(226 days)
Image Processing Unit is intended to be used with compatible laparoscopes, camera heads, light sources, monitors, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures.
Endoscopic Camera Head is intended to be used with compatible laparoscopes, image processing unit, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures.
The Endoscopic Camera System comprises the Image Processing Unit, the Camera Head (including the objective lens), power supply cord and video cables. The Camera Head with integrated cable can be connected to the Image Processing Unit through the LEMO interface.
During surgical procedures, the Endoscopic Camera System is used to provide real-time visible imaging similar to that provided by conventional imaging system used in surgical endoscopy. The area of interest is illuminated with visible light from the light source and the resulting reflected light is collected by a variety of laparoscopes that are attached to the camera head via equipment coupler. The camera head receives optical image from the connected laparoscope and converts optical image into electronic signal using the incorporated image sensor. The Image Processing Unit serves as the control center of the system and should be connected to a compatible light source in order to provide visualization. It can be connected to a 4K video monitor via one of the video cables provided to display image in real time: DVI cable, HDMI cable, 12G-SDI cable, and 3G-SDI cable.
The proposed system is a reusable device and provided non-sterile. The Camera Head should be cleaned and high-level disinfected prior to the first use and after every subsequent use. The recommended compatible Light Source is OPTO-LED104K (510k exempted, product code: NTN).
This FDA 510(k) summary describes the "Image Processing Unit, Model: OPTO-CAM104K; Camera Head, Model: OPTO-CHD104KH" device. However, it does not contain specific acceptance criteria, detailed study designs, or performance results from any clinical or standalone studies conducted to prove the device meets acceptance criteria. The sumamry focuses on non-clinical testing for safety and electrical compatibilty, and the statement of substantial equivalence to a predicate device.
Therefore, many of the requested details about acceptance criteria, study sizes, ground truth, and expert involvement cannot be extracted from the provided text.
Here's what can be gathered:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list acceptance criteria in a table or directly report device performance against defined criteria in a way that would be typical for clinical effectiveness studies. It primarily focuses on compliance with general safety and EMC standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Performance testing" but does not detail the nature of these tests in terms of sample size or data collection methodology relevant to clinical performance.
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)
This information is not provided in the document. The filing is for an endoscopic camera system, not an AI-powered diagnostic device that typically relies on expert-established ground truth for performance evaluation in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
An MRMC comparative effectiveness study was not performed or reported as part of this 510(k) submission. This is not an AI-assisted diagnostic device, but rather an imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an imaging system (hardware), not an algorithm or AI that operates standalone for diagnostic purposes. Its function is to provide visualization for humans during laparoscopic procedures.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided and is not directly relevant for a device whose primary function is visualization during procedures rather than automated diagnosis. The "performance testing" mentioned likely refers to technical specifications of image quality, resolution, latency, etc., compared to design specifications.
8. The sample size for the training set
This information is not provided and is not applicable. The device is a hardware imaging system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons mentioned above.
Summary of what is provided:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Image1 SPIES, K131953) through:
- Non-clinical tests: Verifying compliance with various electrical safety, electromagnetic compatibility, and equipment-specific standards (e.g., ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-18, ASTM D4169-16, AAMI TIR 30:2016, AAMI TIR 12:2020).
- Software Validation: The software of the proposed device was validated as having a "Moderate level of concern (LoC)" according to FDA guidance.
- Performance testing: Stated that performance testing was conducted to demonstrate the system "performs according to specifications and functions as intended," but specific details of these tests, including acceptance criteria and results, are not elaborated.
The provided information establishes the device's technical safety and fundamental functionality in accordance with relevant standards, rather than clinical performance against specific diagnostic or intervention-related acceptance criteria.
§ 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.