(350 days)
Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments are intended for use in open or thoracoscopic surgical procedures. They are designed for cutting, manipulating, grasping, clamping, dissecting or suction.
Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments are designed for cutting, manipulating, grasping, clamping, dissecting, or suction during open, or thoracoscopic surgical procedures. The instruments are reusable and are made from Stainless Steel with monopolar capabilities. The instruments are modular, consisting of a jaw insert and insulated outer tube with interchangeable ratcheting and non-ratcheting handles. The instruments are 250mm in length with a 7mm diameter. The instruments can be used interchangeably with either a ratcheting or non-ratcheting handle. The handles are made from PEEK with a HF connection that fits any standard monopolar cable. The instruments can be used with a visualization system to allow for better visibility during the procedure. This is an independent system and is not system specific. No new visualization systems are being introduced by Aesculap® in this submission.
The provided text is related to a 510(k) premarket notification for surgical instruments, specifically "Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments." It describes the device, its intended use, and a comparison to predicate devices, along with performance data.
However, the request asks for information relevant to the acceptance criteria and study that proves a device meets those criteria, particularly for an AI/ML-enabled medical device. The document provided does NOT describe an AI/ML-enabled medical device. It describes traditional surgical instruments and their performance testing (design verification, electrical safety, biocompatibility, cleaning/sterilization).
Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study details from the provided text. The document does not contain:
- A table of acceptance criteria and reported device performance for an AI/ML device. The performance data tables are for mechanical and electrical properties of surgical instruments.
- Sample size used for the test set or data provenance for an AI/ML device.
- Number of experts used to establish ground truth or their qualifications for an AI/ML device.
- Adjudication method for an AI/ML device.
- MRMC comparative effectiveness study or human reader improvement for an AI/ML device.
- Standalone (algorithm only) performance for an AI/ML device.
- Type of ground truth (expert consensus, pathology, outcomes data) for an AI/ML device.
- Sample size for the training set of an AI/ML device.
- How ground truth for the training set was established for an AI/ML device.
The document describes standard engineering and biological safety tests for physical medical devices.
§ 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.