(89 days)
The Resolution II Clip is indicated for clip placement within the Gastrointestinal Tract for the purpose of:
- Endoscopic Marking
- Hemostasis for:
- Mucosal/sub-mucosal defects
The Resolution II Clip consists of a pre-loaded, radiopaque, single-use clip on a flexible delivery system. The Resolution II Clip is designed to be compatible with Gastroscopes with working channels ≥2.8, and/or Duodenoscopes and Colonoscopes with working channels ≥3.2mm. The Resolution II Clip jaws are engineered to open and close no more than five times, aiding in repositioning of the clip at the lesion site. Opening and closing capability may be limited by clinical circumstances and patient anatomy, among other factors. The Resolution II Clip will be offered in 155cm and 235cm lengths. The deployed clip is constructed of stainless steel while the delivery system is constructed of stainless steel, polyethylene, and polyester materials.
Here's a breakdown of the acceptance criteria and the study information for the Resolution II Clip, based on the provided documents:
Acceptance Criteria and Device Performance for Resolution II Clip
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided documents do not explicitly list quantitative acceptance criteria in a pass/fail format with specific thresholds. Instead, they state that "All device bench test results were acceptable" and "All biocompatibility tests... passed." The table below reflects the types of tests performed and the general findings.
| Test Category | Specific Tests Performed | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Subacute (Subchronic) Toxicity (Intraperitoneal and Intravenous), Genotoxicity (Ames Assay and Mouse Lymphoma), Implantation, USP Physicochemical | Device materials must not cause adverse biological reactions or toxicity as per EN ISO 10993-1:2009. | All biocompatibility tests passed; device considered biocompatible for intended use. |
| Mechanical/Physical | Forces, Tensile Strengths, Corrosion Resistance, Dimensional, Endoscope Compatibility | Device must meet design specifications for mechanical integrity, material properties, and compatibility with specified endoscopes as per ISO 14630:2008. | All device bench test results were acceptable; sufficiently meets design specifications. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench testing and biocompatibility testing rather than a clinical study with a "test set" in the context of human data. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable in this context. The tests were performed on the device itself and its components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation was based on bench testing and biocompatibility testing of the device, not on diagnostic accuracy requiring human expert review of clinical cases.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation was based on bench testing and biocompatibility testing of the device, not on diagnostic accuracy requiring human expert review of clinical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission primarily focuses on demonstrating substantial equivalence to a predicate device through:
- Same intended use.
- Similar technological characteristics (though with fewer deployment steps).
- Bench testing and biocompatibility testing.
The document does not describe any human reader studies or evaluate the improvement of human readers with or without AI assistance, as AI is not a component of this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study was not done. The Resolution II Clip is a medical device (endoscopic clipping device), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm does not apply. The device's performance was evaluated through bench testing and biocompatibility assessments.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance was established by engineering design specifications, industry standards (EN ISO 10993-1:2009, ISO 14630:2008), and material properties. The tests were designed to confirm that the device met these predefined physical, mechanical, and biocompatibility requirements.
8. The Sample Size for the Training Set
This information is not applicable. The Resolution II Clip is a physical medical device, not an AI or machine learning model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
§ 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.