(122 days)
The LumenEye® X1 device is intended to be used to examine the rectum, and using additional accessories, perform tissue sampling of the rectum, if required.
The LumenEye® X1 can enable suitably trained healthcare professionals in clinical environments, when used in conjunction with other tests, to examine the rectum as part of a clinical assessment in adults.
The LumenEye® X1 is not intended to determine a final clinical diagnosis without further confirmatory tests. Following examination, the healthcare practitioner may make recommendations for further investigations as appropriate.
The LumenEye" X1 is a re-usable handheld rigid endoscope that permits insufflation of the rectum and endoluminal high-definition video capture to enable an examination of the rectum (Figure 1). The device has no lumens or channels within the reusable elements of the handle.
The area of interest is illuminated by a distally mounted ring of LEDs which emit white light (5300K). Light reflected from the subject is captured by the HD CMOS sensor. The LEDs and camera sensor are housed in the distal end of a stainless-steel camera tube. The image is transferred via USB protocol to a PC and displayed on a screen. There is limited firmware capability within the sensor which simply enables the LEDs to turn on when a video feed from the camera is requested by the PC. The device functions with any Off-the-shelf (OTS) software with a camera display capability. The full HD CMOS camera provides 1080p, 90° field of view and a frame rate of 60 frames per second. The camera enclosure is IP67 rated.
The device features a 1.8m long PVC cable and is powered via USB 3.0 Type-A connection (maximum input voltage 5V, rated current 500mA).
The provided document does not describe a study involving acceptance criteria and device performance in the context of AI or algorithm-based diagnostics. The document pertains to the 510(k) premarket notification for the "LumenEye® X1 endoscope," which is a rigid endoscope for examining the rectum.
The "acceptance criteria" discussed in the document are related to:
- Reprocessing Validation: "Acceptance criteria were established in accordance with AAMI TIR 30:2011 for amount of residual soil accumulation and extraction efficiency. Acceptance criteria were met after each phase of reprocessing."
- Design Verification Tests: "Design verifications tests and acceptance criteria were defined and performed as a result of this risk analysis assessment."
- EMC and Electrical Safety: "The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the Lumen Eye X1 were confirmed by the following standards."
The document focuses on demonstrating substantial equivalence to a predicate device (Welch Allyn sigmoidoscope) based on intended use, technological characteristics (including optical properties, reprocessing, biocompatibility, software, and electrical safety), and risk analysis. It confirms that the device meets relevant consensus standards for medical devices (e.g., IEC, ISO).
Therefore, I cannot provide a response to your specific questions about acceptance criteria for AI performance, sample sizes for test sets, expert ground truth, MRMC studies, standalone algorithm performance, or training set details, as these are not discussed in the provided text. The LumenEye® X1 is a hardware device (endoscope) with "limited firmware capability within the sensor which simply enables the LEDs to turn on when a video feed from the camera is requested by the PC" and functions with "any Off-the-shelf (OTS) software with a camera display capability," indicating it does not incorporate advanced AI/ML algorithms for diagnostic interpretation.
§ 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.