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The Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is designed to be used with endobronchial ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of the submucosal and extramural lesions of the tracheobronchial tree. Do no use this instrument for any purpose other than its intended use.

The Expect™ Pulmonary device is comprised of the following:

• One (1) Expect™ Pulmonary needle
• One (1) Expect™ Pulmonary adaptor .
• One (1) Syringe .
• One (1) Stopcock .

The Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is an Endobronchial Ultrasound guided Transbronchial Aspiration Needle used for fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. The device consists of a sheath covered needle which extends into the accessory channel of an endobronchial ultrasound (EBUS) endoscope and is locked into place. A handle on the proximal end of the device is used to actuate the needle in order gather samples. Both the sheath and needle length are adjustable while in the scope. A stylet is in place in order to provide protection to the inside of the sheath during device passage through the scope. The stylet may also be used to expel the sample after the procedure.

Expect™ Pulmonary adaptor is an accessory component of the Expect™ Pulmonary device. This needle adaptor is attached and locked onto the biopsy port of the bronchoscope. It allows the Expect™ Pulmonary needle to pass through it and to be secured in place with a luer connection. The adaptor is also designed to seal off the biopsy port while using the suction feature on an EBUS bronchoscope. The proposed Expect™ Pulmonary adaptor will facilitate scope flushing by allowing the adaptor to be attached to the bronchoscope.

Syringe and stopcock accessory components provide and control the vacuum suction to aspirate the sample. They can also be used to expel the samples after the procedure.

The provided text describes the performance data for the Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle with a modified needle adaptor. This device is an accessory to a bronchoscope and is used for fine needle aspiration (FNA) of lesions in the tracheobronchial tree. The study focuses specifically on the changes introduced by the modified adaptor.

Here's an analysis of the acceptance criteria and the study that proves the device meets these criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states "Four (4) non-clinical bench performance tests have been performed on the proposed Expect™ Pulmonary device with the modified needle adaptor." This implies a limited sample size, likely representative samples of the device, for these bench tests. The exact number of devices tested for each of the four bench tests is not specified beyond "Four (4) non-clinical bench performance tests."

The data provenance is from non-clinical bench testing, meaning it was conducted in a laboratory setting. There is no information provided regarding geographical origin (country) for the testing, nor whether it was retrospective or prospective in the sense of patient data. This is product performance verification, not a clinical trial.

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

This information is not applicable as the described tests are non-clinical bench tests rather than clinical studies requiring expert consensus on ground truth. The "ground truth" for these tests would be the established engineering and ISO standards themselves, against which the device's physical performance is measured.

4. Adjudication Method for the Test Set:

This information is not applicable as the described tests are non-clinical bench tests. Adjudication methods like 2+1 or 3+1 typically refer to the resolution of discrepancies between multiple human readers in clinical image interpretation or similar expert-driven evaluations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of how much Human Readers Improve with AI vs without AI Assistance:

This information is not applicable. The device described is a physical medical instrument (a needle and adaptor for FNA), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant.

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

This information is not applicable. The device is a physical instrument, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The Type of Ground Truth Used:

For the non-clinical bench tests, the ground truth is based on established engineering specifications, performance requirements, and ISO standards. For example, the ISO 594-1 liquid leakage test directly uses a standard to determine acceptance. The biocompatibility tests also rely on international standards (ISO 10993-1) for evaluation. Sterilization effectiveness is measured against ISO 11135-1.

8. The Sample Size for the Training Set:

This information is not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of algorithm development.

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

This information is not applicable for the same reasons as point 8.

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The Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is designed to be used with endobronchial ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of the submucosal and extramural lesions of the tracheobronchial tree. Do no use this instrument for any purpose other than its intended use.

The ExpectTM Pulmonary device is comprised of the following:

• Expect™ Pulmonary needle
• Expect™ Pulmonary adaptor
• Syringe
• Stopcock

The Expect™ Pulmonary device is an Endobronchial Ultrasound guided Transbronchial Aspiration Needle used for fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. The device consists of a sheath covered needle which extends into the accessory channel of an endobronchial ultrasound (EBUS) endoscope and is locked into place. A handle on the proximal end of the device is used to actuate the needle in order gather samples. Both the sheath and needle length are adjustable while in the scope. A stylet is in place in order to provide protection to the inside of the sheath during device passage through the scope. The stylet may also be used to expel the sample after the procedure.

Expect™ Pulmonary adaptor is an accessory to be attached and locked onto the biopsy port of the bronchoscope. It allows Expect™ Pulmonary needle to pass through it and to be secured in place with a luer connection.

Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample. They also can be used to expel the samples after the procedure.

The provided document is a 510(k) summary for the Boston Scientific Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new AI/software device.

Therefore, the information required to populate a table of acceptance criteria and reported device performance related to AI/software functionality, as well as details about sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in this document.

This submission focuses on the physical and functional aspects of a medical device (a needle) and its accessories, not on a diagnostic algorithm or AI.

Here's why the requested information cannot be extracted from this document:

1. Nature of the Device: The device is a "Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle." This is a physical medical instrument used for tissue sampling. It is not an AI or software device.
2. Type of Submission: A 510(k) submission primarily aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is done through comparing technological characteristics and performance data (often bench testing, biocompatibility, sterilization) to show that the new device is as safe and effective as the predicate. It does not typically involve clinical efficacy trials or AI performance evaluations as would be required for a novel diagnostic algorithm.
3. Performance Data Section: The "Performance Data" section (Section 7) describes:
   • Biocompatibility Testing: Ensuring the materials are safe for human contact.
   • Sterilization Testing: Ensuring the device can be properly sterilized.
   • Performance Testing Summary: A list of 21 "bench tests" (e.g., Device Flexibility, Needle Sharpness, Handle actuation force, Tensile strength). These are engineering/mechanical tests on the physical device, not evaluations of diagnostic accuracy or AI performance.

In summary, this document does not contain the information required to address your specific questions about acceptance criteria for an AI/software device and the study proving it, because the device in question is a physical medical instrument, not an AI/software product.

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The Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is designed to be used with endobronchial ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of the submucosal and extramural lesions of the gastrointestinal tract. Do not use this instrument for any purpose other than its intended use.

The Expect™ Pulmonary device is comprised of the following: Expect™ Pulmonary needle, Expect™ Pulmonary adaptor, Syringe, Stopcock. The Expect™ Pulmonary needle is an Endobronchial Ultrasound guided Transbronchial Aspiration Needle used for fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract. The device consists of a sheath covered needle which extends into the accessory channel of an endobronchial ultrasound (EBUS) endoscope and is locked into place. A handle on the proximal end of the device is used to actuate the needle in order gather samples. Both the sheath and needle length are adjustable while in the scope. A stylet is in place in order to provide protection to the inside of the sheath during device passage through the scope. The stylet may also be used to expel the sample after the procedure. Expect™ Pulmonary adaptor is an accessory to be attached and locked onto the biopsy port of the bronchoscope. It allows Expect™ Pulmonary needle to pass through it and to be secured in place with a luer connection. Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample. They also can be used to expel the samples after the procedure.

The provided text is a 510(k) summary for the Boston Scientific Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on clinical outcomes or a standalone algorithm performance.

Therefore, many of the requested categories for describing acceptance criteria and a study to prove device performance (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test and training sets) are not applicable or not present in this type of submission.

This document describes a pre-market notification for a medical device that functions as a tool for obtaining tissue samples. The "acceptance criteria" here are related to the device's physical and functional properties, primarily demonstrating that it performs as intended and is as safe and effective as a legally marketed predicate device.

Here's the information extracted and formatted, with "N/A" for criteria not applicable or not found in the text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the successful completion of the performance tests, demonstrating that the device functions as intended and is comparable to predicate devices. The reported device performance is that all tests were successfully completed. No specific numerical performance metrics (e.g., "flexibility must be < X N") are provided, only that the tests were completed with acceptable results.

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

This document describes non-clinical comparative performance bench testing. It does not involve a "test set" in the context of patient data or algorithm evaluation. The testing was conducted on manufactured devices.

• Sample Size: Not specified. Standard practice for bench testing would involve a statistically relevant number of devices, but the exact number is not provided in this summary.
• Data Provenance: N/A (bench testing, not patient data).
• Retrospective or Prospective: N/A (bench testing).

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

N/A. This is a medical device's physical and functional performance test, not a diagnostic algorithm. Ground truth, in this context, refers to engineering specifications and performance standards met by the device itself, not interpretation by experts.

4. Adjudication Method for the Test Set

N/A. Adjudication methods are typically used in clinical studies or expert reviews of data, not for bench testing of device mechanics.

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

N/A. This is a physical medical device (needle), not an AI algorithm. Therefore, no MRMC study comparing human readers with or without AI assistance was performed.

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

N/A. This is a physical medical device (needle), not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance testing is based on engineering specifications and established performance standards for medical devices of this type, as demonstrated by the predicate devices. For biocompatibility, it's based on ISO 10993-1:2009.

8. Sample Size for the Training Set

N/A. This is a physical medical device. There is no "training set" in the context of machine learning. The device design and manufacturing processes are developed based on engineering principles and previous device designs.

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

N/A. No training set as per machine learning definition. Design ground truth is established through engineering design principles, material science, and regulatory requirements, often benchmarked against existing devices (predicates).

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