(165 days)
The Disposable Hemostatic Clips is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
1.Endoscopic marking
2. Hemostasis for:
Mucosal/sub-mucosal defects
The Disposable Hemostatic Clips consist of one pre-loaded clip and delivery system for single patient use only. It is provided in sterile. The clip is made of stainless steel with good superelasticity performance. The clip is pre-loaded in end of the Spring tube part through its deformation and it is deployed from the delivery system during use.The clip is engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. The device is available in four clip opening widths, which are 9mm, 11mm, 13mm and 16mm, and the device effective length is available in 1650mm, 1950mm and 2300mm.
The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria for a medical imaging or AI-driven diagnostic device.
The document is an FDA 510(k) clearance letter for a Disposable Hemostatic Clips device (K232450) manufactured by Zhejiang Soudon Medical Technology Co.,Ltd. It primarily discusses the device's substantial equivalence to a predicate device, its indications for use, and manufacturing/regulatory compliance.
Here's why the requested information cannot be extracted:
- Device Type: The device is a physical medical instrument (hemostatic clips), not an AI algorithm, medical imaging device, or diagnostic tool that would typically have performance criteria like sensitivity, specificity, or AUC based on a test set and ground truth established by experts.
- Study Type: The document explicitly states under "6. Clinical Test Data" that "No Clinical Study is included in this submission." The non-clinical performance data section ("5. Non-clinical Performance Data") lists bench tests (e.g., appearance, dimensional verification, force tests) which are relevant to the physical and mechanical properties of the clips, not their diagnostic accuracy or performance in a clinical setting compared to human readers.
- Absence of AI/Diagnostic Metrics: There is no mention of sensitivity, specificity, accuracy, expert readers, ground truth establishment, or any other metrics common to the type of studies you're asking about for AI or imaging devices.
Therefore, I cannot populate the requested table or answer the questions related to acceptance criteria, AI performance, test set details, expert qualifications, or adjudication methods based on the provided text.
§ 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.