(217 days)
The hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
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- Endoscopic marking
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- Hemostasis for
- · Mucosal/sub-mucosal defects
The Hemoclip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel, and polyester materials. The delivery system will allow for the device to rotate at the distal end. The delivery system is offered in 1650mm, 1950mm and 2300mm working lengths. The clip consists of a stainless steel capsule, and clip arms, a Cobalt Chrome Yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The hemoclip jaws are 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. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device.
The provided document, a 510(k) Summary for the Hemoclip, does not contain information about acceptance criteria for device performance based on diagnostic metrics (e.g., sensitivity, specificity) derived from a study involving human readers or ground truth established by experts.
Instead, this document focuses on establishing substantial equivalence for a medical device (Hemoclip) through a series of bench tests and comparison to predicate devices, without involving clinical trials or diagnostic performance studies in the way one might expect for AI/Software as a Medical Device (SaMD) clearances.
Therefore, many of the requested categories cannot be answered from the provided text.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document lists several bench tests that were performed. The acceptance criteria are implicitly "passing" for each test.
| Test Name | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Open and Close | Passing | Passing |
| Clip releasing force | Passing | Passing |
| Clamping strength | Passing | Passing |
| Tensile Strength | Passing | Passing |
| Separation Force | Passing | Passing |
| Rotation property | Passing | Passing |
| Corrosion | Passing | Passing |
| Appearance | Passing | Passing |
| Size | Passing | Passing |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests mentioned are bench tests, not clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. Ground truth by medical experts (e.g., radiologists) is typically established for diagnostic performance studies, which were not conducted for this device clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically used for establishing ground truth in clinical/diagnostic studies.
5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No Clinical test is included in this submission." This device is a mechanical medical instrument, not an AI/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study was not done. This device is a mechanical medical instrument, not an AI/SaMD.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable/provided. The "ground truth" for the bench tests would be defined by engineering specifications and physical test standards (e.g., a force gauge measurement, a caliper measurement), not medical ground truths like pathology or expert consensus.
8. The sample size for the training set
This information is not applicable/provided. There is no mention of a "training set" as this device is not a machine learning or AI product.
9. How the ground truth for the training set was established
This information is not applicable/provided. There is no mention of a "training set" or its ground truth establishment.
§ 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.