Search Results

The Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q are intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope.

The Single Use 2-Lumen Cannula V PR-V614M is intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope.

The Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series is comprised of nine (9) sterile, single-use, cannulas designed to inject contrast medium in the biliary or pancreatic duct when used in conjunction with a compatible endoscope.

Each device has two sections: the handle (proximal portion) and the insertion portion. The insertion portion is introduced into the biliary or pancreatic ducts through an endoscope. The distal end of the insertion portion is designed for smooth cannulation of the papilla of Vater or the minor papilla. All models are visible under fluoroscopy and feature a distal marking system.

The Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series models are to be used with compatible endoscopes.

The provided 510(k) Premarket Notification document describes a medical device, the "Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series," and its comparison to a predicate device for demonstrating substantial equivalence.

However, the document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of device performance as typically expected for software-enabled devices or those with diagnostic capabilities.

This submission is for a physical medical device (cannulas) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing of its physical properties and biocompatibility. Therefore, many of the requested categories (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to the information provided.

Based on the document, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance data that was provided to demonstrate substantial equivalence, rather than specific and quantitative acceptance criteria with reported numerical device performance against those criteria. The "Analysis" column in the comparison table broadly states "Substantially equivalent" or "Identical," but doesn't provide the detailed numbers that would typically be associated with acceptance criteria for a diagnostic or algorithmic device.

Acceptance Criteria and Reported Performance (General statement from the document):

The document states: "Non-clinical testing demonstrates that the slight differences in device design do not alter the safety, efficacy, or performance of the subject devices when compared to the predicate devices." and "The non-clinical data demonstrate that the subject device is as safe, as effective, and performs as well as or better than the identified predicate device." This is a qualitative conclusion of meeting equivalence rather than presenting specific numerical acceptance criteria.

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

• Sample Size for Test Set: Not specified in the provided document. The performance data refers to various non-clinical tests, and the sample size for these individual tests (e.g., number of cannulas tested for insertion force) is not detailed.
• Data Provenance: Not applicable in the context of clinical data. The tests are non-clinical (laboratory/bench testing).

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

• Not applicable. Ground truth as typically understood for diagnostic performance (e.g., disease presence/absence) is not relevant for these non-clinical, physical device performance tests. "Human Factors Testing" is mentioned, which would involve experts, but the number and qualifications are not provided, nor is it the type of "ground truth" establishment usually refers to in the context of diagnostic AI.

4. Adjudication method for the test set:

• Not applicable. This is typically used for clinical study endpoints or image interpretation, not for physical performance tests of a cannula.

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 physical cannula, not an AI or diagnostic imaging system.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable in the conventional sense. The "ground truth" for the non-clinical tests would be the physical properties and functional performance measured against predefined specifications or predicate device performance.

8. The sample size for the training set:

• Not applicable for a physical device where "training set" doesn't apply in the context of machine learning.

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

• Not applicable for a physical device.

Ask a specific question about this device

The single use BioShield® biopsy valve EUS is used to cover the opening to the biopsy/suction channel of flexible echoendoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.

The BioShield® biopsy valve EUS - Linear is an accessory to a linear echoendoscope. The EUS biopsy valve allows the end user to cover the accessory port of a linear echoendoscope. The BioShield® biopsy valve EUS - Linear consists of tether and cap. The biopsy valves' cap can be removed from the accessory port while being held on the echoendoscope via the tether to the cap. The biopsy valve is a single-use, disposable device that is supplied sterile or nonsterile.

Here's a breakdown of the acceptance criteria and study information for the BioShield® biopsy valve EUS - Linear, based on the provided document:

This document is a 510(k) summary for a medical device called the "BioShield® biopsy valve EUS - Linear." It describes the device's technical characteristics, indications for use, and a summary of performance testing conducted to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Retention Force Testing:
  • 15 BioShield biopsy valves EUS - Linear (non-sterile) from 3 different lots (5 from each lot).
  • 15 BioShield biopsy valves EUS - Linear (sterile) from 3 different lots (5 from each lot).
• Leakage Testing:
  • 15 BioShield biopsy valves EUS - Linear (non-sterile) from 3 different lots (5 from each lot).
  • 15 BioShield biopsy valves EUS - Linear (sterile) from 3 different lots (5 from each lot).
• Device Exchange Testing:
  • 15 BioShield biopsy valves EUS - Linear (non-sterile) from 3 different lots (5 from each lot).
  • 15 BioShield biopsy valves EUS - Linear (sterile) from 3 different lots (5 from each lot).

Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the nature of a 510(k) submission for a new device, this testing would typically be prospective bench testing conducted by the manufacturer (Steris Corporation, located in Mentor, OH, USA).

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

This information is not applicable to this type of device and study. The testing described is bench testing of physical device performance (e.g., retention force, leakage, device passage), not a clinical study involving experts establishing ground truth for diagnostic or interpretative tasks.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. There wasn't a subjective assessment by experts that required adjudication.

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

No, a MRMC comparative effectiveness study was not done. This document describes bench testing of a physical accessory, not a diagnostic or interpretative AI-powered device that would involve 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 biopsy valve, not an algorithm or software. The "performance" being evaluated is the mechanical functionality of the valve itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on measurable physical properties and functional criteria as defined by the acceptance criteria. For example:

• Retention Force: Measured force in pounds.
• Leakage: Visual observation of spraying or geyser-type leaks.
• Device Exchange: Observation of successful passage and non-detachment during instrument usage.
• Biocompatibility/Sterilization: Adherence to established ISO/AAMI standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not a machine learning model that requires a training set.

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

Not applicable. As mentioned above, there is no training set for this device.

Ask a specific question about this device

This device is used for endoscopic cannulation of the ductal system. This device is indicated for adult use only.

The subject devices consist of a catheter with a T-fitting, a Y-body connector, a hub, or a female luer lock on the proximal handle and 3 MM markings at the distal radiopaque tip.

The device distal tip configurations include stainless steel metal, tapered, dome and/or angled tips. ERCP catheters are available in single, double, or triple lumen configurations. All devices have an injection port/wire guide port. Some catheters include a stylet wire to facilitate advancement of the catheter, which is removed prior to wire guide insertion or contrast injection. ERCP catheters are used by passing the device through an endoscope. The injection port/wire guide port is then used to allow fluoroscopic visualization by injecting contrast and/or wire guide access to the desired duct.

This document describes the Cook Medical ERCP Catheters (ERCP, GT, FS-GT, HRC, and SUC) and their substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, therefore no information relevant to the acceptance criteria of such a device can be extracted.

No information available for the requested sections:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

Ask a specific question about this device

The single use BioShield® - ERCP biopsy valve is used to cover the opening to the biopsy/suction channel of Olympus and G5 and newer Fujinon gastrointestinal 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.

Not Found

I am sorry, but the provided text from the FDA 510(k) letter for the BioShield® - ERCP Biopsy Valve does not contain any information regarding acceptance criteria, device performance, or any studies conducted on the device's efficacy or safety.

This document is a formal notification from the FDA confirming that the device is "substantially equivalent" to legally marketed predicate devices, meaning it doesn't require a Pre-Market Approval (PMA) application. It focuses on regulatory classifications, general controls, and compliance requirements.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

Ask a specific question about this device

This instrument has been designed to be used with an Olympus endoscope I mis instrument mas count in the biliary and pancreatic ducts, although it is not designed for the deep insertion into the pancreatic duct.

The subject device is a cannula which has a bending function (angle wire), to be used in accordance with Intended Use of the Device. This bending function enables the subject device to be manipulated in 2 directions and leads to easier insertion into the biliary and pancreatic ducts.

This document is a 510(k) premarket notification for a medical device called the "DISPOSABLE BENDING CANNULA PR-233Q." It focuses on demonstrating substantial equivalence to predicate devices, and therefore, it does not contain acceptance criteria, a study proving device meets acceptance criteria, or information regarding AI performance metrics.

The document describes the device, its intended use, and provides a comparison to predicate devices, focusing on the lack of significant changes that would affect safety or effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or AI performance. The document's purpose is to obtain FDA clearance based on substantial equivalence, not to present a detailed performance study with specific metrics.

Ask a specific question about this device

The Alien™ RX Micro Cannula is indicated for use to cannulate and inject contrast media into the biliary and pancreatic ductal systems. Contrast medium is injected through the cannula and fluoroscopy or x-ray is performed to obtain a cholangiogram.

The proposed Alien™ RX Micro Cannula is a single lumen cannula. It is compatible with the Boston Scientific Microvasive Endoscopy's Rapid Exchange™ platform, and is capable of accommodating a .025" guidewire while passing through a .035" lumen.

The provided FDA document is a 510(k) premarket notification for the "Alien™ RX Micro Cannula." This type of document is for a medical device and describes its intended use and a comparison to a predicate device to establish substantial equivalence. It is not a study report investigating an AI/ML powered device, nor does it contain information about "acceptance criteria" and "device performance" in the way a clinical study or a study validating an AI model would.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these details are not present in the provided text.

The document primarily focuses on:

• Device Name: Alien™ RX Micro Cannula
• Intended Use: To cannulate and inject contrast media into the biliary and pancreatic ductal systems for cholangiography.
• Predicate Device: Contour™ ERCP Cannula (K833417)
• Substantial Equivalence: The document asserts that the Alien™ RX Micro Cannula is substantially equivalent to the predicate device in terms of performance characteristics and biocompatibility.

No information regarding AI/ML models, their performance, or associated validation studies is present in this document.

Ask a specific question about this device

The Wilson-Cook Stricture Measuring Catheter is used to measure biliary and pancreatic strictures to determine stent size. This catheter allows injection of contrast and provides wire guide access to the desired duct. This device is supplied sterile and is intended for single use only.

The Wilson-Cook Stricture Measuring Catheter consists of a stylet wire and catheter. This device is designed for injection of contrast and to measure biliary and pancreatic strictures to determine stent size. This device is supplied sterile and is intended for single use only.

This document describes the premarket notification for the Wilson-Cook Stricture Measuring Catheter. Based on the provided text, here's a summary of the acceptance criteria and supporting study information:

Description of Acceptance Criteria and Study for the Wilson-Cook Stricture Measuring Catheter

The Wilson-Cook Stricture Measuring Catheter is designed for injecting contrast and measuring biliary and pancreatic strictures to determine stent size. The provided document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Wilson-Cook Glo-Tip ERCP Catheters, K851964) rather than presenting a performance study with specific acceptance criteria directly comparable to a disease detection or measurement algorithm.

The "acceptance criteria" here are implicitly related to the device meeting its stated performance characteristics and being safe and effective for its intended use, as validated by visual, dimensional, and functional analysis.

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 or patient cases. The testing mentioned refers to performance characteristic studies of the device itself.

• Sample Size: "Samples" were subjected to visual, dimensional, and functional analysis. The exact number of samples is not specified, but it implies a representative number of units from the manufacturing process.
• Data Provenance: This is not applicable in the context of clinical data, as the tests relate to device characteristics. The tests were likely conducted internally by Wilson-Cook Medical Inc. as part of their product development and regulatory submission process.

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

This information is not applicable to the type of device performance testing described. Ground truth in this context would refer to accurate physical measurements or functional capabilities of the catheter, which are determined by engineering specifications and testing, not expert clinical interpretation of patient data.

4. Adjudication Method for the Test Set

This is not applicable. The device performance testing involved direct measurement and verification against engineering specifications, rather than subjective interpretation requiring adjudication among experts.

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

No, an MRMC comparative effectiveness study was not conducted or reported in this document. The submission is for a medical device (catheter) for its physical and functional capabilities, not for an algorithm that interprets or assists human readers with clinical cases.

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 catheter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance characteristics (visual, dimensional, functional) would be the established engineering specifications and manufacturing standards for the catheter components and its overall assembly. For sterility, the ground truth is the successful validation of the sterilization process to achieve a specified sterility assurance level (SAL). For biocompatibility, the ground truth is the history of safe use of the materials in similar medical devices.

8. The Sample Size for the Training Set

This is not applicable. The concept of "training set" applies to machine learning algorithms. This document describes a physical medical device.

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

This is not applicable.

Ask a specific question about this device

ERCP is a diagnostic procedure for suspected biliary tract obstruction such as strictures or stones. The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage. Patients with diagnosed biliary tract calculi or strictures can then be treated with an assortment of therapeutic modalities.

The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage.

The provided text is a summary of safety and effectiveness for Endoscopic Retrograde Cholangiopancreatography (ERCP) cannulas. It discusses the procedure, contraindications, and manufacturing overview for this medical device.

However, the document does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, or comparative effectiveness studies) as requested in your prompt.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The text focuses on the device's intended use, contraindications for the procedure itself, and manufacturing quality control, rather than performance evaluation data.

Ask a specific question about this device

Ask a specific question about this device