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The US Endoscopy Endoscopic Retrieval Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.

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The provided document is a 510(k) premarket notification letter from the FDA for "The US Endoscopy Endoscopic Retrieval Device." This letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This type of FDA clearance does not typically involve the rigorous multi-reader multi-case (MRMC) comparative effectiveness studies, standalone algorithm performance studies, or detailed statistical evaluations of acceptance criteria that would be conducted for novel AI/ML medical devices.

Instead, substantial equivalence is determined by demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or has different technological characteristics but does not raise different questions of safety and effectiveness.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this type of regulatory document.

Here's why and what can be inferred:

Reasons for Absence of Requested Information:

• Device Type: This is for an "Endoscopic Retrieval Device," which is a physical instrument (likely a forceps or snare) used to grasp and retrieve objects during endoscopy. It is not an AI/ML diagnostic or prognostic device.
• Regulatory Pathway (510(k)): The 510(k) pathway is for demonstrating substantial equivalence to a legally marketed predicate device. This typically involves bench testing, biocompatibility testing, and sometimes limited clinical testing, but not the extensive multi-reader performance studies or detailed statistical analyses of acceptance criteria for diagnostic accuracy characteristic of AI/ML devices.
• Focus of the Document: The provided text is an FDA clearance letter and an "Indications for Use" statement. These documents confirm clearance and define intended use, but do not contain detailed study reports.

Information that CAN be inferred or stated based on the document:

• Acceptance Criteria and Reported Device Performance: This information is not provided in a quantified manner. The letter establishes "substantial equivalence" as the primary acceptance criterion, meaning the device performs similarly to existing predicate devices.
• Sample Size for Test Set and Data Provenance: Not applicable for this type of device and regulatory submission as detailed in the document. Performance would typically be assessed through bench testing (e.g., strength, durability, material compatibility) rather than a clinical "test set" in the context of diagnostic accuracy.
• Number of Experts and Qualifications for Ground Truth: Not applicable. For physical medical devices, "ground truth" might relate to physical properties or performance in a simulated environment, not expert consensus on diagnostic images.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is typically for evaluating the impact of AI on human diagnostic performance, which is not relevant for a physical endoscopic retrieval device.
• Standalone (algorithm-only) Performance: No. This is not an algorithm.
• Type of Ground Truth Used: Not applicable in the context of diagnostic accuracy. "Ground truth" for this device would relate to its mechanical function and safety (e.g., ability to grasp, material integrity, biocompatibility).
• Sample Size for Training Set: Not applicable. This device is not an AI/ML model that undergoes "training."
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is for a physical medical device cleared via the 510(k) pathway based on substantial equivalence. It does not contain the information requested, which is typically associated with the evaluation and clearance of AI/ML diagnostic or prognostic devices.

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Endoscopic Retrieval is a procedure whereby a foreign body, polyp or tissue, stone or calculi is removed from the gastrointestinal tract or biliary tract. A retrieval device is an instrument which enables the physician to grasp and retrieve the object via endoscopic methods.

The retrieval basket is introduced through an endoscope and the basket is placed around the object. Retrieval baskets have been clinically used for more than 20 years.

This document is a 510(k) summary for an endoscopic retrieval device from 1996. It does not contain the detailed information requested regarding acceptance criteria, device performance metrics, study design, expert qualifications, or ground truth establishment for a modern AI/ML-based medical device.

The document describes a traditional medical device (retrieval basket) and its intended use, contraindications, manufacturing overview, and sterilization methods. It references clinical use of retrieval baskets for over 20 years, implying established safety and effectiveness. However, it does not present any specific study data or acceptance criteria in the format requested for AI/ML performance evaluation.

Therefore, I cannot provide the requested table and study details based on the provided text. The information is not present in this 510(k) summary.

Ask a specific question about this device