procedure, the flexible catheter portion is inserted into a bronchoscope's working channel (2.2mm) and advanced forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a lever mechanism that locks onto the Adapter Biopsy Valve. The needle is advanced through the bronchoscope to the sampling site while visualizing both the target and the needle in real time with ultrasound. The handle facilitates advancement of the needle during puncture of the targeted biopsy site. The sample is obtained by penetrating the lesion with the needle while applying suction at the proximal end of the handle. After completing the sampling, the vacuum from the syringe is released to atmosphere, the handle unlocked from the bronchoscope, and the catheter and needle pulled out from the working channel. The removed tissue can then be prepared for cytopathological or microbiological examination and testing.

The ViziShot FLEX is available in one model only (NA-U402SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Olympus Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot FLEX.

This document is a 510(k) premarket notification for the ViziShot FLEX, a device designed for ultrasound-guided fine needle aspiration (FNA) of tracheobronchial lesions. This submission focuses on demonstrating substantial equivalence to a predicate device, the Flexible 19G EBUS Needle (K142909), primarily through bench testing to confirm its performance and technological characteristics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of "acceptance criteria" with quantitative performance metrics for device performance in a diagnostic sense (e.g., sensitivity, specificity for disease detection). Instead, the acceptance criteria are generally qualitative and relate to the device's functional integrity, safety, and operational capabilities in a simulated clinical setting. The "reported device performance" refers to the successful completion of these tests.

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

The document does not explicitly state the specific sample sizes (e.g., number of devices, number of trials) for each individual bench test. It broadly states: "Device performance of the ViziShot FLEX was verified through in vitro (bench) and ex vivo testing. Testing was designed to mimic stresses encountered in a clinical setting. All testing met the pre-determined acceptance criteria as outlined in the test protocols." The provenance of the data is from in vitro (bench) and ex vivo (bovine lung) testing, implying controlled laboratory conditions rather than human clinical data. The country of origin for the data is not specified but is implicitly associated with the manufacturer, Spiration, Inc., based in Redmond, Washington, USA. The data is thus prospective, as it was generated specifically for this 510(k) submission.

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

This type of information is generally not applicable to bench and ex vivo testing studies focused on device functionality and safety. Ground truth in this context would be defined by engineering specifications and objective measurements (e.g., force transducers, calibrated measurement tools, visual inspection against design specifications). There were no human experts establishing a "ground truth" for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "test set" involves objective bench and ex vivo measurements against engineering specifications, not expert interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission focuses on demonstrating substantial equivalence based on engineering and performance characteristics of the device itself, not on the effectiveness of human readers using the device for diagnostic purposes. Therefore, there is no effect size reported for human readers improving with or without AI assistance, as AI is not part of this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The ViziShot FLEX is a mechanical medical device (an aspiration needle), not an AI algorithm. Its performance is intrinsically linked to human operation by a clinician.

7. Type of Ground Truth Used

For the bench and ex vivo testing, the "ground truth" was established by pre-defined engineering specifications, material properties, and functional requirements (e.g., specific force thresholds, dimensional tolerances, successful aspiration of tissue, maintenance of sterility). For biocompatibility, the ground truth was adherence to established ISO standards (ISO 10993-1, ISO 10993-7).

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no concept of a "training set" in the machine learning sense. The "training" for the device's design implicitly comes from prior engineering knowledge and the design of the predicate device.

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

Not applicable, as there is no training set for an AI algorithm. The "ground truth" for the design and development of the device (if one were to stretch the analogy) would be established through established biomedical engineering principles, clinical needs, safety standards, and lessons learned from the predicate device.

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