(248 days)
This product is intended to provide color video displays of images from endoscopic camera systems and other compatible medical imaging systems. This product is a wide-screen, high-definition monitor for real-time use during endoscopic/laparoscopic procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.
CuratOR EX3242-FD is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 3,840 x 2,160 pixels (4K UHD) with a pixel pitch of 0.185 mm.
Based on the provided text, the device in question, CuratOR EX3242-FD, is a color LCD monitor intended for displaying medical images from endoscopic camera systems and other compatible medical imaging systems. It is not an AI-powered diagnostic device, but rather a display monitor.
Therefore, the typical acceptance criteria and study types requested in your prompt (such as accuracy, sensitivity, specificity, expert ground truth, multi-reader multi-case studies, effect size of AI assistance, etc.) are not applicable to this device.
The study described in the document is a comparison of technological characteristics to a predicate device (Olympus 4K UHD LCD Monitor OEV321UH, K220069) to demonstrate substantial equivalence for regulatory clearance.
Here's a breakdown of the information that is available:
1. A table of acceptance criteria and the reported device performance
The provided text does not list specific "acceptance criteria" in the traditional sense for diagnostic performance, as this is a display device. Instead, it compares the technological characteristics of the "Subject Device" (CuratOR EX3242-FD) to a "Predicate Device" (Olympus 4K UHD LCD Monitor OEV321UH). The "performance" in this context refers to meeting or being comparable to the predicate device's specifications.
| Attributes | Subject Device (CuratOR EX3242-FD) | Predicate Device (Olympus 4K UHD LCD Monitor OEV321UH) | Comparison |
|---|---|---|---|
| Regulatory | |||
| Device Name | CuratOR EX3242-FD | Olympus 4K UHD LCD Monitor OEV321UH | Different |
| Regulatory Decision | This submission | K220069 | - |
| Product Code | Same as predicate (GCJ) | GCJ | Same |
| Regulatory Class | Same as predicate (II) | II | Same |
| Regulation Number | Same as predicate (876.1500) | 876.1500 | Same |
| Regulation Name | Same as predicate (Endoscope and accessories) | Endoscope and accessories | Same |
| Classification Panel | Same as predicate (General and Plastic Surgery) | General and Plastic Surgery | Same |
| Indications for Use | Intended to provide color video displays of images from endoscopic/laparoscopic camera systems and other compatible medical imaging systems. Wide-screen, high-definition monitor for real-time use during endoscopic/laparoscopic procedures. Suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments. | Intended to provide 4K 2D color video displays of images from endoscopic/laparoscopic camera systems and other compatible medical imaging systems. Wide-screen, high-definition, medical grade monitor for real-time use during endoscopic/laparoscopic procedures. Suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments. | Substantially Similar |
| Mode of Action | Same as predicate | This monitor displays color video images that are output from medical imaging systems on the LCD panel. LCD panel displays images by controlling the aperture of the liquid crystal according to input signals. | Same |
| Intended Environment | Same as predicate | Hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments | Same |
| Intended Users | Same as predicate | Doctors and Assistants | Same |
| System Parameters and Specifications | |||
| Power | Same as predicate | AC 100-240V/ 50-60Hz | Same |
| Dimensions (excluding max. protrusions) | 760.8 × 463.8 × 91.6 mm | 753.9 × 476.3 × 79.2mm | Different (Minor) |
| Display Dimension | Same as predicate | 2D | Same |
| Input Signals | 12G-SDI, 3G-SDI, DisplayPort, HDMI, DVI-D, DC IN | 12G-SDI1, 12G-SDI2, 3G-SDI, DisplayPort, HDMI, DVI-D, DC IN | Slightly Different |
| Output Signals | 12G-SDI, DVI-D OUT, +5V DC OUT | 12G-SDI1, 12G-SDI2, 3G-SDI, CloneOUT, +5V DC OUT, +12V DC OUT | Slightly Different |
| Display Device | Same as predicate | LCD panel (IPS) | Same |
| Backlight Device | Same as Predicate | LED | Same |
| Viewing Angle | Same as Predicate | Right>89[deg] (CR>10), Left>89[deg] (CR>10), Up>89[deg] (CR>10), Down>89[deg] (CR>10) | Same |
| Active Screen Size | 708(H)×399(V) mm | 697(H)×392(V) mm | Different (Minor) |
| Resolution | Same as predicate | 3840 × 2160 pixels | Same |
| Luminance | 850[cd/m2] typ. | ≥280[cd/m2] | Higher (Subject device is 850, predicate is at least 280) |
| Primary Colors | Same as predicate | RGB | Same |
| Gamma Curve | 1.8, 2.0, 2.2, 2.4, 2.6, DICOM, HLG, PQ | 1.8, 2.0, 2.2, 2.4, 2.6, DICOM, Endoscope, HLG | Slightly Different |
| Color Space | sRGB, BT.2020, Native | Auto, BT.709, BT.2020, Native | Slightly Different |
| Refresh Rate | Same as predicate | 50/60Hz | Same |
| Frame Rate | Same as predicate | 50/60 fps | Same |
| Display Format | Same as predicate | Normal, Multi display, Flip display | Same |
The conclusion states: "It was confirmed that the technological characteristics differences from those of the predicate device do not affect the safety or the effectiveness." This serves as the "acceptance criterion" for this type of submission (substantial equivalence for a display device).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a display device, not a diagnostic algorithm that processes test image sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for diagnostic performance is not relevant for a display monitor's 510(k) submission based on technological equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a monitor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
§ 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.