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

The device consists of a handle, sheath, needle, and stylet. The sheath and needle (together termed the insertion section) are attached to the handle and needle slider respectively. The removable stylet runs the full length of the device and is located within the lumen of 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 distal end of the insertion portion (sheath and needle) of the PeriView FLEX needle is inserted into the working channel of the bronchoscope 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, an air filled syringe or the stylet can be used to expel the sample from the needle.

The PeriView FLEX is available in one model only (NA-403D-2021), with a needle size of 21gauge (21G). The PeriView FLEX Needle can be used with the following optional accessories: vacuum syringe, biopsy valve, and guide sheath. These optional accessories are not included with the Peri View FLEX Needle's packaging and must be obtained separately by the user.

This document is a 510(k) premarket notification for the "PeriView FLEX" aspiration needle. It asserts the substantial equivalence of the new device to a predicate device, the "PeriFLEX" (K162611). Therefore, the study described does not involve a multi-reader, multi-case comparative effectiveness study or a standalone algorithm performance study, as it is a medical device clearance based on equivalence to an already approved device rather than a new AI/software-based diagnostic.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a table format with corresponding performance results in the way one might see for a diagnostic AI device (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated through various bench tests designed to show that the new device performs equivalently to the predicate and meets design specifications. The acceptance criteria are implicitly met by successful completion of these tests.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each non-clinical (bench) test. The testing involved physical devices and materials, not patient data.
• Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective) as the submission is based on non-clinical (bench) testing of the physical device.

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

Not applicable. The ground truth for bench testing is defined by engineering specifications, validated test methods, and compliance with recognized standards. It does not involve expert clinical review or interpretation of results in the way a diagnostic study would.

4. Adjudication Method for the Test Set

Not applicable. Bench tests are objective measurements against predefined specifications, not subjective interpretations requiring 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

No, an MRMC comparative effectiveness study was not done. This device is an aspiration needle (physical medical instrument), not an AI-powered diagnostic or assistive technology.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical testing is based on engineering design specifications, established performance standards (e.g., ISO, AAMI, USP), and the functional equivalence to the legally marketed predicate device. For example, biocompatibility is assessed against ISO 10993 standards, and mechanical properties are assessed against engineering targets to ensure safe and effective operation comparable to the predicate.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/software device that requires a training set.

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

Not applicable. This device is a physical medical instrument, not an AI/software device that requires a training set.

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