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The EvoEndo Model LE Gastroscope is intended for the visualization of the upper digestive tract in adults and pediatric patients, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The gastroscope is a sterile single‐use device and can be inserted orally or transnasally.

The EvoEndo Controller is intended for use with an EvoEndo Endoscope for endoscopic diagnosis, treatment, and video observation.

The EvoEndo Endoscopy System is comprised of two regulated components:

• EvoEndo Model LE Single‐Use Gastroscope (hereafter referred to as the EvoEndo Endoscope)
• EvoEndo Controller (hereafter referred to as the Controller)

The EvoEndo Endoscope is a sterile, single‐use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. The EvoEndo Endoscope is ethylene oxide (EO) sterilized and is comprised of:

• Handle
• Umbilical Bundle that includes air, water, and suction lines, as well as the video connector
• Endoscope shaft with HD Camera

The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable.

The provided FDA 510(k) clearance letter and summary for the EvoEndo Single-Use Endoscopy System (K250900) do not describe a study involving acceptance criteria for device performance in the context of an AI/human reader study. Instead, this submission focuses on extending the indicated age range for an existing medical device (an endoscope system) and increasing its shelf life.

The "performance testing summary" sections (1.7, 1.8, 1.9, 1.10) refer to:

• Non-clinical functional and performance testing (e.g., visual, dimensional, tip deflection, air/water/suction flow rates, optical performance, electrical safety, EMC). These tests have specific acceptance criteria typical for medical device engineering, but they are not related to AI performance, clinical accuracy, or human reader performance.
• Biocompatibility testing
• Human factors/usability engineering testing
• Literature review to support the age extension. This is a scientific review, not a performance study with acceptance criteria of the type requested in the prompt.

Therefore, I cannot fulfill most of the requested information regarding acceptance criteria and studies typical for AI-enabled medical devices or comparative effectiveness studies with human readers. The document does not contain information about:

• A table of acceptance criteria and reported device performance (in the context of clinical accuracy or AI performance).
• Sample sizes used for a test set (clinical images) or the data provenance.
• Number of experts or their qualifications to establish ground truth for a test set.
• Adjudication methods for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study or related effect sizes.
• Standalone (algorithm only) performance.
• Type of ground truth used for clinical validation.
• Sample size for a training set or how its ground truth was established.

The prompt's requirements are designed for AI/imaging analysis devices, which this clearance document does not pertain to. This document is for a physical endoscopy system.

However, I can extract information related to the device and its predicate, as well as the justification for the Indication for Use extension:

Device: EvoEndo Single-Use Endoscopy System
Submission: K250900 (for indication extension and shelf-life extension)
Predicate Device: EvoEndo Single-Use Endoscopy System (K213606)

Summary of Device and Changes:

• Subject Device: EvoEndo Single-Use Endoscopy System (K250900)
  • Components: EvoEndo Model LE Single-Use Gastroscope & EvoEndo Controller
  • Intended Use: Visualization of the upper digestive tract (esophagus, stomach, duodenal bulb) for observation, diagnosis, and endoscopic treatment in adult and pediatric patients (extended from "patients over the age of five years" in predicate). Sterile, single-use, oral or transnasal insertion.
  • Key Differences from Predicate (K213606):
    1. Indicated Age: Removal of "in patients over the age of five years."
    2. Shelf Life: Extended from 6 months to 14 months.
• Predicate Device: EvoEndo Single-Use Endoscopy System (K213606)
  • Intended Use: Same as above, but "in patients over the age of five years."
  • Shelf Life: 6 months.

Acceptance Criteria and "Study" for Indication Extension:

Since this is not an AI-enabled device or a diagnostic device relying on accuracy metrics, the "acceptance criteria" here relate to demonstrating equivalence and safety for the extended indications and shelf life.

Regarding the specific questions in the prompt, based solely on the provided document:

1. A table of acceptance criteria and the reported device performance: As explained above, the "acceptance criteria" for this specific submission relate to the justification for the extended Indication for Use and shelf life, not typical AI/diagnostic performance. The table above attempts to capture this contextually.
2. Sample size used for the test set and the data provenance: Not applicable. No "test set" of clinical images or data was used for a performance validation in this submission type. The justification for age extension was a literature review.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data (like diagnostic accuracy) was not established or presented in this 510(k) for an endoscope.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the current submission, the "ground truth" for the expanded age indication was supported by a clinical literature review and anatomical considerations, along with a risk/benefit evaluation. This is not "ground truth" in the sense of a definitive diagnostic label for performance evaluation.
8. The sample size for the training set: Not applicable. There is no AI training set mentioned.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA document is for the clearance of an endoscope and its extended indications, not an AI-enabled diagnostic device. Therefore, the detailed requirements for AI/diagnostic performance studies cannot be addressed from this document.

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The EvoEndo Model LE Gastroscope is intended for the upper digestive tract in adults and pediativ patients, specifically for the observation, diagnosis treatment of the esophagus, stomach, and duodenal bulb in patients over the age of five years. The gastroscope is a sterile single-use device and can be inserted orally or transnasally.

The EvoEndo Controller is intended for use with an EvoEndo Endoscopic diagnosis, treament, and video observation.

The EvoEndo Endoscopy System is comprised of two regulated components:

• EvoEndo Model LE Single-Use Gastroscope (hereafter referred to as the EvoEndo Endoscope)
• EvoEndo Controller (hereafter referred to as the Controller) ●

The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. The EvoEndo Endoscope is ethylene oxide (EO) sterilized and is comprised of:

• o Handle
• Umbilical Bundle that includes air, water, and suction lines, as well as the video connector ●
• Endoscope shaft with HD Camera ●

The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable.

The provided document, an FDA 510(k) clearance letter for the EvoEndo Single-Use Endoscopy System, describes various tests conducted to demonstrate the device's safety and effectiveness and its substantial equivalence to predicate devices. However, this document does not contain information about an AI/ML-driven medical device. Therefore, it does not include acceptance criteria or a study design for evaluating algorithmic performance.

The document discusses performance criteria for the physical endoscope and its control system, such as:

• Biocompatibility Testing: Cytotoxicity, sensitization, acute systemic toxicity, and material-mediated pyrogenicity testing based on ISO 10993-1. (Acceptance criteria: No concerns in these areas).
• Sterilization Validation: Ethylene oxide (EO) sterilization validation. (Acceptance criteria: Met all criteria, no impact on product safety or effectiveness).
• Electrical Safety and EMC Testing: Conformance to IEC 60601-1:2005/(R)2012, A1:2012, IEC 60601-1-2:2014, and IEC 60601-2-18:2009. (Acceptance criteria: All met).
• Software Testing: Firmware in the EvoEndo Controller determined to be a "moderate level of concern" and documented per FDA guidance "Off-The-Shelf Software Use in Medical Devices". (Acceptance criteria: Documentation in accordance with guidance).
• Bench Performance Testing: Visual, dimensional, functional (camera/video, tip deflection, air/water/suction flow rates, accessory compatibility, 360° bend, simulated repeated use), and transit simulation. (Acceptance criteria: Met, deflection consistent with predicate, equivalent optical performance (resolution, depth of field, geometric distortion, image intensity uniformity, color performance)).
• Photobiological Safety Testing: Per IEC/TR 62471. (Acceptance criteria: Below limits of exempt risk group).
• Human Factors / Usability Engineering Testing: Two-stage usability study with representative intended users on a benchtop model and animal model. (Acceptance criteria: No significant device or user malfunctions or errors resulting in patient harm).

Since the request specifically asks for details related to an AI/ML device and human reader improvement with AI assistance, which are not present in this document, I cannot fulfill those parts of the request based on the provided text.

Specifically, the document does not provide the following information relevant to AI/ML device evaluation:

• A table of acceptance criteria for an AI/ML device's performance.
• Sample sizes, data provenance, number of experts, adjudication methods, or types of ground truth used for AI/ML test sets.
• Information on MRMC studies or the effect size of AI assistance on human readers.
• Standalone performance for an algorithm.
• Training set details (sample size, ground truth establishment) for an AI/ML model.

This is a clearance for a traditional medical device (an endoscope), not a software as a medical device (SaMD) or an AI/ML device that provides diagnostic or therapeutic outputs based on complex algorithms.

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