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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.

The Single Use Aspiration Needle 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 the medallion syringe manufactured by Merit Medical, which consists of the VACLOK Syringe and Stopcock.

This submission (K190239) is for a medical device (Single Use Aspiration Needle NA-U401SX-4025N, also known as ViziShot 2), not an AI/ML device. Therefore, the questions related to AI/ML specific criteria like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets, and adjudication methods are not applicable to the provided document.

The document describes the device, its intended use, and substantial equivalence to a predicate device based on non-clinical testing.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

• Accelerated aging test conducted per ASTM F1980-16 for sterile barrier systems.
• Real-time aging test for three years will be performed to
  demonstrate longer stability and support accelerated aging test results. |
  | Biocompatibility | Device materials are biocompatible and do not pose unacceptable biological risks. | - Biocompatibility testing conducted per FDA's "Use of International Standard ISO 10993-1:2009, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'."
• Specific tests completed: Cytotoxicity, Intracutaneous Study, Sensitization, Systemic Toxicity, Pyrogen Study. |
  | Performance - Bench | Device functions as intended and meets design specifications for aspiration, piercing, visibility, etc. | - Bench testing conducted to ensure devices perform as intended and meet design specifications.
• Specific tests performed: Piercing, Ultrasound visibility, Needle extraction and retraction, Aspiration, Endoscope compatibility, Handle function, Joint Pull Strength, Breakage Strength.
• "Bench testing confirms that the NA-U401SX-4025N meets its essential performances, which are technologically equivalent to those of the reference device." |
  | Risk Analysis | Identified risks are mitigated adequately and meet established in-house acceptance criteria based on ISO 14971:2007. | - Risk analysis conducted in accordance with ISO 14971:2007.
• Design verification tests and their acceptance criteria were identified and performed based on this assessment. |

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

• Sample Size: Not specified in the document. The document refers to "bench testing," "accelerated aging test," and "biocompatibility testing," which inherently involve testing a certain number of devices or samples.
• Data Provenance: The tests were conducted internally by Olympus ("established in-house acceptance criteria"). The country of origin of the data is not explicitly stated, but the submitter is Olympus Medical Systems Corp. in Tokyo, Japan. The tests are non-clinical (bench, lab-based), so retrospective or prospective doesn't directly apply in the same way it would for clinical data.

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

• Not applicable as this is not an AI/ML device dealing with "ground truth" established by human experts in the context of diagnostic interpretation. The "ground truth" for the performance tests would be the established engineering and biological standards and specifications the device is designed to meet.

4. Adjudication method for the test set

• Not applicable. This is not an AI/ML device involving human interpretation and adjudication.

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 not an AI product.

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

• Not applicable. This device is not an AI product.

7. The type of ground truth used

• The "ground truth" for this device's performance is based on engineering specifications, established medical device performance standards (e.g., sterilization, biocompatibility, mechanical strength), and a risk analysis based on ISO 14971:2007. It does not involve expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the AI/ML sense.

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

• Not applicable. This device does not use a "training set."

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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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