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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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The Pure-Vu EVS System is intended to connect to standard and slim colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the irrigation the 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 doctor offices.

The Pure-Vu EVS System enables colon cleaning during colonoscopy using a standard or slim colonoscope with a length of 1630mm – 1710mm and an outer diameter range of 11.7mm – 13.7mm. The Oversleeve, which fits over the colonoscope and is connected to an external Workstation, generates fluid and gas to break up feces. The fecal matter & fluids are removed through the suction channel of the Oversleeve into an external waste container.
The Pure-Vu EVS System consists of the following main components:
Oversleeve (OS) and Umbilical Section (US) - The disposable Oversleeve is mounted on Standard or Slim commercially available colonoscopes 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 fecal material 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 fluids and feces from the colon.
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 the Pure-Vu EVS System, its indications for use, technological characteristics, and a comparison to its predicate device. It also briefly mentions performance data. However, the document does not contain specific acceptance criteria, detailed study results, or information regarding sample sizes for training/test sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, based only on the provided text, I cannot complete the requested table and answer all questions definitively.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance

Detailed Study Information (Not available in the provided text):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not specified in the provided text. The document only mentions "Validation testing for the WS and disposable device was performed with 4 physicians." This appears to refer to human factors or usability testing rather than a clinical performance study with a test set of patient data.

2. 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 specified in the provided text.

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

   • Not specified in the provided text.

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/Not specified. This device is for intra-procedural cleaning during colonoscopy, not an AI-powered diagnostic imaging device requiring reader studies in this context. The document describes a physical medical device (Pure-Vu EVS System) for colon cleaning, not an AI algorithm.

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

   • Not applicable/Not specified. As above, this is a physical medical device, not an AI algorithm. Its performance is intrinsically "human-in-the-loop" as it assists a physician during a colonoscopy.

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

   • Not explicitly stated in the provided text. The performance data section focuses on engineering verification and validation testing (e.g., pressure, flow rates, dimensional compliance, biocompatibility, software compliance) rather than a clinical ground truth for a diagnostic claim. The clinical outcome (effective colon cleaning) is assumed to be evaluated during the "Validation testing for the WS and disposable device was performed with 4 physicians," but the specific metrics and how "ground truth" for cleaning effectiveness were established are not detailed here.

7. The sample size for the training set:

   • Not applicable/Not specified. There is no mention of a "training set" as this is a physical medical device, not an AI model requiring machine learning training.

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

   • Not applicable/Not specified. See point 7.

In summary, the provided document is a 510(k) summary for a physical medical device. It covers the technical performance verification and validation to demonstrate substantial equivalence to a predicate device. It does not contain the detailed clinical study information typically found for AI/ML-based devices regarding diagnostic performance, ground truth, reader studies, and sample sizes for algorithmic evaluation. The "performance data" section focuses on engineering tests (e.g., environmental, mechanical, flow, pressure, software validation) and a mention of "validation testing for the WS and disposable device was performed with 4 physicians" which likely refers to human factors or usability rather than an effectiveness study using a "test set" of patient data for an algorithm.

Ask a specific question about this device

Pure-Vu System is intended to connect to standard or slim colonoscopes and gastroscopes to facilitate intra-procedural cleansing of the GI tract by irrigating and evacuating the irrigation fluids (water), bodily fluids and other debris, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctors' offices.

The Pure-Vu System enables cleansing of the digestive tract during endoscopy using a standard or slim colonoscope with a length of 1630mm - 1710mm and an outer diameter range of 11.7mm - 13.3mm (slim) and 12.8mm - 13.7mm (standard), or gastroscope with length of 950-1030mm and an outer diameter of 10mm - 10.9mm. The Oversleeve, which fits over 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 channels of the Oversleeve into an external waste container.
The Pure-Vu System consists of the following main components:
• Oversleeve (OS) and Umbilical Section (US) - The disposable Oversleeve is mounted on Standard or Slim commercially available colonoscopes or gastroscopes 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/saline and gas, and evacuates bodily fluid and matter. The Workstation [WS] includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the colon, and suction of bodily fluid and matter from the GI tract. 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 Gl tract. A foot pedal activates the cleansing, suction and purging function, and switch between cleansing modes used by the physician.
• Loading fixture - The loading fixture is reusable and aids in assembling the Oversleeve onto the endoscope. Unloading aids - A disposable luer lock syringe/ duckbill check valve assembly used in unloading the Oversleeve from the endoscope.

This document is a 510(k) summary for the Motus GI Pure-Vu System, which is a medical device used for intra-procedural cleansing of the GI tract during endoscopy. The document describes the device, its intended use, and the performance data that supports its substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text, keeping in mind that this is a 510(k) submission and not a typical clinical study report for AI-powered devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and design verification tests conducted for a medical device seeking 510(k) clearance, particularly as it relates to demonstrating substantial equivalence for design modifications. This is not a study for an AI algorithm's performance.

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

2. No damage to the flexible head identified by 100% visual inspection.
3. Maintain pressure of up to 400 mBar.
4. No damage to the gastroscope in 100% of the loading procedures verified by examining images using the gastroscope's optics. | Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance. (Implies criteria met) |

Note: The document states that "Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance." This statement implies that the device met all the specified acceptance criteria for these tests. Specific numerical results validating each criterion are not provided in this summary, which is common for 510(k) summaries where the focus is on demonstrating substantial equivalence rather than presenting detailed raw data.

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

The document does not explicitly state the sample sizes used for each of the performance tests (Steering Test, Head Pull Test, Loading and Pressure Maintenance Test). These are engineering verification and validation tests, not clinical studies. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the same way it would be for a clinical trial involving patient data. These tests would have been performed in a lab setting by the manufacturer (Motus GI Medical Technologies Ltd., Israel).

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

This information is not applicable. The "ground truth" for these performance tests is based on objective, measurable physical properties and engineering specifications, not expert interpretation or clinical judgment. For example, angle differences are measured, force applied is measured, and visual inspections determine damage, not subjective expert opinion.

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

Not applicable. As noted above, these are objective engineering tests, not involving human interpretation or adjudication processes like those in clinical studies.

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 a mechanical system for cleaning the GI tract, not an AI algorithm for image analysis or diagnosis. Therefore, an MRMC study and AI assistance are irrelevant to this submission.

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

Not applicable. This device is a mechanical system, not an algorithm.

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

The "ground truth" in this context is based on engineering specifications and physical measurements. For example:

• Steering test: Measurement of physical angles and direct comparison.
• Head Pull Test: Measurement of force required for linear movement.
• Loading and maintenance of pressure test: Measurement of pressure, visual inspection for damage, and direct observation of loading success.

8. The sample size for the training set

Not applicable. This device is a mechanical system, not an AI-powered device that requires a "training set."

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

Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

In summary:

This 510(k) submission focuses on demonstrating the substantial equivalence of modifications to an existing mechanical medical device (Pure-Vu System) as defined by its physical performance characteristics. The "acceptance criteria" and "study" described are engineering and design verification tests to ensure the modified device performs as intended and introduces no new safety or effectiveness concerns, thereby maintaining substantial equivalence to the predicate device. It is crucial to understand that this document does not pertain to the validation of an AI/ML algorithm or its clinical performance.

Ask a specific question about this device

The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodly fluids and matter, e.g. blood.

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

The Pure-Vu System enables colon cleansing during colonoscopy using a standard or slim colonoscope with a length of 1630mm – 1710mm and a slim colonoscope outer diameter range of 11.7mm – 13.3mm and a standard colonoscope outer diameter range of 12.8mm – 13.7mm. The Oversleeve, which fits over the colonoscope and is connected to an external Workstation, generates fluid to break up feces. The fecal matter & fluids are removed through the suction channels of the Oversleeve into an external waste receptacle.
The Pure-Vu System consists of the following main components:
Oversleeve (OS) and Umbilical Section (US) - The disposable Oversleeve is mounted on Standard or Slim commercially available colonoscopes to allow a physician to cleanse the colon 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/saline and gas, and evacuates fecal material & fluids. The Workstation [WS] includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the colon, and suction of fluids and feces from the colon. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fecal matter and fluids from the colon. A foot pedal activates the cleansing, suction and purging function, and switch between cleansing modes used by the physician. Loading fixture- The loading fixture is reusable and aids in assembling the Oversleeve onto the colonoscope. Unloading aids - A disposable 60cc lure lock syringe and 3-way stopcock used in unloading the Oversleeve from the colonoscope are provided in the disposable packaging.

The provided document describes the Pure-Vu System, a device intended to facilitate intra-procedural cleaning of a poorly prepared colon during colonoscopy. This submission is a special 510(k) to improve the overall ease of use of the system by reducing the size and weight of the Workstation and making other minor modifications to the Oversleeve and loading fixture. The document asserts that these changes do not raise new issues of safety or effectiveness.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with specific numerical targets. Instead, it describes various tests performed to demonstrate that the modifications did not negatively impact the device's performance and that it remains substantially equivalent to the predicate device. The performance is reported as meeting "requirements" or demonstrating "efficiency and integrity."

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

• Sample Size:
  • Usability Testing: 3 physicians and 15 nurses for two separate studies for the Workstation and disposable device.
  • Other tests (e.g., disposable units, disposable package, workstation environmental, loading/unloading) do not specify a "sample size" in terms of clinical cases or patients. These are primarily engineering verification and validation tests performed on manufactured units.
• Data Provenance: The document does not specify the country of origin for the participants in the usability studies or whether these studies were retrospective or prospective. Bench testing was performed by various laboratories (Carmel Environmental Laboratory, DDL labs, Hermon Laboratory, DDL (USA)).

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

• For the usability studies, the "experts" were the users themselves: 3 physicians and 15 nurses. Their qualifications are not further detailed beyond their professional roles.
• For other engineering tests, the acceptance criteria are likely against established engineering specifications and regulations (e.g., ISO, ASTM, IEC standards), so no explicit "ground truth experts" in the medical sense are mentioned for these tests.

4. Adjudication method for the test set:

The document does not describe any formal adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth, particularly in a medical diagnostic context. The usability studies would likely involve observation and feedback collection, but not a consensus determination of a medical finding.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an intra-procedural cleaning system for colonoscopy, not an AI-assisted diagnostic imaging device requiring human reader interpretation studies.

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

Not applicable. This is a medical device for physical intervention (cleaning), not a standalone diagnostic algorithm. The device works with a human operator (trained medical personnel).

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

For the usability studies, the "ground truth" would be user feedback and observed performance regarding ease of use and functionality, rather than a medical diagnostic ground truth. For the engineering tests, the ground truth is against established technical specifications, regulatory standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for safety/EMC), and internal functional requirements.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

Ask a specific question about this device

The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the 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 doctor offices.

The Pure Vu system comprises the following components:
Oversleeve - The Oversleeve is mounted on Standard or Slim commercially available colonoscopes to allow a physician to cleanse the colon.
Workstation (WS) - The Workstation operates by using simultaneous irrigation and evacuation of colon content. Irrigation is based on a mixture of liquid (water or saline) and gas (air). The workstation includes:
Monitoring & Control Unit that continuously monitors and controls irrigation and evacuation. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fecal matter and fluids from the colon. External foot pedals that control the cleansing process to be operated by a physician.
WS Connector (WSC) connects the Oversleeve to the WS and saline or water bag.
Loading fixture to aid the nurse in mounting the Oversleeve onto a colonoscope.

This 510(k) submission is for the Pure Vu System, which is intended to connect to standard colonoscopes to facilitate intra-procedural cleaning of a poorly prepared colon. The submission is for a modification of the device to comply with Slim colonoscopes and extends the hydrophilic coating on the Oversleeve.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics of the device itself (e.g., a specific percentage improvement in cleaning, or a defined force of suction).

However, the "Performance Data" section states: "Performance tests were conducted for all modifications to the Pure Vu System. Specifically, the company performed the following bench tests: Steering test, Head pull test, Loading and maintenance of pressure during the loading procedure."

The "Substantial Equivalence Discussion" then concludes: "Performance data demonstrate that the Pure-Vu System is substantially equivalent." This implies that the results of these bench tests met internal acceptance criteria for demonstrating that the modified device performs comparably to the predicate device. Without further details on the specific values or thresholds used in these tests, a quantitative table of acceptance criteria and reported performance cannot be generated from this document.

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

The document only mentions "bench tests" for performance data. It does not provide details on specific sample sizes for these tests, nor does it indicate the provenance of any data (e.g., country of origin, retrospective/prospective). As an accessory to a medical device (colonoscope), it's possible that clinical studies involving patient data were not part of this specific 510(k) submission focused on modifications.

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

This information is not provided in the document. The performance data mentioned are "bench tests," which typically do not involve establishing ground truth by human experts in the way clinical studies do.

4. Adjudication Method for the Test Set

This information is not provided in the document. As the performance data are "bench tests," an adjudication method by human experts is not applicable in this context.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in this document. The submission focuses on modifications to an accessory device and bench testing for substantial equivalence, not a comparative effectiveness study involving human readers and AI.

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

No, the Pure Vu System is a mechanical device designed to assist a human operator (trained medical personnel) during a colonoscopy. It is not an AI algorithm with standalone performance.

7. The Type of Ground Truth Used

For the mentioned "bench tests" (Steering test, Head pull test, Loading and maintenance of pressure during the loading procedure), the "ground truth" would be the engineering specifications and expected physical properties or performance thresholds of the device components. This is not "expert consensus, pathology, or outcomes data" in the typical sense for medical image analysis or diagnostic devices.

8. The Sample Size for the Training Set

No training set is mentioned as this device is not an AI or machine learning algorithm requiring training data.

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

Not applicable, as there is no training set mentioned.

Ask a specific question about this device

The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the 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 doctor offices.

The Pure-Vu system comprises the following components:
Oversleeve - The Oversleeve is mounted on standard commercially available colonoscopes allowing the physician to clean the colon.
Workstation (WS) - The Workstation operates by using cyclic irrigation and evacuation of colon content. Irrigation is based on mixture of liquid and air. The workstation includes:
Monitoring & Control Unit that continuously monitors and controls irrigation and evacuation. Inlet Module that includes pumps and regulators enabling water & airflow into the cleansing device. Outlet Module that includes pumps to evacuate fecal matter and fluids from the colon. External on\off foot pedals that operate the cleansing process to be used by the physician.
WS Connector (WSC) connects the Oversleeve to the WS and saline or water bag.
Loading fixture to aid the nurse in mounting the Oversleeve on to a colonoscope.

The provided document is a 510(k) summary for the Pure-Vu System, which is an add-on device for colonoscopes. It describes modifications to an already cleared predicate device (Pure-Vu System K160015). As such, it focuses on demonstrating substantial equivalence rather than presenting an exhaustive clinical study to establish new performance criteria.

Therefore, the document does not contain specific acceptance criteria, a detailed study proving performance against such criteria, data provenance, number of experts for ground truth, adjudication methods, MRMC comparative effectiveness studies, standalone algorithm performance, or details about training sets. Instead, it relies on performance tests to ensure the modified device functions as intended and remains substantially equivalent to its predicate.

Here's a breakdown of the information that is available based on your request, and what is not:

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

The document does not provide a table of explicit acceptance criteria with numerical targets. Instead, it states that "Performance tests were conducted for all modifications to the Pure-Vu System" and concludes that "In all instances, the Pure-Vu System functioned as intended." This implies that the device met internal performance specifications for the tested modifications, which would be aligned with the performance of the predicate device.

The document lists the following performance tests conducted:

• Biocompatibility
• Electrical Safety and EMC
• Software validation
• Bench tests
• Bond strength
• Pressure test
• System test
• Steering test

It also details changes in specifications for the modified device compared to the predicate, such as:

The acceptance criteria for these tests would likely be that the modified device's performance falls within an acceptable range, ideally demonstrating equivalence or improvement without introducing new safety or effectiveness concerns, and that it passes the listed regulatory standards (ISO 10993, IEC 60601-1/-1-2).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "Performance tests" and "Bench tests" but does not specify sample sizes for these tests or the data provenance. These are likely internal engineering and quality assurance tests rather than clinical studies with human subjects.

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)

This information is not provided. Given that the listed performance tests are primarily engineering and safety assessments (biocompatibility, electrical safety, bench tests), there would typically not be "expert ground truth" in the clinical sense established by physicians.

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

This information is not provided. Adjudication methods are typically associated with clinical studies involving expert reviews of outcomes, which is not described here.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is not an AI diagnostic tool; it's a mechanical system for intra-procedural colon cleaning. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.

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

This information is not applicable. The Pure-Vu System is a physical device that connects to colonoscopes and is operated by trained medical personnel. It is not a standalone algorithm.

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

For the performance tests described (biocompatibility, electrical safety, bench tests), the "ground truth" would be engineering specifications, compliance with international standards (e.g., ISO 10993, IEC 60601-1), and the intended functional performance of the device's components against design requirements. Clinical ground truth like pathology or outcomes data is not mentioned for the modifications made in this 510(k).

8. The sample size for the training set

This information is not provided and is not applicable as this is a medical device, not an AI/ML algorithm that requires a training set.

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

This information is not provided and is not applicable for the reasons stated above.

Ask a specific question about this device

The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the 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 doctor offices.

The Pure Vu system comprises the following components:

Add-on - The Add-on is mounted on standard commercially available colonoscopes allowing the physician to clean the colon.

Workstation (WS) - The Workstation operates by using cyclic irrigation and evacuation of colon content. Irrigation is based on mixture of liquid and air. The workstation includes: Monitoring & Control Unit that continuously monitors and controls irrigation and evacuation. Inlet Module that includes pumps and regulators enabling water & airflow into the cleansing device. Outlet Module that includes pumps to evacuate fecal matter and fluids from the colon. External on\off foot pedals that operate the cleansing process to be used by the physician.

WS Cartridge (WSC) connects the Add on to the WS and saline or water bag.

Loading fixture to aid the nurse in mounting the Add-on to a colonoscope.

Unloading fixture to aid the nurse in removing the Add-on from a colonoscope.

The Pure Vu System is an accessory to standard colonoscopes designed to facilitate intraprocedural cleaning of a poorly prepared colon by irrigating, cleaning, and evacuating fluids and matter. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a comprehensive study for de novo approval. Therefore, the information provided mainly pertains to the performance validation for demonstrating substantial equivalence.

Here's an analysis of the available information regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, explicit quantitative acceptance criteria for clinical performance are not detailed as they would be for a de novo submission or a comprehensive clinical trial for a novel device. The primary "acceptance criterion" in a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented are primarily to support this claim, focusing on safety and effectiveness.

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

• Animal Study (Effectiveness & Safety):
  • Sample Size: 35 procedures in swine.
  • Data Provenance: Prospective animal study (swine model), likely conducted in a research facility. The specific country of origin is not mentioned.

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

• Animal Study:
  • Number of Experts: 4 experienced gastroenterologists.
  • Qualifications: "Experienced gastroenterologists." No further details on years of experience or specific board certifications are provided in this summary.

4. Adjudication Method for the Test Set

• The document does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for the animal study. The statement "The physicians were satisfied with the Pure Vu ease of advancement and navigation, level of stiffness, and its torque response. They found Pure Vu easy to use and intuitive to operate" suggests individual assessments by the gastroenterologists involved in the procedures. The colon cleansing level was presumably assessed by these same gastroenterologists.

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

• No MRMC comparative effectiveness study was done. The Pure Vu System is a mechanical device for colon cleaning during colonoscopy, not an AI-assisted diagnostic tool for image interpretation. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply to this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• The Pure Vu System is a physical medical device, not an algorithm or software-only diagnostic tool. It is used with human intervention (trained medical personnel using standard colonoscopes). Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply. The device's cleaning function is mechanical assistance during a procedure performed by a human.

7. The Type of Ground Truth Used

• Animal Study: The ground truth for effectiveness (colon cleansing level) and safety (adverse events) in the animal study was established by the performing gastroenterologists based on direct observation during the procedures. This could be considered a form of expert assessment/consensus during live procedures.

8. The Sample Size for the Training Set

• The document does not specify a separate "training set" in the context of device performance. The animal study of 35 procedures appears to be the primary performance validation used for this 510(k) submission. For software validation (IEC 62304), there would have been internal testing and verification, but details on sample size for that are not provided in this summary.

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

• Not applicable, as a distinct training set for performance evaluation (as would be seen in AI/machine learning models) is not detailed in this 510(k) summary for this type of device. The verification and validation of the device's functional aspects (biocompatibility, electrical safety, bench tests) would involve established engineering and quality assurance practices rather than a "ground truth" derived from a training dataset in the clinical sense.

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