(209 days)
The Disposable Hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
- Endoscopic marking
- Hemostasis for
• Mucosal/sub-mucosal defects
The Disposable Hemoclip consists of one pre-loaded clip and delivery system for single patient use only. Disposable Hemoclip 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 many times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. The delivery system consists of a handle and delivery catheter. The delivery system will allow for the device to rotate at the distal end.
The provided text describes a 510(k) premarket notification for a medical device, the Disposable Hemoclip. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a detailed clinical study demonstrating improved patient outcomes or diagnostic accuracy.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets those criteria for software or AI-driven diagnostic devices.
Specifically, the document states:
- "No Clinical Study is included in this submission." This means there is no study that evaluates the device's performance in a clinical setting against specific metrics like sensitivity, specificity, or reader improvement with AI assistance.
- The "acceptance criteria" listed for the device relate to non-clinical performance data (e.g., appearance, size, hardness, open/close performance, rotation performance, releasing force, clipping force, peeling force, connection firmness, dimensional verification, and MR safety testing), and compliance with ISO standards (ISO 10993, ISO 11135-1, ISO 10993-7). These are engineering and material specifications, not performance metrics for diagnostic accuracy or clinical effectiveness in the way an AI/software device would have acceptance criteria.
- The device being discussed is a physical medical instrument (a disposable hemoclip), not a software or AI device. Hence, there are no concepts like "ground truth for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," or "training/test set sample sizes" in the context of an AI/diagnostic algorithm.
In summary, this document is not relevant for describing the acceptance criteria and study proving a device meets those criteria for an AI/software-driven diagnostic device. It details a substantial equivalence claim for a physical medical instrument.
§ 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.