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VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus. Do not use the instrument for any purpose other than its intended use.

This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus.

The provided document does not describe an AI medical device. It is a 510(k) summary for a "VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (HYF-V)", which is a hysterovideoscope for endoscopic diagnosis within the uterus.

The document discusses various non-clinical bench tests (e.g., thermal safety, photobiological safety, noise and dynamic range, composite durability, color performance, image intensity uniformity, resolution, direction of view, field of view), biocompatibility evaluation, sterilization/reprocessing validation, and electrical safety/EMC testing. It explicitly states that software verification and validation testing was not applicable and not performed because the HYF-V does not include any software.

Therefore, I cannot provide details on acceptance criteria and study proving device meets acceptance criteria for an AI device based on this document. The questions regarding sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to the information provided for this hysterovideoscope.

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The PolyScope Flexible Endoscope is indicated in flexible endoscopic procedures for diagnostic and therapeutic applications where flexible endoscopes are standard of care including:

• Gastroenterology, including procedure of the Biliary system involving the hepatic and pancreatic ducts.
• Urology, including procedures involving the bladder, ureter, renal pelvis and kidney.

The PolyScope Xenon-Endoscopic light source LS 200 provides white examination light (sunlight spectrum) for all endoscopic applications including:

• During video endoscopy.
• During fiber endoscopy.
• During micro-endoscopy.
• During endoscopy using rigid optics.
• During usage of forehead illumination.

The PolyScope Flexible Endoscope is comprised from two main components: a disposable, flexible, steerable mini-endoscope and a flexible, modular, reusable optical disposable, Holters, etc. to the catheter to allow the visualization of the desired area.

The PolyScope LS 200 XENON-Endoscopic light source provides white examination light (sunlight spectrum) for all endoscopic applications including:

• During video endoscopy.
• During fiber endoscopy.
• During micro-endoscopy.
• During endoscopy using rigid optics.
• During usage of forehead illumination.

The provided text is a 510(k) summary for the PolyScope Flexible Endoscope and PolyScope Xenon Light Source. It focuses on establishing substantial equivalence to predicate devices based on intended use, general design, and fundamental scientific technology. There is no information provided regarding specific acceptance criteria or a study proving the device meets performance metrics in the way a clinical study would for an AI-powered device.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving the device meets those criteria, as the document doesn't contain that type of information.

The document discusses:

• Device Description and Intended Use: Clearly outlines what the devices are and what they are used for.
• Predicate Devices: Identifies the legally marketed devices to which the PolyScope devices are compared for substantial equivalence.
• Technological Characteristics Summary & Substantial Equivalence Statement: Asserts that the subject devices share the same intended use, general design, and fundamental scientific technology as their predicates.
• Performance Data Summary: States that "appropriate testing including safety, performance and functional testing" was conducted, but does not provide any specific criteria, results, or study details. This typically refers to bench testing, electrical safety, biocompatibility, and sterilization validations, which are not outlined in the provided text.

Specifically, the following information you requested is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance: No test set details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study or test set with ground truth is described.
4. Adjudication method 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: This device is an endoscope and light source, not an AI-powered diagnostic device, so an MRMC study is not relevant here.
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.

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This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with an Olympus video system center, light source, balloon control unit, splinting tube, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopic diagnosis and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral anal insertion.

Indications for Use of the Components are as follows:

SIF-Q180 (SMALL INTESTINAL VIDEOSCOPE)

This instrument has been designed to be used with an Olympus video system center, light source, single use splinting tube, balloon control unit, documentation equipment, video monitor, endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract (including the esophagus, stomach, duodenum, colon, and small intestine) by either oral and anal insertion.

OBCU (BALLOON CONTROL UNIT)

This balloon control unit has been designed for inflating and deflating the balloon attached to the distal end of a single use splinting tube in order to assist the insertion of an Olympus -designated small intestinal endoscope.

The subject device, Small Intestinal Videoscope system, is designed for endoscopy and endoscopic surgery within the small intestine. This system is composed of Small Intestinal Videoscope, Single Use Splinting Tube, and Balloon Control Unit and its accessories. The subject system is compatible with NBI observation which utilizes narrow-band spectrum to enhance contrast of the surface structure and fine capillary patterns of the mucous membranes. Also, the subject system utilizes a balloon attached to the splinting tube to facilitate advancement of the endoscope well within the small intestine.

This 510(k) summary for the Olympus Small Intestinal Videoscope System (K071254) does not contain the information requested about acceptance criteria, device performance, statistical studies, or ground truth establishment.

The document is a premarket notification for a medical device, which primarily focuses on demonstrating substantial equivalence to a predicate device. It addresses:

• General Information: Applicant, manufacturer, official correspondent.
• Device Identification: Trade name, common name, regulation number, regulation name, regulatory class, product code.
• Predicate Device Information: Details of the device it's being compared against.
• Device Description: A brief overview of the system components and their function.
• Indications for Use: The medical conditions and procedures for which the device is intended.
• Comparison of Technological Characteristics: How the new device is similar to and different from the predicate device, highlighting features like NBI observation and balloon technology.
• Conclusion: A statement that the device does not incorporate significant changes that would affect safety and effectiveness compared to the predicate.
• FDA Correspondence: The official letter from the FDA determining substantial equivalence, including regulatory compliance reminders.

The document does NOT provide:

1. Acceptance criteria or reported device performance data: There is no table detailing specific performance metrics (e.g., image resolution, depth of field, illumination, insertion success rates, diagnostic accuracy) or acceptance thresholds for these metrics.
2. Details of any study: No information is given about sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set details. This is typical for a 510(k) submission where substantial equivalence is demonstrated through technological comparison rather than efficacy or performance studies against specific criteria.
3. Type of ground truth used: Since no study is described, no ground truth information is available.

Summary of missing information:

• Acceptance Criteria & Device Performance: Not reported.
• Sample Size (Test Set) & Data Provenance: Not reported, as no study is detailed.
• Number & Qualifications of Experts: Not reported.
• Adjudication Method: Not reported.
• MRMC Comparative Effectiveness Study: Not reported.
• Standalone Performance Study: Not reported.
• Type of Ground Truth: Not reported.
• Sample Size (Training Set): Not reported.
• Ground Truth for Training Set: Not reported.

In essence, this document establishes market clearance based on substantial equivalence to a previously cleared device, focusing on its intended use, design, and technological characteristics, rather than new clinical performance data or specific acceptance criteria.

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EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180: This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180: This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180, BF TYPE 1T180, BF TYPE Q180: These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

VISERA RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE V2: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the nasal lumens and airway anatomy (including nasopharyngeal and trachea).

VISERA RHINO-LARYNGO VIDEOSCOPE OLYMPUS XENF TYPE VTY1: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea).

The EVIS EXERA II 180 System consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the airways, tracheobronchial tree, nasal lumens and airway anatomy.

The primary components of the subject system, which are part of this submission, are:

• EVIS EXERA II Xenon Light Source Olympus CLV-180.
• EVIS EXERA II Video System Center Olympus CV-180,
• EVIS EXERA II Bronchovideoscope Olympus BF -P180, BF -1T180, BF -Q180 .
• VISERA Rhino-Laryngo Videoscope Olympus ENF-V2, XENF-VTY1

The EVIS EXERA II Xenon Light Source Olympus CLV-180 is intended for endoscopic diagnosis, treatment and video observation. The CLV-180 is identical to the predicate device, EVIS EXERA Xenon Light Source CLV-160A cleared under K051645 except that the device size has been slightly changed. The CLV-180 has an optional fitter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI) employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band. Both an endoscopic image by standard white light illumination and that by NBI illumination can be obtained. The user can select either the standard observation mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-180. In comparison to conventional white light observation, NBI observation provides greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes.

The EVIS EXERA II Video System Center Olympus CV-180 is a video processing system intended for use with Olympus endoscopes such as the subject endoscopes. The CV-180 Video System Center contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-180 is identical to the predicate device, EVIS EXERA Video System Center CV-160A, cleared under K051645 except that the device size has been slightly changed.

The CV-180 incorporates the following features:
The CV-180 is compatible with any specified Olympus flexible, both video and fiberoptic, and rigid endoscope.
The CV-180 processes the NBI image, generated by the CLV-160A light source and captured by the endoscope's Charged Coupled Device (CCD), creating an enhanced image of the tissue's vasculature.

Both the CLV-180 and CV-180 can be used with any specified Olympus flexible and ridid endoscope models, including gastroscopes, ultrasound gastroscopes, colonoscopes, sigmoidscopes, choledochoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes, for conventional white light endoscopy. The flexible endoscopes which are the subject of this premarket notification are bronchoscope and rhino-laryngoscope models listed in Table 16-2.

Additionally, when they are combined with the new bronchovideoscopes (BF-P180, BF-1T180, BF-Q180), and rhino-laryngo videoscopes (ENF-V2, XENF-VTY1), both an endoscopic image by white light illumination and that by NBI illumination can be obtained. The user can select either the NBI mode or normal mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-160A; the NBI filter in the CLV-180 is inserted on the light axis when the NBI mode is selected.

The new endoscopes are basically identical to each predicate device shown in Table 16-2 in intended use, and similar in specifications, performance and materials. The CV-180 identifies an NBI-compatible scope when it is connected by using the Scope ID function provided with the scopes.

The provided document, a 510(k) summary for the EVIS EXERA II 180 System, outlines the device's technical specifications and claims substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

The document's purpose is to demonstrate substantial equivalence to existing legally marketed devices, primarily by showing that the new device has "no significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the system." (Page 8). This is a different kind of submission than one requiring a clinical performance study with acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on comparing the specifications of the subject device (EVIS EXERA II 180 System) components (Light Source, Video System Center, Bronchovideoscopes, Rhino-Laryngo Videoscopes) to their respective predicate devices.

Missing Information from the Provided Document:

• Acceptance Criteria and Reported Device Performance: No acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are mentioned.
• Sample Size and Data Provenance (Test Set): There is no mention of a test set, sample size, or data provenance.
• Number of Experts and Qualifications (Ground Truth for Test Set): No experts or ground truth establishment for a test set are described.
• Adjudication Method: No adjudication method is mentioned.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study is described.
• Standalone Performance Study: No standalone performance study of an algorithm is described. The device is an endoscopic system, not an AI algorithm.
• Type of Ground Truth Used: No ground truth types (e.g., pathology, outcomes data) are mentioned for a performance study.
• Sample Size for the Training Set: There is no mention of a training set or its sample size.
• How Ground Truth for the Training Set was Established: No information on training set ground truth establishment is provided.

The document is purely a technical comparison for substantial equivalence rather than a clinical performance study.

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