(182 days)
The Specimen Bag is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.
The Specimen Bag is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Specimen Bag is supplied in a dispending tube for ease of insertion through a standard 10,11or 12mm trocar sheath.
The provided text is a 510(k) Pre-Market Notification for a medical device (Specimen Bag models), indicating it is seeking substantial equivalence to a predicate device. This document primarily details the device's intended use, description, and comparison to the predicate device, along with the non-clinical tests performed.
However, the provided text does not contain information about a study that proves a device meets acceptance criteria related to an AI/Machine Learning algorithm's performance, nor does it provide the detailed breakdown requested regarding acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness studies (MRMC).
The "tests listed below demonstrate the performance of Specimen Bag meets the requirements of its pre-defined acceptance criteria and intended uses" (page 5) refer to a series of engineering and biocompatibility tests typical for a physical medical device, not an AI/ML algorithm. These tests include:
- Tensile strength
- Bag load-bearing
- Opening force
- Rope tension test
- Puncture Force Test
- Pouch Leakage Test
- Biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material-Mediated Pyrogenicity)
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets AI-related acceptance criteria, as this information is not present in the provided document. The device is a "Specimen Bag," a physical medical device, not an AI/ML-driven diagnostic or assistive tool.
§ 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.