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The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the colonoscope to maintain central positioning within the lumen and help control the endoscope's view field and/or endoscope positioning.

The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC ("SPARKC") inflation pump. The G-EYE® Colonoscope includes a reprocessable, reusable balloon (the G-EYE® balloon) that is attached to a standard, commercially available colonoscope which is remanufactured by Smart Medical to include the balloon at its bending section. The installation of the balloon onto the standard colonoscope is considered remanufacturing of the standard colonoscope by Smart Medical, which assumes responsibility for the final device including the G-EYE® balloon and the remanufactured colonoscope. The G-EYE® balloon is inflated by the dedicated SPARKC inflation system, which enables automatic control of the required balloon pressure in one of several user-selected, systemcontrolled pressure levels such that the balloon conforms to the colonic lumen diameter. The G-EYE® Colonoscope is advanced by the endoscopist with the balloon deflated, which essentially preserves the standard colonoscope's diameter and insertion technique. At the cecum, the balloon is inflated to engage the colon walls, and the colonoscope is then withdrawn by the endoscopist using standard withdrawal technique. Withdrawal of the inflated balloon mechanically straightens the colonic folds and anatomic flexures, centers the colonoscope optics within the colonic lumen, and minimizes uncontrolled bowel slippage during withdrawal, therefore maintaining the endoscope's field of view

The provided text describes a 510(k) premarket notification for the G-EYE® System, aiming to demonstrate its substantial equivalence to a previously cleared predicate device. The submission focuses on expanding the range of compatible endoscope models and affirms that this change does not raise new questions of safety or effectiveness.

While the document details various nonclinical tests conducted to support substantial equivalence (reprocessing validation, biocompatibility, software verification/validation, electrical safety, and verification bench testing), it does not provide a table of specific acceptance criteria or reported device performance for these tests in a quantifiable manner. It merely states that "Each of these tests met its acceptance criteria, supporting substantial equivalence to the predicate."

Furthermore, the document mentions the availability of clinical data from five studies involving approximately 4500 subjects, stating that these studies "demonstrated that the device functioned as intended, with no serious device-related adverse events" and "facilitates visualization of the colonic mucosa surface area." However, it does not present the specific acceptance criteria or the study results for these clinical studies in a way that directly addresses quantitative performance metrics or comparative effectiveness.

Given the information provided in the input, it is not possible to fully address all parts of your request. The response below will focus on what can be extracted from the text.

Acceptance Criteria and Device Performance Study for the G-EYE® System

The provided 510(k) summary focuses on demonstrating substantial equivalence of the G-EYE® System to its predicate (K202469), primarily for expanding the range of compatible endoscope models. The study details included are largely general statements confirming that various tests met their acceptance criteria, rather than specific quantitative performance figures.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, a detailed table with quantifiable acceptance criteria and reported device performance cannot be generated. The document states that various tests "met its acceptance criteria" but does not specify these criteria or the test results numerically.

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

• Nonclinical Test Sets: The sample sizes for the specific nonclinical tests (reprocessing, biocompatibility, software, electrical safety, bench testing) are not specified in the document.
• Clinical Data: "In total, the studies included approximately 4500 subjects."
• Data Provenance: The document does not specify the country of origin for the clinical data or whether it was retrospective or prospective.

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

• This information is not provided in the document. The document refers to "clinical studies" but does not detail how ground truth was established within those studies, nor does it mention the number or qualifications of experts involved in establishing ground truth for any test set (clinical or nonclinical).

4. Adjudication Method for the Test Set

• The document does not provide details on any adjudication methods used for the test sets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• The document does not explicitly state that an MRMC comparative effectiveness study was done regarding human readers improving with AI vs. without AI assistance. The focus is on the device's mechanical function (balloon) rather than an AI component assisting human readers. The text mentions "clinical studies" but does not describe them in the context of MRMC studies or effect sizes for human reader improvement.

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

• The G-EYE® System, as described, is a mechanical device that enhances visualization during colonoscopy. It incorporates a balloon and inflation system. There is no mention of an AI algorithm or standalone algorithm performance in the provided text.

7. The Type of Ground Truth Used

• For the nonclinical tests (reprocessing, biocompatibility, software, electrical safety, bench testing), the "ground truth" seems to be defined by adherence to established standards and company-defined acceptance criteria.
• For the clinical data, the "ground truth" for reported outcomes appears to be clinical observation ("device functioned as intended," "no serious device-related adverse events," "facilitates visualization of the colonic mucosa surface area"). There is no explicit mention of pathology, expert consensus, or specific outcomes data as "ground truth" for quantitative performance metrics.

8. The Sample Size for the Training Set

• The document describes a 510(k) submission for a medical device (colonoscope system) that has been previously cleared, and the current submission expands compatibility. It does not mention a "training set" in the context of machine learning or AI models. Therefore, a sample size for a training set is not applicable or provided.

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

• As a "training set" for an AI/ML model is not mentioned, this question is not applicable based on the provided text.

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