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The EndoRotor device is indicated to resect and remove necrotic tissue in symptomatic Walled off pancreatic necrosis /Walled off necrosis (WOPN/WON) after having undergone endoscopic ultrasound (EUS) guided drainage.

The EndoRotor ® is a powered resection tool intended to morcellate necrotic pancreatic tissue through the instrument biopsy channel of an endoscope. The device is to be used after a patient has undergone a procedure to drain any fluid accumulated in the pancreas due to pancreatitis.

This document describes the EndoRotor, an endoscopic pancreatic debridement device. The information provided outlines its regulatory classification, indications for use, device description, and summarizes nonclinical and clinical studies conducted to support its safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the EndoRotor device are related to its effectiveness in reducing the volume of Walled-off Pancreatic Necrosis (WOPN) and its safety profile. A direct set of quantitative acceptance criteria for the device's performance is not explicitly stated in the provided text as 'acceptance criteria,' but rather as effectiveness endpoints evaluated in the IDE study. For the purpose of this response, I will interpret the key effectiveness endpoints from the IDE study as the de facto acceptance criteria used for approval.

Note on (b) (4): The document contains redacted information indicated by "(b) (4)". Where percentages or specific values are given in descriptive text alongside these redactions, I've used the descriptive values (e.g., "more than 98% volume reduction", "82%") if they clearly correspond to the redacted field.

2. Sample Sizes and Data Provenance

Test Set (IDE Study, G180127):

• Sample Size: 30 subjects were treated with the device (Intent-to-Treat, ITT). 22 subjects were included in the Per Protocol (PP) analysis. Multiple procedures were performed, totaling 63 procedures.
• Data Provenance: Multicenter and multinational trial, with ten centers. 23 out of 30 (77%) subjects were treated in U.S. centers. This was a prospective study.

Erasmus Investigator Study (Supporting Data):

• Sample Size: 12 subjects were treated (8 with Version 1, 4 with Version 2 of the device).
• Data Provenance: Conducted in the Netherlands, a prospectively-defined cohort.

Real World Data (Supporting Data):

• Sample Size: Data were collected for 134 EndoRotor DEN/ETN procedures in 108 subjects. For effectiveness analysis with baseline and follow-up imaging, 29 subjects with a known number of procedures were analyzed.
• Data Provenance: Obtained from institutions outside the US. The data were not collected as part of a formally designed retrospective clinical study.

Literature Review (Supporting Data):

• Search Yield: Initially 2,527 articles (after duplicate elimination). Narrowed down to 28, then 5 articles were utilized by FDA for qualitative comparison.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience").

However, it implicitly relies on:

• Treating Physicians/Investigators: For clinical assessments, symptomatology, and determination of additional treatments.
• Radiologists/Clinicians: For CECT interpretations at baseline and follow-up to measure WOPN volume. The protocol required investigators to use the Atlanta Classification for necrotic collections on CECT, suggesting a standardized diagnostic approach interpreted by medical professionals.
• Pathology: To confirm infection through positive culture obtained by fine needle aspiration (FNA) for inclusion criteria.

4. Adjudication Method for the Test Set

The document does not explicitly detail an adjudication method (e.g., 2+1, 3+1) for the test set results. The primary effectiveness endpoint (percent volume reduction) was measured by contrast-enhanced CT, comparing baseline and follow-up scans. While the Atlanta Classification was used for determining necrotic collections, there is no mention of independent readers or an adjudication process for these measurements or other endpoints. Decisions on additional treatments were based on the treating clinician's judgment.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The EndoRotor is a physical medical device for tissue debridement, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable, as the EndoRotor is a physical device, not a standalone algorithm. Its performance is tied to its use by a human operator.

7. Type of Ground Truth Used

The ground truth for the effectiveness endpoints primarily relied on:

• Imaging Data: High-resolution, contrast-enhanced CT (CECT) scans at baseline and 21 (± 7) -day follow-up. This was used to quantitatively measure the volume of WOPN/WON and its reduction.
• Clinical Assessment: Symptomatology, physical examination, adverse events.
• Pathology/Laboratory: Positive culture obtained by fine needle aspiration (FNA) to confirm infection.
• Clinical Judgement: For decisions regarding additional procedures and assessment of adequacy of debridement (though FDA did not rely on subjective endoscopic assessment for effectiveness).

8. Sample Size for the Training Set

The document does not describe a separate "training set" in the context of device development or algorithm training. The clinical studies (IDE, Erasmus, RWD) serve as validation for the device's performance in human subjects.

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

As there is no distinct "training set" described for an algorithm, this question is not fully applicable. However, if interpreted as "how device design and operational parameters were refined," it would involve non-clinical (bench) and animal testing for Version 1 and 2, which informed the device's specifications and performance prior to human trials. Bench testing involved evaluating critical functions and design verification, and animal testing focused on resecting and removing tissue. The "ground truth" for these phases would be engineered performance targets and histological/visual assessment of tissue removal in experimental models.

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The EndoRotor® System is intended for use in airway procedures including removal of granulation tissue and endobronchial lesions.

The EndoRotor® Airway Microdebridement System is a powered resection tool consisting of a power Console with Foot Control, Specimen Trap with pre-loaded filter, and a singleuse Catheter with a cutting tool mounted on the distal end. The EndoRotor's flexible design allows it to be used within the working channel of flexible bronchoscopes in tortuous paths. The Console houses the control panel, drive motor, vacuum control valve, and peristaltic irrigation pump drive. The Catheter includes a debriding cutter and allows for aspiration from the resection site through the bronchoscope working channel to the Specimen Trap.

The provided text describes regulatory information for a medical device (EndoRotor Airway Microdebridement System) and its substantial equivalence determination by the FDA. It does not contain information about acceptance criteria and a study that proves a device meets acceptance criteria in the context of an AI/algorithm-based diagnostic or assistive device.

Instead, the document details:

• Device Identification: EndoRotor Console, Catheter, Specimen Trap, Filter Set, Roll Stand (K190715).
• Intended Use: Airway procedures including removal of granulation tissue and endobronchial lesions.
• Regulatory Classification: Class II, product code ERL (Ear, nose, and throat electric or pneumatic surgical drill).
• Comparison to Predicate Device: XPS 3000 System (Medtronic XOMED, K041413). It highlights similarities in principle of operation (mechanical resection using rotational movement) and differences such as access (flexible bronchoscope vs. rigid), and components (specimen trap).
• Non-Clinical Testing: Biocompatibility, sterilization validation, pyrogenicity, shelf-life, packaging, transport, and functional testing for the catheter; design verification, power-up/set-up, functional, electrical safety, and electromagnetic compatibility testing for the console; procedural testing for the specimen trap. These tests "Met established acceptance criteria." However, specific numerical acceptance criteria and reported performance values are not detailed.
• Clinical Testing: No new clinical study was conducted. Substantial equivalence was based on prior clearance for gastrointestinal use (K181127) where the device demonstrated safety and performance in regions with thin tissue walls, implying its suitability for airway applications.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for an AI/algorithmic device based on the provided text, as this document pertains to a mechanical surgical device. The questions about sample size of test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training sets, and how ground truth was established are all relevant to AI/algorithmic device validation, which is not what this document describes.

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