(155 days)
Endoscopes (GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190, COLONOVIDEOSCOPE CF-HQ190L/I, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I)
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/l), light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190 are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
The EVIS EXERA III COLONOVIDEOSCOPE CF-H190L/I, CF-HQ190L/I, PCF-PH190L/I, PCF-H190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
CV-190 VIDEO SYSTEM CENTER
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
CLV-190 XENON LIGHT SOURCE
This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
The EVIS EXERA III VIDEO SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
The primary components of the subject system, which are part of this submission, are:
- Video System Center OLYMPUS CV-190
- XENON LIGHT SOURCE OLYMPUS CLV-190
- GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190
- COLONOVIDEOSCOPE CF-HQ190L/I, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I
The CV-190 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The OLYMPUS CV-190 allows image display on HDTV (16:9).
The XENON LIGHT SOURCE OLYMPUS CLV-190 is intended for endoscopic diagnosis, treatment and video observation.
In addition, both the CV-190 and CLV-190 can be used with any specified Olympus flexible and rigid including gastroscopes, ultrasound gastroscopes, endoscope models. duodenoscopes. colonoscopes, sigmoidscopes, choledochoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes.
The subject endoscopes could be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/I). light source, document, monitor. EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment within the upper and lower digestive tract.
The provided text describes the 510(k) summary for the EVIS EXERA III VIDEO SYSTEM ENDOSCOPIC VIDEO IMAGING SYSTEM. This document outlines the device, its intended use, and a summary of non-clinical testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the way typically expected for a new AI/ML-driven medical device, especially regarding performance metrics like sensitivity, specificity, accuracy, or diagnostic improvement.
Instead, this submission focuses on demonstrating substantial equivalence by comparing technological characteristics and indicating that risk analysis and validation activities were performed according to established standards.
Therefore, many of the requested details about acceptance criteria and a study proving device performance (especially for AI/ML) cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
No specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported device performance metrics are provided in the document. The submission focuses on demonstrating substantial equivalence through comparison of technological characteristics and compliance with general safety and performance standards.
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. The document does not describe a clinical performance study with a test set in the context of diagnostic accuracy or similar metrics. The "test set" mentioned in the document refers to design verification tests and software validation, not a clinical data set for assessing diagnostic 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)
Not applicable. No ground truth establishment by experts for a clinical test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a clinical test set is described.
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
No such MRMC study is mentioned or referenced. This device is an endoscopic video imaging system, and the submission does not discuss AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not described as an algorithm-only device. It's a video system with integrated components for endoscopic imaging.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth in the context of diagnostic assessment is discussed. The "ground truth" for the non-clinical testing would relate to engineering specifications and safety standards.
8. The sample size for the training set
Not applicable. The document does not describe an AI/ML component that would require a "training set" in the sense of machine learning.
9. How the ground truth for the training set was established
Not applicable.
Summary based on the provided text:
The document is a 510(k) summary for an endoscopic video imaging system seeking approval based on substantial equivalence to predicate devices. It discusses technological characteristics, risk analysis, reprocessing validation, and software validation according to general regulatory standards. It does not contain information about a clinical performance study with acceptance criteria related to diagnostic accuracy, sensitivity, specificity, or the use of AI/ML algorithms and their associated clinical performance metrics.
§ 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.