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The GenCut core biopsy system is utilized through a flexible endoscope or with the superDimension™ navigation system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.

The GenCut™ core biopsy system (GenCut system) is an endobronchial biopsy system that consists of a core biopsy tool, extension tube, locking syringe, and a tissue removal brush. The GenCut system is intended to retrieve tissue specimens from lungs during an endobronchial lung biopsy procedure. The product is used either through a flexible endoscope or in conjunction with the superDimension™ navigation system (cleared under 510(k) K092365).

The core biopsy tool is comprised of a polymeric shaft with steel braid reinforcement and a stainless steel side-cutting tip. The extension tube connects to the proximal end of the core biopsy tool shaft via a connection hub. The extension tube fittings allow the user to provide suction to the shaft via the supplied syringe. Upon completion of sampling, the tissue removal brush can be inserted through the length of the shaft to collect any remaining tissue not expelled through aspiration.

The product is packaged in a Tyvek pouch and sterilized with ethylene oxide. The product package contains the core biopsy tool and the following associated accessories:

• Extension tube .
• Locking syringe .
• Tissue removal brush ●

Here's an analysis of the acceptance criteria and the study proving the GenCut™ Core Biopsy System meets them, based on the provided text:

Acceptance Criteria and Device Performance for GenCut™ Core Biopsy System

The document states, "All acceptance criteria were met" for the preclinical study. However, the specific quantitative acceptance criteria or performance metrics are not explicitly defined in the provided text. The document only broadly states that the device was evaluated for its ability to retrieve specimens from lung tissues.

Therefore, the table below reflects what can be inferred rather than explicitly stated quantitative criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: A "preclinical study was conducted in a porcine model." The exact number of porcine subjects is not specified.
• Data Provenance: Prospective (animal study mimicking clinical use). Country of origin is not specified.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Three physicians.
• Qualifications of Experts: Two pulmonologists and one thoracic surgeon. Years of experience are not specified.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated. It says "All acceptance criteria were met. Therefore, the design of the GenCut system meets the intended use." This implies a consensus or agreement among the experts regarding the successful performance, but the specific process (e.g., 2+1, 3+1) is not detailed.

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

No MRMC comparative effectiveness study was done. The study described is a preclinical animal study evaluating the device's performance, not comparing human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical core biopsy system, not an AI algorithm. Therefore, a standalone (algorithm-only) performance evaluation is not relevant.

7. Type of Ground Truth Used

The ground truth for the animal study was based on the direct observation and assessment of the three expert physicians (two pulmonologists and one thoracic surgeon) during the biopsy procedures in the porcine model. This would likely involve:

• Successful specimen retrieval.
• Quality of the retrieved specimens (though not explicitly detailed).
• Ease of use and functionality of the device.
• Absence of complications related to the device.

8. Sample Size for the Training Set

Not applicable. This device is a physical core biopsy system, not an AI or machine learning model that requires a "training set."

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

Not applicable. As this is not an AI/ML device, there is no "training set" or ground truth associated with it in that context. The "ground truth" for its performance evaluation (animal study) was established by direct expert observation and assessment.

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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

The LungPoint Software is a device that guides a bronchoscope and commercially available endoscopic tools to a prespecified target in or adjacent to the bronchial tree by providing a path, which is displayed on a 3D reconstruction of a CT scan. The Software allows visualization of the interior of the bronchial tree; placement of catheters in the bronchial tree; visualization of a prespecified target in lung tissue; and placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery. The FlexNeedle is an aspiration needle. When used together with the LungPoint Software, the needle can be guided to a prespecified targeted area within the respiratory organs.

The software is installed on an off-the-shelf PC computer system, and is intended to be used with commercially-available flexible bronchoscopes with CT scans that are saved in DICOM format.

The provided text is a 510(k) summary for the LungPoint™ Planning and Virtual Bronchoscopic Navigation (VBN) Software. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies with acceptance criteria and specific statistical results.

Therefore, many of the requested details about acceptance criteria, performance data, test set characteristics, expert qualifications, and ground truth establishment are not explicitly available in the provided text.

Here's an analysis based on the information that is present:

1. A table of acceptance criteria and the reported device performance

The document states: "No new risks were identified as the use of endoscopic tools, like the FlexNeedle, is inherent to the design and intended use of the existing LungPoint Software. Additionally, no new verification and validation testing was performed as the software was not modified in any way to allow for the use of the FlexNeedle."

This indicates that the primary "acceptance criterion" for this specific 510(k) submission was the absence of new risks or modifications to the software that would necessitate new performance testing. Therefore, there is no direct table of acceptance criteria and reported device performance for this submission. The performance of the underlying LungPoint Software would have been established in previous 510(k) clearances (K091160).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the text, as no new performance testing was conducted for this specific submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the text, as no new performance testing was conducted for this specific submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the text, as no new performance testing was conducted for this specific submission.

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

There is no mention of an MRMC comparative effectiveness study or AI assistance in the provided text. The device is described as "guid[ing] a bronchoscope... by providing a path, which is displayed on a 3D reconstruction of a CT scan." This suggests a visualization and navigation tool rather than an AI-assisted diagnostic tool.

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

No standalone performance study is mentioned in the text for this submission. The device is explicitly intended to "aid the physician in guiding endoscopic tools," indicating a human-in-the-loop design.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the text, as no new performance testing was conducted for this specific submission.

8. The sample size for the training set

This information is not provided in the text, as no new performance testing was conducted for this specific submission. The device is not described as being based on machine learning or requiring a "training set" in the context of this 510(k).

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

This information is not provided in the text, as no new performance testing was conducted for this specific submission and the device's mechanism isn't described as requiring a training set in this context.

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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

The superDimension i·Logic inReach System is a device that guides a bronchoscope and endoscopic tools to a target in or adjacent to the bronchial tree on a path identified by CT scan. The superDimension i·Logic inReach System also allows visualization of the target and the interior of the bronchial tree; placement of catheters in the bronchial tree; and placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery. superDimension is introducing the Edge Catheter System for use with the superDimension i·Logic inReach System. The i·Logic inReach System accomodates both the Edge Catheter and the currently available inReach Catheter System.

This 510(k) submission (K102604) for the superDimension® i·Logic™ inReach® System with Edge™ Catheter is a Special 510(k), which indicates a modification to an already cleared device. For such submissions, the FDA typically relies on design control processes, risk management, and verification/validation activities rather than new clinical trials to demonstrate substantial equivalence, especially when the fundamental scientific technology and intended use remain the same.

Therefore, the provided document explicitly states: "Clinical tests were not required to validate the changes to the superDimension inReach System."

This means that the submission does not include a detailed study proving the device meets specific acceptance criteria through a clinical trial or performance study comparing it against predefined metrics. Instead, the justification for meeting acceptance criteria is based on:

• Design Control Process: The Edge Catheter System, i·Logic inReach Software, and Instructions for Use were subjected to the superDimension design control process.
• Risk Management: Risk management was performed to analyze potential hazards associated with the changes.
• Design Verification and Validation: Appropriate design verification and validations were performed to assure the superDimension i Logic inReach System continues to be safe and effective for its intended use.

Since no clinical study data is provided in the document, I cannot fill in the table or answer questions related to sample size, data provenance, expert panels, adjudication, MRMC studies, standalone performance, or training set details. The acceptance criteria themselves are implicitly met through the "safe and effective for its intended use" statement, supported by the design control process rather than quantitative performance metrics from a new clinical study in this specific 510(k).

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