(87 days)
The LAP DISC Hand Access Device is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during laparoscopic surgery. The LAP DISC is indicated for use in laparoscopic procedures, where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The LAP DISC has application in colorectal, urological and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.
The LAP DISC is a sterile, single-use disposable device. The LAP DISC is an abdominal wall closure unit consisting of three overlaid plastic rings that are interconnected by means of a silicone rubber. The two lower rings hold the abdominal wall to maintain peritoneal gas pressure. The bottom ring is a flexible ring made with a shape-memory alloy. The top ring has a structure similar to the aperture in a camera (an Iris Valve). Because the aperture of the Iris Valve can be adjusted continuously, the system can maintain constant peritoneal gas pressure while allowing the insertion of the surgeon's hand and alternatively, it can be used as an insertion site.
The provided text is a 510(k) premarket notification for a medical device, the LAP DISC Hand Access Device. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through technological characteristics and intended use. It does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, expert adjudication, or MRMC studies for an AI/algorithm.
Therefore, I cannot fulfill the request as it pertains to AI/algorithm performance and acceptance criteria. The document is for a physical medical device, not a software or AI-driven one.
However, I can extract information related to the device itself, if that is what you intended to ask about physical device acceptance:
The primary "acceptance criterion" indirectly demonstrated in a 510(k) is substantial equivalence to a predicate device. This is "proven" through a comparison of technological characteristics and intended use.
Here's a breakdown of what is available in the provided text:
- Device Name: LAP DISC Hand Access Device
- Predicate Device: LAP DISC Hand Access Device, cleared under K010870 on 06/18/01
- Modification in this 510(k) (K020307): "a longer sleeve length to accommodate body wall thickness between 5cm and 9cm."
The "study" or demonstration of meeting "acceptance criteria" (i.e., substantial equivalence) is implicitly the comparison presented in the 510(k) submission itself, where the applicant asserts and provides rationale for how the modified device is substantially equivalent to the predicate. The FDA's letter (frames 2 and 3) acknowledges this review and concurs with the substantial equivalence finding.
If you were looking for information on acceptance criteria and studies for a physical device's performance (e.g., tensile strength, leak rate, biocompatibility in a clinical trial setting), that level of detail is typically not included in the public-facing 510(k) summary provided, which is designed to summarize the essential information for clearance.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.