Search Results

The Single Use Hemoclip Device 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 < 3cm, (b) bleeding ulcers, (c) polyps < 1.5cm in diameter, (d) diverticula in the colon, (3) as a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively (4)the age of the intended population for the device is for patients who are 18 and older.

The proposed device Single Use Hemoclip 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.

The provided text describes a 510(k) premarket notification for a medical device (Single Use Hemoclip) and demonstrates its substantial equivalence to predicate devices. However, the document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered medical device, which the provided prompt seems to be specifically asking for.

The acceptance criteria typically outlined in AI/ML medical device submissions (as per the prompt's structure) would include metrics like sensitivity, specificity, AUC, and performance targets against "ground truth" established by experts. The provided document instead focuses on equivalence testing for a physical medical device (a hemoclip), detailing mechanical and biological testing to ensure its safety and performance.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance: Because the document does not define such criteria or report AI/ML performance metrics.
2. Sample size and data provenance for the test set: Not applicable for a physical device.
3. Number of experts and qualifications for ground truth: Not applicable for a physical device.
4. Adjudication method for the test set: Not applicable for a physical device.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for a physical device.
6. Standalone (algorithm-only) performance: Not applicable as there is no algorithm.
7. Type of ground truth used: Not applicable.
8. Training set sample size: Not applicable.
9. How ground truth for training set was established: Not applicable.

The "Performance data" section in the document (Page 8, Item 7) lists bench tests conducted on the Single Use Hemoclip, which are relevant for a physical device, but not for an AI/ML driven one:

• Dimensional verification
• Mechanical Integrity of Clip Assembly
• Clamping Strength Testing
• Tensile Strength Testing
• Release Force Testing
• Rotation Testing

The conclusion states that "The testing performed demonstrated that the proposed and predicate delivery systems are equivalent." This is the "proof" for this specific device, based on physical and material properties, not AI/ML performance.

In summary, the provided document relates to the 510(k) clearance of a physical medical device and thus does not contain the information requested about AI/ML device acceptance criteria and performance studies.

Ask a specific question about this device