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The Disposable Anorectal Staplers have application for general treatment of hemorrhoids.

The Disposable Linear Cutting Staplers have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses.

The Disposable Endoscopic Cutting Staplers has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.

The Disposable Anorectal Staplers are a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 33mm. The staple size is 4.0mm. It cannot be reloaded.

The Disposable Linear Cutting Stapler places two double-staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The Disposable Linear Cutting Staplers is available in 60mm, 80mm and 100mm three specifications, and in two staple sizes 3.8mm and 4.8mm, to accommodate various tissue thickness. Each Disposable Linear Cutting Staplers may be reloaded up to 10 times in a single procedure.

The Disposable Endoscopic Cutting Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 2.5mm, 3.5mm, 4.0mm and 4.8mm. The device may be reloaded and fired up to 10 times in a single procedure.

The provided text describes a 510(k) premarket notification for disposable staplers and does not contain information about an AI/ML device. Therefore, it is not possible to describe the acceptance criteria and study that proves an AI/ML device meets them based on the given input.

The document primarily focuses on demonstrating substantial equivalence of the proposed disposable medical staplers (Disposable Anorectal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers) to existing legally marketed predicate devices. This is achieved through comparisons of technological characteristics, indications for use, and results from non-clinical tests.

The non-clinical tests mentioned include:

• Biocompatibility tests (cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, pyrogen, hemolysis).
• Package integrity tests (dye penetration, sealing strength).
• Simulation transportation test.
• Ex-vivo tissue tests on porcine stomach and intestine (Pressure Rest, Closed Staple Dimension Test, Staple Formation Test, Force Required to Fire Stapler Test).
• Jugular vein test on a porcine model for thin tissues (Burst pressure, closed staple height and staple formation).

The document explicitly states: "No clinical study is included in this submission."

Therefore, none of the specific information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test/training, data provenance, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance can be extracted as it pertains to an AI/ML device.

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Disposable Powered Endoscopic Linear Cutting Staplers and cartridges are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, abdominal, thoracic, and pediatric surgical procedures.

The Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The instruments are packaged with a primary lithium battery pack which must be installed prior to use. The powered stapler and cartridges are sterilized by EO sterilization, and battery pack is sterilized by Gamma irradiation. The instruments deliver six staggered rows of staples, three on either side of the cut line. The staplers are available in three shaft lengths: compact (Model DCE46 and DCE46, 280±10mm), regular (Model DSE46 and DSE60, 340±10mm) and long (Model DLE46 and DLE60. 440±10mm). The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. According to the length of the anastomosis, the cartridges (DCR series) can be divided into two specifications of 46mm and 60mm; the staples inside the cartridges can be divided into 2.5mm, 3.5mm, 4.1mm according to the nail height, and they are distinguished by color. The color codes are white (W), blue (B), yellow (Y), and green (G). There are total 8 models of cartridges within the proposed device: two stapler line length: 46mm and 60mm, each length of the cartridges has four colors which stand for different staple heights: Green (4.1mm), Yellow (3.8mm), Blue (3.5mm), White (2.5mm). The Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges are powered by the internal lithium battery, which has the rated specifications of DC voltage 12V and capability 1400mAh. Battery package model is BP813, composed of four lithium battery cells. The proposed device is resistant to water ingress. Grade of waterproof: Rotating knob to the end of tubular shaft (including rotating knob) is rated IPX4; the Body is rated IPX0.

The provided text is related to a 510(k) premarket notification for a medical device: "Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges." This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states in section 8, "Substantial equivalence does not depend on clinical test data."

Given this, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of human clinical performance or AI/algorithm performance. The information requested in points 1-9 (e.g., sample size for test set, adjudication method, MRMC study, standalone performance, ground truth establishment) is typically associated with studies evaluating the clinical performance or diagnostic accuracy of a device, especially those involving AI or human interpretation, which is not the subject of this 510(k) submission.

The "Performance testing" section (page 7) describes non-clinical bench tests and an animal study, but these are to demonstrate the device's functional integrity and safety characteristics (e.g., staple height, integrity, reliability, electrical safety, biological compatibility, hemostasis, anastomotic pressure resistance) rather than a comparative effectiveness or diagnostic accuracy study in humans.

Therefore, for the prompt's specific request for a study proving the device meets acceptance criteria, and details like MRMC, human reader improvement, ground truth, and training data, the provided document does not contain this type of information.

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