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This instrument has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration(FNA) of submucosal and extramural lesions of the gastrointestinal tract.

The Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N (aka ViziShot 2) is used in conjunction with Olympus ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA). The subject devices consist of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port via the single use adapter biopsy valve (MAJ-1414). The insertion section is composed of the sheath, needle and stylet. The needle tube is stored in the sheath and extended from the sheath to puncture the target tissue to collect specimen by moving the needle slider on the handle. A syringe is attached to the aspiration port on the handle section to aspirate the specimen. The needle is dimpled for echo enhancement. The subject devices will be sold with or without medallion syringe manufactured by Merit Medical, which consists of VACLOK Syringe and Stopcock.

This is a submission for a medical device called the "Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N". This document is a 510(k) summary, which means it's a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with corresponding performance results for each criterion in a summarized format. Instead, it lists the types of performance data collected and states that these tests were conducted "to ensure that the subject devices perform as intended and meet design specifications." The overall conclusion is that the device "raise no new issue of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, efficacy and performance."

Based on the "Performance testing - Bench" section, we can infer some of the areas where acceptance criteria would have been applied:

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

The document does not specify the exact sample sizes for each of the performance tests (e.g., how many needles were tested for piercing or ultrasound visibility). It only states that tests were "conducted."

The provenance of the data is in-house testing conducted by Olympus Medical Systems Corp. or its contractors. The studies appear to be bench tests and lab-based assessments (e.g., sterilization, biocompatibility, mechanical performance). There is no mention of human clinical data or patient data, so the concepts of "country of origin of the data," "retrospective or prospective," and "test set" in the context of clinical data do not apply here.

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

Given that the performance data is entirely based on bench testing (mechanical, biocompatibility, sterilization), the concept of "experts establishing ground truth for a test set" in a clinical diagnostic sense (e.g., for image interpretation) is not applicable. The "ground truth" for these engineering tests would be established by validated test methods, reference standards, and established physical/chemical properties, rather than expert human interpretation.

4. Adjudication Method for the Test Set

As the performance data is derived from bench testing, an adjudication method like 2+1 or 3+1 (typically used for resolving discrepancies in expert interpretations of clinical data) is not relevant. The results of bench tests would be determined by objective measurements against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was done. This device is a physical medical instrument (an aspiration needle) and does not involve AI or human interpretation in a diagnostic workflow where such a study would be applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is not an algorithm or AI-based system, so a standalone performance study in that context is not applicable.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on:

• Design Specifications: The device was tested to perform "as intended and meet design specifications."
• International Standards: Compliance with standards like ISO 10993-1, ISO 14971, ASTM F1980-16, and various ISO standards for sterilization and packaging.
• Validated Test Methods: The bench tests themselves would have employed validated methods to objectively measure parameters like flexibility, piercing force, aspiration volume, etc.

8. The Sample Size for the Training Set

This device does not utilize a "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering development and quality control, not through iterative training on a dataset.

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

Since there is no training set in the AI sense, this question is not applicable.

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This instrument has been designed to be used with ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

The single use aspiration needle NA-U401SX (aka ViziShot 2) is intended to be used in conjunction with Olympus ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA). It consists of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port via the single use adapter biopsy valve (MAJ-1414). The insertion section is composed of the sheath, needle, and stylet. The needle is stored in the sheath and extended from the sheath to puncture the target tissue to collect specimen by moving the needle slider on the handle. A syringe is attached to the aspiration port on the handle section to aspirate the specimen that was punctured with the needle. The needle is dimpled for echo enhancement and also consists of an oval portion for better angulation.

The subject device will be sold with or without medallion syringe manufactured by Merit Medical, which consists of VACLOK Syringe and Stopcock.

The provided text describes a 510(k) premarket notification for the "Single Use Aspiration Needle NA-U401SX" (aka ViziShot 2). This notification primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria as one might find for more complex software or diagnostic devices.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes for test sets, expert involvement, and comparative effectiveness (MRMC or standalone AI performance) is not present in this document. This document details a medical device (a needle), and the "performance" here relates to its physical and functional attributes, not an algorithm's diagnostic capabilities.

However, I can extract the information that is available regarding 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

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

• Sample Size: The document does not specify exact sample sizes (e.g., number of needles tested, number of in-vitro experiments). It refers to "testing" and "analysis" rather than specific numerical units of a test set. This is typical for a 510(k) for a physical device where tests are often on prototypes or manufacturing samples.
• Data Provenance: The studies are non-clinical ("Summary of non-clinical testing") and were conducted in-house by the manufacturer (Olympus Medical Systems Corp. and Aomori Olympus Co., Ltd. in Japan). The specific country of origin for the data generation would therefore be Japan. The data is prospective in the sense that the testing was performed specifically to support this 510(k) submission for the new device.

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

This section is not applicable as the device is a physical medical instrument (an aspiration needle) and not an AI or diagnostic algorithm that requires expert-established ground truth for performance evaluation in the context of diagnostic accuracy. The "ground truth" here is the physical and functional integrity and performance of the device against engineering and safety standards.

4. Adjudication method for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions, typically in diagnostic studies or when establishing ground truth for AI model training/testing. This document describes non-clinical engineering and biocompatibility tests for a physical device.

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

This is not applicable. MRMC studies are specific to evaluating the clinical performance of diagnostic systems or AI tools with human readers. This submission is for a physical medical device (an aspiration needle), not an AI system.

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

This is not applicable. This device is a physical medical instrument and does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance evaluation is established by:

• Engineering specifications and design requirements: For items like flexibility, piercing ability, aspiration, locking force, and needle depth limitation.
• Regulatory standards: Specifically, ISO 14971 (Risk Management), ISO 10993 series (Biocompatibility), ISO 11135 (Sterilization), and ASTM F-1980-07 (Packaging/Shelf Life Accelerated Aging).
• Functional tests: Verification that the device performs its intended functions (e.g., "inserting into endoscope," "ultrasound visibility").

8. The sample size for the training set

This is not applicable. The device is a physical instrument, not an AI model that requires a training set.

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

This is not applicable for the same reason as above; there is no training set for a physical device. Ground truth for the design and testing of the device is established by the engineering and regulatory standards listed in point 7.

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