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The SureClip(TM) Repositionable Hemostasis Clip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: (1) endoscopic marking, (2) hemostasis for (a) mucosal / sub-mucosal defects

Device Description

The proposed device SureClip™ Repositionable Hemostasis Clip is a sterile, single-use endoscopic clipping device, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically a hemostasis clip. Therefore, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria for a novel AI or diagnostic system.

The "acceptance criteria" discussed in this document refer to various engineering and biological safety standards for the device itself, rather than performance metrics for an analytical or diagnostic function.

Based on the provided text, here's an analysis regarding your request:

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

The document does not provide a table of "acceptance criteria" in the sense of predefined performance metrics (e.g., sensitivity, specificity, accuracy) that an AI or diagnostic device would need to meet. Instead, it refers to performance standards for the physical device.

The study indicates that the SureClip™ Repositionable Hemostasis Clip met the requirements of several ISO standards and underwent specific bench tests. The compliance with these standards and the results of the bench tests are the "reported device performance" in this context.

Acceptance Criteria (Standards/Tests)	Reported Device Performance
ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within A Risk Management Process"	The proposed device "meets the requirements" of this standard. This implies that the device's biocompatibility has been evaluated and found acceptable according to the standard.
ISO 11135 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices"	The proposed device "meets the requirements" of this standard. This indicates that the ethylene oxide sterilization process for the device has been developed, validated, and controlled according to the standard, ensuring sterility.
ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals"	The proposed device "meets the requirements" of this standard. This suggests that the levels of ethylene oxide residuals on the device after sterilization are within acceptable limits as defined by the standard.
Bench Tests:	Results:
Dimensional verification	Performed, implying that the device dimensions conform to specifications. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies that the dimensions are comparable and acceptable.
Mechanical Integrity of Clip Assembly	Performed, implying the clip assembly maintains its structural integrity under specified conditions. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the mechanical integrity is comparable and acceptable.
Clamping Strength Testing	Performed, implying the clip can exert and maintain adequate clamping force. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the clamping strength is comparable and acceptable. However, specific values are not provided.
Tensile Strength Testing	Performed, implying the device components can withstand specified tensile forces. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the tensile strength is comparable and acceptable.
Release Force Testing	Performed, implying the clip can be released with an appropriate and controlled force. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the release force is comparable and acceptable.
Rotation Testing	Performed, implying the device can be rotated as intended in use. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the rotational capability and performance are comparable and acceptable.

Important Note: This document does not concern an AI or diagnostic device. The "acceptance criteria" here are related to the safety and fundamental functionality of a physical medical instrument (a hemostasis clip), not to the diagnostic or predictive performance of an algorithm.

The remaining points (2-9) are not applicable to this document as they relate to studies for AI/diagnostic devices, which involve performance metrics like sensitivity, specificity, reader studies, and ground truth establishment. This 510(k) submission focuses on demonstrating substantial equivalence of a physical device through benchmark testing and compliance with recognized standards.

Specifically:

2. Sample sized used for the test set and the data provenance: Not applicable. This document is about a physical device, not an algorithm being tested on data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering specifications and test methodologies, not expert consensus on diagnostic data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a physical device, "ground truth" would be the device meeting its engineering design specifications and safety standards.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

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