(264 days)
The O'Regan, Ligator or Hemorrhoid Ligator is a device for the treatment of hemorrhoids.
The O'Regan, Ligator or Hemorrhoid Ligator is a device for the treatment of hemorrhoids. The technique involves placing elastic bands on tissue in the rectum in the vicinity of the hemorrholds. The bands are placed high enough in the rectum to be above the sensitive area so that any discomfort from the procedure is minimized. The present device provides suction and ligation capability. An elastic band can be stretched over the front end of the ligator by means of the cone shaped loading apparatus. The front end of the ligator is inserted through the anus deep within the rectum. The nozzle is then withdrawn gently as the device is angulated to point directly towards the site to be banded. A mark on the outside of the device will provide a measure as to the level inside the rectum where the band is to be placed. Thus by angling the device acutely in the direction of the tissue to be banded and by measuring the distance from the outside, the band can be placed accurately on the appropriate tissue. The opening at the front end of the device allows only a fairly conservative amount of tissue to be trapped within the chamber and subsequently allow banding of this said amount. This device differs mainly in one respect from other devices available to date. Whereas other devices are designed to be used with the aid of a proctoscope or similar viewing instrument and the band is placed under direct vision, the present device is designed to be used without a proctoscope. The device can be used single handedly, as a proctoscope or an assistant is not necessary to perform the procedure. The device will be made available in a package, labelled clean but not sterile for one time use only. Rubber bands will not be included but are readily available from medical suppliers. The device is made of polypropylene with no colour additive.
The provided text describes a medical device, the O'Regan Ligator, and its intended use. However, it does not include information about acceptance criteria, specific device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications in the way you've outlined for an AI/diagnostic device study.
This document is a 510(k) summary, which is a premarket notification for a medical device. Its purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to present a detailed clinical study demonstrating specific performance metrics against pre-defined acceptance criteria in the manner of a typical AI diagnostic performance study.
Therefore, I cannot populate the table and answer your questions directly from the provided text. The text does mention "clinical data," but it only provides a summary of the conclusions drawn from that data ("as accurately or more accurately by this technique," "size of the bite of tissue banded is also more constant and more precise"). It doesn't provide the raw data, the study design, or the acceptance criteria used.
Here's a breakdown of why the information isn't present in the provided text:
- Acceptance Criteria & Reported Performance: Not explicitly stated as quantifiable metrics. The text makes qualitative claims about accuracy and precision compared to other methods, but no numerical criteria or results are given.
- Sample Sizes (Test Set & Training Set) & Data Provenance: Not mentioned anywhere.
- Number/Qualifications of Experts: Not mentioned.
- Adjudication Method: Not mentioned.
- MRMC Comparative Effectiveness Study: While it compares the device qualitatively to other methods and implies human use, it doesn't describe an MRMC study and certainly no effect size for human readers.
- Standalone Performance: The device is an instrument for a medical procedure performed by a human; it's not an AI algorithm that would have "standalone" performance in that sense.
- Type of Ground Truth: The context suggests the "clinical data" would have been based on clinical outcomes observed by medical professionals, but this is not explicitly stated.
- How Ground Truth for Training Set Was Established: Not applicable as it's not an AI device, and even for a general clinical study, this detail is not provided.
In summary, the provided document is a regulatory submission describing a device, not a scientific paper reporting a study's results against specific acceptance criteria.
If you had a clinical study report or a peer-reviewed publication about the O'Regan Ligator's performance, that document would be more likely to contain the information you're seeking.
§ 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.