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Single Use Rotatable and Repositionable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1) Endoscopic marking 2) Hemostasis for: Mucosal/sub-mucosal defects

The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the clip. The delivery system is available in three different working length. The clip is deployed from the delivery system during use. The hemoclip jaws can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site.

The provided document is an FDA 510(k) premarket notification for a medical device called the "Single Use Rotatable and Repositionable Hemoclip." This type of submission aims to demonstrate that a new device is "substantially equivalent" (SE) to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials as would be required for a Premarket Approval (PMA).

As such, the document does not describe a study that proves the device meets specific acceptance criteria in the manner of a clinical trial for an AI/algorithm-based device. Instead, it focuses on demonstrating equivalence through non-clinical testing and comparison to predicate devices.

Therefore, many of the requested details about acceptance criteria, test set sizes, expert involvement, and ground truth establishment (which are typical for AI/algorithm performance studies) are not applicable to this 510(k) submission.

Here's a breakdown of the information that is available and what is not for this specific product, structured to address your points as much as possible:

Acceptance Criteria and Device Performance (Not applicable in the context of an algorithm or AI performance)

This device is a mechanical medical instrument (hemoclip), not an AI or algorithm-based device. Therefore, the "acceptance criteria" here refer to meeting design specifications and demonstrating performance comparable to predicate devices through bench testing (mechanical and biocompatibility). There are no performance metrics like sensitivity, specificity, or accuracy for an AI.

Table of Acceptance Criteria and Reported Device Performance (as per non-clinical testing for a mechanical device):

Study to Prove Device Meets Acceptance Criteria

The "study" refers to the non-clinical testing described, not a clinical trial or AI performance study.

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

   • Sample Size: Not explicitly stated numerically for each non-clinical test (e.g., how many clips were tested for clamping strength). However, the general statement "Performance test was performed on both the proposed device and predicate device" implies a sufficient number of samples were tested to robustly compare performance and draw conclusions of no significant difference.
   • Data Provenance: The tests were conducted internally by Anrei Medical (Hangzhou) Co., Ltd. in the People's Republic of China, as indicated by the sponsor's identification. This is non-clinical laboratory data.
   • Retrospective or Prospective: These are laboratory bench tests conducted prospectively to gather data for the submission.

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

   • Not Applicable. This is a mechanical device. Ground truth, in the context of an AI device, refers to expert labeling of medical images or other data. For a mechanical device, "ground truth" is measured physical properties or biological responses to materials (e.g., measuring clamping force, observing cell growth in cytotoxicity tests, or confirming sterility). These are objective measurements against established standards, not expert consensus on interpretations.

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

   • Not Applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for AI/imaging devices. For mechanical performance and biocompatibility tests, results are derived from objective measurements and laboratory protocols, not human adjudication between different interpretations.

4. 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:

   • No. This is a mechanical device, not an AI or imaging device. Therefore, MRMC studies are not relevant.

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

   • Not Applicable. As a mechanical device, there is no "algorithm only" performance.

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

   • Objective Measurements Against Standards. The "ground truth" for this device's performance is established by objective physical and biological tests according to recognized international and national standards (e.g., ISO, ASTM, USP). For example:
     • Biocompatibility: Established biological reactions (e.g., no cytotoxicity via cell culture tests).
     • Mechanical Properties: Measured physical forces (e.g., tensile strength in Newtons, clamping force).
     • Sterility: Absence of microbial growth, reaching a specific SAL.
     • Shelf Life: Data demonstrating stability of materials/performance over time.

7. The sample size for the training set:

   • Not Applicable. This is a mechanical device, not an AI requiring a "training set."

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

   • Not Applicable. There is no training set for this type of device.

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