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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 PeriView FLEX needle is a single use tissue biopsy device that consists of five parts: Handle, Stopper, Sheath, Needle, and, Stylet. The sheath and needle (together termed the insertion section) are attached to the handle. The Stopper is removable and is attached between the Handle and the Needle Slider. The removable Stylet runs the full length of the device and is located within the inner lumen of the needle.

The provided text describes the Olympus Surgical Technologies America PeriView FLEX device, which is a single-use tissue biopsy device intended for use through a bronchoscope for collecting intrapulmonary tissue. This is a Special 510(k) Notification, meaning the modified device is compared to its own predicate device (also named PeriView FLEX) and the primary change is the addition of a removable stopper.

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 document provides a summary of performance testing with specifications/objectives.

Note: The specific numerical values for the specifications are not provided in the document, only that they "met specification" or conformed to the ASTM standards.

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

The document states, "All performance testing passed or met prescribed acceptance criteria." However, it does not provide details on the sample size used for the various tests (Stopper Width, Removal Force, Bubble Leak, Accelerated Aging).

The data provenance is from bench testing ("Summary of All Performance Testing (no clinical testing was conducted)"). The country of origin is not explicitly stated for the testing, but the manufacturer is Olympus Surgical Technologies America, located in Southborough, Massachusetts, USA. The testing appears to be retrospective relative to the submission date of the 510(k).

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

This section is not applicable as there was "no clinical testing conducted." The ground truth for the engineering performance tests (stopper width, removal force, etc.) would be established by measuring the device's physical attributes against pre-defined engineering specifications, not by expert interpretation.

4. Adjudication Method for the Test Set

This section is not applicable as there was "no clinical testing conducted" and thus no human interpretation of results requiring adjudication. The performance tests are objective engineering measurements.

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

No, a multi-reader multi-case comparative effectiveness study was not done. The document explicitly states "no clinical testing was conducted." Therefore, there is no effect size reported for human readers with or without AI assistance.

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

No, a standalone study was not conducted in the context of an algorithm or AI. This device is a mechanical tissue biopsy device, not an AI-powered diagnostic or assistive tool. The performance evaluation focuses on its mechanical and material properties.

7. Type of Ground Truth Used

The ground truth used for the performance testing cited (Stopper Width, Removal Force, Bubble Leak, Accelerated Aging) would be engineering specifications and established ASTM standards. For example, for "Stopper Width," the ground truth would be the specific design dimension it was intended to meet. For "Bubble Leak," the ground truth is defined by the passing criteria of ASTM F2096-11.

8. Sample Size for the Training Set

This refers to a training set for an AI/algorithm, which is not applicable to this device as it is a mechanical device with no AI component mentioned.

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

This refers to an AI/algorithm, which is not applicable to this device.

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