(99 days)
The Arthrex Synergy UHD4 System is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.
The Arthrex SynergyUHD4 System consists of a camera head with light source and a Camera Control Unit (CCU). The system is used in conjunction with an endoscope to allow for visualization onto a monitor during minimally invasive surgical procedures.
The provided document is a 510(k) premarket notification for a medical device called the "Arthrex Synergy UHD4 System," which is an endoscopic video camera system. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that the device meets specific performance acceptance criteria through the kind of studies often seen for AI/ML devices.
Therefore, the document does not contain the information requested regarding acceptance criteria and studies proving the device meets those criteria, as typically understood for an AI/ML device performance evaluation. Specifically:
- No acceptance criteria table or reported device performance for an AI/ML component is present.
- No sample sizes for test sets or data provenance are mentioned.
- No number of experts or their qualifications for ground truth establishment are detailed.
- No adjudication method is described.
- No multi-reader multi-case (MRMC) comparative effectiveness study is discussed.
- No standalone (algorithm-only) performance is provided.
- No type of ground truth (e.g., pathology, outcomes data) is specified for an AI/ML model.
- No sample size for a training set is mentioned.
- No method for establishing ground truth for a training set is provided.
Instead, the document focuses on demonstrating that the Arthrex Synergy UHD4 System is "substantially equivalent" to an existing predicate device (K071756: Endohub-1.0 Endoscopic Video Camera with Video Capture). The evidence for this substantial equivalence is described as:
- Bench testing: "Bench testing was performed to demonstrate equivalence to the predicate regarding environmental conditions, power requirements, image capture, and video output and resolution."
- Sterilization and electrical safety validations: These were "performed on the system components and comply with ISO 17665-1 and IEC 60601-1:2012 3rd Edition."
The core objective of this 510(k) submission is to show that "Any differences between the Arthrex SynergyUHD4 System and the predicates are considered minor and do not raise questions concerning safety and effectiveness. There are no significant differences between the new device and predicate that raise issues of safety or effectiveness."
In summary, the provided text describes a 510(k) submission for an endoscopic video camera system, not an AI/ML enabled device, and thus does not contain the specific performance study information requested.
§ 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.