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The BroncTru Transbronchial Access Tool is indicated for use in conjunction with a flexible bronchoscope to puncture the lung, dilate, and establish a working channel, facilitating the guidance of other endoscopic tools to reach target lesions.

The BroncTru Transbronchial Access Tool is a single-use sterile disposable catheter made up of four (4) components:

• i) Needle - used for puncturing of the transbronchial wall.
• ii) Dilator - the long-tapered tip dilator is used to dilate the opening in the transbronchial wall created by the needle. It also provides protection around the sharp needle tip during vascular access.
• iii) Sheath - the sheath inserted into the dilated tracheobronchial wall, provides a port through which a variety of endoscopic tools can be inserted.
• iv) Handle - The handle is operated by the operator to advance and to pull the dilator out leaving only the sheath to guide other devices to the target.

The BroncTru Transbronchial Access Tool is designed to puncture the tracheobronchial wall, the long-tapered tip of the dilator acts to stretch the opening in the tracheobronchial wall to allow for the insertion of the larger sheath. The dilator is then removed, leaving only the sheath inserted into the tracheobronchial wall, providing a channel which allows for subsequent endoscopic tool placement. This allows for access to lesions without a bronchus sign (outside the airways).

The BroncTru Transbronchial Access Tool is a medical device, and the provided document is an FDA 510(k) premarket notification. This document focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria for an AI/CADe device.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, or MRMC studies) is not applicable to this device and the provided document. The device is a physical tool, not an AI, CADe, or image-processing software.

The document primarily discusses the device's physical characteristics, intended use, and various non-clinical performance data to demonstrate that it is as safe and effective as a legally marketed predicate device.

However, I can extract information related to the device's physical performance testing:

Summary of Performance Data for the BroncTru Transbronchial Access Tool (Not AI-related)

The performance data provided supports the substantial equivalence determination by demonstrating the device's physical and functional properties, and its safety, compared to predicate devices.

1. Acceptance Criteria and Reported Device Performance (Non-AI)

The document lists various performance tests conducted, with results indicating "Pass," meaning the device met the established criteria for each test. Specific numerical acceptance criteria are not detailed in the summary, but the "Pass" result indicates compliance.

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

• Sample Size for Test Set: Not specified in the provided summary for bench/biocompatibility tests. These are typically laboratory tests performed on a defined number of device units.
• Data Provenance: The tests are described as having been conducted "in accordance with" various international and FDA-recognized standards. This implies controlled laboratory settings rather than clinical data from specific countries or retrospective/prospective studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: For a physical device and the types of tests described (biocompatibility, sterilization, bench testing), "experts to establish ground truth" in the context of image interpretation or clinical diagnosis are not relevant. These tests rely on standardized protocols and measurements.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in human expert interpretations, typically in clinical studies or expert consensus for ground truth. This is not relevant for the engineering and safety tests described here.

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

• Not Applicable: An MRMC study is designed to evaluate how human reader performance changes with or without AI assistance, or to compare different AI systems. As this is a physical medical tool, such a study is not relevant. The document explicitly states: "No clinical study was performed to demonstrate substantial equivalence."

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

• Not Applicable: This device is a physical tool, not an algorithm or software. Therefore, there is no AI or algorithm-only performance to study.

7. Type of Ground Truth Used

• Not Applicable in the AI/Clinical Sense: For the types of tests performed, "ground truth" refers to the established scientific and engineering principles, material properties, and performance specifications defined by the relevant standards (e.g., ISO, ASTM, USP). The device is tested against these defined physical and chemical properties.

8. Sample Size for the Training Set

• Not Applicable: This is a physical device, not an AI model. Therefore, there is no "training set."

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

• Not Applicable: As above, this is not an AI model, so there is no training set or its associated ground truth establishment.

In conclusion, the provided FDA 510(k) summary for the BroncTru Transbronchial Access Tool details the non-clinical and non-AI-related performance testing conducted to demonstrate its substantial equivalence to a predicate device. The information requested regarding AI/CADe acceptance criteria and studies is not relevant to this type of medical device submission.

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The EasyPath RF Introducer Sheath is a single-use device intended to be used with flexible bronchoscopes as a working channel through which endoscopic tools may be introduced to target tissue. It is indicated for electrosurgical procedures involving cutting and coagulation of soft tissue in the upper airways and tracheobronchial tree.

The EasyPath RF Introducer Sheath is a sterile, single-use, monopolar endoscopic device intended to be inserted through the working channel of a flexible bronchoscope, with an inner diameter (ID) of 2.8 mm or greater, which provides an extended working channel through which endoscopic tools, such as needles, biopsy forceps, or other endoscopic devices may be introduced to target sites. Similar to Empower RF Catheter, the EasyPath incorporates a distal electrode for delivering RF energy for cutting and coagulation of soft tissue in the upper airways and tracheobronchial tree. The monopolar electrode at the distal tip facilitates cutting the target tissue using controlled monopolar radiofrequency (RF) energy.

The EasyPath has a flexible shaft with a 2.65 mm OD with braid reinforced tubing and a stylet, to resist kinking during device advancement and articulation. The stylet is used to provide an atraumatic tip and to provide rigidity (i.e., pushability). Removal of the stylet allows for standard 2.0 mm working channel bronchoscopic accessories to be inserted through the lumen of the sheath. The electrode tip of the sheath is visible, as well as the marker bands to provide the user with an indication of movement relative to the bronchoscope. Radiopaque markers are at the distal end of the sheath to aid visualization of the sheath under fluoroscopy, if utilized.

The provided document is a 510(k) Pre-Market Notification for the Broncus Medical EasyPath RF Introducer Sheath. It describes the device, its intended use, comparison to predicate devices, and performance data to demonstrate substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in a quantitative manner as typically seen for AI/software devices. Instead, it lists the types of testing performed to demonstrate that the device meets product specifications and is "safe and effective for its intended clinical use." The "reported device performance" is essentially that the device met the specifications for each test, thereby supporting substantial equivalence.

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

The document describes various engineering and biological tests, not a clinical study with a "test set" of patient data in the context of AI performance.

• Sample Sizes: Not specified for individual bench or in vivo tests. However, typical regulatory submissions for devices like this involve a sufficient number of samples to ensure statistical significance for each test.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable in the context of this device type. The tests are laboratory-based (bench, in vitro, in vivo animal model) and conducted by the manufacturer or contracted labs as part of the design verification process. The in vivo testing was conducted on porcine lungs.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this device type. There is no "ground truth" to be established by human experts in a diagnostic sense for this electrosurgical introducer sheath. The "ground truth" for its performance is determined by meeting engineering specifications and safety standards through the described testing.

4. Adjudication Method for the Test Set

Not applicable. There is no concept of a "test set" requiring adjudication by human readers for this device.

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

No. This is not an AI device or a diagnostic device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical medical device (introducer sheath) with an electrosurgical function, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established through:

• Engineering Specifications: The device's physical dimensions, material properties, electrical characteristics, and functional performance must meet predefined design specifications.
• Regulatory Standards: Compliance with recognized international and national standards (e.g., ISO, IEC, ASTM) for biocompatibility, sterilization, electrical safety, and packaging.
• Bench Test Results: Direct measurement and observation of device performance under controlled laboratory conditions.
• In-vivo Animal Model Data: Functional and thermal effects demonstrated in living biological tissue (porcine lung).

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" for this type of medical device submission.

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

Not applicable, as there is no "training set."

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The Empower RF Catheter is a single-use, electrosurgical device designed to be used with flexible bronchoscopes. It is indicated for electrosurgical procedures involving soft tissue obstructions in the upper airways and tracheobronchial tree.

The Empower RF Catheter is a sterile, single-use monopolar endoscopic device intended to be inserted through a flexible bronchoscope or a working channel of a flexible bronchoscope with an inner diameter of 2.0 mm. It has a stainless-steel electrode at the distal end, a flexible catheter shaft comprised of a nitinol wire covered by insulation tubing to prevent kinking and facilitate pushability during bronchoscopic procedures and a standard male banana plug at the proximal end. The banana plug connects to a monopolar connecting cable of a compatible electrosurgical unit. Empower is activated by a footswitch accessory supplied with the electrosurgical unit. Empower is provided in a monopolar configuration and thus, must be used in conjunction with a commercially available compatible patient return electrode to complete the return path for the RF electrical current.

The provided text describes a 510(k) premarket notification for the "Empower RF Catheter," an electrosurgical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device, the "EC 2.7 Endoscopic Cutter (K120909)," through comparative analysis and performance testing.

It is important to note that this document does not describe a study involving an AI-based device or a multi-reader, multi-case (MRMC) study. Therefore, several of the requested sections related to AI performance, sample sizes for AI training/testing, ground truth establishment for AI, expert qualifications, and human reader performance improvement with AI assistance cannot be extracted from this text.

The acceptance criteria and performance data provided are for a medical device (an RF catheter), demonstrating its safety and effectiveness through well-established engineering and biological testing standards, rather than clinical efficacy studies or AI performance metrics.

Here's an analysis of the provided text based on the request, focusing on the information that is present:

Device: Empower RF Catheter (Electrosurgical Device)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in a quantitative table format suitable for a direct "acceptance criteria vs. reported performance" comparison. Instead, it describes various tests performed to ensure the device meets design requirements and standards. The "performance data" section lists the types of tests conducted, implying that the device "meets" the requirements of these tests.

Therefore, a direct table of acceptance criteria and reported device performance as typically seen for AI device metrics (e.g., sensitivity, specificity thresholds) cannot be constructed from this document. The performance is demonstrated by compliance with the referenced standards and successful completion of the listed tests.

Note: The document only states that these tests were "performed" and that the results "demonstrate that Empower meets the defined design requirements and supports its safety and effectiveness." Specific quantitative results for each test (e.g., exact tensile strength values, specific electrical leakage currents) are not provided in this summary.

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

This document describes engineering and biological performance testing for a physical medical device, not a data-driven AI model. Therefore, the concept of a "test set" in the context of AI models (e.g., a set of medical images) does not apply here.

• Sample Size for Testing: The document does not specify exact sample sizes for each type of bench or biological test (e.g., how many catheters were subjected to tensile testing, or how many biological samples were used for biocompatibility). This information is typically found in detailed test protocols, not summary documents.
• Data Provenance: Not applicable in the context of a medical device's physical and biological performance testing. The "data" are generated from laboratory and bench tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is not an AI model requiring experts to establish ground truth for image interpretation or diagnosis. The "ground truth" for a physical device's performance is established by scientific and engineering standards and validated test methods.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of human interpretation or AI output requiring adjudication. Performance is measured against engineering and biological standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This document pertains to regulatory clearance for a physical medical device, not a diagnostic AI system or a system requiring human interpretation.

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

Not applicable. This device is a physical electrosurgical catheter, not an algorithm.

7. The Type of Ground Truth Used

For the performance testing of the Empower RF Catheter, the "ground truth" is based on:

• Compliance with recognized international and national standards: e.g., ISO 10993 series for biocompatibility, AAMI TIR 33, ISO 11137 series for sterilization, IEC 60601 series for electrical safety.
• Established engineering principles and test methodologies: For bench tests like tensile testing, dimensional inspection, corrosion resistance, and ex-vivo ablation.
• Defined design requirements: The document states that testing demonstrated the device "meets the defined design requirements."

8. The Sample Size for the Training Set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

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