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The Aer-O-Scope Colonoscope System is intended to provide visualization (via a video monitor) and diagnostic/ therapeutic access to the adult lower gastrointestinal tract, (including but not limited to, the anus, rectum, sigmoid colon, transverse colon, cecum and ileocecal valve) for endoscopy. The Aer-O-Scope Disposable colonoscope is a single use disposable endoscope and cannot be reprocessed.

The Aer-O-Scope 3 Colonoscope System is a flexible, operator-controlled, colonoscope that provides visualization and therapeutic access to the colon. It is comprised of two major components, the Video Controller and the Aer-O-Scope 3 Disposable Colonoscope. The Video Controller contains all components and subsystems required for operation and control of the Aer-O-Scope 3 Colonoscope System. The Aer-O-Scope 3 Disposable Colonoscope includes channels for irrigation, insufflation, lens wash, therapeutic access, and suction. The disposable colonoscope includes an optical imaging head with a CMOS sensor and lenses for visualization with a 200° panoramic omni field of view. All commands are controlled by the operator and regulated through the Video Controller. The Aer-O-Scope 3 Disposable Colonoscope is a single use device and cannot be reprocessed. The main material that comes in contact with the patient is polyurethane that is coated with a biocompatible hydrophilic coating. The Aer-O-Scope 3 Disposable Colonoscope is biocompatible according to the ISO 10993 harmonized and FDA consensus standard.

The provided text describes the regulatory clearance of a medical device (Aer-O-Scope Colonoscope System) but lacks the specific details required to fully address all aspects of your request regarding acceptance criteria and the study that proves the device meets them. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria.

However, based on the available information, here's an attempt to extract and infer what's possible:

There is no explicit table of acceptance criteria and reported device performance provided in the document. The document states that "GI View Ltd. conducted packaging and shelf-life testing which met all the criteria," "Biocompatibility tests were performed and met all the required criteria," "EMC and Electrical safety were tested... and found compliant with the applicable standards," and "Bench tests to measure the safety and effectiveness of device components were performed. Bench tests to measure optical parameters and safety such as photobiological safety, resolution and geometric distortion were performed. In all instances the Aer-O-Scope 3 Colonoscope System functioned as intended and met the individual test specifications and/or FDA consensus standards." For clinical performance, it states, "The data demonstrated that the Aer-O-Scope 3 Colonoscope System (with a wider field of view (200°) compared to the predicate) successfully allows cecal intubation in the intended use population and provides therapeutic access to the lower gastrointestinal tract for screening, diagnostic and surveillance endoscopy (colonoscopy) as the predicate devices."

Given the information, a table like the one requested cannot be constructed precisely as acceptance criteria values are not explicitly stated for each performance aspect, nor are the quantitative results. The text only confirms that criteria were "met" or "functioned as intended."

Here's an attempt to answer the other questions based on the provided text:

• 1. A table of acceptance criteria and the reported device performance:
  As mentioned above, an explicit table is not provided. The document generally states that "all criteria were met" for various tests.

  Acceptance Criteria (Inferred from text)	Reported Device Performance (Summary from text)
  Packaging and Shelf-life standards	Met all the criteria
  Biocompatibility standards	Met all the required criteria
  EMC and Electrical safety standards	Found compliant with the applicable standards
  Device component safety & effectiveness	Functioned as intended; met individual test specifications
  Optical parameters (photobiological safety, resolution, geometric distortion)	Functioned as intended; met individual test specifications and/or FDA consensus standards
  Cecal Intubation Success Rate	Successfully allows cecal intubation
  Therapeutic Access to lower GI tract	Provides therapeutic access to the lower gastrointestinal tract for screening, diagnostic, and surveillance endoscopy
  Overall Safety and Efficacy (in vivo)	Demonstrated overall safety and efficacy

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

  • Test Set Sample Size: The document mentions "Pre-clinical in vivo tests in swine" and a "clinical investigation" in humans.
    • For the clinical investigation, the number of human subjects is not specified.
    • For the in vivo tests, the number of swine is not specified.
  • Data Provenance: The document does not explicitly state the country of origin for the clinical investigation data. Given the "Owner" (GI View Ltd.) is based in "Ramat Gan, Israel," it implies the clinical study could have been conducted in Israel or elsewhere, but this is not confirmed. The document refers to "GI View Ltd. conducted" studies.
  • Retrospective or Prospective: The clinical investigation is described as being performed "to demonstrate safety and effectiveness," which strongly suggests a prospective study.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
  This information is not provided in the document. The text does not elaborate on how ground truth was established for "cecal intubation" or "therapeutic access" during the clinical or pre-clinical studies.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
  This information is not provided in the document.

• 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 involving human readers with and without AI assistance is not mentioned. The document focuses on the device's performance for visualization and therapeutic access, primarily in comparison to a predicate device's functionality, not on AI assistance for human readers.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
  This device is an endoscope system (hardware) for visualization and access, not a standalone AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable to this device's description. The system provides visualization to a human operator.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
  This information is not explicitly detailed. For the clinical investigation, "cecal intubation" success and "therapeutic access" would likely be determined by direct observation by the participating endoscopists. The document does not specify if additional ground truth like pathology reports for lesions found or long-term outcomes data were used to evaluate the device's diagnostic or therapeutic efficacy.

• 8. The sample size for the training set:
  This device is a hardware system, not an AI model that requires a "training set" in the traditional machine learning sense. Therefore, the concept of a "training set" sample size is not applicable.

• 9. How the ground truth for the training set was established:
  As above, this question is not applicable as the device is not an AI model with a training set.

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The Aer-O-Scope Colonoscope System is intended to provide panoramic (3600) visualization (via a video monitor) and diagnostic/therapeutic access to the adult lower gastrointestinal tract, (including but not limited to, the anus, rectum, sigmoid colon, transverse colon, cecum and ileocecal valve) for endoscopy.

The Aer-O-Scope Disposable Scanner (colonoscope component of the Aer-O-Scope Colonoscope System) is a single use disposable device. An Aer-O-Scope Scanner cannot be reprocessed.

The Aer-O-Scope 2 is a flexible, operator-controlled, colonoscope that utilizes a propulsion mechanism to provide visualization and therapeutic access to the colon. It is comprised of two major components, the Controlling Work Station and the Aer-O-Scope 2 Disposable Scanner (the colonoscope component). The work station system console contains all components and subsystems required for operation and control of the Aer-O-Scope Colonoscope System, including a joystick component for controlling scope tip deflection. The Aer-O-Scope 2 Disposable Scanner includes a soft narrow multi-lumen tube with channels for irrigation, insufflation, therapeutic access and suction, CO2 delivery to the balloons and colon and the soft balloons for the propulsion system. The Disposable Scanner also includes an optical imaging head with a CMOS sensor and lenses for both forward visualization and a 360° panoramic omni view. All commands are controlled by the operator and regulated through the Controlling Work Station.

The Aer-O-Scope 2 utilizes a propulsion system for colonic intubation and scanning. The propulsion system relies on CO2 gas and soft pliable balloons that allow the Aer-O-Scope 2 scanner to travel through the colon without the need for pushing force. The tip of the scope with the optical imaging head can be deflected in any direction to ensure full visualization. This propulsion system is identical to the Aer-O-Scope 1 Colonoscope System.

The Aer-O-Scope 2 Colonoscope System contains optional post processing spectral filtering capabilities that assist the physician in examining features captured in standard white light colonoscopy images.

The Aer-O-Scope 2 Disposable Scanner is a single use device and cannot be reprocessed. The main materials that come in contact with the patient are polyurethane and Pebax™ that are coated with a hydrophilic coating. The Aer-O-Scope 2 Disposable Scanner is biocompatible according to the ISO 10993 harmonized and FDA consensus standard.

The provided text is related to the FDA 510(k) clearance for the Aer-O-Scope Colonoscope System and details the substantial equivalence to predicate devices, particularly focusing on mechanical and biocompatibility aspects, rather than detailed performance criteria for an AI/CADe device. Therefore, a direct answer to the request regarding acceptance criteria and study proving performance for an AI/CADe device cannot be fully formulated from the given text.

The text does not include information about:

• A table of acceptance criteria and reported device performance (in terms of clinical efficacy metrics like sensitivity, specificity, PPV, NPV).
• Sample size for the test set or its provenance for clinical performance evaluation.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone (algorithm only) performance.
• The type of ground truth used for clinical performance.
• Sample size for the training set.
• How ground truth for the training set was established.

The provided document describes the Aer-O-Scope Colonoscope System and focuses on its substantial equivalence to predicate devices based on bench testing and pre-clinical in vivo tests. It explicitly states that no clinical data is needed for the determination of substantial equivalence for this device, as the propulsion system is identical to a previously cleared device. Therefore, the questions related to clinical performance metrics, ground truth, expert review, and AI assistance are not addressed by this document.

The document highlights:

• Bench tests to measure forces, biocompatibility, and safety.
• Ex-vivo studies to demonstrate therapeutic access.
• Pre-clinical in vivo tests in swine for overall safety and efficacy.

These are general device safety and performance criteria, not specific clinical performance metrics (e.g., sensitivity/specificity for disease detection) that would be expected for an AI/CADe device.

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The Aer-O-Scope Colonoscope System is intended to provide panoramic (3600) visualization (via a video monitor) and visual access to the adult lower gastrointestinal tract, (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy.

The Aer-O-Scope Disposable Scanner (colonoscope component of the Aer-O-Scope Colonoscope System) is a single use disposable device. An Aer-O-Scope TM Scanner cannot be reprocessed.

The Aer-O-Scope Colonoscope System is a flexible, operator-controlled, colonoscope that utilizes a propulsion mechanism to provide visualization and visual (diagnostic) access to the colon. It is comprised of two major components, the Controlling Work Station and the Aer-O-Scope Disposable Scanner (the colonoscope component). The work station system console contains all internal components and subsystems required for operation and control of the Aer-O-Scope Colonoscope System, including a joystick component for controlling scope tip deflection. The Aer-O-Scope Disposable Scanner includes a soft narrow multilumen tube with channels for irrigation, insufflation, suction, CO2 delivery to the balloons and colon, soft balloons for the propulsion system and an optical imaging head with a CMOS chip and lenses for both forward visualization and a 360° panoramic omni view. All commands are controlled by the operator and regulated through the Controlling Work Station.

Similar to the predicate device, the Aer-O-Scope Colonoscope System utilizes a propulsion system for colonic intubation and scanning. The propulsion system relies on CO2 gas and soft pliable balloons that allow the Aer-O-Scope scanner to travel through the colon without the need for pushing force. A rectal balloon that sits at the base of the rectum and acts as a sealer prevents gas from escaping via the rectum. Two other balloons at the tip of the scope act as driving balloons. The space between the rectal balloon and the driving balloons is filled with low pressured CO2 gas via the rear channel through the rectal introducer that helps move the optical imaging head forward. For retraction, the gas behind the driving balloons is vented via the two-way rear channel in the rectal introducer. The space between the cecum and the driving balloons is filled with low pressure CO2 gas via the front channel, easing the driving balloons back towards the rectum. The tip of the scope with the optical imaging head can be deflected in any direction to ensure full visualization.

The Aer-O-Scope Disposable Scanner is a single use device and cannot be reprocessed. The main materials that come in contact with the patient are polyurethane and Pebax™ that are coated with a hydrophilic coating. The Aer-O-Scope Disposable Scanner has been demonstrated to be biocompatible according to the ISO 10993 harmonized and FDA consensus standard.

The provided document describes the Aer-O-Scope Colonoscope System and a clinical study conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: A total of 56 patients. This was further divided into an 18-patient training cohort and a 38-patient study cohort.
• Data Provenance: Prospective. The clinical study was carried out in the Tel Aviv Medical Center.

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

The document does not specify the number of experts used to establish the ground truth or their qualifications. The "ground truth" for assessing cecal intubation and pathologies was likely determined by the performing physicians themselves during the procedures (both Aer-O-Scope and conventional colonoscopy) and potentially confirmed by subsequent conventional colonoscopy for mucosal damage.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set. The study involved a "tandem colonoscopy" setup where an Aer-O-Scope colonoscopy was followed by a conventional colonoscopy. This design inherently provides a comparison, where the conventional colonoscopy can serve as a reference or confirmation for findings, including mucosal damage. However, a formal adjudication panel or process is not mentioned for conflicting findings or interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study compared the Aer-O-Scope to conventional colonoscopy by performing both procedures on the same patients, but it focused on device performance (intubation rates, safety, visualization) rather than comparing human reader performance with and without AI assistance.

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

The Aer-O-Scope Colonoscope System is a medical device that provides visualization for human operators. It is not an AI algorithm performing diagnostic tasks independently. Therefore, a standalone (algorithm-only) performance study is not applicable and was not performed. The device's performance is intrinsically linked to its use by a human operator.

7. The Type of Ground Truth Used

The ground truth for the clinical study appears to be a combination of:

• Clinical Observation/Physician Assessment: Cecal intubation success was determined by the performing physician.
• Tandem Colonoscopy: The conventional colonoscopy performed immediately after the Aer-O-Scope procedure served as a robust comparison to monitor for any mucosal damage caused by the Aer-O-Scope and potentially confirm pathologies or visualization quality.
• Pathology: The "tertiary objective was to document the number of pathologies visualized during procedures." While this was an observational endpoint, the confirmation of these pathologies would typically involve histopathological examination of biopsies, implicitly.

8. The Sample Size for the Training Set

The document mentions an "18 training cohort" within the total of 56 patients. This refers to a group of patients used for initial training with the device during the clinical study, not a distinct dataset for training an artificial intelligence algorithm. The device itself (the Aer-O-Scope) does not appear to involve AI or machine learning algorithms that require a separate training dataset in the conventional sense.

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

The "training cohort" refers to a group of patients where operators gained proficiency with the device. The ground truth for this cohort would be established in the same manner as the study cohort: through real-time physician assessment during the procedure and comparison with subsequent conventional colonoscopy. There isn't an AI-specific training set ground truth to establish here.

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