(159 days)
This instrument is intended to be used with Olympus endoscope for endoscopic clip placement within the gastrointestinal (GI) tract. It is indicated to be used for
(1) endoscopic marking
(2) hemostasis for
(a) mucosal/sub-mucosal defects
The subject device is composed of two parts, the clip fixing device. The clip can be closed and re-opened. The clip is pre-loaded in the clip fixing device, connected with an operation wire. The clip will open when the slider of the clip fixing device is pushed, and close when it is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider is pulled further, the clip closes completely. The clip will be released when the slider is pushed.
The provided text is a 510(k) summary for a medical device (Single Use Repositionable Clip) and describes non-clinical testing performed to establish substantial equivalence to a predicate device. It does not describe a study involving a comparison of an AI device's performance against human readers or a standalone AI algorithm. Therefore, many of the requested sections regarding AI device performance, reader studies, and AI ground truth cannot be extracted from this document.
However, I can extract information related to the device's acceptance criteria and the non-clinical studies conducted to demonstrate its performance.
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):
| Acceptance Criteria Category | Device Performance (Based on Bench Testing) |
|---|---|
| Basic Performance | Tested and met criteria |
| Clip Reopening Ability | Tested and met criteria |
| Opening Width | Tested and met criteria |
| Rotation Mechanism | Tested and met criteria |
| Compatibility with Endoscopes | Tested and met criteria |
| Tensile Strength | Tested and met criteria |
| Clip Retention (Locked) | Tested and demonstrated to remain locked under simulated conditions within a two-week duration. |
| Biocompatibility | Demonstrated to be biocompatible for both the clip and delivery device. |
| MRI Compatibility | Demonstrated to be MRI conditional. |
Study Details (Non-Clinical Testing):
- Sample size used for the test set and the data provenance: This information is not provided in a detailed manner. The document mentions "performance testing were conducted including the basic performance, ability of the clip to reopen, the opening width, the rotation mechanism, compatibility with endoscopes, and tensile strength," and "bench testing was performed to demonstrate that the clip remains locked." Specific sample sizes for each of these tests are not disclosed, nor is the data provenance beyond "bench testing" and "simulated conditions."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was non-clinical bench testing, not expert-adjudicated data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This was non-clinical bench testing, not expert adjudication.
- 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 document describes a traditional medical device (a repositionable clip), not an AI-powered device, and therefore no MRMC study with AI assistance was performed or reported.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this non-clinical testing was based on established engineering and biocompatibility standards and specific performance requirements for the device (e.g., measuring opening width, tensile strength, retention time, etc.).
- The sample size for the training set: Not applicable. This is not an AI device, so there is no training set in the context of machine learning.
- How the ground truth for the training set was established: Not applicable. As this is not an AI device, there is no training set mentioned in the context of machine learning.
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.