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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 At the cecum, the balloon is inflated to engage the colon walls, and the colonoscope is then withdrawn by the endoscopist using standard withdrawal technique.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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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 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, system-controlled 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 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 is a 510(k) summary for the G-EYE® System, specifically K202469, which is primarily a submission to expand the range of compatible colonoscope manufacturers. The document repeatedly states that the new device (K202469) is "nearly identical" or "substantially similar" to its predicate device (K192588), and that the differences "do not raise different questions of safety or effectiveness."

Therefore, the document does not describe a new study designed to prove the device meets new acceptance criteria for an AI/ML-based device. Instead, it refers to prior performance testing and clinical studies on the predicate device (K192588) to support the substantial equivalence of the new G-EYE® System (K202469). The "Performance Data" section lists several types of tests, but these are primarily engineering and reprocessing validations, not performance against clinical endpoints that would typically require expert ground truth or MRMC studies.

Based on the provided text, it is not possible to answer the detailed questions regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, or sample sizes for AI/ML model training/testing, as the document focuses on the mechanical and reprocessing aspects of a colonoscopy assist device, and its substantial equivalence to a prior cleared version.

Here's a breakdown of what can be extracted and what cannot:

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

• The document states that "Each of these tests met its acceptance criteria, supporting substantial equivalence to the predicate." However, the specific acceptance criteria (e.g., numerical targets for performance metrics) are not detailed within this 510(k) summary. The performance reported is qualitative: the tests "met its acceptance criteria" and "demonstrated that the software performs as intended."
• The clinical performance is described as "the device functioned as intended, with no serious device-related adverse events. In addition, the studies demonstrated that the device served its intended function, and that the mechanical straightening of the and anatomic flexures provided by the G-EYE® System facilitates visualization of the colonic mucosa surface area." No specific metrics like sensitivity, specificity, or ADR improvement are provided.

2. Sample sizes used for the test set and the data provenance:

• The document states: "clinical data is available from four clinical studies that further support the safety and performance of the device for its intended use. In total, the studies included approximately 4000 subjects."
• Sample size for test set: The "4000 subjects" refers to participants in prior clinical studies that support the predicate device, not a specific test set for an AI/ML model. It's unclear how many of these were used as a "test set" in the AI/ML sense, or if a separate, dedicated "test set" was used for the current submission's minor changes.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). These studies were likely conducted for the predicate device's clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The clinical studies mentioned focused on the device's mechanical function and safety, not on AI/ML performance requiring expert ground truth in the context of diagnostic accuracy.

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

• Not applicable/Not specified, as this is not an AI/ML diagnostic device being evaluated for standalone or assisted performance against expert ground truth.

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:

• Not mentioned. This device assists withdrawal by straightening folds, not primarily by providing AI-assisted detection or diagnosis. Therefore, an MRMC study comparing human readers with and without AI assistance is not described or relevant for this specific device's function as presented. The product description emphasizes mechanical straightening and improved visualization, not AI-driven lesion detection.

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

• Not applicable. This device is a mechanical aid to colonoscopy, not a standalone diagnostic algorithm.

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

• For the clinical studies, "ground truth" would likely be based on standard colonoscopy findings (e.g., visual identification of polyps, histopathology of removed tissues) and patient outcomes. The text primarily focuses on the device's ability to "facilitate visualization" and its safety, rather than providing diagnostic outputs that require "ground truth" in the AI/ML sense.

8. The sample size for the training set:

• Not specified. There is no indication that this device uses machine learning that requires a "training set" in the conventional sense. The "software verification and validation" mentioned likely pertains to the control software for the balloon inflation, not an AI/ML detection algorithm.

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

• Not applicable, as no training set for an AI/ML model is indicated.

In summary, the provided 510(k) summary is for a mechanical colonoscopy assist device seeking clearance for expanded compatibility, not an AI/ML diagnostic or detection device requiring the specific types of performance studies listed in the prompt. The "Performance Data" section discusses engineering verification, validation (reprocessing, biocompatibility, software, electrical safety), and references prior clinical studies on the predicate device for overall safety and performance (i.e., its ability to mechanically aid visualization), rather than AI/ML specific metrics.

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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 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, system-controlled 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 (FDA 510(k) summary for the G-EYE® System) does not contain detailed information about acceptance criteria and a study proving the device meets these criteria in the format requested. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set specifically for evaluating the AI component (as the device described is not an AI/software as a medical device in the typical sense but rather a physical colonoscope system with a balloon).
• Data provenance for a test set.
• Details on expert involvement, ground truth establishment, or adjudication methods for a test set.
• Information on MRMC studies or effect sizes of human reader improvement with AI assistance.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for a training set or how its ground truth was established.

The document discusses performance data in the context of demonstrating substantial equivalence to a predicate device, focusing on verification bench testing, reprocessing validation, biocompatibility, software verification/validation, and electrical safety/EMC. It also mentions three clinical studies conducted outside the United States that further support safety and performance, but these are noted as "not required to demonstrate substantial equivalence" and are presented at a high level.

Therefore, many of the requested points cannot be answered from the provided text because the device is a hardware system, not an AI software, and the document focuses on regulatory clearance via substantial equivalence rather than a detailed AI performance study.

However, I can extract the information that is present regarding performance and its acceptance:

Acceptance Criteria and Device Performance (as inferred from the text)

The document doesn't explicitly list quantitative "acceptance criteria" for a study in a table, but it states that various tests "met its acceptance criteria, supporting substantial equivalence to the predicate."

Here's a summary of the performance "studies" and what they aimed to achieve in terms of acceptance:

Other Requested Information:

Since this is a filing for a physical medical device (colonoscope system) and not an AI/software device, much of the requested information (especially points 2-5, 8-9) is not applicable or not provided in the context of an AI performance study.

1. Sample size used for the test set and the data provenance: Not applicable in the context of an "AI test set." For the clinical studies (which were supplementary and not primary for 510(k) clearance): "over 1000 subjects" combined across three studies. Data provenance is "outside the United States." It's not specified if they were retrospective or prospective, but clinical studies are typically prospective.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/diagnostic imaging device requiring expert ground truth in this manner for its 510(k). The clinical studies involved medical professionals using the device.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device and regulatory submission.
4. 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: Not applicable. This device is not an AI assistance tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the clinical studies, the "ground truth" was essentially the observed performance of the device in facilitating procedures, absence of adverse events, and aiding visualization. These are clinical outcomes rather than a "ground truth" for an AI diagnostic task.
7. The sample size for the training set: Not applicable. This is not an AI device trained on data.
8. How the ground truth for the training set was established: Not applicable.

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