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VIDEO SYSTEM CENTER CV-V1: This video system center is intend to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-LV1: This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
COLONOVIDEOSCOPE OLYMPUS CF-LV1L and CF-LV11: This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

The primary components of the V1 SYSTEM consists of two Olympus colonovideoscopes; CF-LV1L and CF-LV11 (which are identical except for their working) lengths, an Olympus gastrointestinal videoscope; GIF-LV1 and a video system center. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract. The V1 SYSTEM is designed to be used with specified monitors, EndoTherapy accessories and other ancillary equipment.
The primary components of the subject system, which are part of this submission, are: VIDEO SYSTEM CENTER OLYMPUS CV-V1 GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-LV1 COLONOVIDEOSCOPE OLYMPUS CF-LV1L COLONOVIDEOSCOPE OLYMPUS CF-LV11
CV-V1 can be used with Olympus endoscope models, such as gastorointestinal videoscope GIF-LV1 and colonovideoscope CF-LV1L/I. The subject premarket notification is specific for gastrointestinal videoscopes and colonovideoscopes.
The GIF-LV1, CF-LV1L/I can be used with VIDEO SYSTEM CENTER OLYMPUS CV-V1. The light source and the LG bundle are not used, instead, there are LEDs in the distal end of the scope that runs by electric power from the CV-V1 and light up the distal end. The newly designed one-touch connector is water proof.

The provided 510(k) summary for the V1 SYSTEM describes a modification to an endoscopic video imaging system, specifically regarding a change in the lighting method from an external light source to integrated LEDs within the endoscopes. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for diagnostic accuracy or clinical outcomes.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable or cannot be extracted from this document, as the submission does not detail a clinical study of the V1 SYSTEM's diagnostic or therapeutic effectiveness against a specific set of acceptance criteria. The focus is on technical performance relative to safety standards and equivalence to a predicate device.

However, I can extract information related to the technical testing conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria for diagnostic performance or specific clinical outcomes. Instead, it refers to the performance of non-clinical tests based on various standards. The acceptance criteria for these tests would typically be compliance with the specified standard.

The document states, "The newly lighting method has been confirmed that the safety and effectiveness are equivalent i compare with the predicate devices." This implies that the performance of the new lighting method was deemed equivalent to the predicate, likely through technical testing and comparison of image quality, illumination, etc., though specific metrics are not detailed here.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. The document describes non-clinical testing rather than a clinical study with a patient "test set." The "test set" would refer to the physical devices (V1 SYSTEM components) themselves. No patient data is mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. The testing described is non-clinical (safety, mechanical, functional, biocompatibility) and does not involve establishing ground truth from expert assessments of clinical data.

4. Adjudication Method

This information is not provided as no expert assessment of clinical data is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. The submission is for a medical device (endoscopic system) which is a tool for human examiners, and the focus is on the device's technical equivalence and safety, not on human reader performance with or without AI assistance.

6. Standalone Algorithm Performance

Not applicable. The V1 SYSTEM is an endoscopic video imaging system, not an AI algorithm. It is a device intended for human-in-the-loop use for diagnosis and treatment.

7. Type of Ground Truth Used

Not applicable in the context of a clinical study for diagnostic accuracy. For the non-clinical tests, the "ground truth" would be established by the specifications and standard requirements outlined in the referenced IEC and ISO standards. For example, for biocompatibility tests, the "ground truth" is whether the materials meet the safety thresholds defined by ISO 10993.

8. Sample Size for the Training Set

Not applicable. The V1 SYSTEM is not an AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. The V1 SYSTEM is not an AI algorithm.

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