(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 The nozzle is then withdrawn gently as the device is angulated to point directly towards the site to be banded.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.
{0}------------------------------------------------
MAY - 5 1997
Image /page/0/Picture/1 description: The image shows the text 'K963166 Page 1 of 2'. The text is written in a bold, handwritten style. The phrase 'Page 1 of 2' indicates that this is the first page of a two-page document.
"510(K) Summary" as required by 807.92(C)
Name: Patrick J. O'Regan Address : 912 - 750 West Broadway Vancouver, B. C. ער 1988 (604) 876-9926 Fax: 872-7533 Ph :
Patrick J. O'Regan Contact Person:
August 2, 1996 Date:
Hemorrhoid Ligator Common Name:
Proprietory Name: O'Regan Ligator
The O'Regan, Ligator or Hemorrhoid Ligator is a Description: device for the treatment of hemorrhoids. The treatment of hemorrhoids by elastic band ligation is credited to Blaisdell who described the technique in the late 1950's, and in the early 1960's Barron popularized this treatment after his reports in the medical literature. 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.
A number of different devices have been available to date. Some of the devices such as the Goltner Ligator rely on a suction technique to draw the tissue into the chamber and an expanded elastic band is placed around the trapped tissue in the chamber thus cutting off it's blood supply and causing the tissue to The resultant healing proves beneficial and helps to necrose. shrink hemorrhoids and restore the anatomy towards normal confiquration. Other devices such as the McGivney Ligator are used in conjunction with a forceps which is used to draw tissue into the chamber before banding.
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. The site to be banded will have been previously identified by means of examination with a sigmoldoscope, a proctoscope or such an instrument. 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.
{1}------------------------------------------------
Page 2 of 2
K963166
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. The aperture has been found by trial and error to be optimal and conservative. This aperture is in fact smaller than that used on any of the other hemorrhoidal ligators available on the market. This ligator is intended to be used only as a hemorrhoid ligator. 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. As mentioned above the site to be banded is initially identified by inserting a viewing device such as a sigmoidoscope or proctoscope. The present device does not require that a proctoscope or anoscope be used in conjunction with the device.
As can be seen from the summary of the clinical data provided, the bands can be placed as accurately or more accurately by this The size of the bite of tissue banded is also more technique. constant and more precise than with other methods. If the band for some reason is not optimal, it can be fairly readily displaced with the examining gloved finger. 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 will be produced by Columbia Plastics Itd. Custom Injection Molding, 19320-60th Avenue, Surrey, B. C. V35 8E5. The device is made of polypropylene with no colour additive.
I hearby certify that, in my capacity as owner and developer of the O'Regan Ligator, I believe to the best of my knowledge, that all data and information submitted in the premarked notification are truthful and accurate and that no material facts have been omitted.
(Signature) ( Name ) (Date)
(Premarket Notification 510k Number)
§ 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.