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This device is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. Do not use for any purpose other than its intended use.

The PeriFLEX Needle is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. The device is supplied sterile and intended for single patient use.

The main components of the device are a handle, a sheath, a needle, and a stylet. The sheath and needle (together termed the insertion portion) are attached to the handle. The removable stylet runs the full length of the device and fits inside the lumen of the handle and the needle.

The needle is housed within the sheath. These components, i.e., the insertion portion, are inserted into the working channel of the endoscope and advanced to the target site. The handle is connected to the insertion and has a needle slider component. The needle slider is controlled manually by the user to extend and retract the needle from the sheath at the target site. Once a sample is collected, the stylet may be used to assist with removing the sample from the needle.

The PeriFLEX Needle is available in one model only (PERIFLEX-21G), with a needle size of 21 gauge (21G). The PeriFLEX Needle can be used with the following accessories: vacuum syringe (to assist with sample collection), biopsy valve (to assist with creating a vacuum), and guide sheath (to extend the working length). However, these accessories are not included with the PeriFLEX Needle's packaging and must be obtained separately by the user.

The provided text describes the PeriFLEX Needle, an aspiration needle for collecting tissue from intrapulmonary regions through a bronchoscope. The submission focuses on demonstrating substantial equivalence to a predicate device through performance testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests conducted. While specific quantitative acceptance criteria are not explicitly stated for each test in a table format, the narrative indicates that the device "met the pre-determined acceptance criteria as outlined in the test protocols."

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

• Sample Size (Test Set): Not explicitly stated with a specific number for each test. The document refers to "in vitro (bench) and ex vivo testing" and "simulated use - ex vivo (bovine lung) bench testing" for biopsy sample size.
• Data Provenance: The testing was conducted as "in vitro (bench)" and "ex vivo (bovine lung) bench testing." This suggests laboratory-based testing rather than human subject data. The country of origin is not specified but is presumably where Spiration, Inc. conducts its R&D, likely the USA given the Redmond, Washington address. The testing is considered prospective as it was performed specifically to support this 510(k) submission.

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

• The document does not mention the use of experts to establish ground truth for the test set. The tests described are primarily engineering and material performance assessments (e.g., force, strength, leak tests, biocompatibility) rather than diagnostic accuracy assessments requiring expert interpretation of results.
• For the "Biopsy Sample Size" test, it involved ex vivo bovine lung, which implies objective measurement of tissue obtained rather than expert consensus on its characteristics.

4. Adjudication Method for the Test Set

• No adjudication method is mentioned or relevant as the testing described is not clinical or diagnostic in nature requiring expert review or consensus.

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

• No MRMC comparative effectiveness study was done or reported. The device is an aspiration needle, not an imaging or diagnostic AI device that would typically undergo such a study. The focus is on the physical and mechanical performance of the tool itself.

6. Standalone (Algorithm Only) Performance

• This is not applicable as the PeriFLEX Needle is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used

• The "ground truth" for the performance tests was based on engineering specifications, material science standards, and objective measurements derived from the in vitro and ex vivo tests. For example, force measurements, leak detection, and observed physical integrity against pre-determined thresholds. For biopsy sample size, it would be the objective measurement of the collected tissue from the ex vivo bovine lung.

8. Sample Size for the Training Set

• Not applicable. There is no algorithm or AI model being developed or trained for this device.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set mentioned or implied.

In summary, the information provided focuses on the physical, mechanical, and biological performance of the PeriFLEX Needle against engineering and safety specifications, rather than clinical efficacy or diagnostic accuracy that would typically involve a "test set" and "ground truth" derived from human clinical data or expert consensus. The study described is a series of pre-clinical bench and ex vivo tests demonstrating the device's conformance to its design requirements and equivalence to predicate devices.

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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

• Inserting into endoscope
• Flexibility of the insertion portion
• Piercing
• Ultrasound visibility
• Needle extraction and retraction
• Aspiration
• Withdrawal from endoscope
• Locking force of handle portion
• Limitation of needle depth |
  | Biocompatibility Testing | Compliance with FDA Guidance," Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1" and relevant ISO standards (ISO 10993-1, -5, -10, -11). | Performed in accordance with the specified FDA Guidance and ISO standards. |
  | Sterilization | Compliance with ISO 11135 (Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices). | Applied ISO 11135. |
  | Packaging/Shelf Life | Compliance with ASTM F-1980-07 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages). | Applied ASTM F-1980-07. |
  | Technological Characteristics (vs. predicate) | Validation testing demonstrated that differences in needle tube shape on proximal side, sheath composition, and materials do not affect the safety or effectiveness of the subject devices. (Specifically, the oval portion of the needle tube and new patient contact materials, with sheath design similar to K904667). | Validation testing demonstrated that these technological features do not affect the safety or effectiveness of the subject devices. |

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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