(143 days)
The Sterile Repositionable Hemostasis Clipping 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
The proposed device Sterile Repositionable Hemostasis Clipping Device 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, the "Sterile Repositionable Hemostasis Clipping Device". This document is submitted to the FDA to demonstrate substantial equivalence to a predicate device, not typically to prove a device meets specific clinical performance acceptance criteria through a study with ground truth. Therefore, many of the requested categories for AI/algorithm performance studies are not directly applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a direct performance table in the typical sense of algorithm-based device performance (e.g., sensitivity, specificity). Instead, it lists bench tests performed to demonstrate equivalence to a predicate device. The general acceptance criterion is that the device "meets the requirements" of relevant ISO standards and that "the testing performed demonstrated that the proposed and predicate delivery systems are equivalent."
| Test Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Biological Evaluation | ISO 10993-1 (Evaluation and Testing) | Meets requirements |
| ISO 10993-7 (Ethylene oxide sterilization residuals) | Meets requirements | |
| Sterilization | ISO 11135-1 (Ethylene Oxide Sterilization) | Meets requirements |
| Bench Tests - Mechanical Integrity | Dimensional verification | Demonstrated equivalence to predicate delivery systems |
| Mechanical Integrity of Clip Assembly | Demonstrated equivalence to predicate delivery systems | |
| Clamping Strength Testing | Demonstrated equivalence to predicate delivery systems | |
| Tensile Strength Testing | Demonstrated equivalence to predicate delivery systems | |
| Release Force Testing | Demonstrated equivalence to predicate delivery systems | |
| Rotation Testing | Demonstrated equivalence to predicate delivery systems |
2. Sample size used for the test set and the data provenance
Not applicable. This is a medical device for physical intervention, not an AI/algorithm-based diagnostic or prognostic device that uses a test set of data. The "tests" mentioned are bench tests on the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device does not rely on expert-established ground truth for its performance evaluation in the context of this 510(k) submission.
4. Adjudication method for the test set
Not applicable.
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. The document explicitly states: "No clinical study is included in this submission." This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical hemostasis clipping device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of AI/algorithm performance. For the bench tests, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device and the relevant ISO standards.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.