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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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The EndoRotor® is intended for use in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.

The EndoRotor®, with the design modifications and expanded indications for use described in the current 510(k) premarket notification, will continue to be marketed as the EndoRotor®. The new EndoRotor® will be referred to as the "modified EndoRotor" in this 510(k) Summary.

The overall device description remains unchanged since initial FDA clearance. Both the predicate and modified EndoRotor® are powered resection tools consisting of a power console, foot control, specimen trap with pre-loaded filter, and a single-use resection catheter that is inserted into the working channel of a compatible endoscope. The design modifications to the EndoRotor® described in the current 510(k) premarket notification include enhancements to improve the ease of use of the console and catheter components as well as provide flexibility to the gastroenterologist.

The provided text describes modifications to an existing device, the EndoRotor®, and does not present an AI/ML device or its associated performance studies. Therefore, I cannot extract information related to AI/ML specific acceptance criteria, and study details like sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment.

Instead, the document details non-clinical and clinical performance testing conducted to support the substantial equivalence of the modified EndoRotor® to its predicate device (K170120) and to support expanded indications for use.

Here's the relevant information about the acceptance criteria and the studies that prove the device meets them:

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

The document doesn't explicitly list acceptance criteria in a quantitative table format with corresponding numerical performance for the modified device in the same way an AI/ML device submission might. Instead, it states that:

2. Sample size used for the test set and the data provenance:

• Non-clinical (Animal Testing for Predicate Device, applicable to modified):

  • Sample Size: 6 porcine animals (4 recovery, 2 acute) for mucosal resections, totaling 124 mucosal resections. Additionally, 4 animals for design validation and usability assessment.
  • Data Provenance: Porcine animal model.

• Clinical (Investigator-led study in UK):

  • Sample Size: 19 patients.
  • Data Provenance: Retrospective, from Queens Alexandra Hospital in Portsmouth, United Kingdom.

• Clinical (Commercial procedures in Western Europe):

  • Sample Size: 78 patients.
  • Data Provenance: Real-world commercial procedures in Western Europe (Austria, Germany, The Netherlands, Switzerland, and the United Kingdom). The document implies this data is also retrospective "compiled data provides real world clinical evidence".

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

• Clinical (Investigator-led study in UK):
  • Number of Experts: Not explicitly stated, but the study was conducted by "Gastroenterologists" in Queens Alexandra Hospital.
  • Qualifications: "trained gastroenterologist" as per the Indications for Use. The study authors are listed as Khandiah K, Subramanian S, Thayalasekaran S, Chedgy F, and Bhandari P, implying multiple gastroenterologists were involved.
• Clinical (Commercial procedures in Western Europe):
  • Number of Experts: Not explicitly stated, but implies "Physicians" performing the procedures.
  • Qualifications: "trained gastroenterologist" as per the Indications for Use.

4. Adjudication method for the test set:

Not explicitly mentioned for the clinical studies. Decisions appear to have been made by the treating gastroenterologists.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This is a medical device submission, not specifically an AI/ML device, and the studies performed focused on the safety and effectiveness of the device itself rather than human reader improvement with AI assistance.

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

Not applicable, as this is a medical device (EndoRotor®), not an algorithm. The device is always under the control of a trained physician.

7. The type of ground truth used:

• Non-clinical (Animal Testing): Histopathological assessment of tissue response (favorable and clinically acceptable tissue response).
• Clinical (Investigator-led study in UK & Commercial procedures): Physician assessment of lesion presence/scarring and procedure outcomes (disease eradication, luminal preservation, avoidance of surgery, no incidences of perforation or delayed bleeding). This can be considered expert consensus/clinical outcomes data.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device; therefore, there isn't a "training set" in that context. The device's design improvements were based on feedback and engineering enhancements.

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

Not applicable for the same reason as above.

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The EndoRotor is intended for use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection).

The EndoRotor is a powered resection tool consisting of a power console, foot control, specimen trap with pre-loaded filter, and a single-use resection catheter that is inserted into the working channel of a compatible endoscope. The catheter consists of an outer cylindrical cannula attached to a braided catheter and a second inner cylindrical cannula positioned inside the lumen of the outer cannula. The inner tube has blades cut into the distal end, which is oriented adjacent to the distal end of the outer tube. A torque coil, located inside the braid, is attached directly to the inner tube, and provides rotation to the cutting tool when actuated by a foot pedal controlled drive motor. The inner tube rotates relative to the outer tube along its longitudinal axis to simultaneously cut tissue at the distal end only when the user actuates suction aspirating tissue through the lumen. The specimen is collected by a micron filter that is positioned in the flow path (in the single use specimen trap) that is mounted in a dedicated slot on the console.

The provided text does not contain typical acceptance criteria for an AI/ML medical device, nor does it describe a study specifically designed to prove that the device meets such criteria in the context of AI/ML performance (e.g., diagnostic accuracy, sensitivity, specificity, or human-in-the-loop improvement). Instead, it describes a device for endoscopic tissue removal (EndoRotor) and the non-clinical and pre-clinical testing performed to establish its safety and effectiveness for FDA 510(k) clearance based on substantial equivalence to a predicate device.

The study presented is a pre-clinical animal study and non-clinical performance testing for a mechanical device, not an AI/ML algorithm. Therefore, many of the requested elements pertaining to AI/ML acceptance criteria, ground truth, expert adjudication, MRMC studies, and training sets are not applicable to the provided document.

However, I can extract information related to the device's performance as presented in the safety and effectiveness studies.

Here's an interpretation based on the provided document, addressing the closest relevant points:

Device: EndoRotor (Mechanical Tissue Resection Device)
Regulatory Submission: 510(k) Premarket Notification (K170120)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify formal, quantitative acceptance criteria for device performance in the same way an AI/ML device would have for accuracy metrics. Instead, the "acceptance criteria" are implied by successful completion of mechanical performance tests, biocompatibility, sterilization, shelf-life testing, and acceptable safety outcomes in an animal study to demonstrate substantial equivalence to the predicate device.

• 97 (79.5%) had mild bleeding (self-limiting, resolved 2 min without intervention).
• 1 (0.82%) had severe bleeding (resolved after epinephrine administration). |
  | Absence of device-related perforation | 2 (1.6%) perforations occurred out of 124 resections, both in the acute group. Attributed to "inadequate (too deep) pre-resection submucosal injection, rather than the device itself." |
  | Deepest affected layer (Microscopic evaluation) | Confirmed that the submucosa or, rarely, the muscularis mucosa was the deepest affected layer through all of the resections, indicating appropriate tissue depth control. |
  | Animals tolerating treatment and surviving | All animals tolerated the treatment procedures and survived to the scheduled necropsy time point. |
  | Specimen handling (No residual specimen in catheter, entire specimen captured) | An evaluation study confirmed: "when proper procedure is followed as provided in the labeling, including a post procedure flush, there is no residual specimen in the catheter". "The study confirms that the entire specimen is captured by the specimen trap." |
  | Usability (Clinical performance meeting system requirements) | "Usability studies were conducted to evaluate the clinical performance of the proposed EndoRotor. The results confirmed that all system requirements related to usability were met." |

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

• Test Set (Animal Study):
  • Sample Size: 6 porcine animals (4 recovery, 2 acute). A total of 124 mucosal resections created.
  • Data Provenance: Not explicitly stated, but typically pre-clinical animal studies are conducted in a controlled lab environment. No country of origin for the data is specified. The study was performed under Good Laboratory Practice (GLP), indicating a controlled, high-quality pre-clinical study.
  • Retrospective/Prospective: Prospective (experimental study in animals).

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

• Ground Truth Establishment: The ground truth for the animal study (e.g., bleeding scores, perforations, deepest affected layer) was established through direct observation during the procedures, necropsy, and microscopic evaluation of resected tissue.
• Number of Experts: Not specified. Pathologists would typically be involved in the microscopic evaluation, and veterinary surgeons in the animal procedures, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Not specified. This is often not explicitly detailed for pre-clinical animal studies unless there are subjective outcome assessments that require multiple observers. The listed outcomes (bleeding scores, perforations, histological depth) typically follow defined protocols.

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

• No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images with or without AI assistance. This document describes a mechanical surgical device and its pre-clinical testing, not a diagnostic AI/ML algorithm.

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

• Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

• For Animal Study (Safety/Physical Performance): Direct physiological outcomes, surgical observations, and histological examination of tissue (e.g., bleeding, perforation, depth of resection).

8. The Sample Size for the Training Set

• Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."

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

• Not applicable. (See #8)

Summary Points:

The provided document describes the regulatory submission for a mechanical medical device (EndoRotor) and its supporting safety and performance data. The "acceptance criteria" and "studies" are geared toward demonstrating mechanical safety, functionality, and biological compatibility, primarily through non-clinical bench testing and a pre-clinical animal study. It does not involve an AI/ML component, and thus concepts like training/test sets for AI, expert adjudication of AI outputs, or MRMC studies for AI assistance are not relevant to this specific premarket notification.

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