(90 days)
The Single Use Reloadable Clip Applicators HX-810 Series, Long Clip HX-610 Series, Short Clip HX-610 Series and Super Short Clip HX-610-135XS have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of:
(1) Endoscopic marking,
(2) Hemostasis for
(a) Mucosal/sub-mucosal defects
The instruments (AKA EZClip) have been designed to be used with an Olympus endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of:
(1) Endoscopic marking,
(2) Hemostasis for
(a) Mucosal/sub-mucosal defects
The provided text is a 510(k) summary for a medical device cleared by the FDA. It does not include information about a study based on analyzing medical images/data, establishing ground truth using experts, or evaluating AI performance. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets those criteria for such a system.
The document describes pre-clinical (bench) testing performed on a physical medical device (endoscopic clip applicator) and its components to demonstrate substantial equivalence to a predicate device.
Here's an analysis of what is available in the document, which primarily focuses on engineering and performance characteristics of the physical device:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted, but it does not provide a table detailing specific acceptance criteria values and the quantitative reported performance for each criterion. It only states that "The subject Single Use Reloadable Clip Applicators (HX-810 Series) have satisfied the pre-defined acceptance criteria for each test item described in the test plan."
The tests performed were:
- Insertability
- Clip opening width
- Clip rotatability
- Clip capability
- Withdrawal from Endoscope
- Mechanical integrity of clip assembly
- Tensile Strength/coil to handle strength
- Applicator repetition
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 available in the provided text. The tests were performed on "finished devices, prior to and after simulated distribution and accelerated aging." This indicates bench testing rather than clinical data from human subjects.
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 is not applicable to the type of device and testing described. Ground truth established by medical experts is typically for diagnostic or prognostic systems that interpret medical data. The tests here are physical performance tests of a medical instrument.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for expert review of data/images, which is not what was performed for this device. These were bench tests against engineering 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
Not applicable. This is for an AI-powered diagnostic/interpretive system, not a physical medical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical device, the "ground truth" would be the engineering specifications and performance standards against which the device was tested (e.g., a clip's opening width must be X mm, a tensile strength must be Y Newtons). These are not established by expert consensus or pathology in the medical sense, but rather by engineering design and regulatory requirements.
8. The sample size for the training set
Not applicable. This is not a data-driven model that requires a training set.
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.