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Lung Vision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endotherapy accessories and ultrasound probe to guide the endotherapy accessories or ultrasound probe to the target area, specifically within the respiratory system.

Lung Vision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area, specifically within the respiratory system.

LungVision tool is designed to be used by pulmonologists or thoracic surgeons during pulmonary procedures.

The LungVision Tool is designed to be connected to a standard Bronchoscope Instrument Port.

The Lung Vision Bronchoscope Adaptor is used to connect the LungVision Handle to the Bronchoscope instrument port / working channel entrance, and to allow the physician to release the tool from the bronchoscope. The current adaptor is for the Olympus Bronchoscope Model BF-1T160.

More types of Bronchoscope Adaptors for other bronchoscopy brands and models.

Lung Vision Tool Sheath can accommodate endo-therapy accessories and ultrasound probes with an outer diameter up to 1.9 mm.

The provided text describes the LungVision Tool, a medical device intended to be used with standard bronchoscopes, endotherapy accessories, and ultrasound probes to guide them to a target area within the respiratory system. The submission demonstrates substantial equivalence to predicate devices K060243 (Olympus Guide Sheath) and K151315 (Boston Scientific Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle).

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabulated format with numerical targets for each test, but it does list the tests performed and implies that the device "met all requirements specifications." The comparison table on pages 4 and 5 highlights the features and specifications for the predicate, reference, and subject device.

2. Sample Sizes used for the Test Set and Data Provenance:

The document describes non-clinical/bench testing, biocompatibility testing, and sterilization validation. It does not refer to a "test set" in the context of clinical or performance data from human subjects.

• Bench Testing: The sample sizes for each specific bench test (e.g., Bronchoscope Compatibility, Tensile Test) are not explicitly mentioned. The testing would involve multiple units of the LungVision Tool.
• Biocompatibility: The specific number of samples for cytotoxicity, sensitization, irritation, and acute systemic toxicity tests are not provided, but these tests (ISO 10993) involve standardized sample sizes for in-vitro and animal testing.
• Sterilization: "Single Lot Release validation" was performed, indicating testing on one lot of devices.
• Data Provenance: The data is generated from non-clinical (bench) studies likely conducted in laboratories within the submitting company's or contractor's facilities. There is no mention of country of origin for the non-clinical data, nor whether it is retrospective or prospective, though bench testing is inherently prospective.

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

This information is not applicable as there was no test set involving human subjects or expert assessment to establish ground truth. The device is a medical instrument (tool), and its performance was evaluated through non-clinical testing against engineering specifications and comparison to predicate devices, not against a "ground truth" derived from human experts.

4. Adjudication method for the test set:

This information is not applicable as there was no test set involving human experts requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was performed."

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

This device is a physical medical tool, not an algorithm or software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. Its performance is assessed through its physical and functional characteristics in bench testing.

7. The type of ground truth used:

The "ground truth" for this device's performance is established through:

• Engineering specifications and design requirements: For bench testing (e.g., tensile strength, dimensions, compatibility).
• International standards (e.g., ISO 10993 for biocompatibility) and regulatory requirements: For safety evaluations.
• Comparison to legally marketed predicate devices: For demonstrating substantial equivalence in intended use, technology, and performance.

8. The sample size for the training set:

This information is not applicable. The device is a physical tool, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

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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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