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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.

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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.

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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.

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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.

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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.

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Evolution® Duodenal Stent System- Uncovered: This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.

Evolution® Colonic Stent System- Uncovered: This device is used for palliative treatment of colonic obstruction or colonic strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

This flexible, self-expanding stent is constructed of nitinol wire. The stent diameter is increased at either end to help provide resistance to migration. The total length of the stent is indicated by radiopaque markers on the inner catheter. indicating the actual length of the stent at the nominal stent diameter.

Introduction System Description:

The stent is mounted on an inner catheter, which accepts a 0.035 inch wire guide and is constrained by an outer catheter. The handle allows for desheathing to deploy the stent and resheathing to recapture the stent during stent deployment.

The provided text is a 510(k) summary for the Evolution® Duodenal Stent System - Uncovered and Evolution® Colonic Stent System - Uncovered. It describes the device, its intended use, and compares it to predicate devices. The document highlights a material formulation change in the outer catheter and discusses performance testing conducted to support substantial equivalence.

However, the document does not provide the detailed information requested in the prompt regarding acceptance criteria, specific study results, sample sizes for test and training sets, expert qualifications, or ground truth establishment methods in the context of an AI-based device. This is because the device in question is a medical stent system, not an AI-powered diagnostic or assistive tool. Therefore, the requested information elements are not applicable to the content provided.

The document mainly focuses on demonstrating substantial equivalence to a predicate device through:

• Identical Indications for Use.
• Identical Technological Characteristics except for the outer catheter material.
• Biocompatibility testing for the new material.
• Performance testing related to the device's mechanical functions (deployment, recapture, tensile strength, dimensions).

Since this is not an AI device, I cannot fill out the requested fields.

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This device is used in palliation of malignant neoplasms in the biliary tree

The Zilver 635® Biliary Stent (ZILBS-635) consists of the following two components: a selfexpanding metal stent and stent delivery system. The stent is a laser cut self-expanding openended cylinder of nitinol. It is a slotted tube that is designed to provide support while allowing conformance to 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 flow in the duct. The ZILBS-635 has radiopaque markers at both ends to assist in fluoroscopic visualization of the stent position. This stent delivery system like the predicate devices allows for co-axial deployment of the stent delivery system accepts a 0.035 inch wire guide. The stent delivery system includes a handle assembly and an introducer assembly. The handle assembly consists of a handle, a wire guide FLLA, holding bushing, a cannula, a check flo hub FLLA/cap and a safety tab. The introducer assembly consists of an outer sheath, an inner carrier and tip. The stent delivery system has an endoscopic pusher ring located on the inner carrier near the proximal end of the loaded stent. The outer sheath has a radiopaque maker band located within the wall of the outer sheath at the distal end. The stent delivery system is supplied with a syringe for flushing through the wire guide FLLA and the check flo hub FLLA.

This document is a 510(k) premarket notification for the Zilver 635® Biliary Stent, seeking substantial equivalence to previously cleared predicate devices. Since this is a submission for a medical device and not an AI/ML product, the information you've requested (acceptance criteria, study details for AI/ML performance, sample sizes, ground truth establishment, expert qualifications, etc.) is not applicable or present in the provided text.

The document focuses on demonstrating that the Zilver 635® Biliary Stent (ZILBS-635) is substantially equivalent to existing predicate devices (Zilver® 635™ Biliary Stent and Zilver® Biliary Stent) for the palliation of malignant neoplasms in the biliary tree.

Here's an overview of the information that is available in the document:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of AI/ML or a clinical study evaluating effectiveness against specific performance metrics for the device in vivo. Instead, it refers to "Performance Data" which includes:

• Biocompatibility evaluation: Conducted in accordance with FDA's Use of International Standard ISO 10993-1.
• Performance testing: "simulated use, deployment testing, dimensional testing, joint strength testing, MRI and shelf life testing were performed as per Cook's design control system."

The specific quantitative results or acceptance criteria for these tests are not provided in this summary. The general conclusion is that "The non-clinical data supports the safety of the subject device and demonstrates that the Zilver 635® Biliary Stent (ZILBS-635) is safe and effective and should perform as intended in the specified use conditions."

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

This information is not applicable and is not present in the document. The document describes non-clinical performance testing (e.g., biocompatibility, simulated use, mechanical testing) rather than a clinical study with a test set of patient 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)

This information is not applicable and is not present in the document, as it pertains to medical devices and not an AI/ML diagnostic or prognostic tool.

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

This information is not applicable and is not present in the document.

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

This information is not applicable and is not present in the document, as it pertains to medical devices and not an AI/ML diagnostic or prognostic tool.

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

This information is not applicable and is not present in the document.

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

This information is not applicable and is not present in the document. For a medical device like a stent, "ground truth" would typically refer to the physical and mechanical properties meeting engineering specifications, and evidence of safety and performance in simulated and potentially clinical environments. The document refers to "biocompatibility evaluation," "simulated use, deployment testing, dimensional testing, joint strength testing, MRI and shelf life testing" as the basis for demonstrating safety and effectiveness.

8. The sample size for the training set

This information is not applicable and is not present in the document.

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

This information is not applicable and is not present in the document.

In summary, the provided text is a regulatory submission for a medical stent, focusing on demonstrating substantial equivalence to predicate devices through engineering and non-clinical performance testing. It does not contain any information related to AI/ML device performance or the specific criteria and studies you've asked about in that context.

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This device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas.

The Evolution® Esophageal Stent System - Partially Covered consists of a self-expanding metal stent and a stent introduction system. The stent is provided pre-loaded in the introduction system. The handle allows for desheathing to deploy the stent and resheathing recapturing the stent during stent deployment. The stent is woven from nitinol wire. The stent is formed with a flange at either end. The increased diameter of the stent at the stent ends helps provide resistance to migration. A silicone membrane applied to the stent covers the complete body of the stent along with part of both flanges. The covering is intended to reduce the risk of tissue ingrowth and provides a seal for tracheoesophageal fistulas. To aid in visibility under fluoroscopy there are four bands at either end of the stent. The stent has a lasso loop which can be used to reposition the stent during the initial placement procedure if desired. The device is supplied sterile, intended for single use only and is available for prescription use only.

This document describes the Cook Ireland Ltd. Evolution® Esophageal Stent System - Partially Covered and its substantial equivalence to predicate devices, but does not contain any information about acceptance criteria, device performance metrics, or study results related to an AI/Machine Learning device or software.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The provided text pertains to a traditional medical device (an esophageal stent) and focuses on its physical characteristics, materials, and non-clinical performance testing (biocompatibility, simulated use, corrosion, etc.) to demonstrate substantial equivalence for regulatory clearance. It does not involve any AI/ML components or studies that would involve performance metrics like sensitivity, specificity, or reader studies with AI assistance.

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Echotip® Ultra Endobronchial High Definition Ultrasound Needle for use with Olympus EBUS scopes: This device is used to sample targeted submucal 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 use with Pentax EBUS scopes: This device is used to sample targeted submucal 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 use with Olympus EBUS 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 use with Pentax EBUS 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.

The Echotip Ultra/ Procore Endobronchial High Definition Ultrasound Needle is 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 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 an additional cutting surface on the distal end of the needle cannula. 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, intended for single use only and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.

The provided document is a 510(k) Pre-Market Notification for a medical device (Echotip Ultra and Echotip Procore Endobronchial High Definition Ultrasound Needles). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data to prove new acceptance criteria and device performance.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria in the way a clinical trial report would. Instead, it focuses on non-clinical performance data supporting the device's safety and substantial equivalence to existing devices.

Here's a breakdown of what can and cannot be extracted from the document based on your request:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity targets) or reported performance metrics that would typically be found in a clinical study report for diagnostic or prognostic devices. The performance data mentioned is non-clinical (e.g., dimensional, visual, force testing, simulated use).

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

• Cannot be provided. The document refers to "performance testing" but does not detail the sample size for a test set in the context of clinical performance (e.g., number of patients or cases). The provenance and study type (retrospective/prospective) are not mentioned as this is a non-clinical evaluation.

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/Cannot be provided. Since this is a non-clinical submission for a biopsy needle, there is no "ground truth" derived from expert review of images or diagnoses. The ground truth for such devices is typically related to the physical characteristics of the tissue sample obtained and the device's mechanical performance.

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

• Not applicable. No adjudication method is mentioned as there's no clinical test set requiring expert consensus or a similar process.

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 biopsy needle, not an AI-powered diagnostic or imaging interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

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

• Not applicable. The device is a physical medical instrument (biopsy needle), not an algorithm.

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

• For the non-clinical performance data mentioned, the "ground truth" would be established by various engineering and laboratory testing standards and measurements (e.g., precise measurements for dimensions, force gauges for stylet removal, direct observation of aspiration, leak testing, joint strength testing). The document states "Performance testing such as dimensional and visual inspections, stylet removal force testing, simulated use testing, device aspiration testing, endoscope evaluation and leak testing, and joint strength testing were performed as per Cook's design control system."

8. The sample size for the training set

• Not applicable. This document describes a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

• Not applicable. As above, no training set is relevant for this type of device.

Summary of what is present:

The document primarily focuses on demonstrating substantial equivalence to predicate devices. It lists the following non-clinical performance data that supports this claim:

• Biocompatibility evaluation: Conducted in accordance with ISO 10993-1:2009 and FDA's G95-1 guidance.
• Device-specific guidance document consultation: "Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology."
• Performance testing:
  • Dimensional and visual inspections
  • Stylet removal force testing
  • Simulated use testing
  • Device aspiration testing
  • Endoscope evaluation and leak testing
  • Joint strength testing

These tests are performed as per Cook's design control system to ensure the device performs as intended and is safe, but they do not involve clinical performance metrics or expert reviews as requested in your prompt for diagnostic (e.g., imaging) devices.

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