Search Results

Ask a specific question about this device

Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/ Stent Sets (GEPD, GPDS, GPSO, GPSOS); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF); Endoscopic pancreatic stent placement is used for pancreatic drainage that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreas, pancreatic fluid collection, pancreatic stones, disrupted duct, fistula/pancreatic leak. Pancreatic stents are also used prophylactically for prevention of post-ERCP pancreatitis.

Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS): Endoscopic pancreatic stent placement for pancreatic drainage of obstructed ducts that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreas, pancreatic fluid collection, pancreatic stones, and disrupted duct.

Pushing Catheter and Guiding Catheter (GC, PC): These devices are indicated for use with biliary and pancreatic stents for the following indications. For endoscopic biliary stent placement for biliary drainage of obstructed ducts that could be caused by common bile duct stones, malignant biliary obstruction and benign or malignant strictures. For endoscopic pancreatic stent placement for pancreatic duct drainage that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreatic fluid collection, pancreatic stones, disrupted duct, fistula / pancreatic leak. Pancreatic stents are also used prophylactically for prevention of post-ERCP pancreatitis.

The intended use of all Cook pancreatic stents and sets is to drain pancreatic ducts. A variety of stents in different sizes are available across the device range to accommodate various patient anatomies, the size and location of the obstruction and physician preference. They are offered in French sizes of between 3Fr and 11.5Fr, and in labelled lengths of between 2cm and 25cm.The subject devices and their components can be supplied as stent only, introducer only (guiding or pushing catheter) or as stent sets combining stent and introducers/introducer systems.

The stent sets can contain one or several of the following stent placement components; a flap protector, a guiding catheter, a pushing catheter or a dedicated introducer system. The flap protector is provided with stents that have duodenal flap-type anti-migration features, and is used to collapse the flap(s) on the device as it is introduced into the working channel of the endoscope. The function of the guiding catheter is to guide the pancreatic stent as part of its introduction to its intended location. The guiding catheter also has a Hub that allows for contrast injection. The function of the Pushing Catheter is to advance the stent, over a pre-positioned wire guide or Guiding Catheter, to its intended location within the anatomy, and to maintain the position of the Stent as it being deployed. The stents are polymeric and some of the stents have radiopaque bands. The stent designs include anti-migrational features such as duodenal pigtails, duodenal bends and ductal and duodenal flaps. To facilitate stent insertion and removal the stent ends are tapered or buffed. Side-ports on the pancreatic stents assist in drainage. All stents are deployed endoscopically over a guide wire in the same manner under fluoroscopic and endoscopic monitoring.

These Cook pancreatic stents and sets are all for professional use and are provided sterile. They are all intended for short-term use and have an indicated indwell of up to 3 months.

The provided document (K233079) describes the Cook Ireland Ltd. Zimmon and Geenen Pancreatic Stents/Stent sets, Johlin Pancreatic Wedge Stent and Introducer Set, and Pushing and Guiding Catheters. This submission is for medical devices, not an AI/ML powered device, therefore, the information requested in the prompt related to acceptance criteria and studies that prove the device meets these criteria is not applicable in the context of AI/ML performance.

Specifically, the document focuses on demonstrating substantial equivalence to a predicate device (Pancreatic Stents & Sets cleared under K172057) through comparisons of technological characteristics and non-clinical performance data. There is no mention of acceptance criteria related to AI/ML device performance metrics like sensitivity, specificity, or AUC, nor any studies involving test sets, ground truth established by experts, or human reader performance with or without AI assistance.

The performance data mentioned in the document are:

• Biocompatibility evaluation: Conducted in accordance with ISO 10993-1: 2018 and FDA's biocompatibility guidance.
• Performance testing: Included simulated use, dimensional and visual testing, tensile strength testing, MRI conditional testing, radiopacity, flow rate, and shelf-life testing.

These tests aim to ensure the physical and material integrity, safety, and functionality of the pancreatic stents and catheters.

Therefore, I cannot provide the requested information in the format of the table or answer the specific questions related to AI/ML acceptance criteria and studies based on the provided text.

Ask a specific question about this device

This device is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal and extramural lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.

The EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) is an endoscopic ultrasound needle consisting of a needle assembly and syringe. The needle assembly is comprised of a handle, sheath, stylet and needle cannula. This device is available in one 22Ga needle size.

Here's a breakdown of the acceptance criteria and the study information for the EchoTip® AcuCore™ Ultrasound Biopsy Needle, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: It's important to note that the document extensively references "acceptance criteria" but rarely provides specific quantitative values for these criteria. It generally states that "All test articles met the acceptance criteria" or "meets the relevant acceptance criteria."

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

• Test Set Sample Size: The document does not specify the exact sample sizes for each non-clinical test. It refers to "All test articles" meeting the acceptance criteria, suggesting a finite number of devices were tested for each performance characteristic.
• Data Provenance: The studies were retrospective in the sense that they were conducted by the manufacturer (Cook Ireland Ltd.) for regulatory submission to demonstrate substantial equivalence. The data is from internal testing (Cook), rather than from external clinical trials on human subjects. The country of origin for the manufacturing and potentially the testing is Ireland, as indicated by "Cook Ireland Ltd."

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

• Not Applicable. The document describes non-clinical performance testing (e.g., puncture force, suction) and simulated use testing in a laboratory setting. There is no mention of a "test set" requiring expert ground truth establishment in the context of diagnostic accuracy, as this is a medical device for biopsy, not an AI or diagnostic imaging system. Therefore, no experts were used for this purpose in this context.

4. Adjudication Method for the Test Set:

• Not Applicable. As the performance testing is non-clinical and objective (e.g., measuring force, length), an adjudication method (like 2+1 or 3+1 used for expert discrepancies) is not relevant. The results are based on direct measurements and pre-defined acceptance thresholds.

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 typically performed for diagnostic imaging or AI systems where human readers interpret medical images/data, and the AI's impact on their performance (with vs. without AI assistance) is evaluated. The EchoTip® AcuCore™ is a physical biopsy needle, and its performance is assessed through mechanical, functional, and simulated use testing, not through human reader interpretation of data.

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

• Not Applicable. This question typically pertains to AI algorithms. The EchoTip® AcuCore™ is a physical medical device (biopsy needle), not an algorithm, so the concept of "standalone performance" in this context is not relevant. The device's performance is inherently tied to its use by a human clinician.

7. The Type of Ground Truth Used:

• The "ground truth" for the non-clinical tests was established by engineering specifications, material science standards, and established physical performance benchmarks. For example, the puncture test would have a "ground truth" derived from target tissue models (e.g., worst-case material representative of liver and pancreatic tissue) and measured force, while the extension length test would have a "ground truth" based on the design specifications and measurements. Biocompatibility relies on established regulatory standards and biological testing outcomes.
• For the "Indications for Use" change, the "ground truth" for the justification essentially relies on alignment with market standards (other cleared devices like Boston Scientific's Acquire) and the fact that procedural steps/risks were not identified as new by the internal quality system.

8. The Sample Size for the Training Set:

• Not Applicable. This question is relevant for machine learning algorithms. The EchoTip® AcuCore™ is a physical medical device and does not involve AI or machine learning, so there is no "training set."

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

• Not Applicable. As there is no training set for this device, the question of how its ground truth was established is not relevant.

Ask a specific question about this device

Endoscopic biliary stent placement for biliary drainage of obstructed ducts that could be caused by common bile duct stones, malignant biliary obstruction, benign or malignant strictures or other obstructed biliary conditions requiring drainage.

The Compass BDS® Biliary Stent includes double pigtails with double radiopaque marker bands. Compass BDS® Biliary Stents are recommended for use with Cook stent introducers (PC-7, PC-7E, and FS-PC-7). The product code for Compass BDS® Biliary Stent is CBBSO-X-Y (CBBSO-7-5, CBBSO-7-10, CBBSO-7-15), where X denotes French size (Fr) and Y denotes the length in centimeters (cm). This product contains a stent and a pigtail straightener. The stent design allows the stent to be introduced on either side and the double-pigtails minimize migration, while side holes enhance biliary fluid drainage. It also has a tapered tip at both ends to facilitate smooth cannulation. The stent has two radiopaque bands on both ends for fluoroscopic visibility.

This application is for a medical device (Compass BDS Biliary Stent), not an AI/ML powered device. Therefore, the requested information regarding AI/ML powered device acceptance criteria and study details are not applicable here.

However, based on the provided document, here's what can be extracted about the device's performance data and substantial equivalence to a predicate device:

The acceptance criteria for the Compass BDS Biliary Stent are implicitly met through a comparison to a predicate device and a series of non-clinical performance tests. The study's conclusion is that the device is substantially equivalent to the predicate device and meets its design input requirements.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not specify sample sizes for the performance tests. The data provenance is Cook Ireland Ltd.'s internal design control system. It does not mention country of origin or whether the studies were retrospective or prospective, but given it's a premarket notification for a device, the tests are primarily non-clinical and conducted by the manufacturer.

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

This information is not applicable as the studies described are non-clinical (biocompatibility and performance testing) of a physical device, not an AI/ML algorithm requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This is not applicable for the non-clinical testing described.

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

This is not applicable as the application is for a physical medical device, not an AI/ML system, and no human reader studies are mentioned.

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

This is not applicable as the application is for a physical medical device, not an AI/ML algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth is established by adherence to recognized international standards (ISO 10993-1:2018) and FDA guidance for biological evaluation. For device performance testing, the ground truth is established by the predefined design input requirements for the device.

8. The Sample Size for the Training Set

This is not applicable as there is no mention of a training set for an AI/ML algorithm.

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

This is not applicable as there is no mention of a training set for an AI/ML algorithm.

Ask a specific question about this device

The EchoTip® Ultra Endoscopic Ultrasound Needle is used with an ultrasound endoscope for fine needle aspiration (FNA) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

The EchoTip ProCore® HD Ultrasound Biopsy Needle is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

Echotip® Ultra Endobronchial High Definition Ultrasound Needle for Olympus scopes: This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA).

Echotip® Ultra Endobronchial High Definition Ultrasound Needle for Pentax scopes: This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA).

Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for Olympus scopes: This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract.

Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for Pentax scopes: This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree.

EchoTip Ultra Endoscopic Ultrasound Needle: This Needle is used in conjunction with an ultrasound endoscope and is available in needle gauge sizes of 19, 22 and 25 Ga. The device comprises of a needle assembly and a syringe. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The purpose of the needle cannula is for puncturing of the target site. The preloaded nitinol stylet is withdrawn from the needle when obtaining sample from the target site. The sheath covers the needle when it is not in use. The device handle allows for needle and sheath length adjustment. The syringe can aid in sample aspiration. The device is supplied sterile and is intended for single use. The device is for Rx use only.

EchoTip ProCore HD Ultrasound Biopsy Needle: This Needle is used in conjunction with an ultrasound endoscope and is available in needle gauge sizes of 19, 20, 22 and 25 ga. The device comprises of a needle assembly and a syringe. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The needle cannula has a bevelled tip design and a notch. The purpose of the needle cannula is for puncturing/biopsy of the target site. The preloaded nitinol stylet is withdrawn from the needle for biopsy. Some variants have a stylet that coils when not in the needle. The sheath covers the needle when it is not in use. The device handle allows for needle and sheath length adjustment. The syringe can aid in tissue aspiration. The device is supplied sterile and is intended for single use. The device is for Rx use only.

EchoTip Ultra / ProCore Endobronchial High Definition Ultrasound Needle: These Needles are used in conjunction with an endobronchial ultrasound endoscope and is available with needle gauge sizes of 22 and 25 Ga. The device is composed of a needle assembly and a syringe. An adapter can also be supplied for use with endobronchial ultrasound endoscopes with metal non-Luer hubs. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The needle cannula has a bevelled tip design and comes either with or without a notch. The purpose of the needle cannula is for puncturing/sampling of the target site. The needle is provided with a preloaded stylet which remains in place during advancement of the needle. The sheath covers the needle when the needle is retracted and not in use. The device handle allows for needle and sheath length adjustment. The stylet/syringe can aid in specimen retrieval. The device is supplied sterile and intended for single use only. The device is for Rx use only.

The provided text is a 510(k) Summary for medical devices, specifically various EchoTip ultrasound needles. It describes the devices, their indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence.

However, it does not contain acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a device based on clinical or diagnostic outcomes, nor does it describe a study that uses such acceptance criteria to demonstrate the device meets them. This document is a regulatory submission focused on proving equivalence to previously cleared devices through non-clinical performance testing and technological comparison.

Therefore, I cannot extract the requested information in the format provided. The document outlines performance testing as part of Cook Ireland's design control system, but these are engineering/material tests, not studies against clinical acceptance criteria.

To elaborate on what is present in relation to performance, albeit not in the requested format:

Performance Data (Non-Clinical):
The document states that performance testing was conducted as per Cook Ireland's design control system. These tests include:

• Tensile testing
• Crumple testing
• Joint strength testing
• Finite element analysis
• Simulated use and drop testing

Purpose of these tests:
To support the safety of the modified devices and demonstrate that they should perform as intended, thereby supporting substantial equivalence to the predicate devices. These are engineering and material science tests, not clinical performance studies for diagnostic accuracy.

Missing Information (as per your request):
The document does not provide:

1. A table of acceptance criteria and reported device performance related to diagnostic outcomes.
2. Sample size used for a clinical test set, nor data provenance (country, retrospective/prospective).
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a clinical test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, effect size regarding human readers improving with/without AI assistance.
6. Information about standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcome data) in a clinical context.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This is expected as the submission is for needle devices, which are instruments used by clinicians, not AI/diagnostic algorithms with specific diagnostic performance metrics. The criteria for these devices are typically related to mechanical integrity, biocompatibility, and functional equivalence to similar devices already on the market.

Ask a specific question about this device

The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System is indicated to directly measure pressures in the hepatic and portal venous vasculatures and is used in conjunction with an ultrasound endoscope.

The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System is a system used to provide endoscopic access to the portal and hepatic veins to measure local blood pressure. As shown in Figure 1, the system is composed of: 1. EchoTip Insight Endoscopic Ultrasound Needle 2. Connecting Tube 3. 10 mL syringe 4. Stopcock 5. Compass CT Pressure Transducer (K133624). The EchoTip® Insight™ Needle functions to provide access to the venous vasculature related to the portal circulation and hepatic outflow to facilitate the measurement of physiological pressure by the Compass® CT pressure transducer, a disposable manometer (cleared under K133624). The needle is enclosed within a 5.2 Fr. outer sheath for protection. The sheath has an adjustable length (0-5 cm) to allow the user to adjust for the working length of the endoscope. The sheath length extension lock ring allows the sheath to be secured in place by tightening the thumbscrew. The needle extension is also adjustable and ranges from 0-8 cm. The "zero" reference ensures complete needle retraction within the sheath. The handle has a safety ring that slides and locks using the thumbscrew at the desired needle extension. The Connecting Tube is used for the transfer of liquids (heparinized saline) between the EchoTip® Insight™ Needle and the Compass® CT pressure transducer. The Connecting Tube uses a female Luer lock to connect to the Compass CT pressure transducer, and a male Luer lock to connect to the stopcock. The Compass CT is a disposable, point-of-use blood pressure measurement and monitoring device that incorporates an embedded pressure sensor and an integrated, pre-programmed diagnostic computer chip with a liquid crystal display. Once the system is connected and primed with heparinized saline, the EchoTipe Insight™ Needle is passed through the accessory channel of an ultrasound endoscope and the needle is advanced to the desired vasculature (portal or hepatic vein) through the liver parenchyma. Using ultrasound guidance, the needle is placed at the desired location, allowed to stabilize, and a measurement reading is taken.

The provided text describes a medical device, the EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System, and its regulatory approval process, including performance testing. However, it does not explicitly define acceptance criteria in a table format with specific numerical targets. The "acceptance criteria" are implied by the successful completion of various tests and the statement that the probable benefits outweigh the probable risks.

Since a table of acceptance criteria and reported device performance, and several other requested pieces of information are not explicitly stated, I will extract and infer as much as possible from the provided text.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit numerical acceptance criteria are not provided. The "reported device performance" is described through the successful completion of various tests.

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

• Bench Performance Test (Simulated Use): "A statistically significant number of distinct needle devices, connecting tubes, and Compass CT transducers were tested..." (Actual number not specified). This was a prospective, benchtop test.
• Animal Study: 17 pressure measurements were carried out in three swine. This was a prospective animal study. Data provenance not explicitly stated, but the authors are from "Gastrointestinal Endoscopy, 2016 Aug" and "2017 May", implying likely US-based research or internationally recognized publication.
• Human Clinical Study: 28 patients. This was a single-center, prospective human pilot study. Data provenance not explicitly stated (journal and authors provided, but not specific country of origin).

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)

The concept of "ground truth" and "experts" as typically understood in AI/ML validation (e.g., for image classification) does not directly apply to this device. This device measures a physiological parameter directly.

• Bench Performance Test: "Known values" of pressure were created by filling a column of liquid. The ground truth was these known physical pressures. No human experts were involved in establishing this ground truth.
• Animal Study: The comparative method used was an "interventional radiologic (IR) trans-jugular balloon catheter tip," which is considered the standard of care for obtaining indirect portal/hepatic pressure. This method itself provides the "ground truth" for comparison. The study was conducted by researchers (likely experts in gastroenterology/endoscopy and interventional radiology, as implied by the journal type and comparison method reference in the title).
• Human Clinical Study: The study provided confirmatory evidence that the device could safely measure PPG. The "ground truth" for pressure measurements was established by the device itself in a clinical setting compared to expected physiological ranges, with safety as the primary endpoint. The clinicians performing the procedure (e.g., gastroenterologists) were experts in their field, overseeing the measurements.

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

Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers interpret data (e.g., images) and their decisions need to be reconciled. This device is a measurement system, not an interpretive one. Therefore, no formal adjudication method was required or described for assessing its performance.

• In the animal study, the comparison was between two measurement techniques.
• In the human study, the focus was on safety and the device's ability to obtain measurements.

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 such MRMC comparative effectiveness study was done. This device is not an AI-assisted diagnostic tool that aids human readers in interpretation. It is a direct physiological measurement device.

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

This question is not directly applicable. The device is a standalone measurement system in that it physically measures pressure. However, it requires a human operator for insertion and operation, and the Compass CT pressure transducer contains an "integrated, pre-programmed diagnostic computer chip with a liquid crystal display" for measurement and monitoring, effectively making its measurement "standalone" once the physical connection is made. There's no separate "algorithm only" performance reported distinct from the device's main function.

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

• Bench Performance Test: Known physical pressures created by a liquid column.
• Animal Study: Measurements obtained from the standard interventional radiologic (IR) trans-jugular balloon catheter method.
• Human Clinical Study: The device's direct pressure measurements, assessed primarily for safety and its ability to obtain these measurements in a clinical setting. Clinical signs and symptoms indicative of cirrhosis in 19 patients provided context for the measurements.

8. The sample size for the training set

No training set is mentioned or applicable to this type of device. The EchoTip® Insight™ is a physical measurement system, not a machine learning model that requires a distinct training phase. The Compass CT pressure transducer has a pre-programmed chip, but its "programming" doesn't involve a machine learning training set in the typical sense.

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

Not applicable, as there is no mention of a training set for a machine learning model.

Ask a specific question about this device

The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.

The Zilver® 518 and 635TM Biliary Stent is a self-expandable stent made of nitinol. The special laser-cut pattern of the nitinol tube provides a construction with strong radial force and high flexibility. It is a slotted tube that is designed to provide support while maintaining flexibility in the duct upon deployment. Post-deployment, the stent is designed to impart an outward radial force upon the inner lumen of the duct, establishing patency in the stented region, thereby maintaining constant flow in the duct. The stent has radiopaque markers (gold rivets) at both ends to assist in fluoroscopic visualization of the stent position. The delivery system for both ZIB5 and ZIB6 devices includes a handle assembly and an introducer catheter assembly. The Zilver® 518 and 635™ Biliary Stent is mounted on the inner catheter of the delivery system and is restrained by an outer sheath. The delivery system is used to deliver the stent to the appropriate location. The stent is deployed by retracting the outer sheath while holding the central metal cannula stationary. Full deployment of the stent occurs when the distal end of the sheath has been retracted past the proximal end of the stent is placed using fluoroscopic and percutaneous techniques.

This is a 510(k) premarket notification for a medical device, not an AI/ML-powered device. Therefore, the common acceptance criteria and study information typically associated with AI models (such as AUC, sensitivity, specificity, MRMC studies, training/test set details, and ground truth establishment) are not applicable.

The document describes the Zilver® 518™ Biliary Stent and Zilver® 635™ Biliary Stent, which are physical medical devices (self-expandable stents). The submission, K182980, is for a modification to the instructions for use of an already cleared device (K163169).

Here's a breakdown of the relevant information provided in the context of the device:

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

Since this is a submission for a modification to "Instructions for Use" and not a new device or a device with new functionality requiring performance metrics, there are no specific performance acceptance criteria or reported device performance metrics in the typical sense (e.g., accuracy, sensitivity). The "acceptance criteria" here relate to demonstrating substantial equivalence for the modified labeling.

The key "acceptance criteria" for this 510(k) appears to be:

• Substantial Equivalence: The modified device (with updated IFU) must be substantially equivalent to the predicate device (Zilver® 518™ and 635™ Biliary Stent, K163169).

Reported Device Performance:
The document explicitly states: "There were no device changes, therefore no additional testing was required to support the determination of substantial equivalence to the predicate devices." This implies that the performance of the device itself (mechanical, biological, etc.) was already established with the predicate device submission (K163169) and is implicitly considered to meet all relevant performance standards. The current submission does not present new performance data.

2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of evaluating an AI model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI model requiring "ground truth" establishment by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In summary: This document is related to a Class II medical device (biliary stent), and the 510(k) submission is specifically for changes to the Instructions for Use (IFU). It asserts substantial equivalence to a previously cleared predicate device (K163169) and states that no additional testing was required because there were no changes to the device's design or materials, only to the labeling. Therefore, the questions related to AI/ML model performance evaluation do not apply to this submission.

Ask a specific question about this device

Stents: Zimmon® Pancreatic Stent/Stent Sets, Geenen® Pancreatic Stent/Stent Sets and Johlin® Pancreatic Wedge Stent and Introducer.
This device is used to drain obstructed pancreatic ducts.
Stent Introducers: Guiding Catheter and Pushing Catheter. This device is used for endoscopic pancreatic stent placement.

The intended use of all Cook pancreatic stents is to drain obstructed pancreatic ducts. A variety of stents in different sizes are available across the device range to accommodate various patient anatomies, the size and location of the obstruction and physician preference. They are offered in French sizes of between 3Fr and 11.5Fr, and in labelled lengths of between 2cm and 25cm.The subject devices and their components can be supplied as stent only, introducer only (guiding or pushing catheter) or as stent sets combining stent and introducers/introducer systems.
The stent sets can contain one or several of the following stent placement components; a flap protector, a guiding catheter, a pushing catheter or a dedicated introducer system. The flap protector is provided with stents that have duodenal flap-type anti-migration features, and is used to collapse the flap(s) on the device as it is introduced into the working channel of the endoscope. The function of the guiding catheter is to guide the pancreatic stent as part of its introduction to its intended location. The guiding catheter also has a Hub that allows for contrast injection. The function of the Pushing Catheter is to advance the stent, over a prepositioned wire guide or Guiding Catheter, to its intended location within the anatomy, and to maintain the position of the Stent as it being deployed. The stents are polymeric and some of the stents have radiopaque bands. The stent designs include anti-migrational features such as duodenal pigtails, duodenal bends and ductal and duodenal flaps. To facilitate stent insertion and removal the stent ends are tapered or buffed. Side-ports on the pancreatic stents assist in drainage. All stents are deployed endoscopically over a guide wire in the same manner under fluoroscopic and endoscopic monitoring.
These Cook pancreatic stents are all for professional use and are provided sterile. They are all intended for short-term use and have an indicated indwell of up to 3 months.

This document is a 510(k) summary for the Zimmon® Pancreatic Stent/Stent sets, Geenen® Pancreatic Stent Sets, Johlin® Pancreatic Wedge Stent and Introducer, Guiding Catheter, and Pushing Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving device performance against those criteria in the way a clinical trial might.

Therefore, much of the requested information regarding acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy), sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details, is not present in this regulatory submission for a Class II medical device.

Here's what can be extracted and what cannot:

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

The document does not provide a table of acceptance criteria for diagnostic or clinical performance (e.g., sensitivity, specificity) because these are drainage stents, not diagnostic AI devices. Instead, it details performance testing conducted to ensure safety and effectiveness of the device itself.

2. Sample sizes 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 applicable in the context of device performance in a clinical diagnostic sense. The document refers to engineering and biocompatibility testing, not clinical trials with patient data test sets. The sample sizes for the various engineering tests (e.g., tensile, flow rate) are not specified.
• Data Provenance: Not applicable for this type of submission. The tests are described as engineering and biocompatibility evaluations performed according to Cook Ireland's design control system, implying lab-based testing rather than clinical data from specific countries.

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. This device is a physical medical stent, not an AI or diagnostic algorithm that relies on expert interpretation for ground truth. Ground truth for engineering tests is based on objective measurements against specifications.

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

Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation in diagnostic studies with AI). This document describes objective engineering and biocompatibility 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

Not applicable. This is not an AI-assisted diagnostic device. It's a pancreatic stent.

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

Not applicable. This is not an AI algorithm.

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

For the non-clinical testing described, the "ground truth" would be established by:

• Biocompatibility: Adherence to established international standards (ISO 10993-1).
• Engineering Tests (Simulated use, dimensional, flow rate, tensile, radiopacity, MRI, shelf life): Objective measurements against pre-defined engineering specifications and performance requirements established internally by Cook Ireland Ltd. during their design control process.

8. The sample size for the training set

Not applicable. This refers to an AI training set, which is not relevant to this medical stent.

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

Not applicable. This refers to an AI training set, which is not relevant to this medical stent.

Summary of Device Performance and Substantial Equivalence:

The core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices (Cook Zimmon Endoscopic Pancreatic Stent K900923 and Wilson-Cook Pancreatic Wedge Stent K990130).

The "study" referenced in the document is the non-clinical performance data collected through various engineering and biocompatibility tests:

• Biocompatibility: Evaluated according to ISO 10993-1.
• Physical/Mechanical Testing: Included simulated use, dimensional and visual verification, flow rate, tensile strength, radiopacity, MRI compatibility, and shelf-life testing. These tests were performed as per Cook Ireland's design control system.

Conclusion from the document: The non-clinical data collected supports the safety and effectiveness of the subject device (the various pancreatic stents and introducers) and demonstrates that they perform as intended in the specified use conditions. This data is used to support the claim of substantial equivalence to the predicate devices. The "acceptance criteria" for these tests would be internal engineering specifications that the device must meet to function safely and effectively and to be considered similar to the predicate.

Ask a specific question about this device

These devices are used to drain obstructed biliary ducts.

The following devices are used for endoscopic biliary stent placement:
Guiding Catheter
Pushing Catheter
Fusion® Pushing catheter
Stent Introducer Set

The following devices (with preloaded stent, if applicable) are intended for endoscopic biliary stent placement to drain obstructed bile ducts:
Oasis® One Action Stent Introduction System
Fusion® Oasis® One Action Stent Introduction System
Oasis® One Action Stent Introduction System with preloaded Cotton-Leung® Biliary Stent.
Oasis® One Action Stent Introduction System with preloaded ST-2 Tannenbaum® Biliary Stent.

The intended use of all Cook biliary stents is to drain obstructed biliary ducts. A variety of stents in different sizes are available across the device range to accommodate various patient anatomies, the size and location of the obstruction and physician preference. They are offered in French sizes of between 5Fr and 11.5Fr, and in labelled lengths of between 1cm and 21cm.The subject devices and their components can be supplied as stent only, introducer only (guiding or pushing catheter), introduction system (guiding and pushing catheter) or as stent sets combining stent and introducers/introduction systems.

The stent sets can contain one or several of the following stent placement components; a flap protector/ pigtail straightener, a guiding catheter, a pushing catheter or a dedicated introducer system. The flap protector/ pigtail straightener can be provided to aid in introduction of the device over the wire (pigtail stents) and introduced into the working channel of the endoscope. The function of the guiding catheter is to guide the stent as part of its introduction to its intended location. The guiding catheter also has a Hub that allows for contrast injection. The function of the Pushing Catheter is to advance the stent, over a pre-positioned wire guide or Guiding Catheter, to its intended location within the anatomy, and to maintain the position of the Stent as it being deployed. Some introducers / introduction systems have a port that will allow use of the device in a short wire configuration. The stents are polymeric with some of the stents have radiopaque bands. The stent designs include centre, duodenal and centre bend shapes and anti-migration features such as pigtails and flaps. To facilitate stent insertion and removal the stent ends are tapered or buffed. Side-ports on the stents assist in drainage. All stents are deployed endoscopically over a guide wire in the same manner under fluoroscopic and endoscopic monitoring.

The document describes the submission of Cook Ireland Ltd.'s various biliary stents and associated introducers/introduction systems (collectively, "the device") for 510(k) premarket notification to the FDA. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices. The listed acceptance criteria and performance data pertain to the performance, safety, and effectiveness of these medical devices.

From the provided text, there is no specific table of acceptance criteria and reported device performance with numerical metrics for the clinical effectiveness of the device (e.g., success rates, complication rates). The document focuses on demonstrating substantial equivalence through comparison of technological characteristics and non-clinical testing.

Here's an extraction of the relevant information regarding the acceptance criteria and the study that proves the device meets them, based on what's available in the text:

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

The document does not provide a table with specific numerical acceptance criteria and corresponding reported performance for clinical effectiveness. Instead, it states that "Design validation and verifications activities (performance testing) performed support the performance, safety and effectiveness of these subject devices and demonstrate no change in the safety and effectiveness profile previously established with the predicate device."

The criteria are implicitly based on demonstrating that the new devices do not raise new questions of safety or effectiveness compared to the predicate devices and meet design input requirements.

Reported Performance Categories:
The performance data is summarized by the types of non-clinical testing performed:

• Biocompatibility evaluation
• Simulated use
• Dimensional and visual testing
• Tensile strength testing
• MRI conditional testing
• Radiopacity
• Flow rate
• Shelf life testing

The conclusion states that the test results "met the design input requirements based on the intended use, and do not raise new questions of safety or effectiveness." This implies that the performance in these non-clinical tests was acceptable relative to the predicate devices and device specifications.

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

• Sample Size: The document does not specify the sample sizes for each type of non-clinical test (e.g., how many stents were tested for tensile strength or flow rate).
• Data Provenance: The studies are described as "Performance testing" and "Design validation and verifications activities" conducted by Cook Ireland Ltd. under their "design control system." This indicates the data is from internal laboratory testing. The country of origin for the data is not explicitly stated beyond Cook Ireland Ltd. being the submitter. The studies are non-clinical (laboratory/bench) studies, not human clinical trials. Therefore, terms like retrospective or prospective human data are not applicable here.

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

• Not applicable. The "ground truth" here is based on engineering specifications, material science, and established biological safety standards (ISO 10993-1). No human experts are used to establish a clinical ground truth for the test set; rather, engineering and scientific experts conduct and interpret the results of the non-clinical tests.

4. Adjudication method for the test set:

• Not applicable. This concept typically applies to clinical trials where human readers or evaluators make assessments that need to be adjudicated for consistency or accuracy. For non-clinical bench testing, results are typically objective measurements against pre-defined specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a medical implant (biliary stent) and associated delivery systems, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant.

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

• Not applicable. This device does not involve an algorithm or AI. The performance studies are mechanical, material, and biocompatibility tests of the physical device.

7. The type of ground truth used:

• The "ground truth" for the non-clinical tests is based on engineering specifications, material properties, and established industry standards (e.g., ISO 10993-1 for biocompatibility). For example, tensile strength testing would compare measurements to a pre-defined maximum and minimum acceptable tensile strength for the material and design. Radiopacity is assessed against a standard for visibility under fluoroscopy.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning product that requires a training set. The "design input requirements" and predicate device data serve as the basis for evaluating the new devices.

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

• Not applicable. As above, there is no training set for this type of medical device. The "ground truth" for evaluating the performance of the device itself comes from engineering and scientific principles, as well as the performance history of the predicate devices.

Ask a specific question about this device

This device is used for treatment of acute non-toxic megacolon, (Ogilvie's syndrome) and colonic strictures.

The CDSG device consists of a colon decompression tube, guiding catheter and wire guide. The colon decompression tube is 14Fr in diameter with a length of 175cm. The device design includes side ports which allow for colon decompression. The device has connections to allow attachment to drainage collection bag or for the device to be flushed. The colon decompression tube, guiding catheter and wire guide can be observed fluoroscopically. The device is supplied sterile, intended for single use only. Use of this device is restricted to a trained healthcare professional.

The CDSM device consists of a colon decompression tube and wire guide. The colon decompression tube is supplied in a range of diameter options, 7Fr. 8.5Fr and 10Fr. The colon decompression tube has a length of 350cm. The device design includes side ports which allow for colon decompression. The device has connections to allow attachment to drainage collection bag or for the device to be flushed. The colon decompression tube and wireguide can be observed fluoroscopically. The colon decompression tube has a design feature (pigtail) at the distal end of the device which helps reduce migration. The device is supplied sterile, intended for single use only. Use of this device is restricted to a trained healthcare professional.

The same wire guide is supplied with both the CDSG and CDSM devices; the wire guide has a flexible distal ball tip.

This document describes a 510(k) premarket notification for a medical device called the "14Fr Colon Decompression Set (CDSG) / Marcon Colon Decompression Set (CDSM)". This is a Class II device (21 CFR § 876.5980, Gastrointestinal Tube and Accessories). The application aims to demonstrate substantial equivalence to a predicate device (Cook Colon Decompression Set, K900035, cleared March 7, 1990).

The provided text does not contain information about a study proving that an AI-driven device meets acceptance criteria. This document describes a traditional medical device (colon decompression sets) and its equivalence with a predicate device based on manufacturing, material, and design comparisons, along with performance testing relevant to its physical function and safety.

Therefore, I cannot provide the requested information regarding AI acceptance criteria, study details, sample sizes for AI training/test sets, expert adjudication, MRMC studies, standalone AI performance, or ground truth establishment for AI.

The document discusses non-clinical performance testing of the device itself (not an AI component). Here’s what is mentioned regarding acceptance criteria and performance data for the described device:

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

The document broadly states: "Performance testing included simulated use, dimensional testing, resistance to collapse, flow rate, tensile strength testing, dimensional and leakage tests, MR safety testing, radiopacity and shelf life testing." And "The results of the non-clinical testing demonstrates that the Colon decompression sets met the design input requirements based on the intended use, and do not raise new questions of safety or effectiveness."

However, specific quantitative acceptance criteria and their corresponding reported performance values for each test are not provided in this regulatory letter. The letter confirms that the tests were performed and the device met the requirements.

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

• Sample Size: Not specified for any of the performance tests (simulated use, dimensional, resistance to collapse, flow rate, tensile strength, leakage, MR safety, radiopacity, shelf life).
• Data Provenance: Not explicitly stated, but typically, these tests are conducted by the manufacturer (Cook Ireland Ltd.) in controlled laboratory settings. There is no mention of country of origin for the "data" as it pertains to patient data; it's product performance data.
• Retrospective or Prospective: These are laboratory performance tests on the manufactured device, not clinical studies on patients. Therefore, the terms "retrospective" or "prospective" do not directly apply in the context of clinical data collection.

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 this device's performance is established by direct physical measurements, engineering specifications, and established biocompatibility standards, not by expert interpretation of medical images or clinical outcomes in the same way an AI device's ground truth would be.

4. Adjudication method for the test set:

• Not applicable for the type of performance testing described. Adjudication methods (like 2+1, 3+1) are typically used for clinical or image-based ground truth establishment, not for direct physical property measurements of a device.

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 product, and no MRMC study involving human readers or AI assistance is mentioned or relevant to its 510(k) submission.

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:

• For the performance testing: The "ground truth" is defined by engineering specifications, material science standards, and biocompatibility standards (e.g., ISO 10993-1, FDA's biocompatibility guidance), which are measured directly.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of AI or machine learning.

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

• Not applicable.

Ask a specific question about this device