Search Results

The endoscope system is used to examine body cavities, hollow organs and canals, specifically the lower GI tract (colon) only, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The endoscope system includes the endoscope with control head, a disposable assembly, an imaging system, and a fluid and air system. The endoscope system features: 1) a smooth control head containing a minimal number of outside angles and joint crevices, 2) a single use disposable system encompassing all of the inner passage channels that start at the manifold, continue through the endoscope cavity, and seal onto the outside of the rigid distal tip, 3) a pneumatically driven air and fluid system eliminating the need for mechanical valves in the contamination path, and 4) a lavage function that provides a bolus of water through the working channel to loosen and flush debris from the field of view as the insertion tube advances through the colon.

The provided text is a 510(k) premarket notification for an endoscope system. It details the device's description, indications for use, and a comparison to predicate devices, but it does not contain information about specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

The document states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance, rather than proof of meeting specific performance acceptance criteria through independent studies.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated based on the given information:

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

The document does not explicitly state acceptance criteria or report specific device performance metrics in the way that would typically be seen in a clinical study. Instead, it compares the physical and functional specifications of the akos endoscope system to several predicate devices.

Note: The "acceptance criteria" here are inferred from the comparison to predicate devices, implying that performance within the range of existing, legally marketed devices for similar specifications is deemed acceptable for substantial equivalence. No specific quantitative performance targets (e.g., image resolution, diagnostic accuracy) are provided in the document.

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

• No information available. The document does not describe a test set or clinical study with a specified sample size or data provenance. The clearance is based on substantial equivalence to predicate devices, not on a new clinical performance study.

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)

• No information available. There is no mention of a test set or ground truth established by experts within this document.

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

• No information available. There is no mention of a test set or adjudication method.

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 information available. This document is for a medical device (endoscope), not an AI-powered diagnostic system, and it predates widespread AI application in this context (1997). No MRMC study or AI assistance is mentioned.

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

• Not applicable. This device is an endoscope system, which is a tool used by a human operator for examination and procedures. It is not a standalone algorithm.

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

• No ground truth discussed. The 510(k) submission primarily focuses on engineering specifications and intended use comparison to predicate devices for substantial equivalence, not on establishing a ground truth for diagnostic accuracy.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

• Not applicable. As above, no training set or ground truth for it is relevant to this device's submission.

Ask a specific question about this device

Ask a specific question about this device

The proposed VSI Model S-V200 Color Video Sigmoidoscope is intended for use to examine the lower bowel tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The VSI Model S-V200 Color Video Sigmoidoscope with Disposable EndoSheath consists of a reusable video sigmoidoscope with a D-shaped cross section containing fiberoptic illumination and imaging bundles and a sterile, disposable, protective sheath containing the air, water and suction/biopsy channels. The sheath is removed and disposed of following each procedure.

The provided text describes a 510(k) summary for the Vision-Sciences Model S-V200 Color Video Sigmoidoscope with Disposable EndoSheath. However, it does not contain the detailed information required to answer all parts of your request regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document focuses on device description, indications for use, and a brief mention of two performance tests. It explicitly states that no biocompatibility data was presented. More importantly, it does not provide any specific acceptance criteria (e.g., numerical thresholds for resolution or angulation) nor does it report the actual device performance metrics against such criteria.

Therefore, I can only provide information based on what is available in the text.

Here's the information that can be extracted or inferred, and the parts that cannot be answered from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any of the tests mentioned (Angulation/Cycle Testing, Resolution).
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not Applicable: The performance tests mentioned (Angulation/Cycle Testing, Resolution) are objective engineering/physical performance tests of the device itself, not diagnostic performance tests involving human interpretation or clinical data. Therefore, "ground truth" in the clinical diagnostic sense with expert consensus is not relevant for these specific tests.

4. Adjudication method for the test set

• Not Applicable: As explained above, these were physical device performance tests, not clinical diagnostic studies requiring adjudication of output.

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: The document does not mention any MRMC study. The device is a sigmoidoscope, which is an optical instrument for direct examination, not an AI-powered diagnostic tool.

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

• Not Applicable: The device described is a physical instrument (sigmoidoscope), not a standalone algorithm.

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

• Not Applicable in the clinical sense: For the Angulation/Cycle and Resolution tests, the "ground truth" would be established by validated engineering standards and measurement equipment. The document does not detail these standards or measurements.

8. The sample size for the training set

• Not Applicable: This is a physical device, and the mentioned tests are physical performance validations, not related to machine learning models that require training sets.

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

• Not Applicable: As above, this information is irrelevant for the type of device and tests described.

Summary of Limitations from the Provided Text:

The provided 510(k) summary is very high-level regarding performance testing. It indicates that tests were performed ("Scope Angulation/Cycle Testing" and "Scope Resolution"), but it lacks crucial details such as:

• Specific numerical acceptance criteria.
• The actual quantitative results of these tests.
• The methodology of these tests (e.g., how resolution was measured, how many cycles were performed).
• Sample sizes for these tests.
• Any details about clinical performance, given that it focuses on physical characteristics.

Ask a specific question about this device

The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the sigmoid colon.

The EndoSheath for use with the VSI Model S-F100 and S-V100 Sigmoidoscopes consists of a sterile, disposable, protective sheath which covers the pation of the scope during a clinical procedure. The sheath is removed and disposed of following each procedure.

The provided text describes a 510(k) Premarket Notification for a medical device, the Modified EndoSheath® for VSI Flexible Sigmoidoscopes, by Vision Sciences Inc. This document focuses on demonstrating the substantial equivalence of the modified device to previously cleared predicate devices through functional and microbial barrier testing.

However, the provided text does not contain the level of detail required to fulfill all the requested information categories, particularly regarding the specifics of clinical studies, expert involvement, and ground truth establishment typically found in comprehensive device performance reports for AI/diagnostic tools. The device described is a physical sheath, and the testing focuses on its physical properties and barrier function, not diagnostic accuracy in the way an AI algorithm would be evaluated.

Therefore, for several categories, the response will state that the information is "Not applicable" or "Not provided in the text."

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and 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)

• Sample Size for Test Set: Not specified in the provided text. The tests mentioned are in vitro functional tests and microbial barrier testing, not tests on a clinical patient sample or data set.
• Data Provenance: Not applicable, as these were in vitro laboratory tests, not human data.

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. The ground truth for these in vitro physical and microbial barrier tests would be established by laboratory testing protocols and established scientific methods, not by expert human interpretation of medical data.

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

• Not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical or image-based studies where human interpretation is involved. This document describes in vitro functional and barrier tests.

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 was not done. This device is a physical sterile sheath, not an AI or diagnostic tool designed to assist human readers.

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

• Not applicable. This device is a physical product, not an algorithm.

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

• The "ground truth" for the tests performed (tensile/elongation, image quality, microbial barrier) would be established by physical standards and microbiological testing protocols. For example, the ground truth for microbial barrier testing would be the absence of bacteriophage penetration under specified conditions. This is not clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

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

Ask a specific question about this device

The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the sigmoid colon.

The SS-F32 EndoSheath for use with the VSI Model S-F100 Sigmoidoscope consists of a sterile, disposable, protective sheath which covers the pation of the scope during a clinical procedure. The sheath is removed and disposed of following each procedure.

Here's a breakdown of the acceptance criteria and study information for the Modified EndoSheath® for VSI Fiberoptic Sigmoidoscope, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that these tests were performed and, based on them, the device was concluded to be safe and effective. However, it does not provide specific numerical thresholds or detailed results for what constitutes "meeting" these criteria (e.g., a specific tensile strength value, or a quantified reduction in viral load). It simply indicates that the tests were conducted and the device passed.

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

The document does not specify the sample size used for the "Sheath Functional and Performance Test 1," "Sheath Tensile Test," or the microbial barrier testing. It also doesn't explicitly state the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of these in vitro tests, it's highly likely they were conducted in a controlled laboratory setting.

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. For in vitro functional and barrier tests, "experts" in the traditional sense of clinical diagnosticians establishing ground truth might not be directly applicable in the same way it would be for image-based AI studies. Rather, the ground truth would be established by the testing methodology itself (e.g., successful containment of pathogens, ability to withstand a certain force).

4. Adjudication Method (for the test set)

The document does not mention any adjudication method, as it's not relevant to the described in vitro testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, not for an in vitro medical device like the EndoSheath.

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

Yes, in a sense, a "standalone" evaluation was done. The tests described (Sheath Functional and Performance, Tensile, Microbial Barrier) evaluate the device's performance properties in isolation, without human intervention as a variable in the outcome of the test.

7. The Type of Ground Truth Used

The ground truth for these tests is based on pre-defined physical and biological performance characteristics.

• For the Sheath Functional and Performance Test, the ground truth would be the successful operation of the sheath in its intended function with the sigmoidoscope.
• For the Tensile Test, the ground truth would be the ability to withstand a specified tensile force without failure.
• For Microbial Barrier Testing, the ground truth would be the effective containment/prevention of passage of the specified viruses (polio virus and Phi X 174 bacteriophage).

8. The Sample Size for the Training Set

This product is a physical medical device, not an AI/ML algorithm that requires a "training set." Therefore, this question is not applicable.

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

As explained above, this question is not applicable to this product.

Ask a specific question about this device

The ES-3840, Video Sigmoidoscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Lower Gastrointestinal Tract. The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Rectum and Sigmoid Colon. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

The ES-3840, Video Sigmoidoscope, must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube, and umbilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/ down/ left/ right angulation, air/water delivery, suction, Forward Water Jet, and an accessory inlet port. The device contains light carrying bundles, to illuminate the body cavity, and a charge couple device (CCD) to collect image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a 300 watt xenon lamp which provides white light that is filtered, via a Red, Green, Blue color wheel, and is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The video processor stores the CCD information until all three color strobes are completed and a full color frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study aspects, and where information is not present:

Key Takeaway from the Provided Text:

The most crucial piece of information for your request is: "The submission for substantial equivalence was not based on an assessment of clinical performance data."

This statement directly indicates that the 510(k) submission for the Pentax ES-3840 Video Sigmoidoscope did not include a study or clinical trial demonstrating its performance against specific acceptance criteria. Instead, substantial equivalence was established through comparison to legally marketed predicate devices based on specifications, components, and accessories.

Therefore, many of the questions you've asked about acceptance criteria and study details cannot be answered from this specific document, as such a study was not part of this clearance.

Detailed Breakdown based on your Request:

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

• Acceptance Criteria: Not explicitly stated or provided in this 510(k) summary. Since no clinical performance study was conducted, there are no reported acceptance criteria for clinical efficacy or diagnostic accuracy.
• Reported Device Performance: Not reported in terms of clinical outcomes, sensitivity, specificity, accuracy, or other performance metrics typically derived from a study. The "performance" discussed in the document is limited to its functional description (e.g., "The instrument contains a working channel," "collects image data").

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. No "test set" from a clinical study was used for this 510(k) submission.

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. No clinical study with a "test set" requiring ground truth establishment was conducted or submitted.

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

• Not applicable. No clinical study with a "test set" requiring adjudication was conducted or submitted.

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. This is a medical device for visualization, not an AI or CAD system. An MRMC study or AI-assisted improvement study is entirely unrelated to this type of device and its 1996 clearance.

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

• No. This is a human-operated sigmoidoscope, not an algorithm.

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

• Not applicable. No clinical study requiring ground truth was conducted or submitted.

8. The sample size for the training set

• Not applicable. No "training set" in the context of a performance study was used for this 510(k). Training sets are typically associated with machine learning or AI algorithm development, which is not relevant here.

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

• Not applicable. (See #8)

Ask a specific question about this device

The ES-3800, Video Sigmoidoscope, is intended to provide optical visualization of, and therapeutic access to, the Lower Gastrointestinal Tract (extent of exam, sigmoid colon). The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems; Large Bowel. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

The ES-3800, Video Sigmoidoscope, must be used with a Video Processor (a software controlled device) The endoscope has a flexible insertion tube, a control body, and umuilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/ down/ left/ right angulation, air/water delivery, suction, CO2 delivery, and an accessory inlet port. The device contains light carrying bundles, to illuminate the body cavity, and a charge couple device (CCD) to collect image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a 300 watt xenon lamp which provides white light that is filtered, via a Red, Green, Blue color wheel, and is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The video processor stores the CCD information until all three color strobes are completed and a full color frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.

I am sorry, but the provided text does not contain the information required to fulfill your request. The document describes a medical device, its intended use, and a comparison to predicate devices, but lacks details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot generate the table and descriptive points you've requested.

Ask a specific question about this device