(53 days)
The device is intended to display medical images from endoscopic camera systems and other compatible medical image systems.
The device is a medical grade monitor for real-time use during endoscopic procedures and is suitable for use in hospital operating rooms, surgical centers, doctor's offices, clinics and similar medical environments.
The MDEC-2523 is a medical grade monitor with a 23,8 inch color TFT-LDC screen size and is intended to display medical images from endoscopic or laparoscopic camera systems and other compatible medical image systems.
The MDEC-2523 consists of an LCD panel and LED backlight integrated into a plastic housing body with an internal metal chassis structure, that also integrates the electronics, sensors, and interconnections. The MDEC-2523 encloses user controls that are used to control and configure the device via the embedded on screen display (OSD) software. The device has a glass cover to protect the LCD panel and allow easy cleaning. The MDEC-2523 is powered by means of an internal power supply.
This monitor displays color video images that are output from medical imaging systems on the LCD (liquid crystal display) panel.
The provided document is a 510(k) premarket notification letter from the FDA regarding a medical LCD monitor (MDEC-2523). It primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to regulatory standards.
Crucially, this document does not include information about a study proving the device meets acceptance criteria related to a clinical performance claim, specifically one involving AI, human readers, or ground truth establishment based on expert consensus, pathology, or outcomes data.
The acceptance criteria and study described in the input prompt are typically associated with devices that make diagnostic or therapeutic claims based on analyzing medical images or data, often involving AI or software. This document is for an LCD monitor, which is a display device. Its performance is assessed through electrical safety, EMC, environmental, and software testing to ensure it correctly displays images without introducing new safety or effectiveness concerns, rather than evaluating its accuracy in diagnosing conditions or improving human reader performance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study as outlined in the prompt's nine points because the provided text does not contain this type of study information.
The non-clinical performance testing conducted for this device, as stated in the document, includes:
- Electrical safety testing (ANSI AAMI E560601-1)
- EMC testing (IEC 60601-1-2 Edition 4.1)
- Environmental testing (Climate, shock and vibration, packed, thermal analysis)
- Software testing
- Usability/human factors
The document explicitly states: "Clinical study - Not Applicable." This further confirms that the type of study outlined in the prompt (involving expert consensus, mrmc, standalone performance etc.) was not performed or required for this device.
§ 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.