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The invendoscopy E210 System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.

The colonoscope component of the invendoscopy E210 System, the invendoscope SC210, is a sterile single use disposable device. The invendoscope SC210 cannot be reprocessed.

The invendoscopy E210 System consists of an invendoscope SC210, an invendo E210 Processing Unit, an invendo E210 Power Unit, an invendo ScopeController and an invendo Drying Adapter. The invendo E210 Processing Unit and the invendo E210 Power Unit together form the invendo SPU E210.

The invendoscope SC210 is a sterile single-use disposable colonoscope. The distal tip of the colonoscope is deflectable and equipped with a CMOS camera and LEDs for illumination. A working channel is incorporated for biopsies and polypectomies. The invendoscope SC210 is furthermore equipped with insufflation, irrigation and suction functions.

The invendo E210 SPU (consisting of invendo E210 Processing Unit and invendo E210 Power Unit) contains the video signal processing technology which enables the endoscope to illuminate, view, record and transmit video data of endoscopic images. The invendo SPU E210 supplies the colonoscope and controls its functions according to the commands of the operator.

The operator uses the invendo ScopeController unit to control the invendoscopy E210 System. The invendo ScopeController allows the operator to control following functions of the colonoscope: deflection of the tip; insufflation; irrigation and suction. The invendo ScopeController also allows the user to record images.

The invendo Drying Adapter is intended to support drying of the inner parts of the invendo SPU E210. It is used to connect a waste container to the invendo SPU E210.

The provided text describes the invendoscopy E210 System and its substantial equivalence to predicate devices, but it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.

The document details:

• The device's intended use and components.
• A comparison of its technology/specifications to predicate devices.
• A list of non-clinical performance testing conducted to validate the design and assure conformity with various design standards (e.g., electrical safety, biocompatibility, packaging integrity, sterilization).
• A statement that "In all instances, the invendoscopy E210 System functioned as intended, performed as well as or better than the predicate and met individual test specifications." and "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment."

However, it does not provide:

1. A table of acceptance criteria and reported device performance with specific metrics.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method.
5. Information on any MRMC comparative effectiveness study.
6. Details of a standalone algorithm performance study.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence primarily through technical comparison and compliance with general safety and performance standards for medical devices, rather than a specific clinical or technical performance study with quantitative acceptance criteria and results.

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The invendoscopy E200 System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.

The colonoscope component of the invendoscopy E200 System, the invendoscope SC200, is a sterile single use disposable device. The invendoscope SC200 cannot be reprocessed.

The invendoscopy E200 System consists of an invendoscope SC200, an invendo SPU E200, an invendo ScopeController and an invendo E200 Drying Adapter.

The invendoscope SC200 is a sterile single-use disposable colonoscope. The distal tip of the colonoscope is deflectable and equipped with a CMOS camera and LEDs for illumination. A working channel is incorporated for biopsies and polypectomies. The invendoscope SC200 is furthermore equipped with insufflation, irrigation and suction functions.

The invendo SPU E200 contains the video signal processing technology which enables the endoscope to illuminate, view, record and transmit video data of endoscopic images. The invendo SPU E200 supplies the colonoscope and controls its functions according to the commands of the operator.

The operator uses the invendo ScopeController unit to control the invendoscopy E200 System. The invendo ScopeController allows the operator to control following functions of the colonoscope: deflection of the tip; insufflation; irrigation and suction. The invendo ScopeController also allows the user to record images.

The invendo E200 Drying Adapter is intended to support drying of the inner parts of the invendo SPU E200. It is used to connect a waste container to the invendo SPU E200.

This document describes the regulatory submission for the invendoscopy E200 System (K161355) and focuses on the performance testing carried out to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text discusses performance testing in a general sense, stating that the device "functioned as intended, performed as well as or better than the predicate and met individual test specifications." However, it does not explicitly provide a table detailing specific quantitative acceptance criteria or granular performance metrics for the device. Instead, it lists the standards against which testing was performed and draws a general conclusion about the device's performance relative to these standards and the predicate devices.

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

The document does not specify the sample size used for performance testing (e.g., number of devices tested, number of simulated procedures, or number of patients). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for any clinical or non-clinical studies. The focus is on non-clinical engineering and biocompatibility tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The performance testing described primarily relates to engineering and material standards, not to clinical efficacy or diagnostic accuracy that would typically require expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided, as the nature of the testing described (largely engineering and compliance with technical standards) does not typically involve adjudication in the clinical sense.

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 conducted as this device is an endoscope system (hardware and associated control units), not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

A standalone performance study for an algorithm was not done. The invendoscopy E200 System is a physical medical device for visualization and diagnostic/therapeutic access, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance testing described, the "ground truth" would be the specifications and requirements defined by the referenced international and national standards (e.g., IEC 60601-1, ISO 10993 series, ASTM standards) and the established in-house acceptance criteria based on ISO 14971. The device's performance was measured against these technical and safety thresholds. It is not based on expert consensus, pathology, or outcomes data in the traditional sense of clinical diagnostic accuracy.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The invendoscopy E200 System is a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

This information is not applicable and therefore not provided, as there is no training set for this type of device.

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