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This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

The insertion portion of the device has a bending mechanism and a flexible tube consisting of the bending portion and an operating portion with a knob to control the bending. A forceps channel runs through the operating portion to the tip for inserting surgical instruments. The insertion portion's tip, called the "Distal end," contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle, Instrument channel outlet, and Light guide. The bending portion is controlled by knobs on the control portion/operation section. The flexible portion, between the bending and control portions, contains light guides (glass fiber bundles), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The control portion/operating section provides a grip and mechanical parts to operate the endoscopes, including a Forceps inlet. The Scope connector links the endoscopes to the light source and video processor.

The provided FDA 510(k) clearance letter and summary for the FUJIFILM Endoscope Models EC-860P/M, EC-860P/L, and EC-860S/L primarily focus on demonstrating substantial equivalence to predicate devices through bench testing and compliance with various consensus standards. It does not describe a clinical study in the traditional sense, where device performance is measured against specific acceptance criteria in a human subject population using metrics like sensitivity, specificity, or accuracy, often seen with AI or diagnostic imaging devices.

Instead, the submission relies on demonstrating that the new endoscope models meet established performance specifications and safety standards through non-clinical testing.

Here's an analysis based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each item. Instead, it refers to the subject device meeting "performance specifications" or demonstrating "substantially equivalent in performance to the predicate devices" for various parameters.

2. Sample size used for the test set and the data provenance

No human or patient test set is described. The "test set" consists of the physical endoscope models themselves, subjected to various bench tests and standard compliance evaluations. The data provenance is derived from these non-clinical tests performed by the manufacturer, rather than patient data.

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

Not applicable. This is not a study requiring expert readers to establish ground truth for clinical performance. The "ground truth" for the non-clinical tests is established by the specifications and standards themselves, and verified by testing personnel.

4. Adjudication method for the test set

Not applicable. There is no expert adjudication process described for clinical interpretation. The compliance with standards and performance specifications is determined through objective measurements and validated test methods.

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 device is an endoscope, not an AI-powered diagnostic system. No MRMC study or AI assistance is mentioned. The clearance is for the physical endoscope models.

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

Not applicable. There is no AI algorithm involved in this device submission.

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

For this submission, the "ground truth" is defined by:

• Consensus standards: e.g., electrical safety (ANSI/AAMI ES 60601-1), biocompatibility (ISO 10993-1), medical device software (IEC 62304), endoscope-specific standards (ISO 8600 series).
• Manufacturer's internal performance specifications: These are the benchmarks against which specific performance parameters (e.g., field of view, resolution, bending capability) are measured.
• Predicate device performance: The "bench testing data regarding 'Optical performance' demonstrated that the subject devices are substantially equivalent in performance to the predicate devices." This implies that the performance of the predicate devices serves as a comparative ground truth for equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. No training set is described.

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The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL & CF-EZ1500DI are intended to be used with a video system center, endoscope position detecting unit, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is intended to be used with a video system center, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

The endoscope consists of three parts: the control section, the insertion section, and the connector section.

1. Control section: The UP/DOWN angulation control knob and the RIGHT/LEFT angulation control knob on the control section are connected to the tip of the bending section by a series of wires. By operating the angulation control knobs, the bending section at the distal end bends vertically or parallel to guide the distal end for insertion and observation. The observation mode can be selected by focus switching function, "near focus mode" featuring innovative resolving power for close observation or "normal focus mode" for normal observation. To realize the dual focus mechanism, Voice Coil Motor (VCM) is incorporated as an actuator. The endoscope contains a cylinder to attach a suction valve for suction and air/water valve. Depressing the suction valve will allow the physician to use the endoscope to suction any fluids which are obscuring a good view of the tissue. Therapeutic instruments can be passed through the instrument channel for performing endoscopic biopsy and other therapies. Depressing the air/water valve will allow the doctor to feed water through the endoscope for lens washing. It also can be operated to feed air for removing any fluids or debris adhering to the objective lens.

2. Insertion section: The insertion section has main parts including the image guide, light guides that bring light from the video system center through the endoscope, and instrument channel where therapeutic tools can be pushed in and out (also the suction channel).

3. Connector section: The connector section connects the endoscope with the video system center (CV-1500) through the universal cord.

It appears crucial information regarding the AI or software components' acceptance criteria and the specific study proving the device meets these criteria is missing from the provided FDA 510(k) clearance letter for the Olympus Endoscopes (K250432).

The document details the substantial equivalence of the new endoscopes (CF-EZ1500DL/DI and GIF-EZ1500) to their predicates based on physical characteristics, intended use, and general performance. It mentions extensive non-clinical testing, including:

• Reprocessing validation
• Biocompatibility testing
• Software verification and validation (mentioning FDA guidance for software in medical devices, but not detailing specific performance criteria or tests related to AI/image analysis capabilities)
• Electrical safety and EMC
• Bench testing (performance characteristics like DOF/FOV, Resolution, Noise, etc.)
• Animal study to confirm WLI, NBI, RDI, and TXI performance.
• Risk management

However, the prompt asks for specifics related to an AI/Software component's acceptance criteria and its performance study. The provided text focuses on the endoscope hardware itself and its basic image capture and display functionalities. There is no mention of any AI-driven image analysis, diagnostic augmentation, or automated detection capabilities that would require the kind of clinical performance study details (e.g., sample size, ground truth, expert adjudication, MRMC studies) outlined in the prompt.

The "Indications for Use" for these endoscopes clearly state their purpose is for "endoscopy and endoscopic surgery" for visualization. They are tools for observation and facilitating therapeutic accessories. They are not described as having an AI component for automated analysis or diagnosis.

Therefore, since the provided document does not indicate the presence of an AI or advanced software feature requiring a separate performance study with associated acceptance criteria, I cannot fulfill most of the requested points.

Here's what can be inferred or stated based on the provided document and the information that is explicitly NOT present:

Based on the provided document, there is no evidence of an AI-driven or advanced image analysis software component in the Olympus Endoscopes (CF-EZ1500DL/DI and GIF-EZ1500) that would necessitate the type of acceptance criteria and performance study described in the prompt.

The 510(k) clearance focuses on demonstrating substantial equivalence to predicate endoscopes by comparing physical and operational characteristics, and through general performance testing of the device hardware and its fundamental image capture capabilities.

However, if we were to hypothetically assume there was an AI/Software component (e.g., for polyp detection), and based on common FDA expectations for such devices, here's how the answer would look, highlighting what's missing:

Acceptance Criteria and Study Proving Device Performance (Hypothetical AI Component)

Note: The provided FDA 510(k) clearance letter for K250432 does not detail any specific AI or advanced image analysis software functionality, nor does it contain the performance study metrics for such a component. The following table and points are constructed under the assumption of such a component existing, to illustrate what an ideal response would contain if the information were available in the document.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical AI Component)

Since no AI/software component is described in the provided document, this table cannot be filled with actual data. Below is a hypothetical example of what such a table would contain if an AI component for, e.g., polyp detection, were present.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: Not specified (as no AI performance study is detailed). Typical AI/CADe clearances involve hundreds to thousands of cases.
• Data Provenance: Not specified. For AI devices, this would typically include details like:
  • Country of Origin (e.g., multi-center, US, Europe, Asia)
  • Retrospective or Prospective collection
  • Diversity of patient demographics, disease prevalence, equipment used, etc.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified. For AI/CADe devices, often 3 or more independent experts are used.
• Qualifications of Experts: Not specified. Typically, this would involve board-certified gastroenterologists or colorectal surgeons with significant experience (e.g., 5-10+ years) in endoscopic procedures, potentially sub-specialized in screening/surveillance or interventional endoscopy.

4. Adjudication Method for Test Set

• Adjudication Method: Not specified. Common methods for AI medical device clearances include:
  • Majority Rule: E.g., 2 out of 3, or 3 out of 5 experts agree.
  • Consensus Reading: Experts review and discuss cases to reach a unanimous decision.
  • 2+1 or 3+1: Initial reads by 2 or 3 experts, with a senior adjudicator resolving discrepancies.
  • Pathology Correlation: Where possible, biopsy/histology results serve as the definitive ground truth.

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

• MRMC Study Conducted?: No mention of an MRMC study. The document states "No clinical study was performed to demonstrate substantial equivalence." This implies that any human-in-the-loop performance evaluation of an AI component was not required or not conducted for this 510(k).
• Effect Size of Human Improvement (if applicable): Not applicable as no MRMC study is mentioned. If performed, this would report metrics like the change in reader sensitivity, specificity, or reading time with AI assistance compared to without.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Conducted?: No explicit mention of a standalone algorithm performance study with specific metrics (e.g., AUC, sensitivity, specificity on a defined dataset). The "Software verification and validation" generally refers to software engineering and quality assurance, not necessarily clinical performance of an AI algorithm itself.

7. Type of Ground Truth Used

• Type of Ground Truth: Not specified. If an AI component were present for lesion detection, ground truth would typically be established by:
  • Expert Consensus: As described in point 3.
  • Pathology/Histology: Biopsy results confirming the presence or absence of lesions. This is often considered the gold standard for many gastrointestinal applications.
  • Clinical Outcomes Data: Long-term follow-up to confirm diagnoses, though less common for initial device clearance.

8. Sample Size for Training Set

• Sample Size for Training Set: Not specified. This information is typically not included in FDA clearance letters unless directly relevant to a novel AI claim. Training set sizes for medical AI can range from thousands to hundreds of thousands of images/cases.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not specified. It would generally be established through similar methods as the test set (e.g., expert annotations, pathological confirmation), often with additional data augmentation or curation processes.

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The PENTAX Medical Video Colonoscope EC38-i20cWL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel.

This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.

The PENTAX Medical Video Colonoscope EC38-i20cWL is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the lower digestive tract.

The provided text is a 510(k) summary for the PENTAX Medical Video Colonoscope (EC38-i20cWL). It describes the device, its intended use, comparison to predicate devices, and non-clinical performance data supporting its substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of an AI-powered device or a study involving human readers and AI assistance (MRMC).

The document specifically states: "The subject device is functionally equivalent to the predicate/reference devices, and the differences between the devices are minor technological changes such as the application of wide field of view for the new endoscope. There is no new technological feature in the subject device in comparison to the reference device, K231249." This indicates that the device is a refined version of an existing product, not a novel AI-powered diagnostic or assistive tool.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, training set details) from the provided text, as this type of information is generally specific to the validation of AI/ML-based medical devices or comparative studies of diagnostic performance against established benchmarks, which are not described in this 510(k) summary. The summary focuses on engineering and safety validation, not on diagnostic performance or AI integration.

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The GripTract-GI Endoscopic Tissue Manipulator (GripTract) Lower GI Models are accessories intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.

GripTract Lower GI Models are indicated for use in the large intestine with any standard endoscope as follows:

The GripTract-GI™ Endoscopic Tissue Manipulator (GripTract) Lower GI Models are disposable, non-sterile accessories intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment. There are four (4) different GripTract Lower GI Models (GT-CL170, GT-CL130, GT-CM170, and GT-CM130) which are indicated for use in the large intestine with standard endoscopes that have specific tip outer diameters and working lengths.

The GripTract Handpiece attaches to the endoscope control body just below the working channel. The soft End Cap with two integrated Fingers for tissue manipulation is placed on the distal end of the endoscope. Two Control Knobs in the Handpiece each operate a corresponding Finger, permitting the User to rotate and extend/retract the Fingers for tissue manipulation and visualization independent of the endoscope's movement or the presence of other tools in the endoscope's working channel.

Here's a breakdown of the acceptance criteria and study information based on the provided document, addressing each of your points:

Important Note: The provided document is a 510(k) summary for a medical device (GripTract-GI Endoscopic Tissue Manipulator Lower GI Models). This type of document focuses on demonstrating substantial equivalence to an existing predicate device rather than proving clinical efficacy or diagnostic accuracy for an AI/software device. Therefore, many of your questions, particularly those related to AI-specific studies (MRMC, standalone AI performance, ground truth establishment for training AI, etc.), are not applicable to this device and information. The device described is not an AI/software device.

The document primarily details non-clinical performance data to support the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with numerical performance targets against which the device was measured like typical AI/diagnostic studies. Instead, it lists various non-clinical tests performed and states whether the device "passed" or exhibited "equivalent force transmission" or "exceeded reported maximum pull forces."

Here's a summary derived from the "Summary of non-clinical performance testing" table and the subsequent paragraphs:

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

As this is a physical medical device (endoscopic tissue manipulator) and not an AI/software, the concept of a "test set" in the context of diagnostic data doesn't apply directly.

• Sample Size: The document does not specify particular "sample sizes" for the non-clinical tests in terms of number of devices tested. It refers to "worst-case simulated use," "repeated worst-case torsional load," and testing "at the dimensional extremes of the product line" for Torque Comparison. For Biocompatibility, it states "Final, finished devices tested."
• Data Provenance: Not applicable in the context of retrospective/prospective patient data or country of origin for such data. The data provenance is from bench performance testing conducted by the manufacturer, Actuated Medical, Inc.

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

Not applicable. "Ground truth" in the context of expert consensus on medical images or diagnostic outcomes is not relevant for this device's non-clinical performance testing. The "ground truth" for these tests would be the measured physical properties and performance characteristics against established engineering specifications and regulations.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies among expert readers in diagnostic AI studies. This is a non-clinical, bench testing document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

Not applicable. This device is a physical medical instrument, not an AI or software that assists human readers in diagnostic interpretation. An MRMC study would not be performed for this type of device.

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

Not applicable. This is not an algorithm or software. It is a physical device operated by a clinician.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is defined by:

• Engineering specifications and design requirements.
• Industry standards (e.g., ISO 10993-1 for biocompatibility).
• Quantitative measurements derived from bench testing (e.g., force measurements, dimensional checks, fatigue cycles).
• Simulated worst-case scenarios and interactions.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no training set of data in that sense.

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

Not applicable. As there is no AI training set, there's no ground truth establishment process for it.

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Endoscopic Video Image Processor: This device is used in conjunction with the video endoscopes produced by our company to process the images collected by the video endoscopes and send them to the display, and provide power for the endoscope.
Single-Use Video Gastroscope: This product is used in conjunction with Endoscopic Video Image Processor and other peripheral equipment for the observation, diagnosis, photography and treatment of upper digestive tract. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product is designed for use in adults.
Single-Use Video Colonoscope: This product is used in conjunction with Endoscopic Video Image Processor and other peripheral equipment for the observation, diagnosis, photography and treatment of lower digestive tract. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product is designed for use in adults.

The proposed device, Digestive Endoscopy System, which includes a Single-Use Video Gastroscope and Single-Use Video Colonoscope, and Endoscopic Video Image Processor is intended for observation, diagnosis, photography and treatment of the upper and lower gastrointestinal tract.
The Single-Use Video Gastroscope is available in two models with different length of image processor connection section, RP-Gl-G02A, RP-Gl-G02B. The Single-Use Video Colonoscope is available in two models with different length of image processor connection section and different diameters, RP-GI-C02B. The Endoscopic Video Image Processor is available in four models with disk space, RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D.
The Single-Use Video Gastrocope and Single-Use Video Colonoscope are sterile and single-patient-use device. The Endoscopic Video lmage Processor is non-sterile and multi-patient-use device, and it will be cleaned and disinfected before first use.

The provided text is a 510(k) summary for an Endoscopic Video Image Processor, Single-Use Video Gastroscope, and Single-Use Video Colonoscope. It does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/human performance study. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and comparison testing.

Therefore, for aspects like acceptance criteria for AI algorithms, sample size for test sets (in an AI context), expert details, adjudication methods, MRMC studies, standalone AI performance, and AI training set details, the information is not available in the provided text.

Based on the provided document, here's what can be extracted regarding performance testing, which is primarily focused on the device's functionality and image quality as an endoscopy system, rather than an AI component:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance values for an AI component. Instead, it describes various performance tests conducted. The implicit acceptance criterion for these tests is that the proposed device performs comparably to or meets the standards of the predicate device or relevant ISO standards.

2. Sample Size used for the test set and the data provenance

This information is not available in the provided text. The "test set" in the context of this document refers to the physical devices (Endoscopic Video Image Processor, Single-Use Video Gastroscope, Single-Use Video Colonoscope) subjected to performance tests, not a dataset for an AI algorithm.

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

This information is not available in the provided text. The studies described are non-clinical engineering and performance tests, not clinical studies requiring expert ground truth for interpretation of medical images.

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

This information is not available in the provided text. Adjudication methods are typically employed in clinical image interpretation studies, which this document does not describe.

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

This information is not available in the provided text. The device described is an endoscope system, not an AI-assisted diagnostic tool.

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

This information is not available in the provided text. There is no mention of an algorithm or AI functionality in this submission.

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

This information is not available in the provided text. The "ground truth" for the non-clinical performance tests would be established by engineering specifications, calibration standards, and comparison with the predicate device.

8. The sample size for the training set

This information is not available in the provided text. The document does not describe an AI training set.

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

This information is not available in the provided text. The document does not describe an AI training set.

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The GripTract-Gl Endoscopic Tissue Manipulator (GripTract) is an accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.

GripTract is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and working length of 168 - 170 cm.

GripTract is a single-use, non-sterile, endoscope accessory intended to ensure complete positioning of an endoscope and assist with optical visualization, diagnosis, and endoscopic treatment. It is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and a working length of 168 - 170 cm.

The GripTract Handpiece attaches to the endoscope control body just below the working channel. The soft End Cap with two integrated Fingers for tissue manipulation is placed on the distal end of the endoscope. Two Control Knobs in the Handpiece each operate a corresponding Finger, permitting the User to rotate and extend/retract the Fingers for tissue manipulation and visualization independent of the endoscope's movement or the presence of other tools in the endoscope's working channel.

The provided text describes the regulatory clearance for the GripTract-GI Endoscopic Tissue Manipulator (K231254). It outlines the device's intended use and provides non-clinical performance data to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The provided document is a 510(k) summary for a medical device (GripTract-GI Endoscopic Tissue Manipulator). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific numerical performance acceptance criteria typical of AI/ML device studies. Therefore, many of the requested criteria (e.g., specific quantitative metrics, sample sizes for training/test sets for AI, expert numbers for ground truth, MRMC studies) are not directly applicable or explicitly stated in this type of regulatory submission for a mechanical device.

However, I can extract the information related to the device's performance and the studies conducted to show its safety and effectiveness.

Acceptance Criteria and Device Performance (based on provided text)

The acceptance criteria for this device are primarily related to its functional performance, safety, and compatibility, demonstrated through various non-clinical tests. The "performance" is reported as "Pass" for each test, indicating that the device met the pre-defined criteria for that specific test.

Study Details (based on provided text)

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

   • Usability Testing: "A total of 15 Users" for both "Set-Up" and "Use" usability tests.
   • Porcine Testing: Number of animals or procedures is not specified, but it's an "in vivo porcine testing" in "worst-case procedure."
   • Other Bench Tests: Sample sizes are not explicitly stated for product specification verifications, distribution, shelf-life, reliability, or bench safety (other than the endoscope viewing area comparison).
   • Data Provenance: The studies are non-clinical, primarily bench and animal (porcine) testing. No explicit mention of country of origin for the data or whether it's retrospective/prospective (these terms are more relevant for human clinical studies).

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

   • This information is not provided. For non-AI mechanical devices, the "ground truth" is typically established by engineering specifications, validated test methods, and potentially expert interpretation for things like tissue damage in animal studies. The "users" in usability testing are relevant, but their "qualification" is broadly "intended user population" (medical specialists).

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

   • Not applicable/mentioned for this type of non-clinical device testing.

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 a mechanical accessory, not an AI-powered diagnostic tool requiring human reader comparison studies.

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

   • Not applicable. This is a mechanical device, not an algorithm. Bench tests evaluate the device's standalone performance.

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

   • Bench Performance: Engineering specifications and ASTM/ISO standards.
   • Usability: Defined user tasks and absence of serious use errors, likely determined by observation and user feedback against pre-defined criteria.
   • Biocompatibility: ISO 10993 standards and their associated pass/fail criteria (e.g., lack of cytotoxicity, sensitization).
   • Porcine Testing: Visual and histological mucosal damage assessment compared to a control (endoscope-only procedures), suggesting pathology as a component of ground truth for tissue effects.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set."

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

   • Not applicable.

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The Pure-Vu EVS System is intended to connect to standard or slim colonoscopes to help facilitate intra-procedural cleansing of the GI tract by irrigating or cleaning irrigation fluid (water), feces, and other bodily fluids and matter, e.g. blood.

It is for use only by trained medical personnel located in hospitals, clinics and doctors' offices.

The Pure-Vu EVS System enables cleaning of the GI tract during endoscopy using a standard or slim colonoscope with a length of 1630mm - 1710mm and an outer diameter range of 11.7mm - 13.2mm or gastroscope with a length of 950 – 1030mm and an outer diameter of 9.2 - 10mm The EVS Flex Channel , which fits alongside the endoscope and is connected to an external Workstation, generates fluid and gas to break up debris The debris & fluids are removed through the suction channel of the EVS Flex Channel into an external waste container/bag.

The Pure-Vu EVS System consists of the following main components:
Disposable device which includes a Flex Channel section and an Umbilical Section (US) - The EVS Flex Channel fits alongside the endoscope to allow a physician to cleanse the GI tract and is connected to the external Workstation via a disposable US. Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water or saline and gas, and evacuates debris and fluids. The Workstation includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the GI tract, and suction of fluid and matter from the GI tract. Irrigation Bag/Bottle (saline or water) which is connected to the irrigation line. Waste Containers for collecting the GI content & fluids that are suctioned from the GI tract through the suction lines. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fluid and matter from the GI tract. A foot pedal activates the cleansing, suction and purging functions, and enables switching between cleansing modes used by the physician.

The provided text describes modifications to the Pure-Vu EVS System and its substantial equivalence to predicate devices, but it does not contain the specific acceptance criteria or a study proving the device meets those criteria, nor any of the detailed information requested.

The document is a 510(k) summary for the Pure-Vu EVS System, a device intended for intra-procedural GI tract cleansing during endoscopy. It focuses on demonstrating substantial equivalence to previously cleared devices (Pure-Vu System K220007 and K210981) due to design changes.

Here's an analysis of the provided information against your requested points:

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

• Not found. The document includes tables comparing the technological characteristics of the subject device with its predicate, such as dimensions, flow rates, and materials. However, it does not present specific acceptance criteria (e.g., minimum pressure tolerance, maximum steering angle impact) with corresponding reported performance values against those criteria. It states that "Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance," but does not provide the specifics of that performance or the criteria used to judge it.

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 "System Validation Testing," it states "Validation testing for the entire Pure Vu EVS system (WS and disposable devices) was performed with 6 physicians." This is the only mention of human-involved testing with a specific number.
• Data provenance: Not specified.

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 found. There is no mention of establishing ground truth or the qualifications of the 6 physicians involved in the validation testing. Their role is described as performing "Validation testing," not establishing ground truth.

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

• Not found. No adjudication method is described.

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 found. This is not an AI-powered device, and no MRMC study or comparative effectiveness study involving human readers or AI assistance is mentioned. The device is a physical system for irrigation and cleaning.

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

• N/A. The device is a mechanical/electro-mechanical system, not an algorithm, so this concept does not apply.

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

• Not found. The document does not describe the establishment or type of ground truth for any evaluation.

8. The sample size for the training set

• N/A. As this is not an AI/machine learning device, there is no concept of a "training set."

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

• N/A. As there is no training set, this is not applicable.

In summary, the provided document outlines the technical specifications, modifications, and verification/validation testing conducted for the Pure-Vu EVS System to demonstrate its substantial equivalence to previously cleared devices. It details various engineering tests (environmental conditioning, dimensions, head pull, steering, pressure, bond strength, software verification) and mentions system validation with 6 physicians. However, it does not provide the kind of detailed clinical study data, acceptance criteria, or ground truth information typically associated with performance evaluation against specific clinical endpoints or for AI/software-as-a-medical-device.

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Ambu® aScope™ Colon:
The aScope™ Colon is a sterile, single-use, flexible colonoscope intended to be used for endoscopic access to and examination of the lower gastrointestinal anatomy.
The aScope™ Colon is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.
Ambu® aBox™ 2:
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ Colon Endoscopy System is a system used for endoscopic procedures in the gastrointestinal anatomy. It consists of a sterile, single-use, flexible endoscope, the Ambu® aScope™ Colon, and a displaying unit, the Ambu® aBox™ 2.
The Ambu® aScope™ Colon is a sterile, single-use flexible colonoscope for accessing and examining the lower gastrointestinal anatomy. The endoscope provides a working channel for use of endotherapy accessories, as well as insufflation suction, rinsing and a water jet function. Visualization is realised via an integrated camera module with bulit-in LEDs for illumination.
The Ambu® aBox™ 2 displaying unit has the following physical and performance characteristics:
Displays the image from Ambu® aScope™ Colon endoscope on the screen Can record snapshots or video of image from Ambu® aScope™ Colon endoscope Can connect to an external monitor Is a reusable device

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

The provided FDA 510(k) Summary for the Ambu® aScope™ Colon and Ambu® aBox™ 2 is for a medical device, not a software AI algorithm. Therefore, the device performance is evaluated based on bench testing of physical and functional characteristics, rather than AI performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML-based medical devices.

Consequently, many of the requested categories (e.g., effect size of human readers with AI, standalone performance, training set details, expert qualifications for ground truth, adjudication methods) are not applicable to this type of device submission. The safety and effectiveness are established through engineering and biological testing, demonstrating that the device performs as intended and is safe for its stated indications.

Acceptance Criteria and Study Details for Ambu® aScope™ Colon Endoscopy System

Due to the nature of this submission being for a physical medical device (an endoscope and its display unit) rather than an AI/ML algorithm, the concept of "acceptance criteria" and "study" differs significantly. The acceptance criteria here refer to the successful completion of various engineering, performance, safety, and biocompatibility tests. The "study" is a compilation of these various tests and validations confirming the device's adherence to established standards and specifications.

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

Overall Conclusion: "In all instances, the Ambu® aScope™ Colon Endoscopy System performed as expected and met the set test specifications."

2. Sample size used for the test set and the data provenance
This information is not provided in the summary. For a physical device, the "test set" would refer to the number of devices or components subjected to each specific test. The provenance would refer to the manufacturing site and conditions, not typically specified in such detail in a 510(k) summary. Given this is a sterile, single-use device, extensive bench testing would typically be performed on a statistically relevant sample size from manufacturing lots, although the exact numbers are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is not an AI/ML algorithm requiring expert ground truth for classification. Ground truth for a physical device is established by engineering specifications, validated test methods, and compliance with recognized standards.

4. Adjudication method for the test set
This is not applicable as the device is not an AI/ML algorithm requiring expert consensus for annotation or diagnosis. Performance is based on objective measurements against predefined specifications.

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
This is not applicable. The device is a direct visualization tool without AI assistance. Its effectiveness is based on its ability to provide clear visualization and facilitate endoscopic procedures, not on enhancing human interpretation through AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical endoscope and a display unit, not an algorithm. Its performance is inherently tied to human operation and observation.

7. The type of ground truth used
For physical device testing, the "ground truth" is established by:

• Engineering Specifications: Designed performance parameters (e.g., length, diameter, bending angles, optical characteristics).
• Validated Test Methods: Standardized procedures to objectively measure these parameters.
• Recognized Standards: Compliance with international and national standards for safety, biocompatibility, sterilization, electrical safety, and electromagnetic compatibility (e.g., IEC 62471, ISO 10993-1, ISO 11135, IEC 60601 series).

8. The sample size for the training set
This is not applicable. The device is not an AI/ML algorithm; therefore, there is no "training set" in the machine learning sense. Design and development are based on engineering principles and preclinical testing.

9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.

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FUJIFILM Endoscope Model EC-760S-A/L

This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Never use this product for any other purposes.

Endoscopy Support Program EW10-VM01

This software provides image information to assist the user in estimating the size of an object displayed in the endoscopic field of view. This software provides no therapeutic or diagnostic function.

FUJIFILM Endoscope Model EC-760S-A/L is comprised of three general sections; a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) image sensor, and laser emitting window in its distal end. The insertion portion assist in delivering air/suction as well as endoscope accessories. such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with the Company's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.

Endoscopy Support Program EW10-VM01 is a software-only device that detects the laser spot position of the dedicated endoscope in the image obtained via the video processor and displays a superimposed scale ("Virtual Scale") in the endoscopic image (e.g., displayed in a monitor). The Virtual Scale images can be either linear or circular. The virtual scale shows the graduated markings at 5mm, 10mm, and 20mm. EW10-VM01 must be installed on a personal computer (PC) that meets the mandatory system requirements for it to function. When the PC with EW10-VM01 connects to the video processor and the Virtual Scale function is turned ON. EW10-VM01 automatically retrieves the calibration data from the EC-760S-A/L. EW10-VM01 uses the data from the calibration table and detects the relative position of the red laser beam in the endoscopic image. EW10-VM01 superimposes the virtual scale images in the endoscopic image in real-time. The virtual scale acts as the virtual reference for the users to estimate sizes.

Here's a breakdown of the acceptance criteria and study information for the Endoscopy Support Program EW10-VM01, based on the provided document.

Acceptance Criteria and Reported Device Performance

The document states that the "Accuracy of Virtual Scale images with Endoscopy Support Program EW10-VM01 has been evaluated." However, it does not explicitly list quantitative acceptance criteria for accuracy (e.g., a specific percentage error or range of deviation) nor does it provide the reported device performance against any such criteria. It only confirms that the evaluation was performed.

Study Details for Endoscopy Support Program EW10-VM01

Given the information in the provided text, many details about the specific study proving the device meets acceptance criteria are not explicitly provided. The document focuses on general compliance with standards and the fact that evaluations were performed, rather than furnishing detailed study methodologies or results for the EW10-VM01 software.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The document generally discusses testing of the Endoscope Model EC-760S-A/L and the EW10-VM01 software.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.

3. Adjudication method for the test set: Not explicitly stated.

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:

   • MRMC Study: Not explicitly stated.
   • Effect Size: Not explicitly stated. The software "provides image information to assist the user in estimating the size of an object," implying an assistive role. However, the document does not compare human performance with and without the assistance.

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

   • The document implies a standalone evaluation of the software's accuracy: "Accuracy of Virtual Scale images with Endoscopy Support Program EW10-VM01 has been evaluated." It also states, "The software does not have a measuring function—the software only calibrates the virtual scale (e.g., by the object recognition), and does not estimate the measurement by itself." This suggests the calibration and display of the virtual scale is the standalone function evaluated, rather than the software performing a measurement autonomously.

6. The type of ground truth used: Not explicitly stated. Given that it relates to the "Accuracy of Virtual Scale images," the ground truth would likely be precise, independently measured physical dimensions of objects in the endoscopic field of view.

7. The sample size for the training set: Not explicitly stated.

8. How the ground truth for the training set was established: Not explicitly stated.

Summary of available information:

The document confirms that the Endoscopy Support Program EW10-VM01 software was evaluated for "Accuracy of Virtual Scale images" and "in-vivo performance testing of visualization of laser spot". It also states that the software was evaluated using IEC 62304:2015 and in accordance with FDA's guidance for software in medical devices. However, it does not provide specific quantitative results, sample sizes, expert details, or ground truth methodologies for these evaluations. The focus of this 510(k) summary is to demonstrate substantial equivalence through compliance with recognized standards and general performance evaluations, rather than to present detailed efficacy study results.

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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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