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The ClearPath Lower GI 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 doctors' offices.

The proposed modified ClearPath Lower Gl is one component of the predicate ClearPath (K091305) which included a number of components: Controller, Tubing Set, Irrigation set (now referred to as the ClearPath Lower GI). We are proposing to only modify the ClearPath Lower GI which attaches to a conventional endoscope. The ClearPath Lower GI includes one suction tube + tip, one irrigation tube + tip, and a sleeve to attach to the endoscope. The ClearPath Lower GI is connected to the ClearPath Controller and the ClearPath Tubing (K091305) and allows for irrigation and evacuation of debris from the colon during an endoscopic procedure. The device can accommodate several sizes and configurations of endoscopes with a change in the attachment ring.

The provided text describes a 510(k) premarket notification for a medical device called "ClearPath Lower GI," an irrigation/evacuation system for colonoscopies. However, the document focuses on demonstrating substantial equivalence to predicate devices through a performance testing summary, rather than presenting a detailed study with specific acceptance criteria and outcome metrics that would typically be found in a clinical trial report.

The performance testing listed aims to verify that the modified device performs as expected and is equivalent to the predicate, but it does not define quantitative acceptance criteria or provide specific numerical results of a study designed to meet those criteria.

Here's an attempt to answer your questions based on the available information, noting where information is not explicitly provided:

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

The document does not explicitly state quantitative acceptance criteria in the format you requested (e.g., a specific success rate, a defined threshold for dislodgement, etc.). Instead, it mentions that "All testing demonstrated that the modified ClearPath Lower GI disposable performed to its specifications and / or was equivalent to the predicate."

Here's a summary of the performance testing categories and the general "reported performance," which is a claim of equivalence/specification compliance rather than specific numerical outcomes:

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: The document does not specify the sample size for the bench or animal testing. For animal testing, it likely refers to a number of individual animals, but this is not quantified.
• Data Provenance: Not explicitly stated. The applicant is "EasyGlide Ltd." from Israel, but whether the testing was conducted in Israel or elsewhere is not mentioned.
• Retrospective or Prospective: Not explicitly stated. Animal testing, by nature, is prospective. Bench testing is also inherently prospective for verifying specific design elements.

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 in the document. The testing involved "trained medical personnel" for the animal studies, but their specific number or qualifications are not detailed.

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

This information is not provided in the document. It's unclear if any formal adjudication method was used for evaluating the animal testing outcomes.

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

• MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not conducted. This device is an irrigation/evacuation system, not an AI-powered diagnostic tool, so such a study would not be relevant.
• Effect Size: Not applicable, as no MRMC study or AI component is involved.

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

No, a standalone (algorithm-only) performance was not done. This device is a physical medical instrument requiring human operation in conjunction with an endoscope, not a standalone algorithm.

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

For the animal study, the "ground truth" would be the direct observation and assessment of the device's performance characteristics by trained personnel during the simulated procedure. This would implicitly involve expert judgment on aspects like "ease of maneuverability," "quality of visibility," and "quality of evacuation." There is no mention of pathology or broader outcomes data for these specific tests.

8. The sample size for the training set

This is not applicable as this device is a physical instrument, not a machine learning model, and therefore does not have a "training set."

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

This is not applicable as there is no training set for this device.

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The ClearPath Upper Gl is intended for irrigating or cleaning the upper digestive tract and evacuating the irrigation fluid, blood and bile in the upper GI tract during endoscopic procedures. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

The ClearPath Upper GI includes one suction tube + tip, one irrigation tube + tip, and a sleeve to attach to the endoscope. The ClearPath Upper GI is connected to the ClearPath Controller and the ClearPath Tubing (K091305) and allows for irrigation and evacuation of debris from the upper gastrointenstinal tract during an endoscopic procedure. The device can accommodate several sizes and configurations of endoscopes with a change in the attachment ring.

The provided document describes a 510(k) premarket notification for the ClearPath Upper GI device, which is an irrigation/evacuation system for endoscopic procedures. The submission is for a modified design of a previously cleared device (K093779).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it describes performance testing in qualitative terms and asserts equivalence to the predicate device.

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

• Test Set Sample Size: The document does not specify a numerical sample size for either the bench or animal testing. It refers to "animal testing," implying more than one animal, but no specific count is given.
• Data Provenance: The testing appears to be conducted by the manufacturer, EasyGlide Ltd., which is based in Kfar Truman, Israel. The study type is prospective as it involves new testing performed for this 510(k) submission, referencing "We have performed bench and animal testing to verify..."

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

The document does not mention the use of experts to establish a "ground truth" in the traditional sense (e.g., for diagnostic accuracy). The testing performed seems to be primarily engineering validation (bench tests) and observational assessment by presumably trained personnel during animal studies. No specific number or qualifications of experts for ground truthing are provided.

4. Adjudication Method for the Test Set

Not applicable. The reported studies are primarily performance verification against specifications and observational assessments during animal trials, not diagnostic accuracy studies requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an irrigation/evacuation system, not a diagnostic imaging device typically requiring MRMC studies to assess human reader performance with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently through bench and animal testing against its specifications and the performance of the predicate device. This is not "algorithm only" performance as the device is a physical medical device. The testing aimed to confirm that the modified device itself, when used as intended, meets its design and functional requirements.

7. Type of Ground Truth Used

The "ground truth" in this context is based on:

• Pre-defined specifications for dimensional, strength, functional, and mechanical testing.
• Observational assessment during animal testing for factors like dislodgement, maneuverability, visibility, irrigation quality, and evacuation effectiveness. This observational assessment likely relies on the expertise of veterinary or medical personnel conducting the animal procedures.
• Equivalence to the predicate device (K093779), meaning the performance of the modified device was compared to the expected performance of the predicate.

8. Sample Size for the Training Set

Not applicable. This device is a physical, mechanical system, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for this type of device.

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The ClearJet is an irrigation / biopsy adapter and irrigation tubing set used to cover the opening to the biopsy / suction / irrigation channel of standard endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

The proposed ClearJet adapter is intended to perform irrigation through the working channel of an endoscope by providing a means to control the fluid irrigation with the cleared ClearPath control unit. The ClearJet's is design to improve procedure reliability by improving visualization during endoscopic procedures. The ClearJet utilizes an irrigation / biopsy valve adapter on doling attachment to an endoscope's working channel port for the purpose of performing a colon or stomach wash. The ClearJet is composed of two major units: - . A disposable Irrigator and - . A Control cabinet It is designed to fit the standard endoscope models of Pentax, Olympus, and Fuijinon.

The ClearJet is an endoscope accessory intended to improve visualization during endoscopic procedures by providing irrigation through the working channel of an endoscope. The 510(k) summary reports that the device's performance was evaluated through comparative flow and pressure testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical data for performance evaluation. The testing described is comparative flow and pressure testing, likely performed on the device itself rather than human or animal subjects. Thus, there's no mention of sample size for a test set derived from patient data, nor its provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The ground truth for this device's performance was established through objective engineering measurements (flow and pressure testing) against predicate specifications, not expert interpretation of clinical data.

4. Adjudication Method

Not applicable. There was no clinical data requiring expert adjudication.

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

No. The document makes no mention of an MRMC study or any comparative effectiveness study with human readers, with or without AI assistance. The device is an accessory for irrigation, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The ClearJet is a physical medical device (an endoscope accessory), not a software algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply.

7. Type of Ground Truth Used

The ground truth used was the specifications of the predicate devices for flow and pressure. The ClearJet's performance was compared against these objective engineering parameters.

8. Sample Size for the Training Set

Not applicable. The ClearJet is a physical medical device, not an AI or machine learning algorithm 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 this device.

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The ClearPath-UGI System is intended for irrigating or cleaning the upper digestive tract and evacuating the irrigation fluid, blood and bile in the upper GI tract during endoscopic procedures. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

The ClearPath UGI's main purpose is to improve procedure reliability by improving procedural visualization during endoscopic procedures. The ClearPath UGI utilizes a suction / irrigation head for the purpose of irrigating or cleaning the upper digestive tract. The ClearPath UGI is composed of two major units: . The disposable Irrigator and . the reusable Control cabinet. The disposable Irrigator is attached to a standard endoscope by means of silicone bands and does not hinder the endoscope's functionality nor affects the procedure sequence in any way. The Control cabinet supplies the water flow and vacuum control using a peristaltic pump. The standard medical facility vacuum system is the vacuum source.

The provided text describes the ClearPath UGI device and its 510(k) submission for substantial equivalence. However, it does not contain information about a study that proves the device meets acceptance criteria in terms of clinical performance, efficacy, or specific performance metrics beyond simple engineering specifications.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on:

• Identical indications for use.
• Identical technology.
• Identical patient-contact materials.
• Identical environment of use.
• Identical performance specifications (Air/Water pressure, Flow rate, Suction specifications).

Therefore, I cannot populate the table and answer several of your questions as the requested information (related to a clinical study, reader performance, ground truth, and training data) is not present in the provided text.

Here's the information that can be extracted or inferred based on the provided document:

1. Table of acceptance criteria and the reported device performance:

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

Not applicable. The document describes engineering specification comparisons, not a clinical test set.

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 applicable. Ground truth for clinical performance was not established in the provided context. The "ground truth" here is the published specifications of the predicate device.

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

Not applicable. No clinical test set or adjudication is mentioned.

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 not an AI diagnostic tool and no MRMC study is mentioned.

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

Not applicable. This is not an AI algorithm; it's a physical medical device accessory.

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

For the purpose of substantial equivalence, the "ground truth" used are the engineering specifications and performance characteristics of the predicate device (K091305 – Easy Glide – ClearPath). The new device's performance was compared against these established specifications.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable. No training set or associated ground truth establishment is mentioned.

Summary of the Study (as described in the document):

The "study" described in the 510(k) summary is a benchtop comparison against a predicate device (K091305 – Easy Glide – ClearPath). The purpose was to demonstrate substantial equivalence for the modified ClearPath UGI device, which has a shorter disposable tubing set and a redesigned irrigation tip, but no modifications to the controller or software.

The study involved confirming that the key performance specifications of the proposed device (Air/Water pressure, Flow rate, Suction specifications) are identical to those of the predicate device. This was presented as "testing to demonstrate that the operating performance of the ClearPath UGI is equivalent to the predicate for flow rate, irrigation and vacuum pressures."

The acceptance criteria were simply that the new device's engineering performance for these specific parameters should match those of the legally marketed predicate device. The document states, "Performance specifications - Irrigation pressures, flow rate and suction pressures are identical to the predicate -. K091305 EasyGlide ClearPath."

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The ClearPath 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) and feces.

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

The ClearPath's main purpose is to improve procedure reliability and decrease colonoscopy procedures cancellation rate by enabling intra-procedural cleaning of a poorly prepared colon.

The ClearPath utilizes a suction / irrigation head for the purpose of irrigating or cleaning the colon and enabling the rapid evacuation of large amounts of water and feces.

The ClearPath is composed of two major units:

• . The disposable Irrigator and
• . the reusable Control cabinet.

The disposable Irrigator is attached to a standard colonoscope by means of silicon bands and does not hinder colonoscope functionality nor affects the procedure sequence in any way.

The Control cabinet supplies the water flow and vacuum control using a peristaltic pump. The standard medical facility vacuum system is the vacuum source.

The provided document describes the ClearPath device, an external uterine monitor for intra-procedural colon cleaning. The information primarily focuses on substantial equivalence to predicate devices based on technical specifications and indications for use, rather than a clinical study evaluating its effectiveness.

However, based on the information provided, here's a breakdown regarding acceptance criteria and the "study" that proves the device meets them, recognizing that this "study" is more accurately described as performance testing for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are implicitly defined by the performance specifications of the predicate device, specifically the Olympus (KeyMed) OFP-1 endoscopic flushing pump (K000948). The ClearPath device aims to be "equal or less than" these specifications, which indicates non-inferiority in performance for certain parameters.

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

The document mentions "testing to demonstrate that the operating performance specifications of the ClearPath is equivalent to the predicates for flow rate, irrigation and vacuum pressures."

• Sample Size: The document does not specify the sample size (e.g., number of devices tested, number of measurements taken). It refers to "testing" in a general sense for technical specifications.
• Data Provenance: This testing appears to be internal engineering or lab testing. There is no information provided regarding country of origin, retrospective or prospective nature, or if it involved human subjects or real-world clinical data. It is likely bench testing data.

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

• Not applicable for this type of performance testing. The "ground truth" for the technical specifications (pressure, flow rate, suction) would be established by calibrated measurement devices and engineering standards, not expert consensus.

4. Adjudication Method for the Test Set:

• Not applicable as this was technical performance testing against established specifications, not a subjective evaluation requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not conducted for this device. The purpose of the submission was to demonstrate substantial equivalence based on technical performance and indications for use, not to prove clinical effectiveness or improvement in human reader performance. This device is an instrument for cleaning during a procedure, not a diagnostic or interpretation aid.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, a standalone "study" (i.e., standalone performance testing) was performed. The device's performance (pressure, flow, suction) was measured independently without human intervention directly influencing the measurement of these parameters. This testing focused on the device's technical capabilities as described in the table above.

7. Type of Ground Truth Used:

• The ground truth for the performance testing was based on established engineering specifications and measurements from the predicate device (Olympus OFP-1 endoscopic flushing pump) and general industry standards for such devices (e.g., standard wall suction levels).

8. Sample Size for the Training Set:

• Not applicable. This device is a mechanical instrument, not an AI or machine learning algorithm 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 this device.

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