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This device is used for endoscopic injection into gastrointestinal mucosa. The intended population is adult use only.

The Gastrointestinal Injection Needles (subject devices) are sterile, single use devices that consist of a needle on an inner catheter fitted inside an outer catheter sheath featuring a luer slip/adjustment wheel handle with either a plastic or metal hub used as an injection port at the proximal end of the device. The devices are compatible with endoscopes with a minimum accessory channel of 2.0 mm or 2.8 mm. The Gastrointestinal Injection Needles have catheters which ranges in length from 195 to 315 cm, outer diameters of 5.4 FR and 6.9 FR, and needle gauges of 21, 23 and 25. Some configurations of the Gastrointestinal Injection Needles include ink marks at the distal end of the device to aid endoscopic visualization.

The provided text describes the regulatory clearance for "Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)" and primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It does not contain information about an AI/ML device or its acceptance criteria and a study proving it.

Therefore, I cannot fulfill your request for:

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 used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states that "non-clinical bench testing demonstrates that the Gastrointestinal Injection Needles meet the performance requirements to fulfill the intended use of the device" and lists the following tests:

• Functional Testing
• Tensile Strength Testing
• Needle Verification and Validation Testing
• Shelf Life Testing
• Packaging Validation
• Biocompatibility testing (in accordance with ISO 10993-1)

However, it does not provide specific acceptance criteria or detailed results from these tests. It only concludes that the testing "confirmed that the subject device performs as intended" and that modifications "do not raise any new questions of safety or effectiveness."

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Howell D.A.S.H.® Sphincterotome with Dome Tip® (Cook Reference Part Numbers DASH-21, DASH-21-480, DASH-1, DASH-260, DASH-480, DASH-ACRO-25-450, DASH-35, DASH-ACRO-35-260, DASH-35-480, DASHACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.

Tri-Tome pc® Triple Lumen Sphincterotome (Cook Reference Part Numbers TRI-20, TRI-20M, TRI-25, TRI-25M, TRI-25M-P, TRI-25M-SLT, TRI-30, TRI-30M): This device is used for cannulation of the ductal system and for sphincterotomy.

Classic Cotton® CannulaTome® (Cook Reference Part Numbers CCPT-25, CCPT-25-MONO, CCPT-25ME), CannulaTome II® Double Lumen Sphincterotome (Cook Reference Part Numbers CT-20, CT-20M, CT-30, CT-30M), Cotton Cannulatome II PreCurved Double Lumen Sphincterotome (Cook Reference Part Numbers CT-25, CT-25M, CT-25M-P UTS®), and Ultra Taper Sphincterotome (Cook Reference Part Numbers UTS-15, UTS-20, UTS-20M, UTS-25, UTS-25M, UTS-30, UTS-30M): This device is used for cannulation of the ductal system and for sphincterotomy.

Billroth II Sphincterotome (Cook Reference Part Numbers PTG-20-6-BII-NG) and Soehendra® BII Sphincterotome (Cook Reference Part Numbers PT-5.5-BII-SOEHENDRA): This device is used for the cannulation of the ductal system and for sphincterotomy.

Models ACU-1 and ACU-1-VL active cords: This device is used to connect Cook monopolar electrosurgical accessories to compatible electrosurgical generators.

The sphincterotomes described in this submission are a sterile, single use devices compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing highfrequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation. The active cords are accessories to sphincterotomes so that a sphincterotome can be connected to an electrosurgical unit.

This document is a 510(k) premarket notification for electrosurgical accessories, specifically sphincterotomes and active cords. It does not describe a study that uses acceptance criteria in the manner you've outlined for performance of an AI/ML device.

The document details the device's technical specifications and compares them to a predicate device (Zimmon® Papillotome K901443) to demonstrate substantial equivalence, a regulatory pathway for medical devices. The "Performance Data" section lists various engineering and biocompatibility tests conducted, but these are for the physical device components and their functionalities (e.g., sterilization, material strength, electrical safety standards) rather than for an AI/ML algorithm's diagnostic or predictive performance.

Therefore, I cannot extract the information you requested about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, as this document pertains to a traditional medical device.

To directly answer your request based on the provided document:

There is no information in this document regarding:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device): Not applicable. The document lists performance tests for traditional device functionality (e.g., sterilization, joint strength), not performance metrics for an AI/ML algorithm.
2. Sample size used for the test set and the data provenance: Not applicable for AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for AI/ML.
4. Adjudication method: Not applicable for AI/ML.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for AI/ML.
6. Standalone (algorithm only) performance: Not applicable for AI/ML.
7. Type of ground truth used: Not applicable for AI/ML.
8. Sample size for the training set: Not applicable for AI/ML.
9. How the ground truth for the training set was established: Not applicable for AI/ML.

The "Performance Data" section (Page 6) lists a series of engineering and biocompatibility tests for the electrosurgical accessories (e.g., GLP Cytotoxicity, IEC 60601 standards for electrical safety, joint strength, packaging integrity). These tests are designed to ensure the physical and electrical safety and functionality of the device components, not the analytical performance of an AI/ML algorithm.

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This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.

The Fusion® OMNI Sphincterotome (subject device) is a sterile, single use device compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing high- frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.

The provided text describes a 510(k) premarket notification for a medical device (Fusion® OMNI™ Sphincterotome), not an AI/ML-based medical device. Therefore, the information required to answer the questions regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), and ground truth establishment for AI/ML performance is not present in the provided document.

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

• Identical Intended Use: The Fusion® OMNI™ Sphincterotome has the same intended use as the predicate device (Wilson-Cook OMNI™ Sphincterotome).
• Minor Technological Differences: These differences (e.g., catheter diameters, wire guide port, slightly decreased voltage) are deemed not to raise new questions of safety and effectiveness.
• Performance Data: This section details non-clinical bench testing, sterilization, shelf life, biocompatibility, and electrical safety/EMC testing, all of which are standard for traditional medical devices to ensure they perform as intended and safely.

There is no mention of an algorithm or AI/ML components, nor any studies that would involve human readers, ground truth established by experts for image interpretation, or training/test sets as would be required for such devices.

Therefore, I cannot provide the requested table or answer the specific questions about AI/ML device performance and validation based on the provided text.

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These devices are used for accessing the duct when standard methods of cannulation have been exhausted.

The Zimmon Needle Knife Papillotome (subject device) is a sterile, single use device compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing highfrequency current through the needle knife, exposing the biliary or pancreatic orifices for selective cannulation.

This document is a 510(k) premarket notification for a medical device called the Zimmon Needle Knife Papillotome. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, this document does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical trial reports or performance testing summaries for software/AI-based medical devices.

The product referenced is an electrosurgical accessory, not a software or AI-driven diagnostic or therapeutic device. The "performance data" mentioned in the document refers to standard medical device testing such as sterilization, shelf-life, biocompatibility, and non-clinical bench testing. These types of tests have different "acceptance criteria" than those requested for an AI/software device.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance related to AI/software, nor can I answer questions about sample sizes for test sets, ground truth establishment, or multi-reader multi-case studies, as these are not relevant to the type of device and submission described in the provided text.

Based on the provided text, here's what can be extracted regarding "performance data" and "acceptance criteria" in the context of this traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation for Table: The document states, "Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrate that the Zimmon Needle Knife Papillotome meets the performance requirements to fulfill the intended use of the device." This indicates that these tests were performed and the device passed, meaning it met their respective acceptance criteria. The specific numerical or qualitative acceptance criteria are not detailed in this FDA clearance letter or 510(k) summary, as these documents typically summarize results rather than provide raw data or full test protocols.

The remaining requested information (2-9) is not applicable or cannot be extracted from this document, as it pertains to AI/software-driven devices or clinical trials, which are not the focus of this 510(k) submission for a physical surgical accessory.

• Sample sized used for the test set and the data provenance: Not applicable in this context. Bench testing typically uses samples per batch or engineering specifications, not "test sets" in the AI sense.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. Ground truth for a needle knife papillotome's performance (e.g., cutting ability, electrical safety) is typically established by engineering standards and objective measurements, not expert consensus on medical images.
• Adjudication method: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is for reader performance improvement with AI, not a surgical tool.
• Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, ground truth for bench testing would be based on objective physical measurements, material properties, and electrical safety standards.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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This device is used to collect cells from the bronchi or upper and lower gastrointestinal tracts.

The Bronchi and Gastrointestinal Cytology Brush (subject device) is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of stainless steel coil spring terminating in a nylon brush at the distal end. The coil spring and brush are secured inside an extruded polytetrafluoroethylene sheath. The brush is advanced from and retracted into the sheath.

The provided text describes a 510(k) premarket notification for a medical device and outlines its comparison to a predicate device and performance data. However, it does not contain the detailed acceptance criteria and the study that proves the device meets those criteria in the format requested.

Here's a breakdown of why the requested information cannot be fully extracted:

• Acceptance Criteria and Reported Device Performance Table: The document states that the device "meets the performance requirements to fulfill the intended use," but it does not list specific numerical acceptance criteria (e.g., minimum brush cell collection efficiency, maximum material degradation over time) or the quantitative results from testing against those criteria.
• Sample Size and Data Provenance (Test Set): No information regarding sample size for a test set, country of origin, or whether data was retrospective or prospective is present. The document mentions "performance testing," but no specifics on the test set are given.
• Number of Experts and Qualifications (Test Set Ground Truth): The document does not describe any study involving experts establishing ground truth for a test set. This type of information would typically be found in a clinical study report.
• Adjudication Method: Since there's no mention of a study involving experts and ground truth establishment, there is no information on an adjudication method.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The device is a physical cytology brush, not an AI or imaging diagnostic tool, so an MRMC study is not applicable to its evaluation.
• Standalone (Algorithm Only) Performance: Similar to the MRMC study, this is not relevant as the device is a physical tool and not an algorithm.
• Type of Ground Truth Used: No information on what type of ground truth was used for performance validation is provided, as specific study details are absent.
• Sample Size for Training Set: The document does not mention any training set, as it refers to a physical device rather than a machine learning model.
• How Ground Truth for Training Set was Established: Again, this is not applicable for the described device.

What the document does provide regarding performance:

The document states:

"Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrate that the Bronchi and Gastrointestinal Cytology Brush meets the performance requirements to fulfill the intended use of the device."

This indicates that a range of tests were performed, but the specific details requested are not disclosed in this summary. These details would typically be found in the full technical documentation submitted as part of the 510(k) application, which is not included here.

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This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.

The Disposable Hemostasis Clip is a sterile, single use device that consists of a metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis in the gastrointestinal tract. The device is compatible with endoscopes with a minimum accessory channel of 2.8 mm. The Disposable Hemostasis Clip is 230 cm long. The deployed clip portion of the Disposable Hemostasis Clip is stainless steel and nitinol while the introducer is nylon, stainless steel and nitinol.

The provided text describes a 510(k) summary for a medical device called the "Disposable Hemostasis Clip" by Wilson-Cook Medical, Inc. / Cook Endoscopy. Based on the provided information, I will answer your questions.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly detailed in the provided document beyond the general statement that the device met "performance requirements to fulfill the intended use." The document indicates the device's performance through non-clinical bench testing, demonstrating its substantial equivalence to predicate devices for its intended use.

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

The document states "Performance testing consisting of non-clinical bench testing demonstrates that the Disposable Hemostasis Clip met the performance requirements to fulfill the intended use of the device." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be non-clinical, implying laboratory or simulated environments rather than human patient data.

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

This type of information is not provided in the document. The performance testing was non-clinical bench testing, which typically does not involve human expert adjudication for ground truth in the same way clinical studies with medical images or diagnoses might.

4. Adjudication Method for the Test Set

As the performance testing was non-clinical bench testing, an adjudication method in the context of human expert review (e.g., 2+1, 3+1) is not applicable and therefore not mentioned in this 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

A Multi Reader Multi Case (MRMC) comparative effectiveness study is not mentioned in the document. This device is a mechanical hemostasis clip, not an AI-powered diagnostic or assistive tool, so an MRMC study comparing human reader performance with and without AI assistance would not be relevant.

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

This question is not applicable as the device is a medical instrument (hemostasis clip), not an algorithm or AI system. Therefore, standalone algorithm performance is not a concept that applies to this device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Given that the testing was "non-clinical bench testing," the ground truth likely involved physical measurements and objective criteria based on pre-defined engineering specifications and intended functionality (e.g., clip strength, deployment success, tissue approximation force against a simulated target). Clinical ground truth (like pathology or patient outcomes) would not be generated in non-clinical bench testing.

8. The Sample Size for the Training Set

This information is not provided and is not relevant for this type of medical device's performance testing described. Training sets are typically associated with machine learning or AI models, which is not the case here.

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

This question is not applicable as there is no mention of a training set or machine learning in the context of this device's regulatory review.

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Intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.

The EchoTip® Ultra Fiducial Needle is composed of a delivery system (i.e., needle, sheath, handle, and stylet) with four pure gold fiducials preloaded and secured within a laser-cut track in the needle. The needle is dimpled to enhance its echogenicity, allowing the user to target tissues using endoscopic ultrasound guidance. The needle stylet is advanced to deploy the fiducials. Once deployed, the fiducials are permanent implants that serve as radiopaque reference points for future therapeutic procedures.

Here's an analysis of the provided text regarding the EchoTip® Ultra Fiducial Needle's acceptance criteria and studies:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a quantitative clinical study. Therefore, many of the requested data points (like sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone performance with precise metrics) are not present in this type of submission. The "acceptance criteria" here are implicitly related to the device meeting its intended use and safety profile, as demonstrated through non-clinical testing and comparison to predicates.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for a Class II device, the "acceptance criteria" are not reported as specific quantitative thresholds (e.g., sensitivity > X%, accuracy > Y%) that would be found in a clinical performance study for an AI/diagnostic device. Instead, acceptance is based on the device demonstrating:

• Ability to meet intended use: Successfully implanting fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
• Substantial equivalence: Demonstrating similar safety and effectiveness to legally marketed predicate devices.
• Biocompatibility: Absence of toxicological concerns.
• Functional performance: No detachment or breakage, fiducial visibility under imaging, and MR Conditional status.

Therefore, the table below reflects the implied acceptance criteria based on the information provided, which largely revolves around successful functional and safety performance, and the reported outcomes from the studies conducted.

Study Details (Based on available 510(k) information)

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

   • Sample size: Not specified. The document mentions "simulated use" and "biocompatibility tests," but does not provide the number of devices or subjects/samples used for these tests.
   • Data provenance: Not explicitly stated, but it would have been generated internally by Cook based on design verification and validation testing. There is no indication of external clinical data or specific geographic origin beyond internal company testing. The nature of the studies (biocompatibility, simulated use) suggests laboratory or animal testing rather than human clinical data.
   • Retrospective or prospective: These were likely prospective engineering/pre-clinical studies conducted specifically for this submission.

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

   • This information is not provided. Given the non-clinical nature of the tests (biocompatibility, simulated use, imaging visibility), "ground truth" as typically defined for a diagnostic AI study (e.g., expert consensus on medical images) is not applicable here. Performance was likely assessed by engineers and technicians against design specifications and international standards (e.g., ASTM for MR compatibility).

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

   • None stated/applicable. Adjudication methods are typically relevant for clinical studies involving human observers and their interpretations, especially for diagnostic devices. These were engineering and biocompatibility tests.

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

   • No, an MRMC comparative effectiveness study was not done. This device is a medical instrument (fiducial marker and delivery system), not an AI-powered diagnostic tool. Therefore, studies comparing human reader performance with and without AI assistance are not relevant or present in this submission.

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

   • No, a standalone algorithm performance study was not done. This is a hardware device, not an algorithm.

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

   • For biocompatibility: Adherence to established international standards (e.g., ISO 10993 series, implied by "cytotoxicity, irritation sensitization and implantation") and chemical characterizations.
   • For functional performance: Design specifications and confirmed functional outcomes (e.g., "no detachment or breakage").
   • For imaging visibility: Direct observation under ultrasound and radiographic imaging techniques.
   • For MR compatibility: Adherence to ASTM F2503-08 and FDA guidance, meaning it met defined criteria for MR safety classifications.
   • This is primarily a "truth by measurement/standard" or "truth by design specification" rather than a clinical "ground truth" derived from patient data.

7. The sample size for the training set:

   • Not applicable. This device is hardware; there is no AI algorithm with a "training set."

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

   • Not applicable. As there is no AI algorithm, there is no training set or ground truth for such a set.

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