(266 days)
The Resolution 360 ULTRA Clip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of:
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Endoscopic marking
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Hemostasis for:
-Mucosal/sub-mucosal defects
The Resolution 360TM ULTRA Clip 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 Resolution 360™ ULTRA Clip delivery system is offered in a 235cm working length.
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 Resolution™ 360 ULTRA Clip 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 clip jaws will be available with a 17mm clip opening.
This document is a 510(k) summary for the Boston Scientific Resolution 360™ ULTRA Clip. It does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, I cannot provide information on acceptance criteria, reader improvement with AI assistance, or standalone algorithm performance for such a device.
However, I can extract information regarding the device acceptance criteria and the bench tests conducted to demonstrate the Resolution 360™ ULTRA Clip meets these criteria.
Here's the information based on the provided text, focusing on the device's physical and functional performance:
Accepted Criteria and Reported Device Performance
The document states that the proposed device was evaluated against predefined acceptance criteria, and the performance met these requirements. While the specific numerical acceptance criteria are not detailed in this summary, the document lists the bench tests performed to demonstrate compliance.
| Acceptance Criterion (Inferred from Test) | Reported Device Performance (Implied "Meets Requirements") |
|---|---|
| Clip Assembly Repeated Open/Close | Met pre-defined acceptance criteria |
| Clip Opening Gap | Met pre-defined acceptance criteria |
| Retention Force | Met pre-defined acceptance criteria |
| Clip Opening Force | Met pre-defined acceptance criteria |
| Clip Close Force | Met pre-defined acceptance criteria |
| Scope Compatibility/Usability | Met pre-defined acceptance criteria |
| Endoscope Damage - Clip Passibility | Met pre-defined acceptance criteria |
| Magnetic Resonance (MR) Conditional | Determined to be an MR Conditional device |
Study Details (Focusing on Device Performance, not AI)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary.
- Data Provenance: The tests are "bench tests," meaning they were conducted in a laboratory setting. The country of origin of the data is not specified, but the applicant is Boston Scientific Corporation, located in Marlborough, MA. The study is prospective in the sense that the tests were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as these are bench tests for a mechanical clip, not a diagnostic device requiring expert interpretation for ground truth. Performance is measured objectively.
4. Adjudication method for the test set:
- Not applicable for bench testing of a mechanical device. Performance is determined by direct measurement against specifications.
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, this was not done. This submission is for a medical device (hemostatic clip), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this was not done. This submission is for a medical device (hemostatic clip), not an algorithm.
7. The type of ground truth used:
- The "ground truth" for these bench tests would be the pre-defined engineering specifications and performance targets for the device's mechanical and functional characteristics.
8. The sample size for the training set:
- Not applicable. This is not an AI/Machine Learning study, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set. The "ground truth" for the device's general design and functional requirements would be established through engineering design principles, industry standards (like ISO 10993, ISO 11135-1, ISO 10993-7), and regulatory guidance (like the FDA Guidance for Establishing Safety and Compatibility of Passive Implants in the MR Environment).
§ 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.