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The invendo C25 Colonoscopy 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, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.

The colonoscope component of the invendo C25 Colonoscopy System, the SC20 colonoscope, is a single-use disposable device. The SC20 colonoscope cannot be reprocessed.

The invendo C25 Colonoscopy System is a modified version of the invendo C20 Colonoscopy System.

Like the predicate device, the invendo C25 Colonoscopy System is steered and controlled by the operator. The distal tip of the colonoscope is deflectable and includes a CMOS camera and LEDs for illumination. A working channel is incorporated to enable biopsies and polypectomies. The invendo C25 Colonoscopy System includes insufflation, irrigation and suction functions.

The invendo C25 Colonoscopy System consists of two components: (1) the invendo C25 base system; and (2) a single-use, disposable colonoscope, the SC20 colonoscope.

The invendo C25 base system provides the SC20 colonoscope with the above mentioned functions and transfers user commands to the colonoscope. To control the colonoscope, the operator uses a handheld control unit. All colonoscope functions are solely activated by the user. The invendo C25 base system consists of the Supply and Processing Unit (SPU or base unit), the handheld control and the drive unit.

The provided document is a 510(k) premarket notification for the invendo C25 Colonoscopy System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study for novel performance claims.

Therefore, many of the requested details about acceptance criteria, clinical study methodology, and training/test set specifics are not applicable or available within this document, as it describes a technical modification and equivalence demonstration, not a de novo clinical performance study against pre-defined metrics.

However, I can extract the information that is present:

1. A table of acceptance criteria and the reported device performance

Since this filing is for substantial equivalence to a predicate device (invendo C20 Colonoscopy System), the "acceptance criteria" are primarily related to meeting established safety standards and demonstrating that the new device performs at least as well as the predicate with its modifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This document does not specify sample sizes for any human clinical test sets, as the testing described is primarily non-clinical (engineering and biocompatibility). The "Evaluation of the performance compared to the predicate device" would have been a non-clinical, comparative engineering/functional test, not a clinical trial.
• Data Provenance: Not applicable, as the document details non-clinical laboratory testing.

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. This document describes non-clinical testing against engineering standards and a predicate device, not a study requiring expert-established ground truth on medical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable for the type of testing described in this 510(k).

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, an MRMC comparative effectiveness study was not done as this is a device modification submission, not an AI-enabled diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable, as this is a medical device (colonoscope system), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the non-clinical tests were the specified engineering standards (e.g., IEC, ISO) and the functional and safety performance of the predicate device.

8. The sample size for the training set

• Not applicable, as this is not an AI/algorithm device that requires a training set. The "design validation" mentioned refers to engineering design and testing, not machine learning model training.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for an AI/algorithm.

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The invendo C20 Colonoscopy 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, colon, cecum and ileocecal valve) for endoscopy and endoscopy surgery.

The colonoscope component of the invendo C20 Colonoscopy System, the SC20 Colonoscope, is a single use disposable device. The SC20 Colonoscope cannot be reprocessed.

The device is contraindicated in patients with fulminant colitis; acute diverticulitis; severe cardiopulmonary illness; or where there is a lack of cooperation on the part of the patient.

The invendo C20 Colonoscopy System has many features in common with currently marked colonoscopes. The invendo C20 Colonoscopy System consists of two separate components: a single use disposable colonoscope and a base system that supplies and controls the colonoscope according to user commands via a handheld control unit. 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 invendo C20 Colonoscopy System is equipped with insufflation, irrigation and suction functions. Deflection, rinsing, insufflation and suction are activated and controlled by the base unit, according to user commands.

Unlike other colonoscopes, the invendo C20 Colonoscopy System is not manually pushed or otherwise manually manipulated by the operator, but instead, moves under the operator's direction through use of a handheld controller that controls, among other things, the device's drive unit. The colonoscope uses a lubricated inverted sleeve technology for advancement and retraction. Unlike other colonoscopes, the invendo C20 Colonoscopy System uses pressure controlled bellows for the deflecting function. The endoscope deflects in any direction depending on the pressure in the bellows. The handheld control is connected to the base unit. Depending on the user commands, the base unit activates and controls the functions of the invendo SC20 Colonoscope.

The colonoscope component of the system is a single-use disposable device. The SC20 colonoscope cannot be reprocessed. The main materials with direct contact with the patient are silicone and polycarbonate. The whole colonoscope, including the lubricant, were demonstrated to be biocompatible per ISO 10993.

Acceptance Criteria and Device Performance for The invendo C20 Colonoscopy System

The invendo C20 Colonoscopy System relies on both non-clinical (bench) and clinical data to demonstrate its safety and effectiveness, showing substantial equivalence to predicate devices. The primary clinical acceptance criterion was the rate of successful cecal intubation.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 61 subjects.
• Data Provenance: The study was conducted in Germany and was prospective in nature.

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

The provided document does not explicitly state the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience").

However, it mentions:

• "Investigators underwent 'pre-study' training where 2-4 training cases were needed to gain proficiency."
• "The investigators were experienced endoscopists that insufflated the colon with either CO2 or water."

This indicates that experienced endoscopists (who acted as the primary users and observers) were involved, and their findings (e.g., successful intubation, lesion detection) likely formed the ground truth for the clinical outcomes. The clinical study was published in "The American Journal of Gastroenterology," suggesting peer-reviewed medical expertise validated the study design and results.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in the clinical study. The "experienced endoscopists" performing the procedures and documenting the outcomes (e.g., cecal intubation, lesion detection) served as the primary evaluators. The results were then reported, implying the investigators' findings formed the basis of the reported performance.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study was a "prospective single arm study" focusing on the performance of the invendo C20 Colonoscopy System alone. It did not compare human readers' performance with and without AI assistance, nor did it involve a direct comparison of the device's diagnostic accuracy against a "gold standard" or another device in a multi-reader setting.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The invendo C20 Colonoscopy System is a device that requires a human operator (an endoscopist) to control its advancement and utilize its visualization and therapeutic capabilities. Therefore, a standalone (algorithm only) performance study was not performed nor would it be applicable since the device inherently operates with a human in the loop. The "device performance" in the clinical study is the performance of the entire system (device + human operator).

7. Type of Ground Truth Used

The ground truth used in the clinical study was primarily based on expert observation and direct procedural outcomes by experienced endoscopists during a prospective study.

• Cecal Intubation: Verified by the endoscopist during the procedure.
• Lesion Detection and Removal: Identified by the endoscopist during the procedure, with polyps removed and potentially histologically confirmed (though not explicitly detailed in this summary). The summary mentions "Thirty-two polyps (88.9%) were removed by either forceps (22) or snare (10)," which implies direct observation and intervention.

This type of ground truth is analogous to "clinical findings by expert practitioners" rather than a separate, external pathology review for every identified lesion.

8. Sample Size for the Training Set

The document does not describe a training set in the context of an algorithm or AI model development. The invendo C20 Colonoscopy System is a mechanical and electronic device, not an AI software. Therefore, the concept of a "training set" for an algorithm is not applicable here. The "training" mentioned for investigators refers to user proficiency with the device, not an algorithm's learning phase.

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

As noted in point 8, there was no algorithm or AI model that required a training set with established ground truth in the typical sense. The "pre-study" training for investigators was about gaining proficiency in operating the device, not training an algorithm.

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