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The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.

The subject device, ViziShot 2 FLEX is a single use aspiration needle to be used in conjunction with compatible ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.

The subject 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. The device is a single-use sterile device.

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 2 FLEX is available in one model only (NA-U403SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot 2 FLEX.

The ViziShot 2 FLEX is a single-use aspiration needle used with ultrasound endoscopes for ultrasound-guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of lesions in the tracheobronchial tree. The device is identical to a previously marketed device (K163469) in formulation, processing, sterilization, and geometry, with the proposed addition of "fine needle biopsy (FNB)" to its Indications for Use, which aligns with the primary predicate device (Cook Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle, K160229).

Here's the breakdown of its acceptance criteria and the study conducted to prove it:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of clinical cases or patient data, as no clinical or animal studies were performed for this submission. The performance testing was primarily bench-based. For the GLP comparison study, the "test article" was the ViziShot 2 FLEX 19G Needle and the "predicate control article" was the Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle. The number of individual devices or samples tested in this comparison is not explicitly stated, but it would involve a sufficient number to generate statistically meaningful results for mechanical and tissue sampling performance.
• Data Provenance: The data provenance is primarily from bench testing conducted in a laboratory setting. No country of origin for clinical or patient data is applicable as such studies were not performed. The GLP comparison study implies a controlled laboratory environment.

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

Since no human "ground truth" (e.g., expert consensus on medical images or pathology slides) was established for a clinical test set, this section is not applicable. The performance tests rely on objective measurements and comparisons, and the GLP comparison study would involve personnel qualified in laboratory testing and potentially pathology for tissue evaluation, though their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was conducted.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission explicitly states "No clinical study was performed to demonstrate substantial equivalence." Therefore, no effect size of human readers improving with or without AI assistance is available.

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

This device is a physical medical instrument (an aspiration needle), not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The performance evaluated relates to the physical and functional aspects of the needle itself.

7. The Type of Ground Truth Used

For the substantial equivalence determination, the "ground truth" for the device's performance was established through:

• Objective Measurements and Standards: Compliance with international and national standards for biocompatibility, sterilization, and packaging/shelf-life (e.g., ISO 10993 series, ANSI/AAMI/ISO standards, ASTM standards).
• Bench Testing Specifications: Evaluation against predefined physical and performance specifications (e.g., insertion/withdrawal forces, durability, echogenicity).
• Comparison to Predicate: The ability to obtain sufficient tissue samples for histologic and core sample analysis, and similar quality of samples, compared to a legally marketed predicate device (Cook Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle) in a GLP (Good Laboratory Practice) study.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for this device.

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The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.

The ViziShot 2 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 2 FLEX is available in one model only (NA-U403SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot 2 FLEX.

The provided text is a 510(k) Summary for the Olympus Surgical Technologies America ViziShot 2 FLEX, a medical device used for fine needle aspiration. It focuses on demonstrating substantial equivalence to a predicate device (ViziShot FLEX) rather than detailing a specific clinical study with acceptance criteria and performance metrics in the way a clinical trial report would.

Therefore, the information requested regarding acceptance criteria and performance data for the device's intended clinical function (e.g., diagnostic accuracy, success rate of aspiration, number of adequate samples) is not present in the provided document. The document primarily describes bench tests and non-clinical testing to ensure the device's physical and material properties are comparable to the predicate device.

However, I can extract information related to the non-clinical testing that verifies the device's physical performance, which serves as a form of acceptance criteria for its design changes.

1. Table of Acceptance Criteria and Reported Device Performance (for Non-Clinical Testing):

The document does not provide a formal table of quantitative acceptance criteria and specific reported performance for each test in the way requested. Instead, it states that "Engineering bench testing confirms that the modified ViziShot 2 FLEX meets its critical product specifications, which are substantially equivalent to those of the predicate ViziShot FLEX."

Below is a representation of the tests conducted, and the implied 'acceptance criteria' is that the ViziShot 2 FLEX performs equivalently or meets the specifications of the predicate device for each category.

The following information is not available in the provided document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information would typically come from a clinical study. The provided document details non-clinical bench testing and biocompatibility testing, not clinical performance. Thus, there is no "test set" in the context of patient data, nor country of origin or retrospective/prospective nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set with ground truth established by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a physical medical instrument (a fine needle aspiration device), not an AI diagnostic algorithm or a system involving human readers in the context of interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. For the non-clinical tests, the "ground truth" would be engineering specifications and standards. For biocompatibility, it's compliance with ISO standards.
8. The sample size for the training set: Not applicable. No clinical training set is mentioned as this device is not an AI/ML product.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding device evaluation:

The document describes non-clinical testing to support the substantial equivalence claim for the ViziShot 2 FLEX. These tests focus on:

• Biocompatibility: Performed on all patient-contacting surfaces, complying with ISO 10993 standards.
• Sterilization: Validated using ANSI/AAMI/ISO standards to ensure the device is sterile and maintains sterility for a one-year shelf life.
• Bench Testing: A range of physical performance tests (e.g., force, durability, angulation, echogenicity) were conducted to ensure the ViziShot 2 FLEX meets its critical product specifications and is "substantially equivalent" to its predicate device, the ViziShot FLEX. The implication is that the device design changes (primarily ergonomic and manufacturing efficiency improvements) did not negatively impact its physical performance or safety.

The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical data, rather than requiring a full-scale clinical trial to prove efficacy from scratch, especially when the changes are minor and do not alter the fundamental technological characteristics or intended use.

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