(103 days)
The ArthroFree System is indicated for use in arthroscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery or wherever a laparoscope is indicated for use. The users of the camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and urologists.
The ArthroFree System is indicated for use in diagnostic and operative endoscopic procedures, supplying illumination and visualization of an interior cavity of the body.
Examples of common general endoscopic surgeries are listed below.
- · laparoscopic cholecystectomy
- · laparoscopic hernia repair
- · laparoscopic appendectomy
- laparoscopic pelvic lymph node dissection
- · laparoscopically assisted hysterectomy
- · laparoscopic and thorascopic anterior spinal fusion
- anterior cruciate ligament reconstruction
- · knee arthroscopy
- · shoulder arthroscopy
- small joint arthroscopy
- · decompression fixation
- · wedge resection
- · lung biopsy
- · pleural biopsy
- · dorsal sympathectomy
- · pleurodesis
- · internal mammary artery dissection for coronary artery bypass
- coronary artery bypass grafting where endoscopic visualization is indicated
- · examination of the evacuated cardiac chamber during performance of valve replacement
The ArthroFree System is a high-definition wireless camera system intended to transmit live video from a surgical site to a patient data console and surgical display during endoscopic surgical procedures. The ArthroFree System also enables the capture of still images and video from the live video stream by transmitting instructions for such capture to a patient data console when indicated by the user. The ArthroFree System is indicated for use in diagnostic and operative endoscopic procedures, supplying illumination and visualization of an interior cavity of the body.
The provided document is a 510(k) summary for the ArthroFree Wireless Surgical Camera System. It primarily focuses on demonstrating substantial equivalence to a predicate device (Stryker Precision HD Camera System). As such, the information typically found in a study demonstrating a device meets acceptance criteria for an AI-powered medical device (e.g., performance metrics like sensitivity, specificity, AUC, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment) is not present in this type of submission.
This document describes a medical device, specifically a surgical camera system, that is primarily hardware with associated software for live video transmission and image/video capture. It is not an AI-powered diagnostic or therapeutic device that would involve the rigorous performance evaluations typically described by your prompt for AI systems.
Therefore, I cannot extract the information requested about acceptance criteria and study details for an AI-powered device from this document. The "Performance Testing Summary" section describes validations typical for a medical device (sterilization, electrical safety, software V&V, etc.), not the type of performance evaluation required for an AI algorithm.
To directly address your prompt based on the provided text, the answer is that the document does not contain the information required to populate the fields related to an AI-powered device's acceptance criteria and study details.
§ 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.